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CO NBS SPECIAL PUBLICATION 400-28

U.S. DEPARTMENT OF COMMERCE / National Bureau of Standards
NATIONAL BUREAU OF STANDARDS

The National Bureau of Standards^ was established by an act of Congress March 3, 1901. The Bureau's overall goal is to strengthen and advance the Nation's science and technology

and facilitate their effective application for public benefit. To this end, the Bureau conducts

research and provides: (1) a basis for the Nation's physical measurement system, (2) scientific and technological services for industry and government, (3) a technical basis for equity in trade, and (4) technical services to promote public safety. The Bureau consists of the Institute for Basic Standards, the Institute for Materials Research, the Institute for Applied Technology,

the Institute for Computer Sciences and Technology, and the Office for Information Programs.

THE INSTITUTE FOR BASIC STANDARDS provides the central basis within the United

States of a complete and consistent system of physical measurement; coordinates that system

with measurement systems of other nations; and furnishes essential services leading to accurate and uniform physical measurements throughout the Nation's scientific community, industry,

and commerce. The Institute consists of the Office of Measurement Services, the Office of Radiation Measurement and the following Center and divisions:

Applied Mathematics — Electricity — Mechanics — Heat — Optical Physics — Center

for Radiation Research: Nuclear Sciences; Applied Radiation — Laboratory Astrophysics ^ — Cryogenics " — Electromagnetics " — Time and Frequency ^. THE INSTITUTE FOR MATERIALS RESEARCH conducts materials research leading to improved methods of measurement, standards, and data on the properties of well-characterized materials needed by industry, commerce, educational institutions, and Government; provides

advisory and research services to other Government agencies; and develops, produces, and

distributes standard reference materials. The Institute consists of the Office of Standard

Reference Materials, the Office of Air and Water Measurement, and the following divisions:

Analytical Chemistry — Polymers —- Metallurgy — Inorganic Materials — Reactor

Radiation — Physical Chemistry.

THE INSTITUTE FOR APPLIED TECHNOLOGY provides technical services to promote

the use of available technology and to facilitate technological innovation in industry and Government; cooperates with public and private organizations leading to the development of

technological standards (including mandatory safety standards), codes and methods of test; and provides technical advice and services to Government agencies upon request. The Insti- tute consists of the following divisions and Centers: Standards Application and Analysis — Electronic Technology — Center for Consumer

Product Technology: Product Systems Analysis; Product Engineering — Center for Building

Technology: Structures, Materials, and Life Safety; Building Environment; Technical Evaluation and Application — Center for Fire Research: Fire Science; Fire Safety Engineering.

THE INSTITUTE FOR COMPUTER SCIENCES AND TECHNOLOGY conducts research and provides technical services designed to aid Government agencies in improving cost effec- tiveness in the conduct of their programs through the selection, acquisition, and effective

utilization of automatic data processing equipment; and serves as the principal focus within

the executive branch for the development of Federal standards for automatic data processing

equipment, techniques, and computer languages. The Institute consists of the following

divisions: Computer Services — Systems and Software — Computer Systems Engineering — Information Technology.

THE OFFICE FOR INFORMATION PROGRAMS promotes optimum dissemination and

accessibility of scientific information generated within NBS and other agencies of the Federal Government; promotes the development of the National Standard Reference Data System and

a system of information . analysis centers dealing with the broader aspects of the National Measurement System; provides appropriate services to ensure that the NBS staff has optimum

accessibility to the scientific information of the world. The Office consists of the following

organizational units: Office of Standard Reference Data — Office of Information Activities — Office of Technical

Publications — Library — Office of International Relations — Office of International Standards.

^ Headquarters and Laboratories at Gaithersburg, Maryland, unless otherwise noted; mailing address Washington, D.C. 20234.

^ Located at Boulder, Colorado 80302. •
JUL 7 1976

Semiconductor Measurement Technology:

NBS/FDA Workshop

Reliability Technology for Cardiac Pacemakers

Harry A. Schafft, Editor

Electronic Technology Division

Institute for Applied Technology

National Bureau of Standards

Washington, D.C. 20234

This activity was supported by

The Food and Drug Administration Bureau of Medical Devices & Diagnostic Products

Silver Spring, Maryland 20910 and

The National Bureau of Standards Washington, D.C. 20234

U.S. DEPARTMENT OF COMMERCE, Elliot L. Richardson, Secretary

Dr. Betsy Ancker-Johnson, Assistant Secretary for Science and Technology

NATIONAL BUREAU OF STANDARDS, Ernest Ambler, Acting Director

Issued June 1976
Library of Congress Catalog Card Number: 76-600030

National Bureau of Standards Special Publication 400-28

Nat. Bur. Stand. (U.S.), Spec. Publ. 400-28. 49 pages (June 1976) CODEN: XNBSAV

U.S. GOVERNMENT PRINTING OFFICE

WASHINGTON: 1976

For sale by the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402 (Order by SD Catalog No. C13.10:400-28). Price $1.25 (Add 25 percent additional for other than U.S. mailing).
PREFACE

The workshop on reliability technology for cardiac pacemakers was con- ducted as part of the Semiconductor Technology Program in the Electronic

Technology Division of the National Bureau of Standards (NBS) with the

partial financial support of the Bureau of Medical Devices and Diagnostic

Products of the Food and Drug Administration.

The Semiconductor Technology Program serves to focus NBS efforts to en- hance the performance, interchangeability , and reliability of discrete semiconductor devices and integrated circuits through improvements in measurement

technology for use in specifying materials in national and international com- merce and for use by industry in controlling device fabrication processes. Its major thrusts are the development of carefully evaluated and well documented

test procedures and associated technology and the dissemination of such information to the electronics community. Application of the output by industry

will contribute to higher yields, lower cost, and higher reliability of semiconductor devices. The output provides a common basis for the purchase specifications of government agencies which will lead to greater economy in government procurement. In addition, improved measurement technology will provide

a basis for controlled improvements in fabrication processes and in essential

device characteristics.

The Program receives direct financial support principally from three major

sponsors: The Defense Advanced Research Projects Agency (ARPA) , the Defense Nuclear Agency (DNA) , and the National Bureau of Standards. The ARPA-supported

portion of the Program, Advancement of Reliability, Processing, and Automation

for Integrated Circuits with the National Bureau of Standards (ARPA/IC/NBS)

,

addresses critical Defense Department problems in the yield, reliability, and

availability of integrated circuits. The DNA-supported portion of the Program

emphasizes aspects of the work which relate to radiation response of electron

devices for use in military systems. There is considerable overlap between the Interests of DNA and ARPA. Measurement oriented activity appropriate to the

mission of NBS is a critical element in the achievement of the objectives of

both other agencies.

Essential assistance to the Program is also received from the semiconductor industry through cooperative experiments and technical exchanges. NBS

interacts with industrial users and suppliers of semiconductor devices through

participation in standardizing organizations; through direct consultations with

device and material suppliers, government agencies, and other users; and through

sjraiposia and workshops. In addition, progress reports are regularly prepared

for issuance in the NBS Special Publication 400 sub-series. More detailed re- ports such as state-of-the-art reviews, literature compilations, and summaries

of technical efforts conducted within the Program are issued as these activities

are completed. Reports of this type which are published by NBS also appear in

the Special Publication 400 sub-series. Announcements of availability of all

publications in this sub-series are sent by the Government Printing Office to those who have requested this service. A request form for this purpose may be

found at the end of this report.

ili

Semioonduator Measurement Technology

NBS/FDA Workshop

Reliability Technology for Cardiac Pacemakers

Harry A. Schafft, Editor

Table of Contents

Page

1. Introduction 1

2. Purpose and Organization of Report 3

3. Highlights 3

4. Electronic Reliability

4.1. Data Banks and Services 5 4.2 Electronics for DoD and NASA 5 4.3 Hybrid Device Processing 7 4.4 Small-Volume Parts Purchase 8 4.5 MOS Devices 9 4.6 Hybrid Devices 9 4.7 Standards for Hybrids 11 4.8 Analyses for High Reliability 11

5. Hermeticity

5.1 Moisture in Microcircuits 12 5.2 Effectiveness of C ommon Leak Detection Methods 14 5.3 Hermeticity Test Guidelines and Pacemakers 15

6. Resource Areas

6.1 Rome Air Development Center 17 6.2 Information Resources 17 6.3 Semiconductor Technology Program at NBS 18 6.4 Metallurgy at NBS 20

6.5 Measurements for EMI at NBS 20

7. Standards Organizations

7.1 Association for the Advancement of Medical Instrumentation ... 21 7.2 American Society for Testing and Materials

7.2.1 Committee F-4 on Surgical Implants 22 7.2.2 Committee F-1 on Electronics 22 7.3 International Society for Hybrid Microelectronics 24

V
Page

Appendix A - Workshop Program 25 Appendix B - Measurement Technology and the Pacemaker Community —

Some Observations 28 Appendix C - Reliability Data Banks and Services 33 Appendix D - Brief Description of Hermeticlty Test Methods 35 Appendix E - Information Resources 37 Appendix F - Companies Offering Seirvices in the Microelectronic Field

(Partial List) 41

vl
Semioonduotor Measurement Technology:

NBS/FDA Workshop

Reliability Technology for Cardiac Pacemakers

by

Harry A. Schafft, Editor

Brief summaries are presented of 20 invited talks on the following topics: procurement and assurance of reliable, long lived semiconductor electronic parts; leak testing of device packages and pacemaker systems; activities of standardization organizations; and availability and use of resources for Information and expertise. The purpose

of the workshop was to address technical questions relevant to the en- hancement and assurance of cardiac pacemaker reliability, and to bring

together representatives from the pacemaker, military, aerospace, and

other communities to discuss areas of mutual concern. The technical

sessions highlighted the problems of pacemaker manufacturers associated

with obtaining high reliability electronic components - problems shared

with the most demanding users in the military and space communities.

It was also noted that no government agency has the authority or re- sponsibility for the development of methods to permit assured procurement of high quality electronic components for critical applications by

organizations in the civilian sector. These organizations must rely on spin-off from military and space programs even when parts of this civilian sector have reliability requirements which are more severe than all

but the most stringent military and space requirements. Included in

appendices are measurement technology areas of concern identified by

the pacemaker community; information about utilizing reliability data

banks and facilities for searching literature and data; and organizations offering services in the microelectronics field.

Key Words: Cardiac pacemaker; data banks; failure analysis; failure

modes; hermeticity; hybrid devices; leak testing; measurement technology; microelectronics; MOS devices; process control; reliability;

semiconductor devices; surgical Implants.

1 . INTRODUCTION

For the first time, experts from the cardiac pacemaker community were joined

by experts from the high-reliability electronics and other technical communities

in a workshop to address technological problems related to assuring the reliability of cardiac pacemakers. The workshop was held on July 28 and 29, 1975, at the

National Bureau of Standards (NBS) in Gaithersburg , Maryland, and was jointly

sponsored by NBS and the Food and Drug Administration (FDA) of the Department of

Health, Education, and Welfare.

The workshop grew out of FDA's concern about the need to recall or to more

frequently monitor about 23,000 pacemakers during the last three years, and about

the number of deaths attributed to pacemaker failures which have resulted from a variety of component and material-related problems. Particular concern focused

on the reliability of the semiconductor electronic components used in pacemakers.

1
and the integrity, or hermeticity, of the pacemaker enclosure and of the com- ponent device packages.

In April of 1975 the Electronic Technology Division of NBS was asked by FDA to organize a workshop which would address problems relevant to cardiac

pacemaker reliability. The Intent of the workshop was to infuse needed technology from other technical communities, particularly the high reliability semiconductor electronics community. The Electronic Technology Division became involved for a number of reasons: because of its work in semiconductor device measurement technology, spanning well over a decade; its expertise in hermeticity

testing; and its experience with evaluating and transferring technology, and

with organizing workshops for information exchange in its area of responsibility.

