52358 Federal Register / Vol. 73, No. 175 / Tuesday, September 9, 2008 / Notices 

2This citizen petition was originally assigned 

docket number 2005P–0023/CP1. The number was 

changed to FDA–2005–P–0369 as a result of FDA’s 

transition to its new docketing system 

(Regulations.gov) in January 2008. 

3This citizen petition was originally assigned 

docket number 2006P–0178. The number was 

changed to FDA–2006–P–0081 as a result of FDA’s 

transition to its new docketing system 

(Regulations.gov) in January 2008. 

community-acquired pneumonia; 

uncomplicated skin and skin structure 

infections; uncomplicated and 

complicated urinary tract infections; 

pyelonephritis; uncomplicated urethral 

and cervical gonorrhea; and acute, 

uncomplicated rectal infections in 

women. 

In January 2003, FDA received revised 

product labeling relating to several 

approved supplements for TEQUIN 

(gatifloxacin). This revised labeling 

deleted references to TEQUIN injection, 

10 milligrams/milliliter (mg/mL) (200 

mg), indicating that this product was no 

longer being marketed; therefore, the 

product was moved from the 

prescription drug product list to the 

‘‘Discontinued Drug Product List’’

section of the Orange Book. In response 

to a citizen petition from Apotex Corp. 

(Docket No. FDA–2005–P–0369),2 FDA 

stated, in the Federal Register of 

February 3, 2006 (71 FR 5858), that 

TEQUIN injection, 10 mg/mL (200 mg), 

was not withdrawn for reasons of safety 

and effectiveness. 

On May 1, 2006, Public Citizen 

Research Group submitted a citizen 

petition (Docket No. FDA–2006–P–

0081),3 under 21 CFR 10.30, requesting 

that FDA immediately ban TEQUIN 

because of the increased risk of 

dysglycemia (hypoglycemia, low blood 

sugar, and hyperglycemia, high blood 

sugar) in humans. Public Citizen states 

that it reached its conclusion based on: 

(1) The relatively high numbers and 

rates of gatifloxacin-associated 

dysglycemia adverse event reports 

calculated from data collected by FDA’s 

Adverse Event Reporting System (AERS) 

and Health Canada’s Adverse Drug 

Reaction Monitoring Program; (2) a 

study by Park-Wyllie et al., published in 

March 2006 in the New England Journal 

of Medicine, that showed that patients 

(diabetic and nondiabetic) receiving 

gatifloxacin had approximately 17 times 

the odds of having a hyperglycemic 

episode and 4 times the odds of having 

a hypoglycemic episode compared to 

those taking macrolide antibiotics; and 

(3) the relatively high numbers and rates 

of gatifloxacin-associated dysglycemic 

events in the manufacturer’s safety 

studies in uninfected patients and other 

studies in infected patients, including 

clinical trials, cohort studies, casecontrol studies, postmarketing 

surveillance studies, and case reports. 

In June 2006, BMS announced that it 

would no longer market TEQUIN. In 

light of pending ANDAs and the citizen 

petition, FDA examined whether all 

TEQUIN products, including TEQUIN 

(gatifloxacin) injection, 10 mg/mL (200 

mg), were withdrawn from the market 

for reasons of safety or effectiveness. 

After considering the citizen petition 

and reviewing agency records 

concerning the drug product, analyses 

of AERS reports, and relevant literature, 

FDA has determined under § 314.161 

that TEQUIN was withdrawn from sale 

for reasons of safety or effectiveness. 

Accordingly, the agency will remove all 

TEQUIN products from the Orange Book 

(§ 314.162). FDA will not accept or 

approve ANDAs that refer to these drug 

products. 

Therefore, the agency has determined, 

under § 314.161, that all dosage forms 

and strengths of TEQUIN (gatifloxacin) 

listed in the table of this document were 

withdrawn from sale for reasons of 

safety. TEQUIN (gatifloxacin) will be 

removed from the list of drug products 

published in the Orange Book. FDA will 

not accept or approve ANDAs that refer 

to any dosage form or strength of 

TEQUIN (gatifloxacin). 

Dated: September 2, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–20938 Filed 9–8–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2004–N–0451] (formerly 

FDA–2004–N–0226) 

Food and Drug Administration 

Modernization Act of 1997: 

Modifications to the List of Recognized 

Standards, Recognition List Number: 

020 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

publication containing modifications 

the agency is making to the list of 

standards FDA recognizes for use in 

premarket reviews (FDA recognized 

consensus standards). This publication, 

entitled ‘‘Modifications to the List of 

Recognized Standards, Recognition List 

Number: 020’’ (Recognition List 

Number: 020), will assist manufacturers 

who elect to declare conformity with 

consensus standards to meet certain 

requirements for medical devices. 

DATES: Effective September 9, 2008. 

Submit written or electronic comments 

concerning this document at any time. 

ADDRESSES: Submit written requests for 

single copies of ‘‘Modifications to the 

List of Recognized Standards, 

Recognition List Number: 020’’ to the 

Division of Small Manufacturers, 

International and Consumer Assistance, 

Center for Devices and Radiological 

Health (CDRH) (HFZ–220), Food and 

Drug Administration, 1350 Piccard Dr., 

Rockville, MD 20850. Send two selfaddressed adhesive labels to assist that 

office in processing your requests, or fax 

your request to 240–276–3151. Submit 

written comments concerning this 

document, or recommendations for 

additional standards for recognition, to 

the contact person (see FOR FURTHER

INFORMATION CONTACT). Submit 

electronic comments to 

standards@cdrh.fda.gov. This document 

may also be accessed on FDA’s Internet 

site at http://www.accessdata.fda.gov/ 

scripts/cdrh/cfdocs/cfTopic/ 

cdrhnew.cfm. See section VI of this 

document for electronic access to the 

searchable database for the current list 

of FDA recognized consensus standards, 

including Recognition List Number: 020 

modifications and other standards 

related information. 

FOR FURTHER INFORMATION CONTACT: 

Carol L. Herman, Center for Devices and 

Radiological Health (HFZ–84), Food and 

Drug Administration, 7520 Standish Pl., 

Rockville, MD 20855, 240–276–8714. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 204 of the Food and Drug 

Administration Modernization Act of 

1997 (FDAMA) (Public Law 105–115) 

amended section 514 of the Federal 

Food, Drug, and Cosmetic Act (the act) 

(21 U.S.C. 360d). Amended section 514 

allows FDA to recognize consensus 

standards developed by international 

and national organizations for use in 

satisfying portions of device premarket 

review submissions or other 

requirements. 

In a notice published in the Federal 

Register of February 25, 1998 (63 FR 

9561), FDA announced the availability 

of a guidance entitled ‘‘Recognition and 

Use of Consensus Standards.’’ The 

document described how FDA would 

implement its standard recognition 

program and provided the initial list of 

recognized standards. 

Modifications to the initial list of 

recognized standards, as published in 


jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 73, No. 175 / Tuesday, September 9, 2008 / Notices 52359 

the Federal Register, are identified in 

table 1 of this document. 

TABLE 1.—PREVIOUS PUBLICATIONS

OF STANDARD RECOGNITION LISTS

October 16, 1998 

(63 FR 55617) 

October 4, 2004 

(69 FR 59240) 

July 12, 1999 

(64 FR 37546) 

May 27, 2005 

(70 FR 30756) 

November 15, 2000 

(65 FR 69022) 

November 8, 2005 

(70 FR 67713) 

May 7, 2001 

(66 FR 23032) 

March 31, 2006 

(71 FR 16313) 

January 14, 2002 

(67 FR 1774) 

June 23, 2006 

(71 FR 36121) 

October 2, 2002 

(67 FR 61893) 

November 3, 2006 

(71 FR 64718) 

April 28, 2003 

(68 FR 22391) 

May 21, 2007 

(72 FR 28500) 

March 8, 2004 

(69 FR 10712) 

September 12, 2007 

(72 FR 52142) 

June 18, 2004 

(69 FR 34176) 

December 19, 2007 

(72 FR 71924) 

These notices describe the addition, 

withdrawal, and revision of certain 

standards recognized by FDA. The 

agency maintains ‘‘hypertext markup 

language (HTML)’’ and ‘‘portable 

document format (PDF)’’ versions of the 

list of ‘‘FDA Recognized Consensus 

Standards.’’ Both versions are publicly 

accessible at the agency’s Internet site. 

See section VI of this document for 

electronic access information. Interested 

persons should review the 

supplementary information sheet for the 

standard to understand fully the extent 

to which FDA recognizes the standard. 

II. Modifications to the List of 

Recognized Standards, Recognition List 

Number: 020 

FDA is announcing the addition, 

withdrawal, correction, and revision of 

certain consensus standards the agency 

will recognize for use in satisfying 

premarket reviews and other 

requirements for devices. In addition to 

these changes, FDA has also established 

a new internal numbering system that 

assigns unique identification 

recognition numbers. FDA believes this 

new numbering system will facilitate 

the use of FDA Form 3654, ‘‘Standards 

Data Report for 510(k)s,’’ which was 

implemented in November 2007. FDA 

will incorporate these modifications in 

the list of FDA Recognized Consensus 

Standards in the agency’s searchable 

database. FDA will use the term 

‘‘Recognition List Number: 020’’ to 

identify these current modifications. 

In table 2 of this document, FDA 

describes the following modifications: 

(1) The withdrawal of standards and 

their replacement by others, (2) the 

correction of errors made by FDA in 

listing previously recognized standards, 

and (3) the changes to the 

supplementary information sheets of 

recognized standards that describe 

revisions to the applicability of the 

standards. 

In section III of this document, FDA 

lists modifications the agency is making 

that involve the initial addition of 

standards not previously recognized by 

FDA. 

TABLE 2.—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS

Old Recognition No. Replacement 

Recognition No. Standard Change 

A. Anesthesia 

1–11 IEC 60601–3–1:1996–08 Medical Electrical Equipment Part 

3–1: Essential Performance Requirements for Transcutaneous Oxygen and Carbon Dioxide Partial Pressure 

Monitoring Equipment 

Withdrawn 

1–46 ISO 5367:2000 Breathing Tubes Intended for Use With 

Anaesthetic Apparatus and Ventilators 

Relevant guidance and Extent of 

recognition 

1–51 ASTM F1101–90(1997) Standard Specification for Ventilators Intended for Use During Anesthesia Withdrawn 

1–62 ISO 5356–1:2004 Anaesthetic and Respiratory Equipment—

Conical Connectors: Part 1: Cones and Sockets 

Relevant guidance 

1–66 ISO 9919:2005: Medical Electrical Equipment—Particular 

Requirements for the Basic Safety and Essential Performance of Pulse Oximeter Equipment for Medical Use 

Relevant guidance 

1–68 CGA V–5:2005 Diameter-Index Safety System (Noninterchangeable Low Pressure Connections for Medical Gas 

Applications) 

Relevant guidance 

1–72 ISO 10651–5:2006 Lung Ventilators for Medical Use—Particular Requirements for Basic Safety and Essential Performance—Part 5: Gas-powered Emergency Resuscitators Relevant guidance, Code of Federal 

Regulations (CFR) Citation and 

Product Codes 

1–73 ISO 10651–4:2002 Lung Ventilators—Part 4: Particular Requirements for Operator Powered Resuscitators Relevant guidance 

B. Biocompatibility 

2–21 2–118 ANSI/AAMI/ISO 10993–11: 2006 Biological Evaluation of 

Medical Devices—Part 11: Tests for System Toxicity 

Withdrawn and replaced with newer 

version 

2–56 2–119 ASTM F813–07 Standard Practice for Direct Contact Cell 

Culture Evaluation of Materials for Medical Devices 

Withdrawn and replaced with newer 

version 


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TABLE 2.—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Old Recognition No. Replacement 

Recognition No. Standard Change 

2–63 2–120 ANSI/AAMI/ISO 10993–6: 2007 Biological Evaluation of 

Medical Devices—Part 6: Tests for Local Effects After Implantation 

Withdrawn and replaced with newer 

version 

2–66 2–121 ASTM F2148–07e1 Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local 

Lymph Node Assay (LLNA) 

Withdrawn and replaced with newer 

version 

2–68 2–122 ASTM F719–81 (2007) e1 Standard Practice for Testing 

Biomaterials in Rabbits for Primary Skin Irritation 

Withdrawn and replaced with newer 

version 

2–69 2–123 ASTM F720–81 (2007) e1 Standard Practice for Testing 

Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test 

Withdrawn and replaced with newer 

version 

2–70 2–124 ASTM F750–87 (2007) e1 Standard Practice for Evaluating 

Material Extracts by Systemic Injection in the Mouse 

Withdrawn and replaced with newer 

version 

2–89 2–125 ASTM F749–98 (2007) e1 Standard Practice for Evaluating 

Material Extracts by Intracutaneous Injection in the Rabbit 

Withdrawn and replaced with newer 

version 

2–92 2–126 ASTM F748–06 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices Withdrawn and replaced with newer 

version 

2–95 ASTM F1984–99(2003) Standard Practice for Testing for 

Whole Complement Activation in Serum by Solid Materials 

Relevant guidance 

2–109 2–128 USP 31–NF26 Biological Test <87> 2008 Biological Reactivity Test, In Vitro—Direct Contact Test Withdrawn and replaced with newer 

version 

2–110 2–129 USP 31–NF26 Biological Test <88> 2008 Biological Reactivity Test, In Vitro—Elution Test Withdrawn and replaced with newer 

version 

2–111 2–130 USP 31–NF26 Biological Test <88> 2008 Biological Reactivity Test, In Vitro, Procedure—Preparation of Sample Withdrawn and replaced with newer 

version 

2–112 2–131 USP 31–NF26 Biological Test <88> 2008 Biological Reactivity Test, In Vitro, Classification of Plastics—

