**A**merican **A**ssociation of **P**hysicists in **M**edicine

Professional Council

Legislation and Regulation Thomas B. Shope, Jr. (OST)

Science Council

Computer Robert A. Phillips (ODE)

Diagnostic X-Ray Imaging Thomas B. Shope, Jr. (OST) Robert A. Phillips
(ODE)

Magnetic Resonance Robert A. Phillips (ODE)

MR Safety and Regulations Robert A. Phillips (ODE)

(chair)

Task Group No. 8: Practical Aspects of Robert A. Phillips (ODE)

Functional MRI

Radiation Protection Thomas B. Shope, Jr. (OST)

Radiation Therapy H. Tom Heaton (OST) Robert A. Phillips (ODE)

Calibration Laboratory Accreditation H. Tom Heaton (OST) Frank Cerra
(OST)

Intravascular Brachytherapy H. Tom Heaton (OST)

Nuclear Medicine Peter Paras (OHIP)

**A**merican **C**ollege of **N**uclear **P**hysicians

Committee on Standardization of Nuclear Medical Peter Paras (OHIP)

Instrumentation

**A**merican **I**nstitute of **U**ltrasound in **M**edicine

Board of Directors Melvin Stratmeyer (OST)

Safety Standards Joint Task Group (AIUM/NEMA) Gerald Harris (OST)

Technical Standards Committee Hector Lopez (OST)

Digital Measurement Subcommittee Hector Lopez (OST)

Doppler Standards Subcommittee Hector Lopez (OST)

Nomenclature Subcommittee Hector Lopez (OST)

Scanner Equivalence Subcommittee Keith Wear (OST)

**A**merican **N**ational **S**tandards **I**nstitute

Accreditation Committee Donald Marlowe (OST) John F. Murray (OC)

Acoustical Standards Management Board (ASA) Melvin Stratmeyer (OST)

Board of Directors David W. Feigal, Jr. (OCD)

B 11.21 Laser Safety for Machine Tools Jerome Dennis (OC)

C 63 Electromagnetic Compatibility (IEEE) Jon P. Casamento (OST) Jeffrey
Silberberg (OST)

SC 8 Medical Device EMC Test Methods (IEEE) Howard Bassen (OST) Jeffrey
Silberberg (OST)

WG on Ad Hoc EMC Measurement Techniques Donald Witters (OST)

> C 63.19 Task Group on Method of Measurements Teresa M. Cygnarowicz
> (ODE)

for Compatibility Between Wireless

Communication Devices and Hearing Aids (IEEE)

Conformity Assessment Policy Committee (CAPC) David W. Feigal, Jr. (OCD)

Executive Standards Council Melvyn Altman (OST)

Government Member Council Melvyn Altman (OST)

Healthcare Informatics Standards Planning Board Charles Furfine (OST)

International Conformity Assessment Melvyn Altman (OST)

Committee (ICAC)

IT 2.31 Subcommittee on X‑Ray Film Walid Mourad (OHIP)

Standards (NAPM)

MD 156 Committee on Dental Materials,

Instruments, & Equipment (ADA)

SC 8 Dental Implants

WG 1 Physical and Chemical Aspects Angela Blackwell (ODE) Pamela D.
Scott (ODE)

WG 2 Biological Aspects of Implants Angela Blackwell (ODE) Pamela D.
Scott (ODE)

Medical Device Standards Board (MDSB) Melvyn Altman (OST)

N 42 Nuclear Instruments vacant

N 43 Equipment for Non-Medical Radiation Frank Cerra (OST) H. Tom Heaton
(OST)

Applications (HPS)

N 43.7 Design Safety Standards for Industrial Charles Gunzburg (OHIP)

Radiographic and Fluoroscopic Equipment (HPS)

N 44 Equipment and Materials for Medical Sankar Basu (ODE)

Radiation Applications (ACR)

S 3 Bioacoustics (ASA) James K. Kane (ODE)

WG 37 Couplers (ASA) vacant

WG 48 Hearing Aids (ASA) Teresa M. Cygnarowicz (ODE)

WG 80 Probe Microphone Hearing Aid Teresa M. Cygnarowicz (ODE)

Measurements (ASA)

WG 81 Assistive Listening Devices (ASA) Teresa M. Cygnarowicz (ODE)

U.S. National Committee to IEC Melvyn Altman (OST)

Z 80 Ophthalmic Standards (OLA) David Whipple (ODE) Robert Landry (OST)

Subcommittee for Contact Lens Products David Whipple (ODE) [Technical
experts:]{.underline}

Jimmy Chen (ODE)

Bernard Lepri (ODE)

James Saviola (ODE)

Myra Smith (ODE)

Karen Warburton (ODE)

Subcommittee for Medical Ophthalmic Donald Calogero (ODE) Robert Landry
(OST)

Products [Technical experts]{.underline}:

Everette Beers (ODE)

Sherri Berman (ODE)