Before designing the workshop it was necessary to have the pacemaker com- munity identify areas that it wanted addressed. This input was obtained during

a series of visits to a representative sample of the community by three NBS

staff members: George G. Harman, Stanley Ruthberg, and Harry A. Schafft. The

face-to-face interactions that these visits provided also facilitated a mutual

assessment which, on the one hand, was valuable in evaluating the input from the

pacemaker community and, on the other hand, allowed the intent of NBS in organizing the workshop to be gauged. These interactions proved to be an important

factor in the development of an effective workshop. The inputs obtained were

summarized in an introductory presentation at the workshop; the text of this

presentation is included in Appendix B.

In addition to obtaining suggested topic areas, the visits also revealed

that much of the technology and the procedures of the high reliability semiconductor device community had already been transferred. Engineers were encountered who had previously been associated with space and military programs and

had brought with them valuable expertise in high reliability technology. Pace- maker manufacturers were found using, to varying extents, independent semiconductor-based organizations which are able to provide procurement and testing

services for high reliability parts that individual pacemaker companies cannot

easily provide for themselves because of their relatively small purchase volumes.

Some manufacturers were also found with ties to semiconductor organizations that

supply high reliability parts from controlled or captive assembly lines. In short,

the pacemaker industry was seen as one very much concerned with and involved in

high reliability technology and faced with problems similar, in many respects,

to the high reliability space and military communities with which the NBS staff

was already familiar.

Therefore, the workshop was designed not only to make available experts

and sources of information for the pacemaker community to probe and explore at

the meeting, but also to encourage meaningful technical exchanges and contacts

2
which would continue beyond the term of the workshop. Realizing that the pacemaker and the semiconductor electronics communities have common interests, it was hoped that by a pooling of efforts better responses could be found to the

complex problems which each has faced in the pursuit of increased reliability.

2. PURPOSE AND ORGANIZATION OF REPORT

The purpose of this report is to summarize briefly the presentations given

at the workshop, and to record information provided by the speakers about service organizations, data banks, information sources, and resource areas that

may be of value to the attendees and other interested parties.

Following a brief summary of the highlights of the workshop are four

sections titled Electronic Reliability, Hermeticity, Resource Areas, and Standards Organizations, the names of the technical sessions of the workshop. In these four sections, brief reviews are provided of the presentations given in

each of the respective sessions, in the order in which they were given. Each

review is headed by a topic title followed by the speaker's name, affiliation,

address, and telephone number, which are provided should the reader wish to contact the speaker for more details. The complete titles of the papers may

be found in the program of the workshop, included as Appendix A. The results

of the discussion periods are not provided except as they are included in the

highlights section. Selected materials given by the speakers and other material

that might be useful for reference are included as appendices.

The reviews of the presentations were prepared primarily from written materials provided by the speakers . Each speaker has read and approved the re- view of his or her presentation, and, where appropriate, the material in the

appendices

.

3. HIGHLIGHTS

The pacemaker community repeatedly emphasized that the reliability re- quirements for components to be used in pacemakers are more severe than all

but the most stringent military and space requirements. These requirements

take on added dimensions with the development and anticipated use of power

sources with operating life of 5, 10, or more years.

Reliability requirements for pacemakers are difficult to fulfill because

high quality components are not readily-available, off-the-shelf items. The

low-volume purchases generally involved do not provide the economic leverage

to encourage special efforts by vendors to supply them.

Basic to the problems of procuring high quality electronic parts and of

assuring their reliability, which the pacemaker and other communities face.

3
are deficiencies In the measurement technology needed to carry out these functions . There are no adequate standard or consensus process control and procurement procedures by which high reliability electronic components may be

purchased; there are no clearly satisfactory means to test with confidence

the reliability of parts purchased in small volume.

An example where the measurement technology is deficient is in testing

the hermetic nature of electronic part and pacemaker packages. A major reason

for a hermetic package is to exclude the presence of t^ater vapor which, especially with minute ionic contaminants, can cause failure of the sealed electronic

device. There are still serious uncertainties related to establishing maximum

acceptable leak rates, to determining how much internal moisture can be tolerated,

and to relating the ingress of moisture to that of the test gases used In the

methods for measuring the leak rates of packages.

Even passing all leak tests is no insurance against failure because,

firstly, package design and materials may be such that subsequent handling

and testing will result in a package leak; and secondly. Inadequate control of

assembly procedures and materials can result in sealing-in the minute amounts

of moisture that can cause failure.

A major government policy question was raised during a discussion period

which serves to cap the concerns expressed about measurement technology and

reliability. Following a presentation on a government program to develop

highly reliable hybrid circuits for an application to nuclear weapons, it was observed that no government agency has the authority or responsibility

for the development of methods to permit assured procurement of high quality

electronic com.ponents for application to the solution of critical problems in

the civilian sector. At the present time, developments in this area rely primarily on spin-off from military and space activity, which is decreasing, and

on developments by an Industry (the semiconductor device industry) principally

oriented to the production of good quality parts in high volume with little incentive to supply high reliability parts In the low volumes required.

As an Indication of the usefulness of the workshop as a vehicle for facilitating useful technical exchanges and contacts, attendees at the closing session recommended that additional meetings be held and that NBS should be the

focal point for organizing such meetings. One recommendation was that NBS hold

an annual three-day meeting devoted to specific problems of Interest to the pacemaker community. Several industrial representatives volunteered to assist NBS in

the development of a follow-up meeting. This Interest was reiterated in a subsequent questionnaire sent to the workshop attendees to which over 90 percent of

the attendees from the pacemaker community responded. As a result of this positive response, NBS plans to sponsor in 1976 another meeting for the pacemaker

community

.

4
4. ELECTRONIC RELIABILITY

4.1 Data Banks and Services

Harold Lauffenburger

Reliability Analysis Center

RADC/RBRAC

Griffiss Air Force Base, NY 13U41

(315) 330-4151

The Government Industry Data Exchange Program (GIDEP) and the Reliability

Analysis Center (RAC) are government funded data programs for acquisition, storage, retrieval, and dissemination of reliability test and experience information. Because both organizations are neither producers nor users of components or systems, the analyses and recommendations provided by GIDEP and RAC are free of proprietary and competitive biases. Because the services provided should be useful

to those In the pacemaker community not already familiar with them, they are sum- marized in Appendix C.

The missions and services of these two programs are complementary and each

Is best employed as an adjunct to the user's in-house reliability engineering ex- pertise and resources

.

4.2 Electronics for Don and NASA

Clyde Lane Rome Air Development Center (RBRM)

Griffiss Air Force Base, NY 13441

(315) 330-3473

To obtain and assure reliable semiconductor products, the Department of

Defense established a system which provides a variety of standardization and

control documents, some of which are listed in table 1. The Rome Air Development Center provides staff and supports activities to operate the system and

make It responsive to changes in technology and needs of the military. These

activities Include device design and process studies, quality and reliability

assurance, failure analysis, field experience, data collection and analysis,

participation on special committees and study groups, and reliability and

maintainability support to electronic systems.

The system is built around three classes (A, B, and C) of device reliability obtained by requiring appropriate levels of rigor for screen tests to re- move faulty parts, physical and electrical characterization, interchangeabllity

guarantees, lot acceptance criteria, supplier and process controls, and Government surveillance. Class A is the highest reliability class and is the one

that is appropriate for electronic parts in pacemakers as it is for most missile and space applications. -

5
Military systems are the primary beneficiaries but the system Is open for use by the civilian sector. In fact, civilian use is encouraged for the mutual

benefit of both because the Increased demand and purchase volume would result in

Increased availability and reduced cost of high reliability parts.

TABLE 1 - LIST OF SELECTED DOD/NASA STANDARDIZATION DOCUMENTS

MIL-STD-883A

MIL-M-38510

Military Standard, Test Methods and Procedures for Mlctoelectronlcs

(15 November 1974)

Scope: Provides uniform methods and procedures for testing microelectronic

devices, Including physical and electrical tests, and basic environmental

tests relevant to military and space operations.

Military Specification, General Specification for Mlcroclrcults

(20 November 1969)

Scope: Establishes general requirements for monolithic, multlchlp, and hybrid mlcroclrcults and for the quality and reliability assurance requirements which must be met in the procurement of mlcroclrcults to be used in military equipment. [A companion document to MIL-STD-883A.

]

Military Standard, Test Methods for Semiconductor Devices (27 February 1970)

Scope: Provides uniform methods and procedures for testing discrete semicon- ductor devices, including physical and electrical tests, and basic environ- mental tests relevant to military and space operations.

Military Specification, General Specification for Semiconductor Devices

(1 April 1968)

Scope: Establishes general requirements for discrete semiconductor devices and for the quality and reliability assurance requirements which must be met in the procurement of discrete devices to be used in military equipment. [A companion document to MIL-STD-750B.]

NHB 5300. 4(3C) Line Certification Requirements for Mlcroclrcults (May 1971)

Scope: Establishes minimum requirements for initiating and maintaining the certification of a manufacturing line to fabricate and assemble high reli- ability mlcroclrcults for Government use. Aspects covered include plant

facilities, equipment, personnel training, process controls, and documentation.

MIL-STD-750B

MIL-S-19500E

MIL-HDBK-217B Military Standardization Handbook, Reliability Prediction of Electronic

Equipment (20 September 1974)

Scope: Deals with reliability prediction of military electronic equipment, and provides a common basis for predicting reliability and comparing reli- ability predictions in military contract work and in proposals.

QPL-19500 Qualified Products List

Scope: A list of discrete electronic devices that have been qualified under

the requirements for the product as specified in the applicable specification.

QPL-38510 Qualified Products List

Scope: A list of semiconductor mlcroclrcults that have been qualified under

the requirements for the product as specified in the applicable specification.

6
4.3 Hybrid Device Processinq

Robert A . Lowry , Jr

.

Micro-Rel, Inc. 100 5 S. Park Lane Tempe, AZ 85281

(602) 968-6411

Process control is the key to achieving high reliability in hybrid devices.

It begins with vendors of piece parts and materials who:

- exercise adequate control over their products, and

- understand explicitly what is expected by the hybrid manufacturer.

It continues at the hybrid facility with:

- second sources for all major piece-part suppliers,

- incoming inspection for lot-to-lot uniformity,

- functional line testing,

- inspection of each device lot after each major assembly operation,

- careful qualification of each process change,

- use of clear, well-defined process specifications, including methods

for rework, and

- a document control system which maintains all process specifications

and their changes, and maintains traceability of all pertinent parts

and materials.

Not to be overlooked in process control is the importance of employee motivation to reduce the chance for human error. Motivation can be engendered by informing all concerned about successes as well as problems, and by developing an appreciation for the importance of the end use to which the devices they produce

will be applied.

The choice of technologies used in-house to manufacture hybrid devices must

consider the availability of supporting equipment. Relatively new technology

may not have equipment sufficiently refined to achieve the process control needed.

Once the technology is selected, production people who have become skilled in the use of the equipment must be supported directly in the production area by key en- gineers with expertise in the technology.

Careful qualification of process changes is accomplished by producing devices

under controlled conditions with the process change and by testing the devices as defined in various military standards. Such qualification can revedl potential

problems not otherwise obvious.

The order of the assembly steps and the timing of inspections affects both

reliability and cost of hybrid devices. Steps must be ordered so that they are sequentially compatible, and inspections should be performed when quality can

7
still be upgraded, if necessary, by performing rework steps. For example, transistor bonding should follow capacitor attachment to avoid flux-induced surface

contamination of the transistors; and inspection of the epoxy die bond should

precede epoxy cure because the die can then still be easily removed and because

the device is thereby saved from an extra high-temperature epoxy cure cycle with

the attendant increased change of device degradation.