Intracutaneous Test 

Withdrawn and replaced with newer 

version 

2–113 2–132 USP 31–NF26Biological Test <88> 2008 Biological Reactivity Test, In Vivo—Classification of Plastics—Systemic 

Injection Test 

Withdrawn and replaced with newer 

version 

C. Cardiovascular/Neurology 

3–2 ANSI/AAMI EC53:1995/(R)2001—ECG Cables and 

Leadwires 

Reaffirmation 

3–3 ANSI/AAMI NS28:1988/(R)2006—Intracranial Pressure Monitoring Devices Reaffirmation 

3–16 3–60 IEC 60601–2–10: Amendment 1: 2001–09, Medical Electrical Equipment—Part 2–10: Particular Requirements for 

the Safety of Nerve and Muscle Stimulators 

Withdrawn and replaced with newer 

version 

3–18 3–61 IEC 60601–2–27: 2005–08, Second Edition, Medical Electrical Equipment—Part 2–27: Particular Requirements for 

the Safety, Including Essential Performance, of Electrocardiographic Monitoring Equipment 

Withdrawn and replaced with newer 

version 

3–20 3–62 IEC 60601–2–31: 2008–03, Edition 2.0, Medical Electrical 

Equipment—Part 2–31: Particular Requirements for the 

Basic Safety and Essential Performance of External Cardiac Pacemakers with Internal Power Source 

Withdrawn and replaced with newer 

version 

3–25 3–63 ISO 11318:2002, Second Edition, Cardiac Defibrillators—

Connector Assembly DF–1 for Implantable Defibrillators—

Dimensions and Test Requirements 

Withdrawn and replaced with newer 

version 


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TABLE 2.—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Old Recognition No. Replacement 

Recognition No. Standard Change 

3–40 ANSI/AAMI SP9:1994, Non-automated Sphygmomanometers Withdrawn 

3–41 ANSI/AAMI EC11:1991/(R)2007—Diagnostic Electrocardiographic Devices Reaffirmation 

3–42 ANSI/AAMI EC13:2002/(R)2007—Cardiac Monitors, Heart 

Rate Meters, and Alarms 

Reaffirmation 

3–43 3–65 ANSI/AAMI EC38:2007—Medical Electrical Equipment—Part 

2–47: Particular Requirements for the Safety, Including 

Essential Performance, of Ambulatory Electrocardiographic Systems 

Withdrawn and replaced with newer 

version 

3–44 ANSI/AAMI BP22:1994/(R)2006, Blood Pressure Transducers Reaffirmation 

3–45 ANSI/AAMI EC57:1998/(R)2003, Testing and Reporting Performance Results of Cardiac Rhythm and ST Segment 

Measurement Algorithms 

Reaffirmation 

3–47 3–66 ASTM F2081–06, Standard Guide for Characterization and 

Presentation of the Dimensional Attributes of Vascular 

Stents 

Withdrawn and replaced with newer 

version 

3–52 ANSI/AAMI EC12:2000/(R)2005, Disposable ECG Electrodes Reaffirmation 

3–57 3–67 ASTM F2129–06, Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices Withdrawn and replaced with newer 

version 

D. Dental/Ear, Nose, and Throat 

4–43 ANSI/ADA Specification No. 5–Dental Casting Alloys:1997 Type of standard, and Relevant 

guidance 

4–50 ANSI/ADA Specification No. 18–Alginate Impression Materials:1992 Title and Relevant guidance 

4–52 4–147 ANSI/ADA Specification No. 27–Resin-Based Filling Materials: 2005 Withdrawn and replaced with newer 

year 

4–62 ISO 1563:1990 Dental Alginate Impression Material Relevant guidance and Extent of 

recognition 

4–63 ISO 1564:1995 Dental Aqueous Impression Materials Based 

on Agar 

Relevant guidance 

4–65 4–151 ISO 3336:1993, Dentistry—Synthetic Polymer Teeth Withdrawn and replaced with newer 

version 

4–66 ISO 4049:1988, Dentistry—Resin-Based Filling Materials Withdrawn—newer version previously recognized 

4–67 ISO 6871–1:1994, Dental Base Metal Casting Alloys Part 1: 

Cobalt-based Alloys—TECHNICAL CORRIGENDUM 

1:1998 

Withdrawn—newer version previously recognized 

4–68 ISO 6871–2:1994, Dental Base Metal Casting Alloys Part 2: 

Nickel-Based Alloys 

Withdrawn—newer version previously recognized 

4–69 ISO 6872:1995/Amendment 1:1997 Dental Ceramic Date of standard and Extent of recognition 

4–73 ISO 7405:1997 Dentistry—Preclinical Evaluation of Biocompatibility of Medical Devices Used in Dentistry—Test 

Methods for Dental Materials 

Extent of recognition and Contact 

person 

4–75 ISO 7785–1:1997 Dental Handpieces—Part 1: High-Speed 

Air Turbine Handpieces 

Relevant guidance and Extent of 

recognition 


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52362 Federal Register / Vol. 73, No. 175 / Tuesday, September 9, 2008 / Notices 

TABLE 2.—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Old Recognition No. Replacement 

Recognition No. Standard Change 

4–76 ISO 7785–2:1995 Dental Handpieces—Part 2: Straight and 

Geared Angle Handpieces 

Relevant guidance and Extent of 

recognition 

4–78 ISO 9168:1991 Dental Handpieces—Hose Connectors Relevant guidance and Extent of 

recognition 

4–83 ISO 11498:1997 Dental Handpieces—Dental Low-Voltage 

Electrical Motors 

Relevant guidance and Extent of 

recognition 

4–84 ISO 13294:1997 Dental Handpieces—Dental Air-Motors Relevant guidance and Extent of 

recognition 

4–88 4–148 ANSI/ADA Specification No. 78–Endodontic Obturating 

Cones: 2005 

Withdrawn and replaced with newer 

version 

4–89 ANSI/ADA Specification No. 53–Polymer-Based Crowns and 

Bridge Resins: 1999 (Reaffirmed 2005) 

Reaffirmation and Relevant guidance 

4–90 ANSI/ASA S3.39:1987 (R2007), Specifications for Instruments to Measure Aural Acoustic Impedance and Admittance (Aural Acoustic Immittance) Reaffirmation and Type of standard 

4–91 ANSI/ADA Specification No. 80–Dental Materials—Determination of Color Stability: 2001 Relevant guidance 

4–92 ANSI/ADA Specification No. 88–Dental Brazing Alloys: 2000 

(Reaffirmed 2006) 

Reaffirmation and Relevant guidance 

4–93 4–159 IEEE ANSI C63.19:2007 Methods of Measurement of Compatibility Between Wireless Communications Devices and 

Hearing Aids 

Withdrawn and replaced with newer 

version 

4–94 ANSI/ADA Specification No. 14—Dental Base Metal Casting 

Alloys: 1982 (Reaffirmed 1998) 

Reaffirmation, Date of standard, 

Type of standard, Offices, Relevant guidance 

4–95 ANSI/ADA Specification No.17:1999, Dental Base Temporary Relining Resin Withdrawn—newer version previously recognized 

4–96 ANSI/ADA Specification No. 30—Dental Zinc Oxide—Eugenol and Zinc Oxide—Non-Eugenol Cements: 2000 (Reaffirmed 2005) Reaffirmation and Relevant guidance 

4–97 ANSI/ADA Specification No. 57—Endodontic Sealing Material: 2000 (Reaffirmed 2006) Reaffirmation, Offices and Type of 

standard 

4–98 ANSI/ADA Specification No. 96:2000, Dental-Water-Based 

Cements 

Withdrawn—newer version previously recognized 

4–99 ISO 4049: 2000 Dentistry—Polymer-based Filling, Restorative and Luting Materials Relevant guidance, Type of standard and Extent of recognition 

4–100 4–133 ISO 6876:2001, Dental Root Canal Sealing Materials Withdrawn (duplicate) 

4–101 ISO 8891:1998, Dental Casting Alloys With Noble Metal 

Content of At Least 25% but Less Than 75% 

Withdrawn—newer version previously recognized 

4–102 4–152 ISO 9693:1999, Metal-Ceramic Dental Restorative Systems Withdrawn and replaced with newer 

version 

4–104 4–149 ANSI/ADA Specification No. 39—Pit and Fissure Sealants: 

2006 

Withdrawn and replaced with newer 

version 

4–105 ANSI/ADA Specification No. 75—Resilient Lining Materials 

for Removable Dentures—Part 1: Short-Term Materials: 

1997 (Reaffirmed 2003) 

Type of standard and Relevant 

guidance 

4–107 ISO 9917–2:1998 Dental Water-Based Cements—Part 2: 

Light-Activated Cements 

Devices affected, Type of standard, 

Relevant guidance and Extent of 

recognition 


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TABLE 2.—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Old Recognition No. Replacement 

Recognition No. Standard Change 

4–109 ISO 13716:1999 Dentistry—Reversible-Irreversible Hydrocolloid Impression Material Systems Type of standard, Relevant guidance, Extent of recognition and 

Code of Federal Regulations 

(CFR) citation 

4–110 ANSI/ADA Specification No. 11—Agar Impression Materials: 

1997 

Type of standard and Relevant 

guidance 

4–111 ANSI/ADA Specification No. 13—Denture Cold-Curing Repair Resins: 1981 (Reaffirmed 2006) Reaffirmation, Date of standard, 

Type of standard and Relevant 

guidance 

4–112 ANSI/ADA Specification No. 16—Dental Impression Paste—

Zinc Oxide-Eugenol Type: 1961 (Reaffirmed 1999) 

Reaffirmation, Date of standard, 

Type of standard and Relevant 

guidance 

4–113 ANSI/ADA Specification No. 20—Dental Duplicating Material: 1972 (Reaffirmed 1995) Reaffirmation, Date of standard, 

Type of standard and Relevant 

guidance 

4–115 4–153 ISO 9917–1:2007 Dentistry—Water-Based Cements—Part 

1: Powder/Liquid Acid-Base Cements 

Withdrawn and replaced with a 

newer year 

4–117 ANSI/ADA Specification No. 12—Denture Base Polymers: 

2002 

Type of standard 

4–119 ANSI/ADA Specification No. 82—Dental Reversible/Irreversible Hydrocolloid Impression Material Systems: 1998 (Reaffirmed 2003) Reaffirmation, Date of standard, 

Type of standard and Relevant 

guidance 

4–120 ISO 10139–2:1999 Dentistry—Soft Lining Materials for Removable Dentures—Part 2: Materials for Long-Term Use Type of standard, Relevant guidance and Extent of recognition 

4–121 ISO 7494–2:2003 Dentistry—Dental Units—Part 2: Water 

and Air Supply 

Type of standard and Extent of recognition 

4–125 ISO 1562:2004, Dentistry—Casting Gold Alloys Withdrawn—newer version previously recognized 

4–126 ISO 10477:2004 Dentistry—Polymer-Based Crown and 

Bridge Materials 

Extent of recognition and Relevant 

guidance 

4–127 ANSI/ADA Specification No. 58—Root Canal Files, Type H 

(Hedstrom): 2004 

Type of standard and Extent of recognition 

4–128 ISO 4823:2000,, Dentistry—Elastomeric Impression Materials and Technical Corrigendum 1:2004 Withdrawn 

4–129 4–150 ANSI/ADA Specification No. 19—Dental Elastomeric Impression Material: 2004 Withdrawn and replaced with newer 

version 

4–130 ANSI/ADA Specification No. 17—Denture Base Temporary 

Relining Resins: 1983 (Reaffirmed 2006) 

Reaffirmation, Processes impacted, 

Extent of recognition, CFR citations and Relevant guidance 

4–131 ISO 3107: 2004 Dentistry—Zinc Oxide/Eugenol and Zinc 

Oxide/Non-eugenol Cements Technical Corrigendum 

1:2006–Third Edition 

Processes impacted and Relevant 

guidance 

4–132 ISO 6874:2005 Dentistry—Polymer-Based Pit and Fissure 

Sealants 

Extent of recognition and Relevant 

guidance 

4–133 ISO 6876:2001 Dental Root Canal Sealing Materials Processes impacted and Extent of 

recognition 

4–134 ISO 7494–1:2004 Dentistry—Dental Units—Part 1: General 

Requirements and Test Methods 

Extent of recognition 

4–135 ISO 10139–1:2005 Dentistry—Soft Lining Materials for Removable Dentures—Part 1: Materials for Short-term Use Relevant guidance and Extent of 

recognition 


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52364 Federal Register / Vol. 73, No. 175 / Tuesday, September 9, 2008 / Notices 

TABLE 2.—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Old Recognition No. Replacement 

Recognition No. Standard Change 

4–136 ASTM F2504–05 Standard Practice for Describing System 

Output of Implantable Middle Ear Hearing Devices 

Relevant guidance 

4–137 ISO 6877:2006 Dentistry—Root-Canal Obturating Points Extent of recognition 

4–139 ANSI/ADA Specification No. 48—Visible Light Curing Units: 