Bruce Drum (ODE)

Malvina Eydelman (ODE)

Robert Faaland (OST)

Bernard Lepri (ODE)

Donna Lochner (ODE)

Sharon Miller (OST)

Ralph Rosenthal (ODE)

Ming Shih (ODE)

Phyllis Silverman (ODE)

> Subcommittee for Ophthalmic Instruments Robert Landry (OST) Everette
> Beers (ODE)

[Technical experts]{.underline}:

Bernard Lepri (ODE)

Sharon Miller (OST)

Subcommittee for Optical Devices for Low Bernard Lepri (ODE)

Vision

Subcommittee for Sunglasses David Whipple (ODE) Robert James (OST)

Z 88 Respiratory Protection Committee

Z 88.2 Subcommittee on Infectious Gwendolyn Smith (ODE)

Diseases Protection

Z 136 Safe Use of Lasers Committee (LIA) Jerome Dennis (OC) Richard
Felten (ODE)

(vice-chair)

Z 136.1 Biological Effects of Lasers (LIA) Janusz Beer (OST) Richard
Felten (ODE)

Z 136.3 Laser Safety in Medical Jerome Dennis (OC) Richard Felten (ODE)

Facilities Subcommittee (LIA)

Z 136.4 Laser Control Measurements Jerome Dennis (OC) Robert Faaland
(OST)

Subcommittee (LIA)

Z 136.6 Outdoor Lasers (LIA) L. Dale Smith (OC)

Z 311 Photobiological Safety of Lamps and Robert Landry (OST) Everette
Beers (ODE)

Lighting Systems Subcommittee (IES) Sharon Miller (OST)

**A**merican **S**ociety of **M**echanical **E**ngineers

Pressure Vessel for Human Occupancy (PVHO)

Committee

Subcommittee on Medical Hyperbaric Chambers Christy Foreman (ODE) Joanna
Weitershausen (ODE)

**A**ssociation for the **A**dvancement of **M**edical
**I**nstrumentation

Aids for Ostomy and Incontinence (U.S. TAG Rao Nimmagadda (ODE)

for ISO TC 173, SC 3)

Apnea Monitoring Committee Jeffrey Silberberg (OST) Harrison Dodge (OST)

Autologous Transfusion Committee Catherine Wentz (ODE)

Biological Evaluation Committee (U.S. TAG Melvin Stratmeyer (OST) Raju
Kammula (ODE)

for ISO TC 194) Donald Marlowe (OST)

(cochair US TAG)

WG 1 Systematic Approach to Biological Raju Kammula (ODE) Melvin
Stratmeyer (OST)

Evaluation and Terminology (U.S. sub-TAG

for ISO TC 194, WG 1)

WG 2 Degradation Aspects Related to Doyle Gantt (ODE) Scott McNamee
(OST)

Biological Testing (U.S. sub-TAG for ISO

TC 194, WG 2)

WG 3 Animal Protection Aspects (U.S. sub- Melvin Stratmeyer (OST)

TAG for ISO TC 194, WG 3)

WG 4 Clinical Investigations (U.S. sub-TAG Kimber Richter (OC) Celia
Witten (ODE)

for ISO TC 194, WG 4) (cochair)

WG 5 Cytotoxicity (U.S. sub-TAG for ISO Katharine Merritt (OST) Nirmal
Mishra (ODE)

TC 194, WG 5)

WG 6 Mutagenicity, Carcinogenicity, Nirmal Mishra (ODE) Katharine
Merritt (OST)

Reproductive Toxicity (U.S. sub-TAG for (cochair)

ISO TC 194, WG 6)

WG 7 Systemic Toxicity (U.S. sub-TAG for Melvin Stratmeyer (OST)
Katharine Merritt (OST)

ISO TC 194, WG 7)

WG 8 Irritation and Sensitization (U.S. sub- Katharine Merritt (OST)
Daniel W.C. Brown (ODE)

TAG for ISO TC 194, WG 8 (cochair)

WG 9 Effects on Blood (U.S. sub-TAG for Raju Kammula (ODE) William
Letzing (ODE)

ISO TC 194, WG 9) (cochair)

WG 10 Implantation (U.S. sub-TAG for Raju Kammula (ODE) Nirmal Mishra
(ODE)

ISO TC 194, WG 10)

WG 11 Allowable Limits for Leachable Ronald P. Brown (OST) Melvin
Stratmeyer (OST)

Substances (U.S. sub-TAG for ISO TC

194, WG 11)

WG 12 Sample Preparation & Reference Donald Marlowe (OST) Raju Kammula
(ODE)

Materials (U.S. sub-TAG for ISO TC 194, (cochair)

WG 12)

WG 13 Toxicokinetics Study Design Hoan-My Do Luu (OST) Ronald P. Brown
(OST)

(U.S. sub-TAG for ISO TC 194, WG 13)