4.4 Small -Volume Parts Purchase

Robert Fischer^

Continental Testing Laboratories

Fern Park, FL 32731

Procuring and assuring highly reliable parts is more difficult when small

purchase quantities are involved. For this reason, the pacemaker and other relatively small communities requiring high reliability parts should be alert to, and

use as appropriate, the services that a variety of independent semiconductor-based

organizations can provide.'^ Such organizations can provide procurement and test services that individual pacemaker companies may not economically be able to provide for themselves. Because they serve many companies, such organizations are able to deal directly with device manufacturers with greater success because the

combined purchase volume is sufficient to merit the extra attention required of

the vendor. Furthermore, such organizations can more efficiently provide test services and the broad expertise required to assure that the electronic parts

purchased are of adequately high quality. Also, there are other semiconductor

organizations which are able and willing to supply high quality parts from con- trolled or captive assembly lines, according to mutually agreed upon processes

and procedures.^

Now with Custom Devices, 4246 E. Wood Street, Phoenix, AZ 85040; Telephone:

(602) 268-1371.

•A partial list of organizations offering services in the microelectronic field

was distributed during the workshop and is reproduced in Appendix F. [Editor]

'Recommended reading is a report which reviews the merits and drawbacks of different types of product assurance methods and specification systems, and proposes an approach where devices are obtained from vendors in wafer form on the

basis of stringent wafer acceptance tests and are subsequently processed on a controlled line under strict quality control conditions. [A. G. Stanley, Re- view of Hip;h-Reliability Procurement Practices in the Semiconductor Industry,

Report No. ESD-TR-74-11, January 1974. Report available at a cost of $4.00

for hard copy and $2.25 for microfiche from the National Technical Information

Service (NTIS), Springfield, VA 22151 by using the NTIS accession number

AD 773 833."]

8
4.5 MOS Devices

John D. Heightley

Sandia Laboratories

Albuquerque, NM 87115

(505) 264-6303

In the test and procurement of high reliability MOS devices at Sandia, the

principal reliability problems have been found to be oxide contamination and

static discharge.

An efficient screen test to remove MOS devices with oxide contamination

is to subject the devices to dc bias at high temperatures (125°C to ISCC) for

168 hours; if more than 11/2 percent of the devices fail the electrical tests

that follow, the devices that pass are subjected to the high-temperature, bias

stress for another 168 hours; if more than 1 1/2 percent of these devices fail

the electrical tests, the entire lot is scrapped.

Great care must be exercised to avoid device damage due to static discharge

during handling and testing.^ Static discharge may not always cause a catastrophic failure but can cause subsequent degradation of the device characteristics.

The only way to eliminate dice and packaged parts that have processing- and

assembly-induced faults is to exercise very close control over these operations.

To obtain high-quality, high-reliability integrated circuits, the customer must

have a knowledgeable resident inspector at the manufacturing facility to assure

that the required specifications are being met and that adequate controls are being exercised. Demonstrated 10 million device-hour operation with zero failures

has been achieved for MOS devices manufactured with carefully specified and con- trolled processes, and screened with high-temperature biased tests.

^.6 Hybrid Devices

Charles Tapp

Sandia Laboratories

Albuquerque, NM 87115

(505) 254-3751

Sandia 's approach for achieving high reliability hybrid microcircuits can be reduced to three parts

(1) the development of in-house expertise in the materials and processes utilized in the manufacture of hybrid microcircuits, with the

^A library of the various techniques that have been employed to prevent MOS device

failure due to electrostatic discharge (ESD) has been compiled by the Reliability

Analysis Center. For information and assistance on ESD protection, contact Lee Mirth, RAC Project Engineer, RADC(RBRAC), Bldg. 3, Griffiss AFB , NY 13441; Telephone: (315) 330-4151. [Editor]

9
decision to use a single hybrid technology compatible with beam

leaded devices;

(2) the use of as simple a chemical and metallurgical system as possible to maximize the probability of thoroughly understanding all the possible reactions and interactions; and

(3) the development and maintenance of a close coordination

with the single production source for the hybrid microcircuits

.

Achievement of in-house expertise has involved an Investment, since 1970,

of approximately 20 workyears per year researching elements of this hybrid technology. The information gathered has been put into report form which is available to pacemaker manufacturers.^*^ Also available is a list of specifications

for the hybrid technology used in production . ^ >

Before a newly developed technology is transferred to the production line, a special facility at the manufacturer's site is used to simulate the production en- vironment. This is done to exercise the new technology and thereby search for

possible problems that would not have been found in development, and to determine

that the new technology is compatible with other processes and procedures already

incorporated on the production line.

The metallurgical system chosen uses gold, thin-film technology. Thermocompression bonding of gold wire to gold metallization is the fundamental interconnection used. Some applications requiring very low inductance necessitates the use of a thoroughly investigated lead-indium solder. For some devices, particularly MOG devices which are available only with aluminum terminations, one-mil

aluminum ultrasonic wire bonds are used.

Does this approach to high reliability work? The first two years of production experience have been very satisfactory. The yields have been consistently

higher than the goals set. The hardware produced performs for an order of 'magnitude longer than is required and there have been no field failures.

^C. M. Tapp and R. K. Traeger, Bibliography, Sandia Laboratory Hybrid Microcircuit

and Related Thin Film Technology (June 1974). [Available at a cost of $4.00 from

the National Technical Information Service (NTIS), Springfield, VA 22151 by using

the NTIS order number SAND74-0009 .] ^C. M. Tapp and T. A. Wiley, A Review of Hybrid Microelectronics (June 1974). [Available at a cost of $4.50 from the National Technical Information Service (NTIS),

Springfield, VA 22151 by using the NTIS order number SLA-73-1063 .] ^C. M. Tapp and D. J. Sharp, A Compilation of Specifications Describing Hybrid Microcircuit Technology (June 1974). [Available at a cost of $7.75 from the National

Technical Information Service (NTIS), Springfield, VA 22151 by using the NTIS

order number SLA-74-0300 .]

'*A TV tape cassette reviewing the hybrid production facility at Sandia is available

on request from C. M. Tapp, Department 2430, Sandia Laboratories, Albuquerque, NM 87115

.

10
4.7 Standards for Hybrids

Daniel D . Zimmerman

Johns Hopkins University

Applied Physics Laboratory

Laurel, MD 20810

(301) 953-7100, X2609

A standards document for hybrid microcircuits has been developed by the

Standards and Specifications Committee of the International Society for Hybrid

Microcircuits (ISHM) .

This document. Hybrid Microelectronics Standard Specification Guidelines,^

establishes uniform methods for the procurement and test of hybrid microcircuit

assemblies. Such assemblies include thick and thin film hybrid microcircuits,

microcircuit arrays, and the elements from which such microcircuits and arrays

are formed, including active and passive chip parts. Multiple levels of general

performance requirements are defined. This is done in recognition of the varying

applications of hybrid microcircuits and of the need for corresponding provisions

for product quality assurance and control. Where appropriate, reference is made

to applicable documents available from sources other than ISHM.

As the document becomes more widely used, the comments received by ISHM on

this work will be reviewed and analyzed for application in future revisions.

Recognizing the need to extend the document, particularly in test methods, ISHM

is coordinating with other standards organizations for the preparation and adoption of needed standard test methods where none now exist.

4.8 Analyses for Hiqh Reliability

John Devaney

Hi-Rel Laboratories

San Marino, CA 91108

(213) 357-6083

Destructive physical analysis is a relatively new approach to join failure

analysis in improving reliability in microelectronics. Whereas failure analysis

is used to determine why failure occurred, destructive physical analysis is used

to detect potential weaknesses in devices of a given production lot which could

lead to premature failure. It is an approach that is gaining rapid and widespread

acceptance; for example, some current Air Force and NASA programs are requiring

^Mr. Zimmerman was chairman of the ISHM Standards and Specifications Committee

responsible for the document. [Editor]

^The document identified as ISHM SPA 001 is available from ISHM, P. 0. Box 3255,

Montgomery, AL 36109 at a cost of $25.

11
it to be used. The analysis is performed on random samples from production lots

shipped to the user. The devices in the sample are subjected to visual, microscopic, and scanning electron microscope (SEM) inspections, and to wire bond pull

and die shear tests to look for the effects of processing anomalies, mishandling,

etc

.

It is important to use the results of these analyses to identify problem

areas. It is perhaps equally important to assure that the information gained

be used for constructive communications among analysis facility, user, and supplier. Otherwise, it is possible that the goal of increasing the availability

of more consistently reliable products would be negated by the use of this information to find scapegoats

.

5. HERMFTICITY

5.1 Moisture in Microcircuits

Robert W. Thomas

Rome Air Development Center (RBRM)

Griffiss Air Force Base, NY 1341+1 (315) 330-4632

There are problems with assuring that the presence of water vapor is kept

to a minimum in semiconductor device packages.

That the standard hermeticity tests are not infallible is illustrated by a recent problem encountered in a high- reliability system. Devices which had passed

helium fine leak and bubble gross leak tests specified by MIL-STD-883A failed after

50 hours of operation due to moisture-induced gold migration short circuits.

Analysis revealed that the thermal shock test, prescribed in the qualification

procedure, had fractured the glass-to-metal seal in the lead frame of the packages.

The fractures, which allowed water vapor into the package interiors during the subsequent water quench, went undetected by the hermeticity tests that followed.

The problem of hermeticity tests goes deeper. Devices used on the Apollo

program had a leak rate^ of 1.7*10 ® atm cm^/s when measured seven years ago. Recent measurements revealed a very low water vapor concentration, about 200 ppm.

Leak rate is generally considered to be the quantity of gas (in pressure-volume

units) flowing through a leak per unit time, where the pressure on the low-pressure side of the leak has a negligible effect on the flow rate. It is implicitly

assumed that the gas is at room temperature, is air, and is at one atmosphere pre; sure on the high-pressure side of the leak. Leak rate is commonly given in units atm cm^/s (10 Pa m^/s) which is equivalent to a mass flow rate of about 4 x 10"^

g mol/s. [Editor]

12
even though a leak rate of 10"^ atm cm^/s would have allowed well over a 90 percent exchange of the environment in that time. Thus, fine leak test methods do not provide accurate information about the leak rate for water vapor.

Assuring a hermetic package is only part of the solution to achieving a dry

environment for the device. The emission of surface adsorbed moisture is a major

source of water vapor in the package. Component parts must be baked at a high

temperature (-^ISO'C) for a long time ('x^lO hr) and then be assembled in a dry at- mosphere without exposure, even for a few seconds, to the atmosphere. Plastic

and epoxy materials may continue to evolve moisture unless careful bake-out procedures are used. They are, therefore, not recommended for die attachment in high

reliability applications unless careful evaluations are conducted. Because of

the high moisture permeability of plastic and epoxy materials, they are not recommended for use as device sealing materials.

Water vapor measurement data accumulated over the last two years and threshold

values for moisture related failures are listed in table 2. The threshold values

for water vapor concentrations are intended as general guidelines recognizing that

these values are dependent on the process and the presence of other contaminants,

such as ionic chlorine, which may be required to activate failure mechanisms.

TABLE 2 - WATER VAPOR CONCENTRATIONS IN SEMICONDUCTOR

DEVICE PACKAGES, AND MOISTURE -RELATED FAILURE - RADC ACCUMULATED DATA (1973-1975)

Typical Water Vapor Concentrations

Package Concentrations (ppm)

Ceramic (Cerpack) 500 to 1,000

Dual-Inline

(DIPS) 5,000 TO-5 500 MIL-STD 38510 Parts 800 Hybrid 5,000 to 10,000

Device Failure and Water Vapor Concentrations

Failure Mode Water Vapor Concentration (ppm) Demonstrated Failures Failure-Free Upper Limit

Nichrome Disappearance

Aluminum Disappearance

Gold Migration

MOS Inversion

5.000 to 10,000

50,000 to 250,000

15,000 to 150,000

5,000 to 20,000

500 1,000

1,000

200

'Measured at package ambient of 100''C.