2004 

Relevant guidance 

4–140 ISO 6871–2:1994/Amd 1:2005, Dental Base Metal Casting 

Alloys—Part 2: Nickel-Based Alloys 

Withdrawn—newer version previously recognized 

4–141 ISO 6871–1:1994, Dental Base Metal Casting Alloys—Part 

1: Cobalt-Based Alloys 

Withdrawn—newer version previously recognized 

4–142 ISO 6871–1:1994/Amd 1:2005, Dental Base Metal Casting 

Alloys—Part 1: Cobalt-Based Alloys 

Withdrawn—newer version previously recognized 

4–143 ANSI/ADA Specification No.96, Dental-Water-Based Cements Reaffirmation, Type of standard and 

Relevant guidance 

4–145 ISO 22803:2004 Dentistry—Membrane Materials for Guided 

Tissue Regeneration in Oral and Maxillofacial Surgery—

Contents of a Technical File 

Relevant guidance and Devices affected 

4–146 ISO 22674:2006 Dentistry—Metallic Materials for Fixed and 

Removable Restorations and Appliances 

Devices affected and Processes impacted 

E. General 

5–7 12–185 IEC 60601–1–3(1994–07) Medical Electrical Equipment—

Part 1: General Requirements for Safety; General Requirements for Radiation Protection in Diagnostic X-Ray 

Equipment 

Transferred 

5–8 5–41 IEC 60601–1–4:2000 Medical Electrical Equipment—Part 1–

4: General Requirements for Safety—Collateral Standard: 

Programmable Electrical Medical Systems, Edition 1.1 

Withdrawn and replaced with newer 

version 

5–16 5–42 ASTM D903–98(2004) Standard Test Methods for Peel or 

Stripping Strength of Adhesive Bonds 

Withdrawn and replaced with newer 

version 

5–19 ASTM E876/1995 Standard Practice for Use of Statistics in 

the Evaluation of Spectrometric Data 

Withdrawn 

5–25 5–43 ANSI/ESD S20.20–2007 Standard for the Development of 

an Electrostatic Discharge Control Program for Protection 

of Electrical and Electronic Parts, Assemblies and Equipment (Excluding Electrically Initiated Explosive Devices) 

Withdrawn and replaced with newer 

version 

5–28 IEC 60601–1–2, (Second Edition, 2001) Medical Electrical 

Equipment—Part 1–2: General Requirements for Safety—

Collateral Standard: Electromagnetic Compatibility—Requirements and Tests 

Extent of recognition 

5–30 AAMI/ANSI/IEC 60601–1–2 Medical Electrical Equipment—

Part 1–2: General Requirements for Safety—Collateral 

Standard: Electromagnetic Compatibility—Requirements 

and Tests (AAMI/ANSI/IEC 60601–1–2:2001 is the U.S. 

version of IEC 60601–1–2:2001 with identical requirements for electromagnetic compatibility (EMC) of medical 

electrical equipment.) 

Type of standard and Extent of recognition 

5–33 5–44 IEC 60601–1–8:2006 Medical Electrical Equipment—Part 1–

8: General Requirements for Basic Safety and Essential 

Performance—Collateral Standard: General Requirements, Tests and Guidance for Alarm Systems in Medical 

Electrical Equipment and Medical Electrical Systems, Second Edition 

Withdrawn and replaced with newer 

version 


jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 73, No. 175 / Tuesday, September 9, 2008 / Notices 52365 

TABLE 2.—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Old Recognition No. Replacement 

Recognition No. Standard Change 

5–34 IEC 60601–1–2 Medical Electrical Equipment—Part 1–2: 

General Requirements for Safety—Collateral Standard: 

Electromagnetic Compatibility—Requirements and Tests 

(Edition 2:2001 with Amendment 1:2004; Edition 2.1 (Edition 2:2001 consolidated with Amendment 1:2004)) 

Extent of recognition 

5–35 AAMI/ANSI/IEC 60601–1–2 Medical Electrical Equipment—

Part 1–2: General Requirements for Safety—Collateral 

standard: Electromagnetic Compatibility—Requirements 

and Tests (Edition 2:2001 with Amendment 1:2004) 

(AAMI/ANSI/IEC 60601–1–2:2001 with Amendment 

1:2004 is the U.S. version of IEC 60601–1–2:2001 with 

Amendment 1:2004, with identical requirements for electromagnetic compatibility (EMC) of medical electrical 

equipment) 

Type of standard and Extent of recognition 

5–36 ANSI/AAMI/ISO TIR 16142:2006: Technical Information Report: Medical Devices—Guidance on the Selection of 

Standards in Support of Recognized Essential Principles 

of Safety and Performance of Medical Devices, Second 

Edition 

CFR Citations, Product codes and 

Relevant guidance 

F. General Hospital/General Plastic Surgery 

6–16 ISO 7886–1:1993 Sterile Hypodermic Syringes for Single 

Use—Part 1: Syringes for Manual Use 

Withdrawn 

6–117 ASTM F2172–02: Standard Specification for Blood/Intravenous Fluid/Irrigation Fluid Warmers Relevant guidance 

6–118 ASTM F2196–02 Standard Specification for Circulating Liquid and Forced Air Patient Temperature Management Devices Relevant guidance, Contact person 

6–131 6–203 ASTM D6499–07 Standard Test Method for the 

Immunological Measurement of Antigenic Protein in Natural Rubber and Its Products 

Withdrawn and replaced with newer 

version 

6–160 6–204 ISO 8537:2007 Sterile Single-Use Syringes, With or Without 

Needle, for Insulin 

Withdrawn and replaced with newer 

version 

6–166 6–215 ASTM F2132–01(2008) Standard Specification for Puncture 

Resistance of Materials Used in Containers for Discarded 

Medical Needles and Other Sharps 

Withdrawn and replaced with newer 

version 

6–167 ASTM D6319–00a(2005) Standard Specification for Nitrile 

Examination Gloves for Medical Application 

Relevant guidance 

6–188 6–205 USP 31:2008 Nonabsorbable Surgical Suture Withdrawn and replaced with newer 

version 

6–189 6–206 USP 31<11>2008 Sterile Sodium Chloride for Irrigation Withdrawn and replaced with newer 

version 

6–190 6–207 USP 31:2008 Absorbable Surgical Suture Withdrawn and replaced with newer 

version 

6–191 6–208 USP 31<881>:2008 Tensile Strength Withdrawn and replaced with newer 

version 

6–192 6–209 USP 31<861>:2008 Sutures—Diameter Withdrawn and replaced with newer 

version 

6–193 6–210 USP 31<871>:2008 Sutures Needle Attachment Withdrawn and replaced with newer 

version 

6–194 6–211 USP 31<11>: 2008 Sterile Water for Irrigation Withdrawn and replaced with newer 

version 

6–195 6–212 USP 31<11>: 2008 Heparin Lock Flush Solution Withdrawn and replaced with newer 

version 


jlentini on PROD1PC65 with NOTICES
52366 Federal Register / Vol. 73, No. 175 / Tuesday, September 9, 2008 / Notices 

TABLE 2.—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Old Recognition No. Replacement 

Recognition No. Standard Change 

6–196 6–213 USP 31<11>: 2008 Sodium Chloride Injection Withdrawn and replaced with newer 

version 

6–198 ASTM F2100–07 Standard Specification for Performance of 

Materials Used in Medical Face Masks 

Relevant guidance 

6–201 ISO 8536–4:2007 Infusion Equipment for Medical Use—Part 

4: Infusion Sets for Single Use, Gravity Feed 

Relevant guidance 

G. In Vitro Diagnostic 

7–6 7–131 CLSI ILA18–A2 Specifications for Immunological Testing for 

Infectious Diseases 

Withdrawn and replaced with newer 

version 

7–11 7–132 CLSI MM03–A2 Molecular Diagnostic Methods for Infectious 

Diseases 

Withdrawn and replaced with newer 

version 

7–12 CLSI/NCCLS C12–A Definitions of Quantities and Conventions Related to Blood pH and Gas Analysis; Approved 

Standard (1994) 

Withdrawn 

7–13 CLSI/NCCLS C21–A Performance Characteristics for Devices Measuring PO2 and PCO2 in Blood Samples; Approved Standard (1992) Withdrawn 

7–15 CLSI/NCCLS C25–A Fractional Oxyhemoglobin, Oxygen 

Content and Saturation, and Related Quantities in Blood: 

Terminology, Measurement, and Reporting; Approved 

Guideline (1997) 

Withdrawn 

7–16 CLSI/NCCLS C27–A Blood Gas Preanalytical Considerations: Specimen Collection, Calibration, and Controls; 

Approved Guideline (1993) 

Withdrawn 

7–18 7–133 CLSI C30–A2, Point-of Care Blood Glucose Testing in Acute 

and Chronic Care Facilities 

Withdrawn and replaced with newer 

version 

7–21 CLSI C42–A, Erythrocyte Protoporphyrin Testing; Approved 

Guideline (1996) 

Contact person 

7–22 7–134 CLSI GP20–A2 Fine-Needle Aspiration Biopsy (FNAB) 

Techniques 

Withdrawn and replaced with newer 

versions 

7–25 NCCLS H8–A2 Detection of Abnormal Hemoglobin Using 

Cellulose Acetate Electrophoresis—Second Edition; Approved Standard (1994) 

Withdrawn 

7–26 NCCLS H9–A Chromatographic (Microcolumn) Determination of Hemoglobin A2; Approved Standard (1989) Withdrawn 

7–27 NCCLS H10–A2 Solubility Test to Confirm the Presence of 

Sickling Hemoglobins—Second Edition; Approved Standard (1995) 

Withdrawn 

7–29 NCCLS H14–A2 Devices for Collection of Skin Puncture 

Blood Specimens—Second Edition; Approved Guideline 

(1990) 

Withdrawn 

7–34 7–135 CLSI H44–A2 Methods for Reticulocyte Counting (Flow 

Cytometry and Supravital Dyes) 

Withdrawn and replaced with newer 

version 

7–35 CLSI H47–A One-Stage Prothrombin Time (PT) Test and 

Activated Partial Thromboplastin Time (APTT) Test; Approved Guideline (1996) 

Contact person 

7–36 7–136 CLSI ILA02–A2 Quality Assurance of Laboratory Tests for 

Autoantibodies to Nuclear Antigens 

Withdrawn and replaced with newer 

version 

7–37 CLSI ILA06–A Detection and Quantitation of Rubella IgG 

Antibody 

Contact person 


jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 73, No. 175 / Tuesday, September 9, 2008 / Notices 52367 

TABLE 2.—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Old Recognition No. Replacement 

Recognition No. Standard Change 

7–38 CLSI/NCCLS I/LA10–A Choriogonadotropin Testing: Nomenclature, Reference Preparations, Assay Performance, and 

Clinical Application; Approved Guideline (1996) 

Withdrawn 

7–39 CLSI/NCCLS I/LA17–A Assessing the Quality of Systems for 

Alpha-Fetoprotein (AFP) Assays Used in Prenatal Screening and Diagnosis of Neural Tube Defects; Approved 

Guideline (1997) 

Withdrawn 

7–40 NCCLS I/LA18–A Specifications for Immunological Testing 

for Infectious Diseases; Approved Guideline (1994) 

Withdrawn 

7–41 CLSI ILA19–A Primary Reference Preparations Used to 

Standardize Calibration of Immunochemical Assays for 

Serum Prostate Specific Antigen (PSA); Approved Guideline (1997) 

Contact person 

7–42 CLSI ILA20–A Evaluation Methods and Analytical Performance Characteristics of Immunological Assays for Human 

Immunoglobulin E (IgE) Antibodies of Defined Allergen 

Specificities; Approved Guideline (1997) 

Contact person 

7–43 7–137 CLSI LA04–A5 Blood Collection on Filter Paper for Newborn 

Screening Programs 

Withdrawn and replaced with newer 

version 

7–46 7–138 CLSI M27–A2, Reference Method for Broth Dilution 

Antifungal Susceptibility Testing of Yeasts 

Withdrawn and replaced with newer 

version 

7–49 CLSI H26–A Performance Goals for the Internal Quality 

Control of Multichannel Hematology Analyzers; Approved 

Standard 

Contact person 

7–50 NCCLS D11–A2 Glossary and Guidance for 

Immunodiagnostic Procedures, Reagents, and Reference 

Materials—Second Edition, Approved Guideline 

Withdrawn 

7–51 7–139 CLSI GP27–A2 Using Proficiency Testing to Improve the 

Clinical Laboratory 

Withdrawn and replaced with newer 

version 

7–52 CLSI / NCCLS NRSCL 8–A Terminology and Definitions for 

use in NCCLS Documents; Approved Standard 

Withdrawn 

7–53 7–140 CLSI GP22–A2 Continuous Quality Improvement Withdrawn and replaced with newer 

version 

7–55 7–141 CLSI H18–A3 Procedures for the Handling and Processing 

of Blood Specimens 

Withdrawn and replaced with newer 

version 

7–58 7–142 CLSI H11–A4 Procedures for the Collection of Arterial Blood 

Specimens 

Withdrawn and replaced with newer 

version 

7–59 13–9 CLSI / NCCLS AUTO2–A Laboratory Automation: Bar 

Codes for Specimen Container Identification; Approved 

Standard 

Transferred 

7–60 13–10 NCCLS AUTO1–A Laboratory Automation: Specimen Container/Specimen Carrier; Approved Standard Transferred 