WG 14 Material Characterization (U.S. Joseph Hutter (OST) Leroy
Schroeder (OST)

sub-TAG for ISO TC 194, WG 14) (cochair)

WG 15 Strategic Approach to Biological Melvin Stratmeyer (OST) Ronald P.
Brown (OST)

Assessment (U.S. sub-TAG for ISO TC 194,

WG 15)

Blood/Gas Exchange Device Committee Arthur Ciarkowski (ODE) Ronald A.
Robinson (OST)

(U.S. sub-TAG for ISO TC 150, SC 2, WG 4) (cochair)

Blood Filter Committee Betsy Poindexter (CBER) Jaroslav Vostal (CBER)

Blood Pressure Monitoring Committee (U.S. Sandy F.C. Stewart (OST)

sub-TAG for IEC 62D, WG 1)

Board of Directors Kimber Richter (OC)

Cardiac Valve Prostheses Committee (U.S. Sandy F.C. Stewart (OST) Diane
M. Nell (ODE)

sub-TAG for ISO TC 150, SC 2, WG 1)

Cochlear Implants Committee (U.S. sub-TAG for Teresa Cygnarowicz (ODE)

ISO TC 150, SC 6, WG 3)

Defibrillator Committee (U.S. sub-TAG for IEC Vincent Pierdominici
(WEAC) Carole C. Carey (ODE)

62D, WG 13)

ECG Committee (U.S. sub-TAG for IEC 62D, vacant Robert Cangelosi (OHIP)

WG 1)

> WG 1 Ambulatory Electrocardiograph (U.S. Nancy Pressly (OSB)

sub-TAG for IEC 62D, WG 1)

WG 2 Arrhythmia Monitoring Carole C. Carey (ODE)

WG 3 Cables & Leads (U.S. sub-TAG for Robert Cangelosi (OHIP)

IEC 62D, WG 1) (cochair)

WG 4 Cardiac Monitor and Diagnostic ECG Charles Ho (ODE) Kenneth Takaki
(WEAC)

(U.S. sub-TAG for IEC 62D, WG 1)

WG 6 ECG Electrode (U.S. sub-TAG for vacant

IEC 62D, WG 1)

WG 7 Signal Averaging Carole C. Carey (ODE) Kevin Milne (OST)

WG 8 Standard Communications Protocol Charles S. Ho (ODE)

Electrical Safety Committee vacant Irene M. Naveau (ODE)

Electromagnetic Compatibility Committee Jeffrey Silberberg (OST) Donald
Witters (OST)

(U.S. TAG for IEC SC 62A, WG 13) (cochair)

Electromedical Equipment

WG 1 Anesthesia Equipment sub-TAG Peter Carstensen (OHIP)

WG 2 EEG/Electroconvulsive Equipment (U.S. vacant

sub-TAG for IEC 62D, WG 2)

WG 4 Electro-optical Equipment (U.S. sub-TAG Neil R. Ogden (ODE)

for IEC 62D, WG 4)

WG 5 Hospital Beds (U.S. sub-TAG for 62D, Joan F. Todd (OSB) Irene M.
Naveau (ODE)

WG 10)

WG 7 Transcutaneous Partial Pressure Peter Carstensen (OHIP)

Monitoring Equipment (U.S. sub-TAG for

IEC 62D, WG 1)

WG 8 Ultrasound (U.S. sub-TAG for IEC 62D, Gerald Harris (OST)

WG 2)

WG 9 Lung Ventilators sub-TAG Peter Carstensen (OHIP)

WG 12 Luminaries (U.S. sub-TAG for IEC 62D, William M. Burdick (ODE)

WG 12)

High Frequency Therapeutic Device Committee Kathryn Daws-Kopp (ODE)

(U.S. sub-TAG for IEC 62D, WG 14)

Human Factors Engineering Committee (U.S. Peter Carstensen (OHIP)
Charles A. Sawyer (OHIP)

sub-TAG for IEC 62A, WG 5)

Infant Incubator Committee (U.S. sub-TAG for Nancy Pressly (OSB)

IEC 62D, WG 9)

Infusion Device Committee (U.S. sub-TAG for William M. Burdick (ODE)

IEC 62D, WG 8 & ISO TC 150, SC 6, WG 4)

WG 1 Enteral Administration Sets Connector Eileen Woo (OSB) Walter Scott
(OHIP)

International Standards Committee Donald Marlowe (OST)

Mechanical Circulatory Support Systems Committee Michael Berman (ODE)
Jean E. Rinaldi (OST)

(U.S. sub-TAG for ISO TC 150, SC 6, WG 6)

Medical Device Software Committee John F. Murray (OC) Donna-Bea Tillman
(ODE)

(co-chair)

Executive Board John F. Murray (OC) Donna-Bea Tillman (ODE)

Medical Devices for Injection (U.S. TAG for Walter Scott (OHIP)

ISO TC 84)

WG 1 Needle-free injections Von Nakayama (ODE) Stewit Bezabeh (ODE)