13
5.2 Effectiveness of Common Leak Detection Methods

Ralph McCullough

Texas Instruments, Inc. Box 5012, Dallas, TX 75222

(214) 238-3931

When measuring for a leak rate of a given magnitude, all hermeticity test methods may allow some packages with such a leak to escape undetected (escape

rate) and they may also reject some packages without such a leak (overkill rate).

This may happen for a number of reasons: the pressures and pressurization times

may not provide sufficient tracer gas or fluid in the package to permit detection

over the entire leak rate range of interest; the leak channel may be plugged during pressurization or measurement; the package may have surface contamination

which acts as a getter for the tracer gas; or a void may exist near the surface

which makes it appear that the package has a leak when, in fact, it does not. The tendency for such misreadings to occur depends on the method used and the

type and construction of the package tested. Hence, it is important to understand these considerations when using hermeticity test methods.

The effectiveness (in terms of escape and overkill rates) of five commonly

used hermeticity test methods was studied under a contract to the Rome Air De- velopment Center (RADC) and is described in a report.^ The methods studied are

the helium and radioactive tracer gas methods, which are used to test for fine

leaks (< 10~^ atm cm^/s); and the bubble, pressure-bubble, and weight gain methods, which are used to test for gross leaks (> 10"^ atm cm^/s). [Brief descriptions of the hermeticity test methods mentioned in this report are given

in Appendix D - Editor.]

Selected for the study were 700 test packages with leak rates ranging

from less than 10"^ atm cm^/s to greater than 10"^ atm cm^/s. Seven package

types^ were involved; package internal volume ranged from 0.006 to 1.07 cm^.

Results of the study indicated that while the bubble method can detect

leak rates less than 10" ^ atm cm^/s, the escape rate is so high as to raise

questions about its use. Although the pressure-bubble method showed a lower

escape rate than the bubble method, it had an overkill rate that was higher

than the bubble method for a number of package types. Of the three gross-leak

methods, the best test results were obtained with the weight gain method; it

had the smallest escape and overkill rates. For example, all devices having

leaks equal to and larger than 10"^ atm cm^/s were detected, and except when

^R. McCullough-, S. Banks, and J. Roberts, Investigation of Microcircuit Seal

Testing, Report No. RADC-TR-75-89 (April 1975).

2tO-3 (metal; 1.07 cm^), TO-84 (metal; 0.006 cm^), TO-lOO (metal; 0.086 cm^),

C-PAC (ceramic; 0.012 cm^), C-DIP (ceramic, 0.014 cm^), MOS DIP (metal/

ceramic; 0.041 cm^), and 1x1 Ceramic (ceramic; 0.45 cm^).

14
used on a ceramic package with a volume of 0.5 cm^, the weight gain method

was relatively effective in the 10"^ atm cm^/s range. When the weight gain

was combined with one of the fine leak methods, the only packages which es- caped detection had leak rates of less than 3 x 10 ^ atm cm^/s.

5.3 Hermeticity Test Guidelines and Pacemakers

Stanley Ruthberg

Electronic Technology Division

National Bureau of Standards

Washington, DC 2023U

(301) 921-3621

The selection of a defi-nitive maximum leak rate pertinent for moisture

ingress is still not possible, be it for the small electronic components or for the larger pacemaker packages. Specifications on leak rates are at best

empirical because it is not yet possible to predict the rate at which moisture

will enter a container characterized by a given leak rate.^

A number of hermeticity test methods^ are evaluated in table 3. These

methods are divided into two groups : one for gross leaks (with leak rates greater than about 10~^ atm cm^/s) and one for fine leaks. To span the range

of leak rates that are of interest to reliability engineers, at least one method from each group is needed because a no-leak indication by a fine leak

method does not imply the nonexistence of a gross leak. While it is desirable

first to eliminate packages with large leak rates, this is not done because

the gross leak test methods commonly used Involve contact with a fluid which

can plug a small leak channel and prevent its detection with one of the fine

leak test methods. To obviate this Inefficient test sequence and to avoid

possible contamination by small amounts of the test fluid that might penetrate

the package, a differential pressure method^ using a dry gas is suggested. While

this method is not considered suitable for small semiconductor device packages,

it would be feasible for packages with larger volumes.

The fine leak test methods commonly used for semiconductor devices, the back

pressurization procedure of the helium leak detector method and the radioisotope

method, are both indirect methods for measuring leak rates and require the application of gas flow models. Without reference to the appropriate gas flow

model no relationship can be made between the measured and true leak rates.

^Work contracted by NBS is now addressing the relationship between leak rate and

moisture penetration.

^Brief descriptions of the hermeticity test methods mentioned in this report are given in Appendix D. [Editor]

^W. M. Bullis , Ed., Semiconductor Measurement Technology: Combined Quarterly

Report, October 1, 1973 to March 31, 1974, Section 11.5, NBS Spec. Publ. ^+00-4 (November 1974).

15
The difficulty associated with such modelling is that flow, be it molecular,

laminar, or in between, depends on conditions of the test, the test gas used,

and the characteristics of the leak. Extension of gas flow modelling to real

packages with real leaks is needed before either method can be used with ac- curacy and confidence.

To avoid the problems attendant with using the indirect procedures for

large device packages and pacemaker packages, these packages should be designed with a vent allowing access to the package interior. With this access, the direct flush procedure of the helium leak detector method may be

used which can give a direct, quantitative measure of the leak rate.

TABLE 3 - EVALUATION OF SELECTED GROSS AND FINE LEAK RATE MEASUREMENT METHODS

Method

BUBBLE

WEIGHT-GAIN

DIFFERENTIAL

PRESSURE

HELIUM LEAK

DETECTOR

Direct Mode

(.preflll and flush methods)

Indirect Mode

(back

pressurlzatlon)

RADIOISOTOPE

Range

(atm cm^/s)

IQ-'* to 10-1

-v-lQ-^ to 10" 1

'v-lQ-'* to 10"

IQ- 10 to 10-2

10-8 to iQ-2

'\-10-9 to 10-2

Advantages

relative simplicity

wide leak-rate range quantitative measure

of leak rate low escape rate

use of dry gas which will not plug fine- leak channels

wide leak-rate range direct leak-rate measurement high sensitivity

• flexibility

• inert gas used

• wide leak-rate range

In comparison with back pressurization procedure of helium method:

• more direct

• faster testing rate

• package volume does not affect pressurization time or minimum measurable

leak rate

Disadvantages

need for smooth package

need to observe entire package

high escape rate

test fluid may penetrate

and eventually cause contamination failure

in package with fine leak sensitive balance with

large-mass capability

needed

test fluid may penetrate

and eventually cause contamination failure

in package with fine leak

insufficient sensitivity

for small-volume

packages

sensitive to temperaturegradient effects

special seal environment

required (for prefill

method

leak-rate range decreased

by long holding time

(for prefill method) vent in package required

(for flush method)

requires gas flow model

requires long pressurization times

requires gas flow model

requires handling pre- cautions because of radioactivity measurement range relatively narrow for given

test sequence. (To avoid unsafe radio- active levels, test is performed in stages

starting with the gross

end of the leak-rate

range.) .

16
6. RESOURCE AREAS

6.1 Rome Air Development Center

Clyde Lane

Rome Air Development Center (RBRM)

Griffiss Air Force Base, NY 13441

(315) 330-3473

Activities underway at the Rome Air Development Center (RADC) in which

RADC could serve as a resource for the pacemaker and other interested communities are listed below:

• microcircuit contamination control

• desorption isotherms for microelectronic surfaces

• reliability evaluation and electrical characterization of memories

• thermal resistance of microelectronic packages

• quality assurance procedures for complex microcircuits

• hybrid microcircuit prelidding burn-in

• evaluation of mechanical stress limit prediction procedures for large

microcircuit packages

• failure-rate models for discrete semiconductors

6.2 Information Resources

Carolyn P. Brown Library

National Bureau of Standards

Washington, DC 20234

(301) 921-3405

Library and other information sources that may be useful to the cardiac

pacemaker community are summarized in Appendix E. The three information

sources included in the summary are listed below.

1. Federally Sponsored Sources

• Regional Medical Library Program

• National Technical Information Service

• Defense Documentation Center

2. Non-Prof it Sources

• Coordinator of Service to Business and Industry, Georgia Institute

of Technology

• Illinois Institute of Technology Research Institute

3. Commercial Sources

• Lockheed Information Retrieval Service

• System Development Corporation Search Service

• Institute for Scientific Information

17
6.3 Semiconductor Technology Program at NBS

Alvin H. Sher

Electronic Technology Division

National Bureau of Standards

Washington, DC 20234

(301) 921-3132

The goals of the Semiconductor Technology Program are to provide Federal

agencies, industry, and the general public with methods for assuring the reproducibility, serviceability, and reliability of solid state and other electronic

components. The approach is one of developing and disseminating improvements in

measurement technology that can be used in specifying materials and devices at

the buyer-seller interface, and in controlling device fabrication processes by

the industry. Work in the Program is supported jointly with other Government

agencies, both civilian and military, that have mutual interests in measurement

technology.

The task areas presently underway in the Program are:

• silicon characterization • wafer test

• oxide characterization • assembly and packaging

• test patterns • thermal properties of devices

• photolithography

Of particular interest to the pacemaker community is work in test patterns and

in assembly and packaging.

Test patterns are special structures included on silicon wafers used in

integrated circuit production. They are powerful measurement tools that can monitor electrically various process parameters and provide a means by which

both the manufacturer and user can be assured of manufacturing control. NBS work, headed by Dr. Martin G. Buehler, involves the development, analysis, and

cataloging of recommended test structures, and the demonstration of their use- fulness .

In the assembly and packaging area are activities in test methods to con- trol and evaluate die attachment, interconnection bonding, and hermetic sealing. Stanley Ruthberg heads the NBS effort in hermeticity testing which was begun in response to industry needs determined through field visits and affirmed later in an NBS workshop on hermeticity. The workshop renewed industry

interest in cooperative work on improved test methods now carried on in the

ASTM Committee F-1 on Electronics by a section chaired by Ruthberg. NBS efforts in hermeticity are in evaluating and improving the precision, agreement,

and applicability of currently employed methods, and in developing wider-range,

noncontaminating methods.

18
The details of these and other activities in the Program are given in

progress reports which have been published. Also, about one hundred publications on topics ranging from theoretical solutions of problems to "how-to"

manuals for the optimum use of equipment have resulted from work under this

Program; a list of these publications is available on request.

Another feature of the Program was the inauguration of a series of workshops on various measurement-related topics of concern to the electronics

community. Subjects of the four workshops held to date are listed below

with the dates; reports on each have been published.

1. Measurement Problems in Integrated Circuit Processing and

Assembly - September 1973.

2. Hermeticity Testing for Integrated Circuits - March 1974.

3. Test Patterns for Integrated Circuits - September 1974.

4. Surface Analysis for Silicon Devices - April 1975.

Work of the Program is worthwhile only if its output is used voluntarily;

NBS has no regulatory authority to enforce the use of any measurement technology

it develops. The measurement tools developed must stand on their own merits in

answering measurement needs in ways that are practical and economically feasible.

To assure use of the Program's outputs requires care in the selection of

problems that are of critical importance and whose solutions will have broad and

long-range impact. The selection is made with the aid of guidance obtained from

extensive and direct contacts with appropriate parts of the semiconductor electronics and other communities.