7–61 13–11 NCCLS AUTO3–A Laboratory Automation: Communications 

with Automated Clinical Laboratory Systems, Instruments, 

Devices, and Information Systems; Approved Standard 

Transferred 

7–62 13–12 NCCLS AUTO4–A Laboratory Automation: Systems Operational Requirements, Characteristics, and Information 

Elements; Approved Standard 

Transferred 

7–63 13–13 NCCLS AUTO5–A Laboratory Automation: 

Electromechanical Interfaces; Approved Standard 

Transferred 

7–64 13–14 NCCLS POCT1–A Point-of-Care Connectivity; Approved 

Standard 

Transferred 


jlentini on PROD1PC65 with NOTICES
52368 Federal Register / Vol. 73, No. 175 / Tuesday, September 9, 2008 / Notices 

TABLE 2.—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Old Recognition No. Replacement 

Recognition No. Standard Change 

7–67 7–143 CLSI EP14–A2 Evaluation of Matrix Effects Withdrawn and replaced with newer 

version 

7–68 13–15 NCCLS GP19–A2 Laboratory Instruments and Data Management Systems: Design of Software User Interfaces 

and End-User Software Systems Validation, Operation, 

and Monitoring; Approved Guideline—Second Edition 

Transferred 

7–70 7–144 CLSI H4–A5 Procedures and Devices for the Collection of 

Diagnostic Blood Specimens by Skin Puncture 

Withdrawn and replaced with newer 

version 

7–72 7–145 CLSI H42–A2 Enumeration of Immunologically Defined Cell 

Populations by Flow Cytometry 

Withdrawn and replaced with newer 

version 

7–74 7–146 NCCLS M6–A2 Protocols for Evaluating Dehydrated 

Mueller-Hinton Agar 

Withdrawn and replaced with newer 

version 

7–77 7–147 CLSI M22–A3 Quality Control for Commercially Prepared 

Microbiological Culture Media 

Withdrawn and replaced with newer 

version 

7–79 7–148 CLSI M28–A2 Procedures for the Recovery and Identification of Parasites From the Intestinal Tract Withdrawn and replaced with newer 

version 

7–80 CLSI MM01–A2 Molecular Diagnostic Methods for Genetic 

Diseases 

Withdrawn 

7–83 NCCLS C46–A Blood Gas and pH Analysis and Related 

Measurements; Approved Guideline 

Withdrawn 

7–85 7–149 CLSI C24–A3 Statistical Quality Control for Quantitative 

Measurement Procedures 

Withdrawn and replaced with newer 

version 

7–90 7–150 CLSI H43–A2 Clinical Flow Cytometric Analysis of Neoplastic Hematolymphoid Cells Withdrawn and replaced with newer 

version 

7–93 NCCLS EP10–A2, Preliminary Evaluation of Quantitative 

Clinical Laboratory Methods; Approved Guideline 

Withdrawn 

7–94 7–152 CLSI EP12–A2 User Protocol for Evaluation of Qualitative 

Test Performance 

Withdrawn and replaced with newer 

version 

7–95 7–153 CLSI EP15–A2 User Verification of Performance for Precision and Trueness Withdrawn and replaced with newer 

version 

7–98 7–154 CLSI MM02–A2 Immunoglobin and T-Cell Receptor Gene 

Rearrangement Assays 

Withdrawn and replaced with newer 

version 

7–99 CLSI MM5–A Nucleic Acid Amplification Assays for Molecular Hematopathology Contact person 

7–103 7–155 CLSI H03–A6 Procedures for the Collection of Diagnostic 

Blood Specimens by Venipunture 

Withdrawn and replaced with newer 

version 

7–106 7–156 CLSI M02–A9 Performance Standards for Antimicrobial Disk 

Susceptibility Tests 

Withdrawn and replaced with newer 

version 

7–107 7–157 CLSI M11–A7 Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria Withdrawn and replaced with newer 

version 

7–108 7–158 CLSI M7–A7 Methods for Antimicrobial Susceptibility Tests 

of Anaerobic Bacteria 

Withdrawn and replaced with newer 

version 

7–109 CLSI AUTO7–A Laboratory Automation: Data Content for 

Specimen Identification; Approved Standard 

Withdrawn 

7–111 7–159 CLSI H21–A5 Collection, Transport, and Processing of 

Blood Specimens for Testing Plasma-Based Coagulation 

Assays and Molecular Hemostasis Assays 

Withdrawn and replaced with newer 

version 


jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 73, No. 175 / Tuesday, September 9, 2008 / Notices 52369 

TABLE 2.—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Old Recognition No. Replacement 

Recognition No. Standard Change 

7–114 13–16 CLSI LIS01–A Standard Specification for Low-Level Protocol 

to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems 

Transferred 

7–115 13–17 CLSI LIS02–A2 Standard Specification for Transferring Information Between Clinical Instruments and Computer Systems; Approved Standard-Second Edition Transferred 

7–116 13–18 CLSI LIS03–A Standard Guide for Selection of a Clinical 

Laboratory Information Management System 

Transferred 

7–117 13–19 CLSI LIS04–A Standard Guide for Documentation of Clinical 

Laboratory Computer Systems 

Transferred 

7–118 13–20 CLSI LIS05–A, Standard Specification for Transferring Clinical Observations Between Independent Computer Systems Transferred 

7–119 13–21 CLSI LIS06–A Standard Practice for Reporting Reliability of 

Clinical Laboratory Information Systems 

Transferred 

7–120 13–22 CLSI LIS07–A Standard Specification for Use of Bar Codes 

on Specimen Tubes in the Clinical Laboratory 

Transferred 

7–121 13–23 CLSI LIS08–A Standard Guide for Functional Requirements 

of Clinical Laboratory Information Management Systems 

Transferred 

7–122 13–24 CLSI LIS09–A Standard Guide for Coordination of Clinical 

Laboratory Services within the Electronic Health Record 

Environment and Networked Architectures 

Transferred 

7–125 CLSI/NCCLS M28–A2 Volume 25, No. 16 Procedures for 

the Recovery and Identification of Parasites From the Intestinal Tract; Approved Guideline 

Withdrawn 

H. Materials 

8–32 ASTM F1586–02: Standard Specification for Wrought Nitrogen Strengthened 21 Chromium–10 Nickel–3 Manganese–2.5 Molybdenum Stainless Steel Bar for Surgical 

Implants (UNS S31675) 

Contact person 

8–44 ASTM F0136–02a: Standard Specification for Wrought Titanium–6 Aluminum–4 Vanadium ELI (Extra Low Interstitial) 

Alloy for Surgical Implant Applications (UNS R56401) 

Contact person 

8–46 8–154 ASTM F0621–08: Standard Specification for Stainless Steel 

Forgings for Surgical Implants 

Withdrawn and replaced with newer 

year version 

8–50 ASTM F1091–02: Standard Specification for Wrought Cobalt–20 Chromium–15 Tungsten–10 Nickel Alloy Surgical 

Fixation Wire (UNS R30605) 

Contact person 

8–52 ASTM F1350–02: Standard Specification for Wrought 18 

Chromium–14 Nickel–2.5 Molybdenum Stainless Steel 

Surgical Fixation Wire (UNS S31673) 

Contact person 

8–53 ASTM F1472–02a: Standard Specification for Wrought Titanium -6Aluminum -4Vanadium Alloy for Surgical Implant 

Applications (UNS R56400) 

Contact person 

8–54 8–155 ASTM F1580–07 Standard Specification for Titanium and Titanium–6 Aluminum–4 Vanadium Alloy Powders for Coatings of Surgical Implants Withdrawn and replaced with newer 

year version 

8–57 ISO 5832–2:1999, Implants for Surgery—Metallic Materials—Part 2: Unalloyed Titanium Contact person 

8–58 ISO 5832–3:1996, Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6–Aluminium 4–Vanadium 

Alloy 

Contact person 


jlentini on PROD1PC65 with NOTICES
52370 Federal Register / Vol. 73, No. 175 / Tuesday, September 9, 2008 / Notices 

TABLE 2.—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Old Recognition No. Replacement 

Recognition No. Standard Change 

8–59 ISO 5832–4:1996, Implants for Surgery—Metallic Materials—Part 4: Cobalt-Chromium-Molybdenum Casting 

Alloy 

Contact person 

8–61 ISO 5832–6:1997, Implants for Surgery—Metallic Materials—Part 6: Wrought Cobalt-Nickel-Chromium-Molybdenum Alloy Contact person 

8–63 ISO 5832–11:1994, Implants for Surgery—Metallic Materials—Part 11: Wrought Titanium 6–Aluminium 7–Niobium 

Alloy 

Contact person 

8–76 ASTM F138–03: Standard Specification for Wrought 18 

Chromium–14 Nickel–2.5 Molybdenum Stainless Steel Bar 

and Wire for Surgical Implants (UNS S31673) 

Contact person 

8–77 8–156 ASTM F0139–08, Standard Specification for Wrought 18 

Chromium–14 Nickel–2.5 Molybdenum Stainless Steel 

Sheet and Strip for Surgical Implants (UNS S31673) 

Withdrawn and replaced with newer 

year version 

8–79 ASTM F0961–03, Standard Specification for Cobalt–35 

Nickel–20 Chromium–10 Molybdenum Alloy Forgings for 

Surgical Implants [UNS R30035] 

Contact person 

8–81 ASTM F1609–03 Standard Specification for Calcium Phosphate Coatings for Implantable Materials Contact person 

11–81 8–157 ISO 9583:1993 Implants for Surgery—Non-Destructive Testing—Liquid Penetrant Inspection of Metallic Surgical Implants Transferred 

8–82 8–158 ASTM F1713–08 Standard Specification for Wrought Titanium–13 Niobium–13 Zirconium Alloy for Surgical Implant 

Applications (UNS R58130) 

Withdrawn and replaced with newer 

year version 

11–82 8–159 ISO 9584:1993 Implants for Surgery—Non-Destructive Testing—Radiographic Examination of Cast Metallic Surgical 

Implants 

Transferred 

8–86 ASTM F1926–03 Standard Test Method for Evaluation of 

the Environmental Stability of Calcium Phosphate Coatings 

Relevant guidance 

8–88 ASTM F2024–00 Standard Practice for X-Ray Diffraction 

Determination of Phase Content of Plasma-Sprayed 

Hydroxyapatite Coatings 

Relevant guidance 

8–98 8–162 ASTM F451–99a(2007)e1 Standard Specification for Acrylic 

Bone Cement 

Withdrawn and replaced with newer 

year version 

8–104 ASTM F1108–04 Standard Specification for Titanium–

6Aluminum–4Vanadium Alloy Castings for Surgical Implants (UNS R56406) 

Contact person 

8–108 ASTM F1295–05 Standard Specification for Wrought Titanium–6 Aluminum–7 Niobium Alloy for Surgical Implant 

Applications (UNS R56700) 

Contact person 

8–110 ASTM F1377–04 Standard Specification for Cobalt–28 Chromium–6 Molybdenum Powder for Coating of Orthopedic 

Implants (UNS R30075) 

Contact person 

8–112 ASTM F1044–05 Standard Test Method for Shear Testing of 

Calcium Phosphate Coatings and Metallic Coatings 

Relevant guidance 

8–113 ASTM F1147–05 Standard Test Method for Tension Testing 

of Calcium Phosphate and Metal Coatings 

Relevant guidance 

8–119 ASTM F688–05 Standard Specification for Wrought Cobalt–

35 Nickel–20 Chromium–10 Molybdenum Alloy Plate, 

Sheet, and Foil for Surgical Implants (UNS R30035) 

Contact person 


jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 73, No. 175 / Tuesday, September 9, 2008 / Notices 52371 

TABLE 2.—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Old Recognition No. Replacement 

Recognition No. Standard Change 

8–120 8–160 ASTM F0560–07 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, 

UNS R05400) 

Withdrawn and replaced with newer 

year version 

8–123 ISO 5832–5:2005 Implants for Surgery—Metallic Materials—

Part 5: Wrought Cobalt-Chromium-Tungsten-Nickel Alloy 

Contact person 

8–127 ISO 5834–2:2006 Implants for Surgery—Ultra-high-molecular-weight polyethylene—Part 2: Moulded Forms Relevant guidance 

8–129 ASTM F67–06 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, 

UNS R50400, UNS R50550, UNS R50700) 

Contact person 

8–130 ASTM F620–06 Standard Specification for Alpha Plus Beta 

Titanium Alloy Forgings for Surgical Implants 

Contact person 

8–131 ASTM F799–06 Standard Specification for Cobalt–28 Chromium–6 Molybdenum Alloy Forgings for Surgical Implants 

(UNS R31537, R31538, R31539) 

Contact person 

8–132 ASTM F1088–04ae1 Standard Specification for BetaTricalcium Phosphate for Surgical Implantation Contact person 

8–137 ASTM F0075–07 Standard Specification for Cobalt–28 Chromium–6 Molybdenum Alloy Castings and Casting Alloy for 

Surgical Implants (UNS R30075) 

Contact person 

8–138 ASTM F0745–07 Standard Specification for 18 Chromium–

12.5 Nickel–2.5 Molybdenum Stainless Steel for Cast and 

Solution-Annealed Surgical Implant Applications 

Contact person 

8–139 ASTM F1314–07 Standard Specification for Wrought Nitrogen Strengthened 22 Chromium - 13 Nickel - 5 Manganese - 2.5 Molybdenum Stainless Steel Alloy Bar and 