Medical Equipment Management Committee William M. Burdick (ODE)

Multi-parameter Patient Monitoring Equipment Carole C. Carey (ODE) Kevin
Milne (OST)

Committee (U.S. sub-TAG for IEC 62D, WG 1) (cochair)

Neurosurgery Committee (U.S. sub-TAG for IEC Robert J. DeLuca (ODE)

62D, WG 2)

WG 1 ICP Devices vacant

WG 2 Implantable Neurostimulator (U.S. Steven M. Hinckley (ODE) Victor
Krauthamer (OST)

sub-TAG for ISO TC 150, SC 6, WG 5)

WG 3 Transcutaneous Electrical Stimulator Robert J. DeLuca (ODE) Marie
Schroeder (ODE)

(U.S. sub-TAG for IEC 62D, WG 2) (cochair)

Pacemaker Committee (U.S. sub-TAG for ISO/IEC Mitchell Shein (ODE)
Carole C. Carey (ODE)

JWG 1, TC 150, SC 6, WG 2 & IEC 62D, MT 30)

Protective Barriers Committee vacant

Quality Management and Corresponding General Kimberly Trautman (OC)
Melvyn Altman (OST)

Aspects of Medical Devices (U.S. TAG for ISO Melvin Stratmeyer (OST)

TC 210)

WG 1 Application of Quality Systems to Kimberly Trautman (OC) Jan Welch
(OC)

Medical Devices (U.S. sub-TAG for ISO TC (cochair)

210, WG 1)

WG 2 General Aspects Stemming from the Melvyn Altman (OST)

Application of Quality Principles to Medical

Devices (U.S. sub-TAG for ISO TC 210, WG 2)

WG 3 Symbols and Nomenclature for Carol Herman (OST)

Medical Devices (U.S. sub-TAG for ISO

TC 210, WG 3 & IEC 62A, WG 5)

WG 4 Application of Risk Management to William Midgette (OST) Arthur
Ciarkowski (ODE)

Medical Devices (U.S. sub-TAG for ISO TC

210, WG 4, & IEC 62A, WG 15)

Renal Disease and Detoxification Committee Gema Gonzalez (ODE) Barbara
McCool (ODE)

(U.S. sub-TAG for IEC 62D, WG 7 &

ISO TC 150, SC 2, WG 5)

TG 3 Hemodialysis Systems Gema Gonzalez (ODE)

TG 5 Dialysate Gema Gonzalez (ODE) Barbara McCool (ODE)

Sphygmomanometer Committee (U.S. sub-TAG Sandy F.C. Stewart (OST)

For IEC 62D, WG 1)

Standards Board Carol Herman (OST)

Sterilization Standards Committee (U.S. TAG Victoria Hitchins (OST) Chiu
Lin (ODE)

for ISO TC 198) (cochair)

Executive Board Victoria Hitchins (OST)

WG 1 Industrial EO Sterilization vacant J. Michael Kuchinski (ODE)

(U.S. sub-TAG for ISO TC 198, WG 1)

WG 2 Radiation Sterilization (U.S. sub- vacant Harry Bushar (OSB)

TAG for ISO TC 198, WG 2)

TG 2 Radiation Sterilization Parametric vacant

Release Task Group

WG 3 Industrial Moist Heat Sterilization (U.S. Elizabeth Riegal (OC)
Susan Gouge (ODE)

sub-TAG for ISO TC 198, WG 3)

WG 4 Biological Indicators (U.S. sub- Janie Fuller (OSB) Candace McManus
(OC)

TAG for ISO TC 198, WG 4)

WG 5 Sterilization Terminology Victoria Hitchins (OST) Sharon
Lappalianen (ODE)

WG 6 Chemical Indicators (U.S. sub- Susanna Barrett (ODE) Candace
McManus (OC)

TAG for ISO TC 198, WG 6)

WG 7 Packaging (U.S. sub-TAG for Cathy Nutter (ODE) Victoria Hitchins
(OST)

ISO TC 198, WG 7)

WG 8 Microbiological Methods (U.S. sub-TAG Cathy Nutter (ODE) Victoria
Hitchins (OST)

for ISO TC 198, WG 8)

WG 9 Aseptic Processing (U.S. sub-TAG John Levchuk (ODE) Thomas Arista
(ORA)

for ISO TC 198, WG 9)

WG 10 Liquid Chemical Sterilization (U.S. Susanna Barrett (ODE) Candace
McManus (OC)

sub-TAG for ISO TC 198, WG 10)

WG 11 General Criteria for Sterilization Chiu Lin (ODE) Teresa Jimenez
(ORA)

Processes (U.S. sub-TAG for ISO TC 198, WG 11)

WG 12 Instructions for Reusable Device Chiu Lin (ODE) Martha O'Lone
(ODE)

Reprocessing (U.S. sub-TAG for ISO TC 198,

WG 12)