After a selection is made, progress of work through the research and development stages is reported in publications, at meetings of standards committees, and

through other channels to prospective users of the Program's output. Feedback re- ceived from these contacts provide guidance in redirecting the work, if necessary,

to respond to changing measurement needs and priorities.

If the result of the work is a new or improved measurement method, it is

documented and tested in-house first and then in interlaboratory tests through

standards groups in cooperation with industry. Ultimately the output is incorporated into a standard test method or published to provide ready reference material, or both. Staff members encourage the implementation of the methods developed through visits and, in some cases, through direct training activities

on production lines, as well as through talks, publications, and videotaped presentations.

19
6.4 Metallurgy at NBS

William Ruff

Metallurgy Division

National Bureau of Standards

Washington, DC 20234

(301) 921-2991

There are two metallurgical studies underway in the NBS Metallurgy

Division pertinent to the cardiac pacemaker community. Inquiries for details of these and other studies are invited. One study involves crevice

corrosion of metals used in biological implants and the identification of

harmful corrosion products. The other study is of the effect of various

solutions on titanium alloj^s in connection with the formation of protective

oxide films, the effects of sterilization and surface preparations on this

film, and the influence of mechanical wear on the film and its subsequent

exposure to saline solutions. Electron microscope and diffraction methods

have been employed to characterize such films in these studies.

6.5 Measurements for EMI

John W, Adams

Electromagnetics Division

National Bureau of Standards

Boulder, CO 80302

(303) 499-1000, x3741

There are several difficult measurement problems that must be addressed

before effective procedures can be suggested to protect pacemakers against

electromagnetic interference (EMI) . More study is needed in the measurement

of electric and magnetic fields to which the implanted pacemaker is exposed

before any standard procedure can be prepared to determine the susceptibility

of pacemakers to EMI. Many variables are involved in such measurements, for

example, frequency, orientation, polarization, and modulation of the electromagnetic fields. The size, shape, conductivity, permittivity, and orientation

of the body to the electromagnetic field are also variables because they affect

the coupling of the electromagnetic energy into the body. Furthermore, the

conductivity and permittivity is a function of the body tissue. Realistic,

upper bounds may be established which can greatly reduce the number of variables that need to be involved and some data to do this are available.^

Another measurement problem that needs to be considered is how to simulate

the electromagnetic fields and the bodies enclosing the pacemaker. There are

^C. C. Johnson and A. W. Guy, Nonionizing Electromagnetic Wave Effects in

Biological Materials and Systems, Proc. JEEE 60_, 692-718 (1972).

20
procedures for generating test fields over a limited set of conditions, for

example, at a few discrete frequencies, or even over a limited bandwidth.

But, does such limited testing provide adequate assurance or simply a false

sense of security?

Two recently developed devices should be considered for EMI measurements: (1) isotropic broadband probes,^ useful in determining the maximum

value of electric or magnetic fields regardless of frequency or direction of

the source; and (2) TEM cells for generating electromagnetic fields. More

development of the second is still needed, however, to overcome their present

limitations

,

7. STANDARDS ORGANIZATIONS

7.1 Association for the Advancement of Medical Instrumentation (AAMI)

Guy S. Hammer, II AAMI, Suite 602

1901 N. Ft. Myer Drive

Arlington, VA 22209

(703) 525-4890

The Association for the Advancement of Medical Instrumentation (AAMI) is con- cerned with all medical instruments, devices, and systems, and their applications

in the areas of medical research, diagnosis, therapy, and administration. Formed

in 1965 to promote the interests and serve the needs of the medical instrumentation

field, membership now includes some 3,000 individuals, 200 corporations, and 100

institutional members. One of AAMI's primary coordination efforts is the development and promulgation of medical device standards. Among present efforts relative

to cardiac pacemakers are the preparation of a pacemaker standard on labeling and

performance requirements and terminology for cardiac pacemakers under contract

from FDA, and the administration of the Secretariat of Subcommittee 2 (Cardiovascular) , under the ISO Technical Committee 150 on Implants for Surgery, which

is also preparing a pacemaker standard.

F. M. Greene, Development of Electric and Magnetic Near-Field Probe, NBS

Tech. Note 658 (January 1975).

M. L. Crawford, Generation of Standard EM Fields Using TEM Transmission Cells,

IEEE Trans. Electromagnetic Compatability EMC-16 , 189-195 (November 1974).

21
7.2 American Society for Testing and Materials (ASTM)

7.2.1 ASTM Committee F-4 on Surgical Implants

Emanuel Horowitz

Institute for Materials Research

National Bureau of Standards

Washington, DC 20231

(301) 921-2878

ASTM Committee F-4 was founded in 1962 to serve as a forum for discussion

of problems of surgical implants and for development of consensus standards for use by manufacturers, surgeons, scientists, engineers, and representatives of

the public interest.

The formation of this committee was inspired by orthopedic surgeons and

early activities concerned mainly metallurgical orthopedic implants. Interests

and activities have expanded to include other surgical disciplines such as car- diovascular implants and implants for neurosurgery. In recent years, the scope

of the committee's materials work has been enlarged to include polymers, ceramics,

and composites; and consideration is being given to an activity devoted to design

data, criteria, and guidelines. The entire committee and its subcommittees and

task groups meet twice yearly and have produced 36 surgical implant standards.

7.2.2 ASTM Committee F-1 on Electronics

Robert I. Scace

Electronic Technology Division

National Bureau of Standards

Washington, DC 20234

(301) 921-3625

ASTM Committee F-1 on Electronics develops test methods, specifications,

recommended practices, and nomenclature for electron devices, with emphasis on

the areas of materials, manufacturing process control, and test equipment. Committee F-1 is one of the few standards organizations that require an interlaboratory evaluation of a method before it can be issued as a completed standard. This

concept was introduced to prevent the issuance of standard methods that work only

in committee.

The subcommittees of Committee F-1 are listed in table 4. Those that should

be of greatest potential interest to pacemaker manufacturers are the Hybrid Microelectronics and Assembly Subcommittees which are each divided into three sections

as listed. Documents issued by Committee F-1 that may be of interest are listed

in table 5. Committee F-1 encourages the participation of the pacemaker community in the activities of the Committee that are of interest to them.

22
TABLE 4 - SUBCOMMITTEES OF ASTM COMMITTEE F-1 ON ELECTRONICS

Lasers Hybrid Microelectronics

Metallic Materials ^v^^'"^f thick films Semiconductor Crystals thin films Semiconductor Process Materials Assembly

- . J ^ encapsulation Semiconductor Measurements . ^ ^ hermetlclty

Quality and Hardness Assurance Interconnection

TABLE 5 - SELECTED DOCUMENTS OF

RTBRID CIRCUITS D2442 Alumina Ceramics for Electronic

Applications, Spec. F109 Surface Imperfections on Ceramics, Definitions

F356 Beryllla Ceramics for Electrical

Applications, Spec. F357 Solderability of Thick-Film Conductors F390 Sheet Resistance of Thin Metallic Films F394 Modulus of Rupture of Ceramic Substrates

7C07 Adhesion of Thin Metal Films to Substrates

7C09 Glossary of Thin and Thick Film Terms

7B10 Adhesion of Thick Films to Substrates

7A11 Determining Dimensions and Surface Characteristics of Substrates

7C16 Noise Quality of Resistive Films

7B20 Temperature Coefficient of Film Resistors

7B21 Viscosity of Pastes Used in Thick Film

Electronics

7B22 Determining Thickness, Area, Texture of Thick Film Components

7B36 Specifying Thick Film Pastes

7C41 Thin Film Adhesion Testing

INTERCONNECTION BONDING F72 Gold Wire for Lead Bonding, Spec. 3A04 Aluminum Bonding Wire, Spec. 8E04 Aluminum 1% Silicon Wire for Lead Bonding,

Spec. 8E28 Glossary, Interconnection Bonding

8E29 Visual Inspection of Lead Bonding Wire

8E30 Pull Strength of Wire Bonds

8E31 Visual Inspection of Bonded Devices

8E33 Strength of Bonded Beam Lead Devices

(Pulloff Test) 8E34 Strength of Bonded Beam Leads (Etch & Peel) 8E43 Non-destructive Bond Pull Test

rM COMMITTEE F-1 ON ELECTRONICS

CONTAMINATION CONTROL

F21 Hydrophobic Surface Films by Atomizer Test F22 Hydrophobic Surface Films by Water-Break Test

F24 Counting Particulate Contamination on Surfaces

F25 Counting Airborne Particulate Contamination

in Clean Rooms

F35 Identification of Particle Contaminants by X-Ray Diffraction

F50 Counting and Sizing of Airborne Particles by

Light-Scattering

F51 Counting Particulate Contaminants on Clean Room Garments

F52 Silting Index of Processing Fluids

F59 Identification of Metal Particulate Contami- nation by Ring Oven Technique

F60 Detection of Microbiological Contaminants in Water

F71 Morphological Key Identification of Fibers

for Contamination Control F91 Leaks in Laminar Flow Clean Room Work Station Filters

5F35 Particle Concentration in Liquids, Class,

for

5F36 Particle Concentration on Surfaces, Class, for

HERMETICITY

F78 Calibration of Helium Leak Detectors

F79 Hennetlcity by Dye Penetration

F98 Hermetlclty by Bubble Test F134 Hermeticlty by Helium Mass Spectrometer

8D05 Hermetlclty of Electron Devices by Radio- isotope Test

ENCAPSULANTS

F74 Hydrolytic Stability of Plastic Encapsulants

FlOO Shrinkage Stresses in Plastic Embedment Materials

F135 Embedment Stress Caused by Casting Com- pounds

8C06 Completeness of Cure of Encapsulants

8C26 Microclrcuit Coatings, Evaluating

8C33 Transfer Molding Compounds for Encapsulation

23
The Committee has three meetings a year during which work is planned,

documents are reviewed and revised, and group and individual interactions

take place in open, non-proprietary discussions. The membership includes

some 230 individuals from over 100 companies, government agencies, universities, and other organizations.

7.3 International Society for Hybrid Microelectronics (ISHM)

Daniel D. Zimmerman

Johns Hopkins University

Applied Physics Laboratory

Laurel, MD 20810

(301) 953-7100, x2609

The International Society for Hybrid Microelectronics (ISHM) is a nonprofit technical organization devoted to the advancement of hybrid microelec

tronics and the dissemination of knowledge in this field. Founded and incor

porated in 1967 to provide a focus and common denominator for the diverse

technical disciplines on which hybrid microelectronics is based, it now has more than two dozen chapters in the United States and six international

affiliate chapters in Europe and Japan, having a total membership of about

2600. Its efforts in standards began with the creation of a committee on standards in 1972 whose efforts have resulted in the document Hybrid Microelectronics Standard Specification Guidelines. For the future, ISHM plans

to conduct seminars on the use of this document, and plans to publish a Design Guideline for Hybrid Microelectronics, an annual business and market

report, and a hybrid microcircuit reliability report.

Acknowledgement

Thanks go to the speakers for their full cooperation in the preparation

of this report by readily providing me with the written materials, on which

this report is based, and reviewing their edited sections. Special thanks

go to E. Jane Walters for preparing the camera-copy draft of the report with

care and dispatch.