Wire for Surgical Implants (UNS S20910) 

Contact person 

8–142 ASTM F1978–00(2007)e2 Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray 

Coatings by Using the Taber Abraser 

Relevant guidance 

8–144 ASTM F0754–00 Standard Specification for Implantable 

Polytetrafluoroethylene (PTFE) Polymer Fabricated in 

Sheet, Tube and Rod Shapes 

Contact person 

8–145 ASTM F0090–07 Standard Specification for Wrought Cobalt–20 Chromium–15 Tungsten–10 Nickel Alloy for Surgical Implant Applications (UNS R30605) Contact person 

8–147 ASTM F0562–07 Standard Specification for Wrought 

35Cobalt–35Nickel–20Chromium–10Molybdenum Alloy for 

Surgical Implant Applications (UNS R30035) 

Contact person 

8–149 ISO 5832–1:2007 Implants for Surgery—Metallic Materials—

Part 1: Wrought Stainless Steel 

Contact person 

8–150 ISO 5832–9:2007 Implants for Surgery—Metallic Materials—

Part 9: Wrought High Nitrogen Stainless Steel 

Contact person 

8–151 ISO 5832–12:2007 Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-Chromium-Molybdenum 

Alloy 

Contact person 

8–152 ASTM F1537–07 Standard Specification for Wrought Cobalt–28Chromium–6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539) Contact person 

I. OB-GYN/Gastroenterology 


jlentini on PROD1PC65 with NOTICES
52372 Federal Register / Vol. 73, No. 175 / Tuesday, September 9, 2008 / Notices 

TABLE 2.—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Old Recognition No. Replacement 

Recognition No. Standard Change 

9–4 IEC 60601–2–16 (1998) Medical Electrical Equipment—Part 

2–16: Particular Requirements for the Safety of 

Haemodialysis, Haemodiafiltration and Haemofiltration 

Equipment 

Relevant guidance and Contact person 

9–6 IEC 60601–2–36 (1997) Medical Electrical Equipment—Part 

2–36: Particular Requirements for the Safety of Equipment for Extracorporeally Induced Lithotripsy 

Title, Relevant guidance, CFR Citation, and Product Codes 

9–7 IEC 61846 (1998) Ultrasonics—Pressure Pulse 

Lithotripters—Characteristics of Fields 

Relevant guidance, CFR Citation, 

and Product Codes 

9–21 ISO 8600–4:1997 Optics and Optical Instruments—Medical 

Endoscopes and Certain Accessories—Part 4: Determination of Maximum Width of Insertion Portion 

Relevant guidance 

9–23 ASTM F1518–00 Standard Practice for Cleaning and Disinfection of Flexible Fiberoptic and Video Endoscopes 

Used in the Examination of the Hollow Viscera 

Relevant guidance, CDRH Office 

and Division associated with recognized standard 

9–25 AAMI / ANSI HF18:2001 Electrosurgical Devices Withdrawn 

9–28 9–47 ANSI/AAMI RD16:2007 Cardiovascular Implants and Artificial Organs—Hemodialyzers, Hemodiafilters, Hemofilters, 

and Hemoconcentrators 

Withdrawn and replaced with newer 

version 

9–29 9–48 AAMI / ANSI RD17 :2007 Cardiovascular Implants and artificial organs—Extracorporeal Blood Circuit for 

Hemodialyzers, Hemodiafilters, and Hemofilters 

Withdrawn and replaced with newer 

version 

9–32 ASTM D3492–03 Standard Specification for Rubber Contraceptives (Male Condoms) Relevant guidance 

9–34 ISO 4074:2002/Cor.1:2003(E) Natural Latex Rubber 

Condoms—Requirements and Test Methods, Technical 

Corrigendum 1 

Relevant guidance 

9–37 ISO 8600–1:2005 Optics and Photonics—Medical 

Endoscopes and Endotherapy Devices—Part 1: General 

Requirements ISO 8600–1:2005 

Relevant guidance 

9–38 ISO 8600–3:1997 Amendment 1 2003, Optics and Optical 

Instruments—Medical Endoscopes and Endoscopic Accessories Part 3: Determination of Field of View and Direction of View of Endoscopes with Optics 

Relevant guidance 

9–39 ISO 8600–5:2005 Optics and Photonics—Medical 

Endoscopes and Endotherapy Devices—Part 5: Determination of Optical Resolution of Rigid Endoscopes with 

Optics 

Relevant guidance 

9–40 ISO 8600–6:2005 Optics and Photonics—Medical 

Endoscopes and Endotherapy Devices—Part 6: Vocabulary 

Relevant guidance 

9–41 ASTM D6324–05 Standard Test Methods for Male Condoms 

Made from Synthetic Materials 

Relevant guidance 

9–42 IEC 60601–2–18 (1996) Amendment 1 2000 Medical electrical equipment—Part 2: Particular Requirements for the 

Safety of Endoscopic Equipment 

Relevant guidance 

9–43 ISO 16038:2005 Rubber Condoms—Guidance on the Use 

of ISO 4074 in the Quality Management of Natural Rubber 

Latex Condoms 

Relevant guidance 

J. Ophthalmic 

10–21 ISO 11979–2:1999 Ophthalmic Implants—Intraocular 

Lenses—Part 2: Optical Properties and Test Methods 

Withdrawn 


jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 73, No. 175 / Tuesday, September 9, 2008 / Notices 52373 

TABLE 2.—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Old Recognition No. Replacement 

Recognition No. Standard Change 

10–23 ISO 11981:1999 Ophthalmic Optics—Contact Lenses and 

Contact Lens Care Products—Determination of Physical 

Compatibility of Contact Lens Care Products With Contact 

Lenses 

Withdrawn 

10–42 ISO 11979–2:1999/Corrigendum1:2003 Ophthalmic Implants—Intraocular Lenses—Part 2: Optical Properties 

and Test Methods 

Extent of recognition and Process 

impacted 

10–44 ISO 11981:1999/Corrigendum1:2005 Ophthalmic Optics—

Contact Lenses and Contact Lens Car Products—Determination of Physical Compatibility of Contact Lens Care 

Products with Contact Lenses 

Relevant guidance and Process impacted 

K. Orthopedic 

11–73 ISO 5838–1:1995 Implants for Surgery—Skeletal Pins and 

Wires—Part 1: Material and Mechanical Requirements 

Type of standard and Contact person 

11–74 ISO 5838–2:1991 Implants for Surgery—Skeletal Pins and 

Wires—Part 2: Steinmann Skeletal Pins—Dimensions 

Type of standard and Contact person 

11–75 ISO 5838–3:1993 Implants for Surgery—Skeletal Pins and 

Wires—Part 3: Kirschner Skeletal Wires 

Type of standard and Contact person 

11–79 ISO 7206–8:1995 Implants for Surgery—Partial and Total 

Hip Joint Prostheses—Part 8: Endurance Performance of 

Stemmed Femoral Components with Application of Torsion 

Type of standard, CFR Citation, 

Product codes and Relevant guidance 

11–80 ISO 8828:1988 Implants for Surgery—Guidance on Care 

and Handling of Orthopaedic Implants 

Contact person Processes Impacted 

11–81 8–157 ISO 9583:1993 Implants for Surgery—Non-Destructive Testing—Liquid Penetrant Inspection of Metallic Surgical Implants Transferred 

11–82 8–159 ISO 9584:1993 Implants for Surgery—Non-Destructive Testing—Radiographic Examination of Cast Metallic Surgical 

Implants 

Transferred 

11–155 ISO 7207–2:1998 Implants for Surgery—Components for 

Partial and Total Knee Joint Prostheses—Part 2: Articulating Surfaces Made of Metal, Ceramic and Plastics Materials 

Type of standard and Relevant 

guidance 

11–164 11–203 ASTM F1541–02(2007) Standard Specification and Test 

Methods for External Skeletal Fixation Devices 

Withdrawn and replaced with newer 

version 

11–166 11–204 ASTM F0897–02(2007) Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and 

Screws 

Withdrawn and replaced with newer 

version 

11–168 ASTM F1781–03 Standard Specification for Elastomeric 

Flexible Hinge Finger Total Joint Implants 

Type of standard 

11–171 ASTM F1814–97a(2003) Standard Guide for Evaluating 

Modular Hip and Knee Joint Components 

Type of standard and Relevant 

guidance 

11–172 ASTM F1798–97(2003) Standard Guide for Evaluating the 

Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants 

Type of standard and Relevant 

guidance 

11–175 ASTM F1582–98(2003) Standard Terminology Relating to 

Spinal Implants 

Type of standard, CFR Citation, 

Product codes and Relevant guidance 

11–177 11–205 ASTM F1264–03(2007) Standard Specification and Test 

Methods for Intramedullary Fixation Devices 

Withdrawn and replaced with newer 

version 


jlentini on PROD1PC65 with NOTICES
52374 Federal Register / Vol. 73, No. 175 / Tuesday, September 9, 2008 / Notices 

TABLE 2.—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Old Recognition No. Replacement 

Recognition No. Standard Change 

11–178 ASTM F1440–92(2002) Standard Practice for Cyclic Fatigue 

Testing of Metallic Stemmed Hip Arthroplasty Femoral 

Components Without Torsion 

Processes impacted, Type of standard, CFR Citation, Product codes 

and Relevant guidance 

11–179 ASTM F2068–03 Standard Specification for Femoral Prostheses—Metallic Implants Processes impacted, Type of standard, CFR Citation, Product codes 

and Relevant guidance 

11–180 ASTM F0366–04 Standard Specification for Fixation Pins 

and Wires 

Type of standard and Contact person 

11–181 ASTM F1717–04 Standard Test Methods for Spinal Implant 

Constructs in a Vertebrectomy Model 

Type of standard and Relevant 

guidance 

11–182 11–206 ASTM F1800–07 Standard Test Method for Cyclic Fatigue 

Testing of Metal Tibial Tray Components of Total Knee 

Joint Replacements 

Withdrawn and replaced with newer 

version 

11–183 ASTM F1875–98(2004) Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral 

Head-Bore and Cone Taper Interface 

Type of standard, CFR Citations, 

Product codes and Relevant guidance 

11–184 ISO 8827:1988 Implants for surgery—Staples with Parallel 

Legs for Orthopaedic Use—General Requirements 

Type of standard and Contact person 

11–185 ASTM F2267–04 Standard Test Method for Measuring Load 

Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression 

CFR Citations, Product codes and 

Relevant guidance 

11–186 ASTM F2077–03 Test Methods for Intervertebral Body Fusion Devices Type of standard, CFR Citations, 

Product codes and Relevant guidance 

11–187 11–207 ASTM F2193–02(2007) Standard Specifications and Test 

Methods for Components Used in the Surgical Fixation of 

the Spinal Skeletal System 

Withdrawn and replaced with newer 

version 

11–188 ISO 14243–1:2002 Implants for Surgery—Wear of Total 

Knee-Joint Prostheses—Part 1: Loading and Displacement Parameters for Wear-Testing Machines With Load 

Control and Corresponding Environmental Conditions for 

Test 

Type of standard, CFR Citations 

and Product codes 

11–189 ISO 14243–2:2000 Implants for Surgery—Wear of Total 

Knee-Joint Prostheses—Part 2: Methods of Measurement 

Type of standard, Extent of recognition, CFR Citations and Product 

codes 

11–190 ISO 14243–3:2004 Implants for Surgery—Wear of Total 

Knee-Joint Prostheses—Part 3: Loading and Displacement Parameters for Wear-Testing Machines With Displacement Control and Corresponding Environmental 

Conditions for Test 

Type of standard, CFR Citations 

and Product codes 

11–191 ISO 14879–1:2000 Implants for Surgery—Total Knee-Joint 

Prostheses—Part 1: Determination of Endurance Properties of Knee Tibial Trays 

Type of standard 

11–192 ASTM F1223–05 Standard Test Method for Determination of 

Total Knee Replacement Constraint 

Type of standard CFR Citations and 

Product codes 

11–194 11–208 ISO 14630:2008 Non-Active Surgical Implants—General Requirements—3d Edition Withdrawn and replaced with newer 

version 

11–195 ASTM F1612–95(2005) Standard Practice for Cyclic Fatigue 

Testing of Metallic Stemmed Hip Arthroplasty Femoral 

Components with Torsion 

Type of standard, CFR Citations, 

Product codes and Relevant guidance 

11–196 ASTM F1672–95(2005) Standard Specification for Resurfacing Patellar Prosthesis Type of standard and Relevant 

guidance 


jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 73, No. 175 / Tuesday, September 9, 2008 / Notices 52375 

TABLE 2.—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Old Recognition No. Replacement 

Recognition No. Standard Change 

11–197 ASTM F0983–86(2005) Standard Practice for Permanent 

Marking of Orthopaedic Implant Components 

Contact person and Processes impacted 

11–198 ASTM F0382–99(2003)e1 Standard Specification and Test 

Method for Metallic Bone Plates 

Type of standard and Contact person 

11–199 ASTM F0565–04 Standard Practice for Care and Handling 

of Orthopedic Implants and Instruments 

Contact person and Processes impacted 

11–200 11–209 ASTM F2083–07 Standard Specification for Total Knee 

Prosthesis 

Withdrawn and replaced with newer 

version 

11–201 ASTM F0564–02(2006) Standard Specification and Test 

Methods for Metallic Bone Staples 

Contact person 

11–202 11–210 ASTM F0543–07 Standard Specification and Test Methods 

for Metallic Medical Bone Screws 

Withdrawn and replaced with newer 

version 

L. Physical Medicine 

16–19 ISO 7176–4:1997 Wheelchairs—Part 4: Energy Consumption of Electric Wheelchairs and Scooters for Determination of Theoretical Distance Range Contact person and Type of standard 