WG 13 Washer-Disinfectors (U.S. sub-TAG Chiu Lin (ODE) Victoria Hitchins
(OST)

for ISO TC 198, WG 13) (cochair)

WG 40 Steam Sterilization Hospital Practices Candace McManus (OC)
Elizabeth Riegel (OC)

(U.S. sub-TAG for ISO TC 198, WG 3)

WG 41 Ambulatory Care and Office-Based Cathy Nutter (ODE)

Steam Sterlization

WG 42 Dry Heat Sterilization John Levchuk (ODE) Elaine Mayhall (ODE)

WG 43 Hospital Steam Sterilizer Janie Fuller (OSB)

WG 61 Chemical Sterilants Hospital Practices Susanna Barrett (ODE)
Candace McManus (OC)

WG 62 Hospital EO Sterilizer Janie Fuller (OSB)

WG 63 Sterilization Residuals (U.S. sub-TAG Howard Cyr (OST)

for U.S. TC 194, WG 11 & ISO TC 198)

WG 82 Decontamination Martha O\'Lone (ODE) Victoria Hitchins (OST)

WG 83 Reusable Surgical Textiles Processing Felicidad Marshall (ODE)
Gwendolyn Smith (ODE)

TG 1 Strike-Through Chiu Lin (ODE) Gwendolyn Smith (ODE)

WG 90 Microbiological Quality (SALs) of Cathy Nutter (ODE) Victoria
Hitchins (OST)

Processed Medical Devices (cochair)

WG 91 Resistometer Christopher Demitrius (WEAC) Elaine Mayhall (ODE)

WG 92 Process Challenge Devices Chiu Lin (ODE) Patricia Fox (ODE)

(cochair)

WG 93 Cleaning of Reusable Medical Devices Victoria Hitchins (OST)
Steven Turtil (ODE)

(cochair)

WG 94 Rigid Sterilization Container Systems Patricia Fox (ODE)

Vascular Prostheses Committee (U.S. sub-TAG Dorothy Abel (ODE)

For ISO TC 150, SC 2, WG 3) (cochair)

Waveform Testing Committee Sandy Weininger (OST)

(cochair)

**ASTM** International

Board of Directors Donald Marlowe (OST)

(vice chairman)

D11 Rubber

D11.40 Consumer Rubber Products Chiu S. Lin (ODE)

D11.40.01 Condoms TG Colin Pollard (ODE) John Farnham (OC)

Lesley Kerr (WEAC)

Martin K. McDermott (OST)

D11.40.02 Glove Durability TG Donna L. Walsh (OST) Srilekha Das (OST)

D11.40.06 Latex Chemical Sensitivity TG vacant

D11.40.07 Skincare/Latex Compatibility TG vacant Srilekha Das (OST)

D11.40.08 IEMA TG

Latex Protein WG Melvin Stratmeyer (OST) Anne D. Lucas (OST)

Vesna Tomazic (OST)

D11.40.09 Chemotherapy Gloves TG Martha O'Lone (ODE) Terrell Cunningham
(ODE)

D11.40.10 Medical Glove Selection Guide TG Terrell Cunningham (ODE)
Arthur Yellin (OHIP)

D11.40.12 Medical Glove TG Chiu S. Lin (ODE) Jane Driscoll (WEAC)

Donna L. Walsh (OST)

Maximum Powder WG Chiu S. Lin (ODE) Maria P. Chaput (WEAC)

E10 Nuclear Technology and Applications

E10.01 Dosimetry for Radiation Processing Petro Shandruk (OHIP)

E20 Temperature Measurement

E20.08 Medical Thermometry vacant

E31 Healthcare Informatics Clara Sliva (ODE) Alberto Gutierrez (OIVD)

E31.13 Clinical Laboratory Information Clara Sliva (ODE) Indira Konduri
(OSB)

Management

E36 Conformity Assessment Melvyn Altman (OST) Kaiser Aziz (OST)

E48 Biotechnology Larry Bockstahler (OST)

(membership secretary)

E48.02 Characterization and Identification of Larry Bockstahler (OST)

Biological Systems Subcommittee (chairperson)

E48.02.03 Task Group on Viruses Larry Bockstahler (OST)

(chairperson)

F02 Flexible Barrier Materials Patrick Weixel (OC) Srilekha Das (OST)

F02.60 Medical Packaging Cathy Nutter (ODE) Patrick Weixel (OC)

F04 Medical & Surgical Materials and Devices Donald Marlowe (OST)

Division I on Resources

F04.11 Polymeric Materials Hany Demian (ODE) John S. Goode (ODE)

F04.11.04 Poly-L-Lactic Acid (PLLA) Hany Demian (ODE) John S. Goode
(ODE)

F04.11.06 Bioabsorbable Polymer- Hany Demian (ODE) John S. Goode (ODE)

Degradation Test Methods

F04.11.07 Rev F 451 Acrylic Bone Cement Hany Demian (ODE) John S. Goode
(ODE)