24
Appendix A

Workshop Program

Monday, July 28

WELCOMING REMARKS

F. Karl Willenbrock, Director, Institute for Applied Technology, National

Bureau of Standards, Washington, DC 20234

INTRODUCTION TO WORKSHOP

Measurement Technology and the Paoemaker Community - Some Observations

Harry A. Schafft, National Bureau of Standards, Washington, DC 20234;

(301) 921-3625

SESSION I: ELECTRONIC RELIABILITY

Chairperson: George G. Harman, National Bureau of Standards

Presentations

Reliability Data Banks and Services

Harold Lauf f enburger , Reliability Analysis Center, RADC/RBRAC, Griff iss Air Force Base, NY 13441; (315) 330-4151

A System to Obtain and Assure Reliable Semiconductor Products for DoD and

NASA

Clyde Lane, Rome Air Development Center (RBRM) , Grifflss Air Force Base. NY 13441; (315) 330-3473

Hybrid Processing - General Areas

Robert A. Lowry, Jr., Micro-Rel, Inc., Tempe, AZ 85281; (602) 968-6411

Test and Procurement of High Reliability Parts

Robert Fischer,^ Continental Testing Labs, Fern Park, FL 32731

Test and Procurement of High Reliability MOS Devices

John Heightley, Sandia Labs, Albuquerque, NM 87115; (505) 264-6303

Design and Development of High Reliability Hybrid Microelectronics for ERDA Applications

Charles Tapp, Sandia Labs, Albuquerque, NM 87115; (505) 264-3751

ISHM Standards for Hybrid Microelectronics

Daniel D. Zimmerman, Johns Hopkins University Applied Physics Laboratory,

Laurel, MD 20810; (301) 953-7100 x2609

Destructive Physical Analysis and Failure Analysis for High Reliability

John Devaney, Hi-Rel Labs, San Marino, CA 91108; (213) 357-6083

Panel and Open Discussions

Topic: How to obtain reliable electronic parts and how to substantiate their

long-term reliability?

ADJOURN

Now with Custom Devices, 4246 E. Wood Street, Phoenix AZ 85040; (602) 268-1371

25
Tuesday, July 29

SESSION II: HERMETICITY

Chairperson: W. Murray Bullis, National Bureau of Standards

Presentations

Moisture Myths and Miarocivouits

Robert W. Thomas, Rome Air Development Center fRBRM') . GriffIss Air Forr.p Ran NY 13341: (315) 330-4632

Effectiveness of Commonly Used Hermetioity Test Methods

Ralph E. McCullough, Texas Instruments, Inc., Box 5012, Dallas, TX 75222;

(214) 238-3931

Guidelines for Hermetioity Testing of Paaemakers

Stanley Ruthberg, National Bureau of Standards, Washington, DC 20234;

(301) 921-3621

Discussion Period

SESSION III: RESOURCE AREAS

Chairperson: Harry A. Schafft, National Bureau of Standards

Presentations

Activities at the Rome Air Development Center

Clyde Lane, Rome Air Development Center (RBRM) , Griffiss Air Force Base, NY 13441; (315) 330-3473

Information Resources

Carolyn P. Brown, National Bureau of Standards, Washington, DC 20234;

(301) 921-3405

The Semiconductor Technology Program at NBS

Alvin H. Sher, National Bureau of Standards, Washington, DC 20234; (301)

921-3132

Efforts in Metallurgy at NBS

William Ruff, National Bureau of Standards, Washington, DC 20234; (301)

921-2991

Measurements Needed to Determine Pacemaker's Susceptibility to EMI

John W. Adams, National Bureau of Standards, Boulder, CO 80302; (303)

499-1000 x3741

SESSION IV: STANDARDS

Chairperson: Judson C. French, National Bureau of Standards

Overview of Organizations and Activities

Association for the Advancement of Medical Instrumentation (AAl^lI) Guy S. Hammer, II, AAMI, Suite 602, 1901 N. Ft. Myer Drive, Arlington, VA

22209; (703) 525-4890

American Society for Testing and Materials (ASTM)

Committee F-4 on Surgical Implants

Emanuel Horowitz, National Bureau of Standards, Washington, DC 20234;

(301) 921-2878

Committee F-1 on Electronics

Robert Scace, National Bureau of Standards, Washington, DC 20234; (301)

921-3625

26
International Society for Hybrid Mioroeleotronics (ISHM)

Daniel D. Zinmerman, Johns Hopkins University, Applied Physics Laboratory,

Laurel, MD 20810; (301) 953-7100, x2609

SESSION V: LOOKING AHEAD

Chairperson: Harry A. Schafft, National Bureau of Standards

Open Discussion

ADJOURN

27
Appendix B

Measurement Technology and the Pacemaker Community — Some Observations

Harry A. Schafft

Electronic Technology Division

National Bureau of Standards

Washington, DC 20234

(301) 921-3625

The observations to follow on the technical areas of interest to the

cardiac pacemaker community are based on visits between May and July, 1975,

to most of the domestic manufacturers of cardiac pacemakers; and to a number

of pacemaker hospital centers, hybrid device manufacturers, and testing houses.

Visits were made to 15 organizations in all which involved about 11 days of

interviews and tour time. The inputs were used as a guide to select topics

to be addressed at the workshop, consistent with NBS's abilities to respond.

With that preface, what are the areas of interest to the pacemaker com- munity? The list shown in table Bl is believed to contain all of the important ones. The listing is not meant to show an order of importance because

no objective measures were available to assign degrees of importance. Before

examining these areas a little closer, it should be pointed out that all of

these areas, except perhaps for the last one, have a unifying element — measurement technology. In each area the problem or interest arises out of a deficiency in the associated measurement technology. This will be seen as the items in the list are reviewed.

For electronics, the questions of how to best obtain high reliability parts

and how to make sure that they are, in fact, reliable to the degree desired consistently received the greatest interest.

Under the heading of high reliability of parts, the interest is in which

fabrication processes are best, what should be specified in the fabrication and

assembly stages of the part, and what should be included in the purchase specifications for the part. Some suggested that there should be a medical-grade set

of specifications and processes for electronic parts used in pacemakers.

Table Bl. AREAS OF INTEREST AND CONCERN

Electronics Sterilization

• Hermeticity Power Sources

• Weld Inspection Acceleration Tests

EMI Standardization

Leads Information and Service Resources Materials

28
To substantiate reliability there is interest in such topics as reliability prediction, accelerated tests, screen tests, burn-in tests, and longterm wearout modes.

The problem of obtaining and assuring high reliability parts takes an added dimension as longer-lived batteries are introduced. Pacemakers will

no longer be expected to operate for only a couple of years. The expectation is that the new power sources will allow pacemakers to operate 5, 10, or more years. With this extended time frame the problem of obtaining and

assuring reliability is one for which people only have approaches to a solution.

With the push to longer-lived pacemakers there is a need to reduce power

consumption and to reduce size and weight. For the electronics, this means

greater interest in increased integration and in the use of newer and more sophisticated technologies. Hence, there is a general interest in evaluating

and comparing discrete devices, integrated circuits, and hybrid devices; and

in comparing different processes such as bipolar, CMOS, and even I^L. Those

who are using such technologies as CMOS, for example, are concerned about

doing all things necessary to assure that they will continue to have a reliable

product. Those who are considering using a new technology are wondering about

the kinds of problems they may encounter.

There is also a good deal of interest in comparing the reliability of

pacemaker electronic systems with high reliability systems of DoD and NASA. The feeling is that pacemaker reliability would compare favorably. Unfortunately, failure rate data for pacemaker electronic circuits are not readily

available. Failure rate data need to be compared for circuits of comparable

size and complexity.

In the area of hermetlcity testing there is a general Interest in the

capabilities and limitations of the various methods used. There is considerable Interest in determining if the test conditions used in the helium leak testers are adequate for the leak-rate levels desired. Also, there is much

interest in determining the maximum acceptable leak rates for electronic

parts and pacemakers, and how much internal moisture can be tolerated.

Related to interest in hermetlcity tests is the interest in weld inspection technologies for pacemakers where nondestructive methods are desired.

The next area, electromagnetic interference or EMI is one where inputs

range from "it is not a significant problem", to "the problem is overplayed

and needs to be put In perspective", to "it is a problem of real concern and

efforts in standardization and education are needed". Those who saw it as a problem said both that the electromagnetic environment is ill-defined, varied.

29
and is at high levels which are expected to increase and that the proliferation

of tests and test conditions make it difficult to compare and evaluate different

pacemakers and pacemaker designs.

Areas of interest that were suggested for discussion for EMI are the characterization of the electromagnetic environment pertinent to pacemakers and the extent to which this environment can be controlled or modified to reduce EMI,

standard test procedures and conditions for determining the susceptibility of

pacemakers to interference, and design and material factors for reducing this

susceptibility

.

The electrical lead that carries electrical pulses between the heart and

the pacemaker is another subject that received a varied response. It ranged

from "it is no problem at all", to "it is a potential problem for longer-lived

pacemakers to come", to "it is a problem of great concern". The last response

came mostly from the physicians who were interviewed. Perhaps this is because

the physicians have to deal with the lead problems and see it first hand. Manufacturers implicitly recognize that there is a problem with leads because while

they guarantee their pacemakers, most do not guarantee their leads.

The manufacturers are made to be more remote from the problem because very

few if any leads are returned to the manufacturers. Understandably, it is usually inconvenient and difficult to remove most leads. Nevertheless, this situation handicaps the manufacturer in being able to evaluate his lead's performance

in the field and to obtain valuable input on lead life and lead failure mechanisms and modes. Perhaps there is a need here for better communication between

physicians and manufacturers.

Specifically, problems with leads are fracture failure — adjacent to the

connection to the pacemaker, at loops in the lead, and (curiously enough) at stress-relief suture sites. Fractures have been seen to occur at inclusion

and tool-work sites in the wire. Another problem is corrosion at the connection to the pacemaker resulting from body-fluid seepage to the metal-metal

connection. Again, the interest is in test methods, methods to determine, in

a reasonable time, the quality or life of leads. So there is interest in ac- celerated tests. There do not appear to be any standard accelerated or stress

tests for leads that are being used in the industry. Also, there is interest

in methods to determine fatigue and life-span information about materials for

leads. ,

The subject of leads is a complex one, one which may better be addressed

in a later workshop. In the meantime, one possible avenue to explore is offered. This involves the use of acoustic emission techniques to monitor the

approach of fracture in metals.^ Studies have shown that as a metal is stressed,

^Acoustic emission work at NBS has been done by Dr. Melvin Linzer, NBS , Materials

Building, Room A 367, Washington, DC 20234. Telephone (301) 921-2858.

30
it will emit acoustic noise bursts at a rate which increases as fatigue fracture of the metal is approached.^ These studies have been made on metals different from those now used in pacemaker leads and on specimens considerably

larger than the wire used in leads. However, if these results can be extrapolated to leads, it may be possible to monitor the approach to fracture failure,

which could be useful in developing and using accelerated stress tests for leads,

and it may be possible to anticipate fatigue fracture of the implanted lead.

There is general interest in material-related subjects, such as the corro- sion of metals, lead wire, and connectors when exposed to body fluids. There is

interest in the biocompatability of various sealants, and the bonding of epoxies

and plastics to metals. Also, there is interest in means for evaluating epoxies,

rubbers, and plastics. Such broad interests could not be responded to in this

workshop except to have Dr. William Ruff describe some of the metallurgy work

being done at NBS that is relevant to some of these topics.

Another area that was mentioned by some was the need for better methods to evaluate and qualify sterilization procedures. This is an area far removed from

NBS expertise and should possibly be addressed elsewhere.

The subject of power sources came up repeatedly. When it was suggested

that the pacemaker industry was probably as much aware as any group of the

state-of-art technology of power sources, especially for long-term, very low

power-load applications, the response was that the real need in the industry

is for better tests and procedures for qualifying and comparing batteries, and

for substantiating life and reliability. What is needed are effective accelerated tests that can be used to test their batteries in a time short compared with

the expected life. Interviewees suggested that perhaps NASA had experience in

battery testing that they could share. The Space Power Technology Branch at NASA

Goddard Space Flight Center reports, however, that their work is solely in batteries used in space craft that can be recharged many times and are intended for

much higher power levels than are of interest to the pacemaker people.