16–20 ISO 7176–5:1986 Wheelchairs—Part 5: Determination of 

Overall Dimensions, Mass and Turning Space 

Contact person and Type of standard 

16–23 ISO 7176–10:1988 Wheelchairs—Part 10: Determination of 

Obstacle-Climbing Ability of Electric Wheelchairs 

Contact person and Type of standard 

16–24 ISO 7176–11:1992 Wheelchairs—Part 11: Test Dummies Contact person and Type of standard 

16–25 ISO 7176–13:1989 Wheelchairs—Part 13: Determination of 

Coefficient of Friction of Test Surfaces 

Contact person and Type of standard 

16–26 ISO 7176–14:1997 Wheelchairs—Part 14: Power and Control Systems for Electric Wheelchairs—Requirements and 

Test Methods 

Contact person and Type of standard 

16–27 ISO 7176–15:1996 Wheelchairs—Part 15: Requirements for 

Information Disclosure, Documentation and Labeling 

Contact person and Type of standard 

16–28 ISO 7176–16: 1997 Wheelchairs—Part 16: Resistance to Ignition of Upholstered Parts—Requirements and Test 

Methods 

Contact person and Type of standard 

16–29 ISO 7176–6:2001 Wheelchairs—Part 6: Determination of 

Maximum Speed, Acceleration and Deceleration of Electric Wheelchairs 

Contact person and Type of standard 

16–30 ISO 7176–9:2001 Wheelchairs—Part 9: Climatic Tests for 

Electric Wheelchairs 

Contact person and Type of standard 

16–31 ANSI/RESNA WC/Volume 1–1998 Section 1: Determination 

of Static Stability 

Contact person and Type of standard 

16–32 ANSI/RESNA WC/Volume 2–1998 Section 2: Determination 

of Dynamic Stability of Electric Wheelchairs 

Contact person and Type of standard 

16–33 ANSI/RESNA WC/Volume 2–1998 Section 3: Test Methods 

and Requirements for the Effectiveness of Brakes 

Contact person and Type of standard 

16–34 ANSI/RESNA WC/Volume 2–1998 Section 4: Determination 

of Energy Consumption of Electric Wheelchairs 

Contact person and Type of standard 

16–35 ANSI/RESNA WC/Volume 1–1998 Section 5: Determination 

of Overall Dimensions, Mass, and Turning Space—Wheelchair 

Contact person and Type of standard 


jlentini on PROD1PC65 with NOTICES
52376 Federal Register / Vol. 73, No. 175 / Tuesday, September 9, 2008 / Notices 

TABLE 2.—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Old Recognition No. Replacement 

Recognition No. Standard Change 

16–36 ANSI/RESNA WC/Volume 2–1998 Section 6: Determination 

of Maximum Speed, Acceleration, and Retardation of 

Electric Wheelchairs 

Contact person and Type of standard 

16–37 ANSI/RESNA WC/Volume 1–1998 Section 7: Wheelchairs - 

Determination of Seating and Wheel Dimensions 

Contact person and Type of standard 

16–38 ANSI/RESNA WC/Volume 1–1998 Section 8: Wheelchairs—

Static, Impact and Fatigue Strength Tests 

Contact person and Type of standard 

16–39 ANSI/RESNA WC/Volume 2 - 1998 Section 9: Climatic 

Tests for Electric Wheelchairs 

Contact person and Type of standard 

16–40 ANSI/RESNA WC/Volume 2 - 1998 Section 10: Determination of the Obstacle-Climbing Ability of Electric Wheelchairs Contact person and Type of standard 

16–41 ANSI/RESNA WC/Volume 1 - 1998 Section 11: Wheelchairs—Test Dummies Contact person and Type of standard 

16–42 ANSI/RESNA WC/Volume 1 - 1998 Section 13: Determination of Coefficient of Friction of Test Surfaces Contact person and Type of standard 

16–43 ANSI/RESNA WC/Volume 2 - 1998 Section 14: Wheelchairs—Testing of Power and Control Systems for Electric 

Wheelchairs 

Contact person and Type of standard 

16–44 ANSI/RESNA WC/Volume 1 - 1998 Section 15: Wheelchairs—Requirements for Information Disclosures, Documentation and Labeling Contact person and Type of standard 

16–45 ANSI/RESNA WC/Volume 1 - 1998 Section 16: Wheelchairs—Determination of Flammability Title change, Contact person and 

Type of standard 

16–46 ANSI/RESNA WC/Volume 1 - 1998 Section 20: Wheelchairs—Determination of the Performance of Stand-Up 

Wheelchairs 

Contact person and Type of standard 

16–47 ANSI/RESNA WC/Volume 1 - 1998 Section 22: Wheelchairs—Set Up Procedures Contact person and Type of standard 

16–48 ANSI/RESNA WC/Volume 1 - 1998 Section 93: Maximum 

Overall Dimensions 

Contact person and Type of standard 

16–49 ANSI/RESNA WC/Volume 1 - 1998 Section 0: Nomenclature, Terms, and Definitions Contact person and Type of standard 

16–50 ISO 7176–3:2003 Wheelchairs—Part 3: Determination of Effectiveness of Brakes Contact person and Type of standard 

16–158 ISO 7176–1:1999 Wheelchairs—Part 1: Determination of 

Static Stability 

Contact person and Type of standard 

16–159 ISO 7176–2:2001 Wheelchairs—Part 2: Determination of 

Dynamic Stability of Electric Wheelchairs 

Contact person and Type of standard 

M. Radiology 

12–17 NEMA MS 8–1993 (2000), Characterization of the Specific 

Absorption Rate for Magnetic Resonance Imaging Systems 

Relevant guidance and Contact person 

12–61 12–177 UL 122 (2007): Standard for Photographic Equipment—Ed. 

5.0 

Withdrawn and replaced with newer 

version 

12–64 12–178 IEC 60601–2–45 Ed. 2.0, (2006) Medical Electrical Equipment—Part 2–45: Particular Requirements for the Safety 

of Mammographic X-ray Equipment and Mammographic 

Stereotactic Devices 

Withdrawn and replaced with newer 

version 


jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 73, No. 175 / Tuesday, September 9, 2008 / Notices 52377 

TABLE 2.—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Old Recognition No. Replacement 

Recognition No. Standard Change 

12–69 NEMA MS 6–1991 (R2000) Characterization of Special Purpose Coils for Diagnostic Magnetic Resonance Images Relevant guidance, Contact person 

and CFR Citations 

12–95 NEMA MS 2–2003 Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images Relevant guidance and Contact person 

12–96 NEMA MS 3–2003 Determination of Image Uniformity in Diagnostic Magnetic Resonance Images Relevant guidance and Contact person 

12–97 NEMA MS–1–2001 Determination of Signal-to-Noise Ratio 

(SNR) in Diagnostic Magnetic Resonance Imaging 

Relevant guidance, Contact person 

and CFR Citations 

12–103 12–179 ANSI / IESNA RP–27.3–2007 Recommended Practice for 

Photobiological Safety for Lamps—Risk Group Classification and Labeling 

Withdrawn and replaced with newer 

version 

12–120 IEC 60601–2–44 (2002–11): Medical Electrical Equipment—

Part 2–44: Particular Requirements for the Safety of X-ray 

Equipment for Computed Tomography—Ed. 2.1 

Relevant guidance and CFR Citations 

12–123 12–180 IEC 61689:2007 Ultrasonics—Physiotherapy Systems—Field 

Specifications and Methods of Measurement in the Frequency Range 0,5 MHz to 5 MHz Ed. 2.0 

Withdrawn and replaced with newer 

version 

12–125 NEMA MS 5–2003 Determination of Slice Thickness in Diagnostic Magnetic Resonance Imaging Relevant guidance and Contact person 

12–129 12–181 NU 1–2007 Performance Measurements of Gamma Cameras Withdrawn and replaced with newer 

version 

12–131 12–184 IEC 61217 2002 Consolidated Ed. 1.1, 2007 Amendment 2 

Ed. 1.0 Radiotherapy Equipment—Coordinates, Movements, and Scales 

Withdrawn and replaced with newer 

version 

12–150 IEC / ISO 10918–1:1994 Technical Corrigendum 1:2005 Information Technology—Digital Compression and Coding 

of Continuous-Tone Still Images—Part 1: Requirements 

Relevant guidance, Contact person, 

CFR Citations, Product code, and 

Devices affected 

12–151 NEMA MS 4 (2006) Acoustic Noise Measurement Procedure 

for Diagnosing Magnetic Resonance Imaging Devices 

Relevant guidance, Contact person 

and CFR Citations 

12–158 NEMA MS 10–2006 Determination of Local Specific Absorption Rate (SAR) in Diagnostic Magnetic Resonance Imaging Relevant guidance, Contact person 

and CFR Citations 

12–159 NEMA MS 11–2006 Determination of Gradient-Induced 

Electric Fields in Diagnostic Magnetic Resonance Imaging 

Relevant guidance, Contact person 

and CFR Citations 

12–160 NEMA MS 12–2006 Quantification and Mapping of Geometric Distortion for Special Applications Relevant guidance, Contact person 

and CFR Citations 

12–161 IEC 60601–2–33 (2006), Medical Electrical Equipment—Part 

2–33: Particular Requirements for the Safety of Magnetic 

Resonance Equipment for Medical Diagnosis 

Relevant guidance and Contact person 

12–164 12–182 IEC 60601–2–37:2007 Medical Electrical Equipment—Part 

2–37: Particular Requirements for the Basic Safety and 

Essential Performance of Ultrasonic Medical Diagnostic 

and Monitoring Equipment 

Withdrawn and replaced with newer 

version 

12–165 NEMA XR 22–2006 ‘‘Quality Control Manual’’ Template for 

Manufacturers of Displays and Workstations Labeled for 

Final Interpretation in Full-Field Digital Mammography 

Relevant guidance 

12–166 NEMA XR 23–2006 ‘‘Quality Control Manual’’ Template for 

Manufacturers of Hardcopy Output Devices Labeled for 

Final Interpretation in Full-Field Digital Mammography 

Relevant guidance 

12–168 IEC 60825–1 Ed. 2.0 (2007) Safety of Laser Products—Part 

1: Equipment Classification, and Requirements 

Contact person and Processes impacted 


jlentini on PROD1PC65 with NOTICES
52378 Federal Register / Vol. 73, No. 175 / Tuesday, September 9, 2008 / Notices 

TABLE 2.—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Old Recognition No. Replacement 

Recognition No. Standard Change 

12–169 IEC 60601–2–22 Ed. 3.0 (2007) Medical Electrical Equipment—Part 2–22: Particular Requirements for Basic Safety and Essential Performance of Surgical, Cosmetic, 

Therapeutic and Diagnostic Laser Equipment 

Contact person, Processes impacted and Title 

12–170 12–183 NEMA PS 3.1 - 3.18 (2008) Digital Imaging and Communications in Medicine (DICOM) Set Withdrawn and replaced with newer 

versions 

5–7 12–185 IEC 60601–1–3 2008 Edition 2.0 Medical Electrical Equipment—Part 1–3:General Requirements for Basic Safety 

and Essential Performance—Collateral Standard: Radiation Protection in Diagnostic X-ray Equipment 

Transferred 

N. Software/Informatics 

13–4 ANSI/UL 1998, Software in Programmable Components CFR Citations, Product codes, Relevant guidance and Extent of recognition 

13–5 IEEE 1074:1997, Standard for Developing Software Life 

Cycle Processes 

Withdrawn 

13–8 IEC 62304 Ed. 1.0, Medical Device Software—Software Life 

Cycle Processes 

CFR Citations, Product codes, Relevant guidance, and Extent of 

recognition 

7–59 13–9 CLSI AUTO2–A2 Laboratory Automation: Bar Codes for 

Specimen Container Identification; Approved Standard 

Transferred 

7–60 13–10 CLSI AUTO1–A Laboratory Automation: Specimen Container/Specimen Carrier; Approved Standard Transferred 

7–61 13–11 CLSI AUTO3–A Laboratory Automation: Communications 

with Automated Clinical Laboratory Systems, Instruments, 

Devices, and Information Systems; Approved Standard 

Transferred 

7–62 13–12 CLSI AUTO4–A Laboratory Automation: Systems Operational Requirements, Characteristics, and Information 

Elements; Approved Standard 

Transferred 

7–63 13–13 CLSI AUTO5–A Laboratory Automation: Electromechanical 

Interfaces; Approved Standard 

Transferred 

7–64 13–14 CLSI POCT1–A2 Point-of-Care Connectivity; Approved 

Standard 

Transferred 

7–68 13–15 CLSI GP19–A2 Laboratory Instruments and Data Management Systems: Design of Software User Interfaces and 

End-User Software Systems Validation, Operation, and 

Monitoring; Approved Guideline—Second Edition 

Transferred 

7–114 13–16 CLSI LIS01–A Standard Specification for Low-Level Protocol 

to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems 

Transferred 

7–115 13–17 CLSI LIS02–A2 Standard Specification for Transferring Information Between Clinical Instruments and Computer Systems; Approved Standard-Second Edition Transferred 