F04.11.08 Rev F648 UHMWPE Hany Demian (ODE) John S. Goode (ODE)

Glenn A. Stiegman (ODE)

F04.12 Metallurgical Materials Stanley A. Brown (OST)

F04.13 Ceramics Materials Peter Allen (ODE) Erin Keith (OC)

F04.13.04 Rev F 603-Polycrystalline Peter Allen (ODE)

Alumina

F04.13.05 CPC Crystalline Characterization Peter Allen (ODE)

F04.13.09 CPC Environmental Stability Katharine Merritt (OST)

F04.15 Materials Test Methods Terry O. Woods (OST)

F04.15.07 PLA Degradation Testing Hany Demian (ODE)

F04.15.08 Abrasion of Coatings Peter Allen (ODE)

F04.15.11 MRI Compatibility Testing Terry O. Woods (OST) Loren A.
Zaremba (ODE)

F04.15.14 Corrosion Testing Stanley Brown (OST)

F04.15.16 Tissue Adhesive Task Methods George Mattamal (ODE) Patricia
Fox (ODE)

F04.15.17 Cleanliness Testing of Machine Erin Keith (OC)

Components

F04.16 Biocompatibility Test Methods Melvin Stratmeyer (OST) Raju
Kammula (ODE)

F04.16.01 Biological Response to Katharine Merritt (OST)

Particulate Debris

F04.16.05 Recovery of Foreign Particulates Katharine Merritt (OST)

for Tissue

F04.16.08 Immunological Testing John Langone (OST) Dan B. Lyle (OST)

F04.16.09 Characterization of Particulate Stanley A. Brown (OST)

Debris (chairperson)

F04.18 Device Retrieval Analysis Stanley Brown (OST) Donald Marlowe
(OST)

Division II on Orthopaedic Devices Mark Melkerson (ODE)

(chairperson)

F04.21 Osteosynthesis Jodi N. Anderson (ODE) Glenn A. Stiegman (ODE)

F04.21.01 Bone Screws Laurence Coyne (WEAC) Jodi N. Anderson (ODE)

Donald Marlowe (OST)

Glenn A. Stiegman (ODE)

F04.21.03 Intramedullary Rods Glenn A. Stiegman (ODE) Jodi N. Anderson
(ODE)

F04.21.04 External Fixation Devices Jodi N. Anderson (ODE) Glenn A.
Stiegman (ODE)

F04.21.05 Bone Staples Laurence Coyne (WEAC) Jodi N. Anderson (ODE)

Donald Marlowe (OST)

Glenn A. Stiegman (ODE)

F04.21.06 Fixation Wire and Cable Laurence Coyne (WEAC) Jodi N. Anderson
(ODE)

Donald Marlowe (OST)

Glenn A. Stiegman (ODE)

F04.21.11 Bone Plates Laurence Coyne (WEAC) Jodi N. Anderson (ODE)

Donald Marlowe (OST)

Glenn A. Stiegman (ODE)

F04.22 Arthroplasty John Goode (ODE) Glenn A. Stiegman (ODE)

F04.22.01 Modular Tibial Stem Test John Goode (ODE)

Method

F04.22.09 Femoral Stem Test Method John Goode (ODE) Glenn A. Stiegman
(ODE)

F04.22.10 Hip Wear John Goode (ODE) Glenn A. Stiegman (ODE)

F04.22.14 Total Knee Specification -- F2083 Peter Allen (ODE) John Goode
(ODE)

F04.25 Spinal Devices Mark Melkerson (ODE) Aric Kaiser (ODE)

> (chairperson)

F04.25.01 Spinal Terminology Mark Melkerson (ODE) Aric Kaiser (ODE)

F04.25.02 Component Testing Mark Melkerson (ODE) Aric Kaiser (ODE)

F04.25.03 Component - Component Mark Melkerson (ODE) Aric Kaiser (ODE)

Interfaces

F04.25.04 Constructs Mark Melkerson (ODE) Aric Kaiser (ODE)

F04.25.04.01 Static & Fatigue Test Mark Melkerson (ODE) Aric Kaiser
(ODE)

Methods for Spinal Implant Constructs

In a Corpectomy Model

F04.25.04.02 Standard Guide for Mark Melkerson (ODE) Aric Kaiser (ODE)

Testing of Spinal Implant Constructs

(Stability)

Division III on Medical/Surgical Devices

F04.30 Cardiovascular Standards Jean Rinaldi (OST)

F04.30.06 Interventional Cardiology Deanna Busick (OST) Jonette Rogers
Foy (ODE)

John P. Holden (ODE)

Walter Scott (OHIP)

F04.31 Neurosurgical Standards Terry Woods (OST)

F04.32 Plastic & Reconstructive Surgery Stephen Rhodes (ODE)

F04.32.01 Mammary Implants Stephen Rhodes (ODE)