The subject of accelerated tests brought a gleam in the eyes when discussed.

There is an interest in accelerated tests for entire pacemakers, for leads, for

the electronics, for devices, batteries, and materials. The need for these ac- celerated tests is to qualify products, compare products, assure quality control,

substantiate reliability. These are subjects for many workshops, not just one.

Standards is another subject of considerable interest which is heightened

by the industry's vulnerability to liability suits. With a multiplicity of test methods, procedures, and processes, and with few clearly established standards,

^D. 0. Harris and H. L. Dunegan , Continuous Monitoring of Fatigue Crack Growth

by Acoustic Emission Techniques, Technical Report DE-73-2 (February 1973),

Dunegan/Endevco, Livermore , CA.

31
there is concern that it may be difficult to substantiate in court that all

due precautions and the best procedures and tests were used to produce the

product which may, nevertheless, have not performed to expectations.

Finally, there is the matter of information and service resources which generated significant interest. There is great interest in reliability data and other information banks for electronic components. How

do different device and circuit types and different technologies fare with

time? Are there certain product lots that have developed problems?

32
Appendix C

Reliability Data Banks and Services

Harold A . Lauffenburger

IIT Research Institute

Reliability Analysis Center

RADC/RBRAC, Griffiss AFB, NY ISWl

(315) 330-4151

1 . Government Industry Data Exchange Program (GIDEP)

GIDEP Is a program that is both funded and operated by the federal

government. The program is directed to the acquisition, storage, retrieval,

and dissemination of reliability test and usage information on parts and

components, test equipment calibration procedures, and other reliability

data obtained in the development, test, and field operation of weapon and

aerospace systems, and such other equipment and systems as are of interest

to GIDEP participating agencies. This information includes, but is not limited to, the results of controlled tests conducted and calibration procedures developed by contractors, subcontractors, and government activities

engaged in the design, development, production, and support of equipment

for the government. Primary emphasis is placed on the results of user tests rather than vendor tests. Government specifications, contractor proprietary

information, and classified information is not within the scope of this program.

The data in the GIDEP System is readily accessible to participants

through either remote terminals or 16mm microfilm with computer indexes. Data is stored in one of four data banks. These are the Engineering Data

Bank , the Metrology Data Bank , the Failure Rate Data Bank , and the Failure

Experience Data Bank . These data banks are supplemented by (1) an Urgent

Data Request System which allows the participant to rapidly query all other

GIDEP participants on his specific problems, and (2) the GIDEP ALERT System

which provides information to participants on potential problem areas that

may be encountered during engineering design and production of parts, materials, processes, or safety practices.

Participation in the GIDEP Program is open to government agencies, their

contractors, commercial device producers, and equipment producers. While

there are no direct charges for participants, all are required to submit data

generated within their own organization.

33
Additional information may be obtained from the GIDEP Program Operations

Center at:

Fleet Missile Systems Analysis and

Evaluation Group Annex; Code 862 Attn: GIDEP Operations Center

Naval Weapons Station, Seal Beach

Corona, CA 91720

(71A) 736-4677 or Autovon 933-4677

2. Reliability Analysis Center (RAC)

RAC collects and maintains a comprehensive accumulation of Information

pertinent to the reliability of microelectronic and high-technology discrete devices, primarily. This information represents the combined experiences of hundreds of government, Industrial, and Independent organizations which have been systematically and aggressively solicited by RAC. Data acquisition is enhanced and extended through direct and continuous interaction with the reliability staff of the Rome Air Development Center.

RAC makes available this information by various means: (1) Reliability

Data Compendia where validated failure rates and histories of environmental

susceptibility and malfunctions are provided and regularly updated, (2) Reference Bibliographies of the current technical literature, (3) survey study

reports, (4) quarterly Issues of the RAC Newsletter, and (5) direct consulting assistance in such areas as reliability assessment and prediction, sur- vey studies, data analysis, part selection and applications, and system re- liability and maintenance support.

Detailed information on the publications and services available from RAC

may be obtained by communicating with Harold A. Lauf f enburger

.

34
Appendix D

Brief Description of Hermeticity Test Methods

Bubble Method : The package is immersed in a heated fluid, usually a fluorocarbon, and a visual inspection is made. A leak is indicated by the emanation of bubbles from the package as the interior gas expands and escapes

through the leak.

Pressure-Bubble Method : The package is immersed first in a relatively low

boiling-point fluid under pressure and then in a heated fluid where a visual

inspection is made. A leak is indicated by the emanation of bubbles from th

package due to the escape of the low boiling-point fluid forced into the pac

age during the first immersion.

Weight Gain Method : The package is weighed before and after immersion in a liquid under pressure to force the liquid into the package cavity. A leak,

whose magnitude may be calculated, is indicated if after the package is re- moved from the liquid and dried a gain in weight is measured.

Differential Pressure Method (for large-volume packages) : The package is

placed in a test chamber which is then evacuated. A source chamber at known

internal gas pressure is connected to the test chamber by opening an access

valve. A gross leak is indicated if the pressure in the combined volume is

lower than expected, for the volumes of the package and of the source and

test chambers. If a gross leak is not indicated, a smaller leak rate may

be detected by opening a valve between the test chamber and a reference

chamber until an equilibrium pressure is reached, after which the valve is

closed. A growing differential pressure between the two chambers indicates

a smaller leak in the package, the magnitude of which may be calculated.

Helium Leak Detector Method (Indirect Mode) : The package is held under pres

sure in a helium atmosphere for a period of time to force helium into the

package cavity through any leak channels that may exist. After pressurization, a measured leak rate is determined by measuring, with a mass spectrometer, the quantity of helium escaping from the package.

Helium Leak Detector Method (Direct Mode) : Prefill Proaedure: The package is sealed in a helium atmosphere.

A measured leak rate is determined by measuring the quantity of

helium escaping from the package.

Flush Procedure: The procedure requires that a vent be part of

the package which can be connected directly to a mass spectrometer

^mentioned in the report

.

35
to detect the penetration of any helium that is used to flush

the outside of the package. The integrity of the seal off of

the vent may be tested in a number of ways. One way is first

to fill the package with helium and then seal off the vent while it faces downward (to keep the helium in the package, by

buoyancy), and test in the same way as in the prefill procedure.

Radioisotope Method : The package is held under pressure in an atmosphere

of the radioisotope isotope krypton-85. After pressurization. a measured

leak rate is determined by measuring, with a scintillation crystal, the amount of the radioactive gas that is inside the package.

36
Appendix E

Information Resources

Carolyn P . Brown Library

National Bureau of Standards

Washington, DC 20234

(301) 921-3405

1. Federally Sponsored Information Sources

The National Library of Medicine ^ administers a Regional Medical

Library Program in which the country is divided into 11 regions with one library designated as the central resource library for the region. Radiating from these 11 libraries are many others which are Medline centers,

where the on-line system, Medline, is available. Medline is the name of

a data base composed of citations from the most important biomedical

journals, some 3000 in number, going back several years. Some of these centers provide Medline service free to authorized users; most charge a fee to outsiders. Priority of use is given to those in the health care and medical research fields, but the pacemaker community should come somewhere next in line. Call the local hospital library or medical

school or the Regional Medical Library to find the name of the nearest Medline center that will serve you. Regional medical centers in the areas of the pacemaker manufacturers are listed in table El.

TABLE El

REGIONAL MEDICAL LIBRARIES^

NEW ENGLAND REGION (CT, ME, MA, NY, RI, VT) Francis A. Countway Library of Medicine

10 Shattuck Street, Boston, MA 02115

SOUTHEASTERN REGION (AL, FL, GA, MS, SC, TN,

PR) \ A. W. Calhoun Medical Library

Emory University, Atlanta, GA 30322

NEW YORK AND NORTHERN NEW JERSEY REGION

(NY and the 11 northern counties of NJ) New York Academy of Medicine Library

2 East 103 Street, New York, NY 10029

MIDWEST REGION (IL. IN, lA, MN, ND, WI) John Crerar Library

34 West 33 Street, Chicago, IL 60616

PACIFIC SOUTHWEST REGION (AZ, CA, HI, NV) Center for the Health Sciences University of California

Los Angeles, CA 90024

Serving areas where most cardiac pacemaker manufacturers are located.

The National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20014.

Telephone: (301) 656-4000.

37
The National Technical Information Service (NTIS) Is a part of the Department of Commerce and Is charged with the handling of technical Information

produced by Federal agencies and Federal contractors and grantees. It stores

and makes available. In paper copy or microfiche, reports in many subject areas.

Reports filed by NTIS are listed in an abstracting journal, the Government

Reports Announcements and its index, the Government Reports Index. From these are selected 24 subject categories to appear as weekly newsletters, the Weekly

Government Abstracts; annual subscriptions may be ordered. Subscriptions to Selected Categories in Microfiche may also be ordered so that the full publication, on microfiche, of reports in a subject field selected may be received.

In addition, NTIS will do custom searches of its files on request and has

some Published Searches in anticipation of requests. The reports in these

searches may then be ordered from NTIS. Paper copy prices are according to the number of pages. The basic price for all titles in microfiche is $2.25,

with a few exceptions.

The Defense Documentation Center (DDC) services are extended to all Federal Government agencies and their contractors, subcontractors, and grantees.

DDC reports that are not classified become available to the public through

NTIS. There Is a possibility for organizations without current Defense Department contracts to be declared eligible for services under the Defense

Potential Contractors Program. This requires that some Defense Department

agency make a request that the organization be listed as a potential contractor.

2. Non-Profit Information Sources

Two examples are given of the kind of services that may be found locally.

Both of these institutions, which are non-profit, are willing to accept assignments from anywhere.

The coordinator of Service to Business and Industry, 2 Georgia Institute of

Technology, is connected to a large technical library of some 750,000 volumes

and 600,000 technical reports, and to a computer search center. A literature

search service (manual or computerized, as needed) is offered at a fee of

$15.00 an hour plus charges for computer time and other actual costs. Reference assistance is offered free, by telephone, as long as it does not take more

3 than about 15 minutes . Interllbrary loans can be arranged and a photocopy service is available at a handling fee of $2.50 plus 10 cents a page. Personnel

^National Technical Information Service, U. S. Department of Commerce, Springfield,

VA 22161. Telephone: (703) 321-8543.

Coordinator of Service to Business and Industry, Library, Georgia Institute of

Technology, Atlanta, GA 30332. Telephone: (404) 894-4526.

%all James B. Dodd.

38
training In elementary information retrieval can be arranged and some published

technical material for this work is available.

The Illinois Institute of Technology Research Institute^ (IITRI) offers

some of the same services and some different ones. It offers on-line literature searches at a price based on the number of terms entered, and batch retrospective searches with the same kind of costs attached. It offers document delivery, but only of material available through the Institute of Scientific In- formation to be mentioned later. An alerting service on a recurring basis can be arranged. A weekly service for individual profiles is $125 or more, a year.

The group rate for seven or more requestors of the same topic is about $50 per

year, each. The Institute also provides the service of searching private data

bases

.

In any search for information, the local public library should not be forgotten. Some libraries, especially the larger ones, have excellent programs for

supplying many kinds of Information. Many states have a central resource center. For example, the Pennsylvania State Library System has an information

service for small businesses that is run through the Carnegie Library of Pittsburgh .

3. Commercial Information Sources Two major suppliers of on-line access to a number of data bases are the

Lockheed Information Retrieval Service^ and the System Development Corporation

Search Service.^ The information in these data bases range from chemical data

to up-to-date business and manufacturing statistics.

Generally, it is advisable to use the expertise of a service organization

or a library to perform searches. Effective personal use of the data bases re- quires a significant Investment in time. While it is not difficult to learn to use these systems, they are sufficiently complicated and change often enough to require considerable training and continuous practice to acquire and maintain

adequate skill. In addition to personal time, minimum costs for access to these

data bases are approximately $1200 a year for terminal rental, and from $50 to $150 a month for computer connect time and line charges, depending on location

and rate of use.