7–116 13–18 CLSI LIS03–A Standard Guide for Selection of a Clinical 

Laboratory Information Management System 

Transferred 

7–117 13–19 CLSI LIS04–A Standard Guide for Documentation of Clinical 

Laboratory Computer Systems 

Transferred 

7–118 13–20 CLSI LIS05–A Standard Specification for Transferring Clinical Observations Between Independent Computer Systems Transferred 

7–119 13–21 CLSI LIS06–A Standard Practice for Reporting Reliability of 

Clinical Laboratory Information Systems 

Transferred 


jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 73, No. 175 / Tuesday, September 9, 2008 / Notices 52379 

TABLE 2.—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Old Recognition No. Replacement 

Recognition No. Standard Change 

7–120 13–22 CLSI LIS07–A Standard Specification for Use of Bar Codes 

on Specimen Tubes in the Clinical Laboratory 

Transferred 

7–121 13–23 CLSI LIS08–A Standard Guide for Functional Requirements 

of Clinical Laboratory Information Management Systems 

Transferred 

7–122 13–24 CLSI LIS09–A Standard Guide for Coordination of Clinical 

Laboratory Services within the Electronic Health Record 

Environment and Networked Architectures 

Transferred 

O. Sterility 

14–24 AAMI/ANSI/ISO 11134:1993 Sterilization of Health Care 

Products—Requirements for Validation and Routine Control-Industrial Moist Heat Sterilization 

Withdrawn 

14–53 AAMI/ANSI ST66:1996 Sterilization of Health Care Products—Chemical Indicators—Part 2: Indicators for Air Removal Test Sheets and Packs Withdrawn 

14–54 AAMI/ANSI/ISO 11737–2:1998 Sterilization of Medical Devices—Microbiological Methods—Part 2: Tests of Sterility 

Performed in the Validation of a Sterilization Process 

CFR Citations, Product codes and 

Devices affected 

14–55 AAMI/ANSI/ISO 14160:1998 Sterilization of Single-Use Medical Devices Incorporating Materials of Animal Origin—

Validation and Routine Control of Sterilization by Liquid 

Chemical Sterilants 

Relevant guidance 

14–60 ASTM F1327:1998 Standard Terminology Relating to Barrier 

Materials for Medical Packaging 

Withdrawn 

14–63 ASTM F1886: 1998 (2004) Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual 

Inspection 

CFR Citations and Product codes 

14–64 ASTM F1929:1998 (2004) Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration CFR Citations and Product codes 

14–70 AAMI/ANSI/ISO 14161:2000 Sterilization of Health Care 

Products—Biological Indicators—Guidance for the Selection, Use and Interpretation of Results, 2ed. 

CFR Citations, Product codes and 

Devices affected 

14–76 AAMI/ANSI/ISO 10993–7:1995 (R) 2001 Biological Evaluation of Medical Devices—Part 7: Ethylene Oxide Sterilization Residuals CFR Citations, Product codes and 

Contact person 

14–88 AAMI/ANSI/ISO 14937:2000 Sterilization of Health Care 

Products—General Requirements for Characterization of a 

Sterilizing Agent and the Development, Validation, and 

Routine Control of a Sterilization Process for Medical Devices 

CFR Citations and Product codes 

14–90 14–256 ASTM F2095–07 Standard Test Methods for Pressure 

Decay Leak Test for Nonporous Flexible Packages With 

and Without Restraining Plates 

Withdrawn and replaced with newer 

version 

14–116 AAMI ST72:2002 Bacterial endotoxins—Test Methodologies, 

Routine Monitoring, and Alternatives to Batch Testing 

CFR Citations, Product codes, Type 

of standard, Guidance and Extent 

of recognition 

14–120 ASTM D3078:2002 Standard Test Method for Determination 

of Leaks in Flexible Packaging by Bubble Emission 

CFR Citations, Product codes and 

Type of standard 

14–123 ASTM F2096–04 Standard Test Method for Detecting Gross 

Leaks in Medical Packaging by Internal Pressurization 

(Bubble Test) 

CFR Citations, Product codes, 

CDRH Office and Division associated with recognized standard 


jlentini on PROD1PC65 with NOTICES
52380 Federal Register / Vol. 73, No. 175 / Tuesday, September 9, 2008 / Notices 

TABLE 2.—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Old Recognition No. Replacement 

Recognition No. Standard Change 

14–135 AAMI/ANSI ST63:2002 Sterilization of Health Care Products—Requirements for the Development, Validation and 

Routine Control of an Industrial Sterilization Process for 

Medical Devices—Dry Heat 

CFR Citations, Product codes and 

Type of standard 

14–136 AAMI/ANSI ST67:2003 Sterilization of Health Care Products—Requirements for Products Labeled ’Sterile’ 1st Edition CFR Citations, Product codes and 

Guidance 

14–138 ISO 13408–2:2003 Aseptic Processing of Health Care Products—Part 2: Filtration CFR Citations, Product codes, Type 

of standard and Guidance 

14–139 ISO 14644–1:1999 Cleanrooms and Associated Controlled 

Environments—Part 1: Classification of Air Cleanliness 

CFR Citations, Product codes and 

Type of standard 

14–140 ISO 14644–2:2000 Cleanrooms and Associated Controlled 

Environments—Part 2: Specification for Testing and Monitoring to Prove Continued Compliance With ISO 14644–1 

CFR Citations, Product codes and 

Type of standard 

14–141 ISO 14644–4:2001 Cleanrooms and Associated Controlled 

Environments—Part 4: Design, Construction and Startup 

CFR Citations, Product codes and 

Type of standard 

14–142 ISO 14698–1:2003 Cleanrooms and Associated Controlled 

Environments—Biocontamination Control—Part 1: General 

Principles and Methods 

CFR Citations, Product codes and 

Type of standard 

14–143 ISO 14698–2:2003 Cleanrooms and Associated Controlled 

Environments—Biocontamination Control—Part 2: Evaluation and Interpretation of Biocontamination Data 

CFR Citations, Product codes and 

Type of standard 

14–148 ASTM F2250–03 Standard Practice for Evaluation of Chemical Resistance of Printed Inks and Coatings on Flexible 

Packaging Materials 

CFR Citations, Product codes and 

Type of standard 

14–149 ASTM F2251–03e1 Standard Test Method for Thickness 

Measurement of Flexible Packaging Material 

CFR Citations, Product codes and 

Type of standard 

14–150 ASTM F2252–03 Standard Practice for Evaluating Ink or 

Coating Adhesion to Flexible Packaging Materials Using 

Tape 

CFR Citations, Product codes and 

Type of standard 

14–164 AAMI/ANSI ST81:2004 Sterilization of Medical Devices—Information to be Provided by the Manufacturer for the 

Processing of Resterilizable Devices 

CFR Citations, Product codes, and 

Devices affected 

14–165 ISO 14644–5:2004 Cleanrooms and Associated Controlled 

Environments—Part 5: Operations 

CFR Citations, Product codes and 

Type of standard 

14–166 ISO 14644–7:2004 Cleanrooms and Associated Controlled 

Environments—Part 7: Separative Devices (Clean Air 

Hoods, Gloveboxes, Isolators and Mini-Environments) 

CFR Citations, Product codes and 

Type of standard 

14–168 14–245 ASTM F2338–07 Standard Test Method for Nondestructive 

Detection of Leaks in Packages by Vacuum Decay Method 

Withdrawn and replaced with newer 

version 

14–169 ASTM F2391–05 Standard Test Method for Measuring 

Package and Seal Integrity Using Helium as Tracer Gas 

CFR Citations, Product codes and 

Type of standard 

14–170 ASTM F2475–05 Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials CFR Citations, Product codes and 

Type of standard 

14–191 ISO 13408–4:2005 Aseptic Processing of Health care Products—Part 4: Clean-in-Place Technologies CFR Citations, Product codes, Type 

of standard and Relevant guidance 

14–193 AAMI/ANSI/ISO 11607–1:2006 Packaging for terminally 

Sterilized Medical Devices—Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems, 

3d ed. 

CFR Citations, Product codes, Devices affected and Relevant guidance 


jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 73, No. 175 / Tuesday, September 9, 2008 / Notices 52381 

TABLE 2.—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Old Recognition No. Replacement 

Recognition No. Standard Change 

14–194 AAMI/ANSI/ISO 11607–2:2006 Packaging for Terminally 

Sterilized Medical Devices—Part 2: Validation Requirements for Forming, Sealing and Assembly Processes, 1st 

ed. 

CFR Citations, Product codes, Devices affected and Relevant guidance 

14–197 ASTM F1608:00(2004) Standard Test Method for Microbial 

Ranking of Porous Packaging Materials (Exposure Chamber Method) 

CFR Citations and Product codes 

14–199 ASTM D4169–05 Standard Practice for Performance Testing 

of Shipping Containers and Systems 

Related CFR Citations and Product 

codes 

14–202 14–246 USP 31:2008 Biological Indicator for Dry-Heat Sterilization, 

Paper Carrier 

Withdrawn and replaced with newer 

version 

14–203 14–247 USP 31:2008 Biological Indicator for Ethylene Oxide Sterilization, Paper Carrier. Withdrawn and replaced with newer 

version 

14–204 14–248 USP 31:2008 Biological Indicator for Steam Sterilization, 

Paper Carrier 

Withdrawn and replaced with newer 

version 

14–205 14–249 USP 31:2008 <61> Microbial Limits Test Withdrawn and replaced with newer 

version 

14–206 14–250 USP 31:2008 <71> Microbiological Tests, Sterility Tests Withdrawn and replaced with newer 

version 

14–207 14–251 USP 31:2008 <85> Biological Tests and Assays, Bacterial 

Endotoxin Test (LAL) 

Withdrawn and replaced with newer 

version 

14–208 14–252 USP 31:2008 <151> Pyrogen Test (USP Rabbit Test) Withdrawn and replaced with newer 

version 

14–209 14–253 USP 31:2008 <161> Transfusion and Infusion Assemblies 

and Similar Medical Devices 

Withdrawn and replaced with newer 

version 

14–210 14–254 USP 31:2008 Biological Indicator for Steam Sterilization—

Self Contained 

Withdrawn and replaced with newer 

version 

14–220 AAMI/ANSI ST79:2006 Comprehensive Guide to Steam 

Sterilization and Sterility Assurance in Health Care Facilities 

Type of Standard 

14–221 AAMI/ANSI/ISO TIR 11139:2006 Sterilization of Health Care 

Products—Vocabulary 

CFR Citations, Product codes, Title, 

Devices affected, and Type of 

standard 

14–222 AAMI/ANSI/ISO 18472:2006 Sterilization of Health Care 

Products—Biological and Chemical Indicators—Test 

Equipment 

Type of standard 

14–223 ANSI/AAMI/ISO 11138–1:2006 Sterilization of Health Care 

Products—Biological Indicators—Part 1: General Requirements 

Type of standard, Guidance and Extent of recognition 

14–224 AAMI/ANSI/ISO 11137–1:2006 Sterilization of Health Care 

Products—Radiation—Part 1: Requirements for Development, Validation, and Routine Control of a Sterilization 

Process for Medical Devices 

CFR Citations, Product codes, and 

Type of standard 

14–225 AAMI/ANSI/ISO 11137–2:2006 Sterilization of Health Care 

Products—Radiation—Part 2: Establishing the Sterilization 

Dose 

CFR Citations, Product codes and 

Type of standard 

14–226 AAMI/ANSI/ISO 11137–3:2006 Sterilization of Health Care 

Products—Radiation—Part 3: Guidance on Dosimetric Aspects 

CFR Citations, Product codes and 

Type of standard 


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52382 Federal Register / Vol. 73, No. 175 / Tuesday, September 9, 2008 / Notices 

TABLE 2.—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Old Recognition No. Replacement 

Recognition No. Standard Change 

14–227 AAMI/ANSI/ISO 11737–1:2006 Sterilization of Medical Devices-Microbiological Methods-Part 1: Determination of the 

Population of Microorganisms on Products, 2d, ed. 