F04.33 Medical/Surgical Instruments vacant

04.33.01 Needle Disposal/Puncture vacant

Resistance -- Z5799Z

F04.34 Urological Materials and Devices

F04.34.01 Ureteral Stents Laura Byrd (ODE)

F04.35 GI Endoscopes Mary Jo Cornelius (ODE) Karen Baker (ODE)

Jack McCracken (OHIP)

> F04.36 Cotton Products for Medical Use Felicidad Marshall (ODE) Howard
> Cyr (OST)

George Kroehling (OC)

Division IV on Tissue Engineered Medical Products

F04.41 Classification and Terminology vacant Kurt Stromberg (CBER)

for TEMPS

F 04.42 Biomaterials and Biomolecules David Kaplan (OST)

F 04.43 Cells and Tissue Engineered Constructs Ellen Areman (CBER) Jeff
Toy (ODE)

F04.44 Assessment David Krause (ODE) Aric Kaiser (ODE)

F04.45 Safety Kimberly Benton (CBER)

Division IX on Administrative

F04.90 Executive Subcommittee vacant

F04.93 U.S. TAG ISO TC 150 Implants for Surgery

F04.93.03 Neurosurgical Implants Terry Woods (OST)

F04.95 U.S. TAG ISO TC 168 Prosthetics Donald Marlowe (OST)

And Orthotics (chairperson)

F04.96 U. S. TAG ISO TC 194 Biological Donald Marlowe (OST) Melvin
Stratmeyer (OST) Evaluation of Medical Devices (chairperson)

F12 Security Systems and Equipment

F12.60 Controlled Access Security, Search

and Screening Equipment

F12.63 Task Group on Weapons Donald M. Witters (OST) Jon P. Casamento
(OST)

Detection

F23 Protective Clothing

F23.30 Surgical Masks Felicidad Marshall (ODE)

F29 Anesthetic and Respiratory Equipment Peter Carstensen (OHIP)

F29.10 on Anesthesia Workstations

F29.10.01 Anesthesia Gas Machines Peter Carstensen (OHIP)

F29.10.02 Breathing Systems/Performance Peter Carstensen (OHIP)

F29.10.03 Connectors and Adaptors vacant

F 29.10.05 Anesthesia Gas Scavenging Peter Carstensen (OHIP)

Systems (AGSS)

F29.10.06 Lung Ventilators for Use in Peter Carstensen (OHIP)

Anesthesia

F29.11 on Gas Monitors

F29.11.01 Capnographs and Anesthetic Peter Carstensen (OHIP) Lisa Harris
(ODE)

Agent Analyzers

F29.11.02 Nitric Oxide Delivery Devices Joanna Weitershausen (ODE)
Michael Bazaral (ODE)

F29.11.04 Oxygen Analyzers Peter Carstensen (OHIP)

F29.11.05 Pulse Oximeters Sandy Weininger (OST) Hina Patel (ODE)

F29.12 on Airways

F29.12.01 Tracheal Tubes Brenda Hayden (OC)

F29.12.02 Naso/Oropharyngeal Airways Michael Bazaral (ODE) Hina Patel
(ODE)

F29.12.03 Breathing Tubes/Bags Michael Bazaral (ODE)

F29.12.04 Tracheostomy Tubes\--Adult vacant

F29.12.05 Tracheostomy Tubes\--Pediatric Michael Bazaral (ODE)

F29.12.06 Suction Catheters vacant

F29.13 on Laryngoscopes and Bronchoscopes

F29.13.01 Laryngoscopes\--Bulbs/ Michael Bazaral (ODE)

Handles/Blades (Rigid)

F29.14 on Ventilators

F29.14.01 Lung Ventilators (Other than for Paula Simenauer (OHIP)

Anesthesia)

F29.14.03 Humidifiers Paula Simenauer (OHIP)

F29.14.04 Home Care Ventilators Nancy Pressly (OSB)

F29.14.05 Oxygen Concentrators Peter Carstensen (OHIP)

F29.14.06 Resuscitators Christy Foreman (ODE)

F29.14.20 Continuous Positive Airway Christy Foreman (ODE) Lisa Harris
(ODE)

Pressure Ventilators for Obstructive

Sleep Apnea

F29.15 on Harmonization of Alarms

F29.15.01 Harmonization of Alarms Peter Carstensen (OHIP)

F29.16 on Terminology Ann Graham (OSB)

F29.17 on Medical Surgical Suction and Drainage

F29.17.01 Medical Surgical Suction and vacant

Drainage

F30 Emergency Medical Services Robert Gottesman (OST)

G03 Durability of Nonmetallic Materials Leroy Schroeder (OST) Srilekha
Das (OST)

G04 Oxygen Christy Foreman (OC)

**I**nstitute of **E**lectrical and **E**lectronic **E**ngineers

P1140 Measurement of Electrical & Magnetic Donald Witters (OST)