^Illinois Institute of Technology Research Institute, Computer Search Center, 10 West 35 St., Chicago, IL 60616. Telephone: (312) 225-9630.

^Lockheed Missiles and Space Company, Information Retrieval Service, 3251 Hanover St.,

Palo Alto, CA 94304. Telephone : (415) 493-4411.

^System Development Corporation, Search Service, 2500 Colorado Avenue, Santa Monica,

CA 90406. Telephone: C213) 829-7511.

39
The Institute for Scientific Information^ (ISA) has an agreement with publishers of scientific journals whereby the contents pages of journals are sent to ISA before publication. These contents pages are then published in one of several

weeklies called Current Contents - Life Sciences, Current Contents - Physical and

Chemical Sciences, etc. Subscription rates are dependent on the subject field and

the number of copies ordered. An Individual subscription will cost from about $100

to $150 a year. Original Article Tear Sheet (OATS) is a service by which ISA will

supply any of the articles it cites. The price depends on the number of pages

(about 30 cents a page)

.

The Automatic Subject Citation alert (ASCA) is a subject profile drawn up individually from Current Contents. ASCA Topics are regularly-run profiles. An individual ASCA subscription may cost as little as $115 a year. Citation alerts

may be ordered by author or combination of authors, organization name, journal,

or articles citing a particular earlier work or author, as well as by subject

terms.

Institute for Scientific Information, 325 Chestnut Street, Philadelphia, PA 19105.

Telephone: (215) 923-3300.

40
Appendix F

Companies Offering Services in the Microelectronic Field

(Partial List)i

AMKOR Electronics, Inc.

P. 0. Box 801

Valley Forge, PA 19482

Tel: 215-666-9040

Barry & Associates, Inc.

745 Distel Drive

Los Altos, CA 94022

Attn: Garry Barry

Tel: 415-968-0688

TWX: 910-370-6574

Howard Boysen

8945 Complex Drive

San Diego, CA 92123

Tel: 714-279-0961

Cal-Tex Semiconductor, Inc.

P. 0. Box 2808

Santa Clara, CA 95051

Tel: 408-247-7660

Caribbean Electronic Services

P. 0. Box 878

Adelphi, MD 20783

Attn: Douglas R. Price

Tel: 301-439-8890

Carter Semiconductor, Inc. Bay View, Amityville

Long Island, NY 11701

Tel: 516-842-5660

IC Package Assembly

Custom Devices

4246 E. Wood Street

Phoenix, AZ 85040

Tel: 602-268-1371

Dana Laboratories, Inc. 2401 Campus Drive

Irvine, CA 92664

Tel: 714-833-1234

ELE Corporation

535 S. Magnolia Avenue

Ontario, CA 91761

Tel: 415-984-5919

Electronic Arrays

55 Middlefield Road

Mountain View, CA 94043

Tel: 415-964-4321

Interlek

400 El Camino Road

P. 0. Box 332 San Mateo, CA 94401

Tel: 415-348-8222

Komy Corporation

1199 Worcester Road

Natick, MA 01760

Microcircuits Eximport

Services

3080 Olcoff Street

Suite lOlD

Santa Clara, CA 90505

Attn: R. Vincent Bert

Tel: 408-246-0896

Ness International Corp.

196 Tuscaloosa Avenue

Atherton, CA 94025

Tel: 415-323-4681

Pacific Trading Co. 2390 Walsh Avenue

Santa Clara, CA 95050

TWX: 910-338-0123

Pantronix, Inc. 2396 Walsh Avenue

Santa Clara, CA 95050

Attn: Stanley Wong

Tel: 408-248-5646

Semiconductor Services, Inc.

(SSI)

One Harrison Avenue

Salem, MA 01970

Tel: 617-745-2450

Unicorp

625 N. Pastoria Avenue

Sunnyvale, CA 94086

Tel: 408-738-1700

American Electronic Labs, Inc. M/S 1377, P. 0. Box 552

Lansdale, PA 19446

Tel: 215-822-2929

Approved Engineering Test Laboratories

15037 Ventura Blvd.

Sherman Oaks, CA 91403

Tel: 213-783-5985

213-872-3701

IC Testing

Associated Testing Labs

Wajme, NJ

Contact

Engineering Sales Assoc.

P. 0. Box 544

Scottsdale, AZ 85252

Tel: 602-945-5781

California Test Labs Div. AETL

619 East Washington Blvd. Los Angeles, CA 90015

Tel: 213-747-4235

Continental Testing Labs, Inc.

763 U.S. Highway 17-92

Fern Park, FL 32730

Tel: 305-831-2700

DCA Reliability Lab, Inc. 645 Clyde Avenue

Mountain View, CA 94040

Tel: 415-964-9700

Most of the entries were provided by Integrated Circuit Engineering. No attempt

was made to make the listing complete. The inclusion of an organization in this

list does not imply recommendation or endorsement by the National Bureau of

Standards

.

41
Data Test Service, Inc. 822 Challenge Drive

Concord, CA 94520

Tel: 415-825-9322

Electro Fab

P. 0. Box 2111

537 S. Raymond Avenue

Pasadena, CA 91105

Tel: 213-795-5613

Electronic Test Center

2031 E. Cerritos Avenue

Anaheim, CA 92806

Tel: 714-774-4820

Electronic Test Center

69 Hickory Drive

•Walthara, MA 02154

Tel: 617-890-1340

GCA Technology Division

OCA Corporation

Bedford, MA 01730

Tel: 617-275-9000

Integrated Circuit Engineering (ICE) , Suite 211

6710 E. Camelback Road

Scottsdale, AZ 85251

Tel: 602-945-4564

Lithic Systems, Inc.

P. 0. Box 869

10010 Imperial Avenue

Cupertino, CA 95014

Tel: 408-257-2004

Microelectronic Evaluation

Center, Inc. 1735 Kaiser Avenue

Irvine Industrial Complex

Santa Ana, CA 92705

Tel: 714-546-5551

Microelectronic Testing

Laboratories

Division of Datatron, Inc 17312 Gillette Avenue

Santa Ana, CA 92705

Tel: 714-546-5551

Semiconductor Services,

Inc. (SSI)

One Harrison Avenue

Salem, MA 01970

Tel: 617-745-2450

Scanning Electron Analysi

Laboratories, Inc. 5301 Beethoven Street

Los Angeles, CA 90066

Tel: 213-398-2720

Trio-Tech, Inc. of California

100 Fountain Street

Framingham, MA 01701

Tel: 617-879-8520

Alpha Analytical Labs.

(Div. of Alpha Metals)

Jersey City, NJ 07304

Tel: 201-434-6778

Applied Space Products

825 San Antonio Road

Palo Alto, CA 94303

Tel: 415-326-7425

Commonwealth Scientific Corp.

500 Pendleton Street

Alexandria, VA 22314

Tel: 703-548-0800

Continental Testing Labs, Inc.

763 U.S. Highway 17-92 Fern Park, FL 32730

Tel: 305-831-2700

GCA Technology Division

Bedford, MA 01730

Tel: 617-275-9000

Analytic Services

Hi Rel Laboratories

2116 Huntington Drive

San Marino, CA 91108

Tel: 213-289-3818

Integrated Circuit Engineering (ICE) , Suite 211

6710 E. Camelback Road

Scottsdale, AZ 85251

Tel: 602-945-4564

Interpretive Analytical

Services, Building 574

Dow Chemical USA

Midland, MI 48646

Tel: 517-636-5314

Walter C. McCrone Associates

Inc

.

439 East 31st Street

Chicago, IL 60616

Tel: 312-842-7100

Microanalysis Laboratory

15825 Shady Grove Road

Rockville, MD 20850

Tel: 301-948-7480

Scanning Electron Analysis

Laboratories, Inc. 5301 Beethoven Street

Los Angeles, CA 90066

Tel: 213-398-2720

SEM-Tec

P. 0. Box 492

Tempe, AZ 85251

Structure Probe, Inc. 230 Forrest Street

Metuchen, NJ 08840

Tel: 201-549-9350

Uthe Technology International

325 N. Mathilda Avenue

Sunnyvale, CA 94086

Tel: 408-738-3301

42
IS-114A (REV. 7-73)

U.S. DEPT. OF COMM. BIBLIOGRAPHIC DATA

SHEET

1. PUBLICATION OR REPORT NO. NBS SP 400-282. Gov't Accession

No.

3. Recipient's Accession No.

TITLE AND SUBTITLE

Semiaonduotor Measurement Teohnology

NBS/FDA Workshop

Reliability Technology for Cardiac Pacemakers

5. Publication Date June 1976

6. Performing Organization Code

AUTHOR(S)

Harry A. Schafft, Editor

8, Performing Organ. Report No.

PERFORMING ORGANIZATION NAME AND ADDRESS

NATIONAL BUREAU OF STANDARDS

DEPARTMENT OF COMMERCE

WASHINGTON, D.C. 20234

10. Project/Task/Work Unit No.

11. Contract/Grant No.

I, Sponsoring Organization Name and Complete Address (Street, City, State, ZIP)

National Bureau of Standards, Washington, DC 20234

Food and Drug Administration, Bureau of Medical Devices and

Diagnostic Products, Silver Spring, MD 20910

13. Type of Report & Period Covered

14. Sponsoring Agency Code

}. SUPPLEMENTARY NOTES

Library of Congress Catalog Card Number: 76-600030

. ABSTRACT (A 200-woTd or less factual summary of most significant information. If document includes a significant

bibliography or literature survey, mention it here.) Brief summaries are presented of 20 invited talks on the following topics: procurement

and assurance of reliable, long lived semiconductor electronic parts; leak testing of

device packages and pacemaker systems; activities of standardization organizations; anc availability and use of resources for information and expertise. The purpose of the

workshop was to address technical questions relevant to the enhancement and assurance

of cardiac pacemaker reliability, and to bring together representatives from the pacemaker, military, aerospace, and other communities to discuss areas of mutual concern.

The technical sessions highlighted the problems of pacemaker manufacturers associated

with obtaining high reliability electronic components - problems shared with the most

demanding users in the military and space communities. It was also noted that no government agency has the authority or responsibility for the development of methods to

permit assured procurement of high quality electronic components for critical applications by organizations in the civilian sector. These organizations must rely on spinoff from military and space programs even when parts of this civilian sector have re- liability requirements which are more severe than all but the most stringent military

and space requirements. Included in appendices are measurement technology areas of concern identified by the pacemaker community; information about utilizing reliability

data banks and facilities for searching literature and data; and organizations offering services in the microelectronics field.

|7. KEY WORDS (six to twelve entries; alphabetical order; capitalize only the first letter of the first key word unless a proper

, riame; separated by semicolons) Cardiac pacemaker; data banks; failure analysis; failure modes

hermeticity; hybrid devices; leak testing; measurement technology; microelectronics;

MOS devices; process control; reliability; semiconductor devices; surgical implants.

19. SECURITY CLASS

(THIS REPORT)

UNCL ASSIFIED

21. NO. OF PAGES

49

20. SECURITY CLASS

(THIS PAGE)

UNCLASSIFIED

22. Price $1.25

is. AVAILABILITY Unlimited

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Springfield, Virginia 22151 USCOMM-DC 29042-P74

US. GOVERNMENT PRINTING OFFICE: 1976 210-801/280 1-3

Announcement of New Publications on Semiconductor Measurement Technology

Superintendent of Documents,

Government Printing Office,

Washington, D.C 20402

Dear Sir:

Please add my name to the announcement list of new publications to be issued in the series: National Bureau of Standards Special Publication 400-.

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