CFR Citations, Product codes, Devices affected, CDRH Office and 

Division associated with recognized standard 

14–228 ANSI/AAMI/ISO 11135–1:2007 Sterilization of Health Care 

Products—Ethylene Oxide—Part 1: Requirements for the 

Development, Validation, and Routine Control of a Sterilization Process for Medical Devices 

CFR Citations, Product codes, Devices affected, and Type of standard 

14–229 ASTM F1980–07 Standard Guide for Accelerated Aging of 

Sterile Barrier Systems for Medical Devices 

CFR Citations and Product codes 

14–230 ASTM F2203–02(2007) Standard Test Method for Linear 

Measurement Using Precision Steel Rule 

CFR Citations, Product codes and 

Type of standard 

14–231 ASTM F2217–02(2007) Standard Practice for Coating/Adhesive Weight Determination CFR Citations, Product codes and 

Type of standard 

14–232 ASTM F2227–02(2007) Standard Test Method for Non-Destructive Detection of Leaks in Non-Sealed and Empty 

Medical Packaging Trays by CO2 Tracer Gas Method 

CFR Citations, Product codes and 

Type of standard 

14–233 ASTM F2228–02(2007) Standard Test Method for Non-Destructive Detection of Leaks in Medical Packaging Which 

Incorporates Porous Barrier Material by CO2 Tracer Gas 

Method 

CFR Citations, Product codes and 

Type of standard 

14–234 ASTM F2097–07 Standard Guide for Design and Evaluation 

of Primary Flexible Packaging for Medical Products 

CFR Citations, Product codes and 

Type of standard 

14–235 ASTM F1140–07 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages CFR Citations, Product codes and 

Type of standard 

14–236 ASTM F2054–07 Standard Test Method for Burst Testing of 

Flexible Package Seals Using Internal Air Pressurization 

Within Restraining Plates 

CFR Citations, Product codes and 

Type of standard 

14–237 ASTM F88–07 Standard Test Method for Seal Strength of 

Flexible Barrier Materials 

CFR Citations, Product codes and 

Type of standard 

14–239 ISO 13408–3:2006 Aseptic Processing of Health Care Products—Part 3: Lyophilization CFR Citations and Product codes 

14–240 ISO 13408–5:2006 Aseptic Processing of Health Care Products—Part 5: Sterilization-in-Place CFR Citations and Product codes 

14–241 ISO 13408–6:2005 Aseptic Processing of Health Care Products—Part 6: Isolator Systems CFR Citations and Product codes 

14–242 ISO 14644–3:2005 Cleanrooms and Associated Controlled 

Environments—Part 3: Test Methods 

CFR Citations and Product codes 

14–243 ISO 14644–6:2007 Cleanrooms and Associated Controlled 

Environments—Part 6: Vocabulary 

CFR Citations and Product codes 

14–244 ISO 14644–8:2006 Cleanrooms and Associated Controlled 

Environments—Part 8: Classification of Airborne Molecular Contamination 

CFR Citations and Product codes 

P. Tissue Engineering 

15–12 ASTM F2103–01(2007)e1 Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials 

Intended for Use in Biomedical and Tissue-Engineered 

Medical Product Applications 

CFR Citations and Product codes, 

Relevant guidance, Type of 

standard and CDRH Office and 

Division associated with recognized standard 


jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 73, No. 175 / Tuesday, September 9, 2008 / Notices 52383 

TABLE 2.—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Old Recognition No. Replacement 

Recognition No. Standard Change 

15–5 ASTM F2347–03, Standard Guide for Characterization and 

Testing of Hyaluronan as Starting Materials Intended for 

Use in Biomedical and Tissue Engineered Medical Product Applications 

CFR Citations and Product codes, 

Relevant guidance, Type of 

standard and CDRH Office and 

Division associated with recognized standard 

15–6 ASTM F2450–04, Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue Engineered 

Medical Products 

CFR Citations and Product codes, 

Relevant guidance, Type of 

standard and CDRH Office and 

Division associated with recognized standard 

15–7 ASTM F2315–03, Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels CFR Citations and Product codes, 

Relevant guidance, Type of 

standard and CDRH Office and 

Division associated with recognized standard 

15–8 ASTM F2064–00(2006), Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for use in Biomedical and Tissue-Engineered Medical Products Application CFR Citations and Product codes, 

Relevant guidance, Type of 

standard and CDRH Office and 

Division associated with recognized standard 

15–9 ASTM F2311–06, Standard Guide for Classification of 

Therapeutic Skin Substitutes 

CFR Citations and Product codes, 

Relevant guidance, Type of 

standard and CDRH Office and 

Division associated with recognized standard 

15–10 ASTM F2451–05, Standard Guide for in vivo Assessment of 

Implantable Devices Intended to Repair or Regenerate Articular Cartilage 

CFR Citations and Product codes, 

Relevant guidance, Type of 

standard and CDRH Office and 

Division associated with recognized standard 

15–11 ASTM F2212–02(2007)e1, Standard Guide for Characterization of Type I Collagen as a Starting Material for Surgical 

Implants and Substrates for Tissue Engineered Medical 

Products 

CFR Citations and Product codes, 

Relevant guidance, Type of 

standard and CDRH Office and 

Division associated with recognized standard 

III. Listing of New Entries 

In table 3 of this document, FDA 

provides the listing of new entries and 

consensus standards added as 

modifications to the list of recognized 

standards under Recognition List 

Number: 020. 

TABLE 3.—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS

Recognition No. Title of Standard Reference No. and Date 

A. Biocompatibility 

2–127 Biological Evaluation of Medical Devices—Part 10: Tests for Irritation and 

Delayed-Type Hypersensitivity—Amendment 1 

ANSI/AAMI BE 78:2002/A1:2006 

B. Cardiovascular/Neurology 

3–70 Manual, Electronic or Automated Sphygmomanometers ANSI/AAMI SP10:2002/A1:2003—

Amendment 1 to ANSI/AAMI 

SP10:2002 

3–71 Manual, Electronic and Automated Sphygmomanometers ANSI/AAMI SP10:2002/A2:2006—

Amendment 2 to ANSI/AAMI 

SP10:2002 

C. Dental/ Ear, Nose, and Throat 

4–151 Dentistry—Artificial Teeth for Dental Prostheses ISO 22112:2005 


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52384 Federal Register / Vol. 73, No. 175 / Tuesday, September 9, 2008 / Notices 

TABLE 3.—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Recognition No. Title of Standard Reference No. and Date 

4–152 Metal-Ceramic Dental Restorative Systems ISO 9693:1999/Amendment 1:2005 

4–154 Dentistry—Elastometric Impression Materials-Third Edition ISO 4823:2000 

4–155 Dentistry—Elastomeric Impression Materials Technical Corrigendum 1–Third 

Edition 

ISO 4823:2000 Technical Corrigendum 1:2004 

4–156 Dentistry—Elastomeric Impression Materials Amendment 1–Third Edition ISO 4823:2000 Amendment 1:2007 

4–157 Dentistry—Zinc Oxide/Eugenol and Zinc Oxide/Non-eugenol Cements-Third 

Edition 

ISO 3107: 2004 

4–158 Dentistry—Soft Lining Materials for Removable Dentures—Part 1: Materials 

for Short-Term Use Technical Corrigendum 1 

ISO 10139–1:2005 Technical Corrigendum 1:2006 

D. General Hospital/ General Plastic Surgery 

6–214 Standard Test Method for Human Repeat Insult Patch Testing of Medical 

Gloves 

ASTM D6355–07 

E. In Vitro Diagnostic 

7–160 Abbreviated Identification of Bacteria and Yeast; Approved Guideline CLSI M35–A, 

7–161 Laboratory Detection and Identification of Mycobacteria; Proposed Guideline. CLSI M48–P 

7–162 Point-of-Care Monitoring of Anticoagulant Therapy; Approved Guideline CLSI H49–A 

7–163 Body Fluid Analysis for Cellular Composition CLSI H56–A 

7–164 Microwave Device Use in the Histology Laboratory; Approved Guideline CLSI GP28–A 

7–165 Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation 

of Instrumental Methods; Approved Standard-Second Edition 

CLSI H20–A2 

7–166 Fine Needle Aspiration Biopsy (FNAB) Techniques; Approved Guideline—

Second Edition 

CLSI GP20–A2 

7–167 Nongynecologic Cytologic Specimens: Collection and Cytopreparatory Techniques; Approved Guideline CLSI GP23–A 

7–168 Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi; Approved Standard CLSI M38–A 

F. Materials 

8–161 Standard Test Method for Tension Testing of Nickel-Titanium Superelastic 

Materials 

ASTM F2516–07 

G. OB-GYN/Gastroenterology 

9–46 Medical Electrical Equipment—Part 2–2: Particular Requirements for the 

Safety of High Frequency Surgical Equipment 

ANSI/AAMI 60601–2–2:2006 

9–49 Concentrates for Hemodialysis AAMI / ANSI RD61:2006 

9–50 Dialysate for Hemodialysis ANSI/AAMI RD52:2004 

9–51 Cardiovascular Implants and Artificial Organs—Haemodialysers, 

Haemodiafilters, Haemofilters and Haemoconcentrators 

ISO 8637:2004 

9–52 Cardiovascular Implants and Artificial Organs—Extracorporeal Blood Circuit 

for Haemodialysers, Haemodiafilters and Haemofilters 

ISO 8638:2004 

9–53 Standard Practice for Reprocessing of Reusable, Heat-Stable Endoscopic 

Accessory Instruments (EAI) Used with Flexible Endoscopes 

ASTM F1992–99(2007) 

9–54 Standard Specification for Rubber Contraceptives—Vaginal Diaphragms ASTM D6976–08 

H. Ophthalmic 

10–56 Ophthalmics Multifocal Intraocular Lenses ANSI Z80.12–2007 


jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 73, No. 175 / Tuesday, September 9, 2008 / Notices 52385 

TABLE 3.—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Recognition No. Title of Standard Reference No. and Date 

10–57 Phakic Intraocular Lenses ANSI Z80.13–2007 

I. Physical Medicine 

16–161 Safety Standard for Platform Lifts and Stairway Chairlifts ASME A18.1–2005 

J. Sterility 

14–255 Standard Terminology Relating to Flexible Barrier Packaging ASTM F17–07a 

IV. List of Recognized Standards 

FDA maintains the agency’s current 

list of FDA recognized consensus 

standards in a searchable database that 

may be accessed directly at FDA’s 

Internet site at http:// 

www.accessdata.fda.gov/scripts/cdrh/ 

cfdocs/cfStandards/search.cfm. FDA 

will incorporate the modifications and 

minor revisions described in this notice 

into the database and, upon publication 

in the Federal Register, this recognition 

of consensus standards will be effective. 

FDA will announce additional 

modifications and minor revisions to 

the list of recognized consensus 

standards, as needed, in the Federal 

Register once a year, or more often, if 

necessary. 

V. Recommendation of Standards for 

Recognition by FDA 

Any person may recommend 

consensus standards as candidates for 

recognition under the new provision of 

section 514 of the act by submitting 

such recommendations, with reasons for 

the recommendation, to the contact 

person (see FOR FURTHER INFORMATION

CONTACT). To be properly considered 

such recommendations should contain, 

at a minimum, the following 

information: (1) Title of the standard, (2) 

any reference number and date, (3) 

name and address of the national or 

international standards development 

organization, (4) a proposed list of 

devices for which a declaration of 

conformity to this standard should 

routinely apply, and (5) a brief 

identification of the testing or 

performance or other characteristics of 

the device(s) that would be addressed 

by a declaration of conformity. 

VI. Electronic Access 

Persons interested in obtaining a copy 

of ‘‘Guidance on the Recognition and 

Use of Consensus Standards’’ by using 

the Internet. CDRH maintains an entry 

on the Internet for easy access to 

information including text, graphics, 

and files that may be downloaded to a 

personal computer with Internet access. 

Updated on a regular basis, the CDRH 

home page includes device safety alerts, 

Federal Register reprints, information 

on premarket submissions [including 

lists of approved applications and 

manufacturers’ addresses], small 

manufacturer’s assistance, information 

on video conferencing and electronic 

submissions, Mammography Matters, 

and other device-oriented information. 

The CDRH Web site may be accessed at 

http://www.fda.gov/cdrh. A search 

capability for all CDRH guidance 

documents is available at http:// 

www.fda.gov/cdrh/guidance.html. 

Guidance documents are also available 

at http://www.regulations.gov. 

This Federal Register document on 

modifications in FDA’s recognition of 

consensus standards is available at 

http://www.fda.gov/cdrh/fedregin.html. 

VII. Submission of Comments and 

Effective Date 

Interested persons may submit to the 

contact person (see FOR FURTHER

INFORMATION CONTACT) written or 

electronic comments regarding this 

document. Two copies of any mailed 

comments are to be submitted, except 

that individuals may submit one paper 

copy. Comments are to be identified 

with the docket number found in 

brackets in the heading of this 

document. FDA will consider any 

comments received in determining 

whether to amend the current listing of 

modifications to the list of recognized 

standards, Recognition List Number: 

020. These modifications to the list or 

recognized standards are effective upon 

publication of this notice in the Federal 

Register. 

Please note that on January 15, 2008, 

the FDA Division of Dockets 

Management Web site transitioned to 

the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. Electronic 

comments or submissions will be 

accepted by FDA only through FDMS at 

http://www.regulations.gov. 

Dated: August 27, 2008. 

Daniel G. Schultz, 

Director, Center for Devices and Radiological 

Health. 

[FR Doc. E8–20939 Filed 9–8–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0043] 

[FDA No. 225–08–8001] 

Memorandum of Understanding 

Between the Food and Drug 

Administration and the University of 

Pennsylvania 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is providing 

notice of a memorandum of 

understanding (MOU) between FDA and 

the University of Pennsylvania (Penn). 

The purpose of this MOU is to establish 

terms of collaboration between FDA and 

Penn focused primarily but not 

exclusively, in the areas of translational 

therapeutics, diagnostics, 

bioinformatics, new clinical trial 

models, drug/device co-development, 

and pharmacoepidemiology. Beyond the 

collaborations in the traditional 

academic programs for training, 

research, and outreach, this MOU will 

also include collaborations with Penn 

extended partnerships such as the 

Institute for Translational Medicine and 

Therapeutics which includes the 

Children’s Hospital of Philadelphia, the 

Wistar Institute, and the University of 

Sciences in Philadelphia. 

DATES: The agreement became effective 

on July 24, 2008. 

FOR FURTHER INFORMATION CONTACT: 

For FDA: Wendy R. Sanhai, Office of 

the Commissioner, Office of 

Scientific and Medical Programs 

(HF–18), Food and Drug 


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