Near Fields in Frequency Range of 5Hz & 30MHz

> P1140.1 Measurement Techniques for ELF & Donald Witters (OST)

VLF Magnetic Fields & Electric Fields from

Desktop Computer Displays & Associated

Desktop Devices

SCC 28 Sectional Committee on Radiofrequency Howard Bassen (OST) Melvyn
Altman (OST)

Radiation Hazards Executive Committee

SC 1 Subcommittee on Instrumentation Howard Bassen (OST)

SC 4 Safety Levels and/or Tolerances with Howard Bassen (OST)

Respect to Personnel

WG 3 High Frequency Effects (From Low vacant

Frequencies To and Including the Resonance

Region)

Software Safety Planning Group John F. Murray (OST) James Lee (ODE)

Joanna Weitershasen (ODE)

Technical Committee on Ultrasonics, Ferroelectrics Gerald Harris (OST)

& Frequency Control (UFFC)

**NCCLS**

Board of Directors Lillian Gill (OCD)

Delegate Carol Herman (OST) Steve Gutman (OIVD)

International Advisory Committee vacant

Nominating Committee Carol Herman (OST)

[Area Committee on Alternative Site Testing]{.underline}

SC on Ancillary Blood Glucose Testing vacant J. David Lyle (ODE)

SC on Point of Care Connectivity vacant

SC on Point-of-Care Testing Cornelia Rooks (OHIP) J. David Lyle (ODE)

[Area Committee on Automation]{.underline} James Callaghan (OIVD)

SC on Remote Access to Hospital Diagnostic Steven S. Pelham (OST)

Devices via the Internet

SC on Specimen Identification vacant

[Area Committee on Clinical Chemistry and Toxicology]{.underline}

SC on Analysis of Body Fluids in Clinical Ellen Chen (OST)

Chemistry

SC on Biochemical Bone Markers vacant

SC on GC/MS vacant

SC on Glycohemoglobin Measurements V. Michelle Chenault (OST) Nina Chace
(OIVD)

SC on Stability of Specimens during Delivery Sousan Altaie (ODE)

and Storage in the Clinical Chemistry

Laboratory

[Area Committee on Evaluation Protocols]{.underline} Kristin Meier (OSB)
Kaiser Aziz (OST)

Max Robinowitz (OIVD) Greg Campbell (ODE)

SC on Limits of Detection and Limits of vacant

Quantitation

SC on Qualitative/Semi-Quantitative Testing vacant Steve Gutman (OIVD)

SC on Total Error vacant

SC on Uniformity of Claims Steve Gutman (OIVD)

SC on Unit-Use Testing Veronica Calvin (ODE) J. David Lyle (ODE)

SC on User Demonstration of Performance Kaiser Aziz (OST) Michelle
Clark-Stuart (ODE)

J. David Lyle (OST) Arleen Pinkos (OIVD)

Thomas Simms (OIVD)

Geretta Wood (ODE)

[Area Committee on General Laboratory]{.underline} Max Robinowitz (OIVD)
Kaiser Aziz (OST)

[Practices]{.underline} Steve Gutman (OIVD)

SC on Microwave Ovens vacant

[Area Committee on Hematology]{.underline} Larry Brindza (OIVD)

Ginette Michaud (OIVD)

SC on Blood Count Louise Magruder (OIVD)

WG on Leukocyte Differential Counting vacant

SC on Body Fluid Analysis Josephine M. Bautista (OIVD)

SC on Coagulation Testing Larry Brindza (OIVD) Josephine M. Bautista
(OIVD)

Ginette Michaud (OIVD)

SC on DNA Cytometry Louise Magruder (OIVD) Ginette Michaud (OIVD)

Geretta Wood (ODE)

SC on Fetal Red Cell Detection Michelle Clark-Stuart (ODE)

SC on Hemoglobinopathies Nina Chace (OIVD)

Ginette Michaud (OIVD)

SC on Point-of-Care Hemostasis/ Ginette Michaud (OIVD) Valarie Dada
(OIVD)

Coagulation Marilyn Lightfoote (OST)

[Area Committee on Immunology and]{.underline} Deborah M. Moore (OIVD)
Kaiser Aziz (OST)

[Ligand Assay]{.underline} Srikrishna Vadlamudi (ODE)

SC on Clinical Evaluation of Immunoassays Thomas E. Simms (OIVD) Steve
Gutman (OIVD)

SC on Fluorescence Calibration and Quantitative vacant

Measurement of Fluorescence Intensity

SC on Maternal Serum Screening vacant Geretta Wood (ODE)

[Area Committee on Microbiology]{.underline} Sousan Altaie (OIVD)

SC on Abbreviated Identification of Marian Heyliger (ODE) Sahar Dawisha
(ODE)

Bacteria and Yeasts Susan Gouge (ODE)

Roxanne Shively (ODE)

SC on Antifungal Susceptibility Tests vacant

SC on Antimicrobial Susceptibility Testing Sally Selepak (OIVD) Tonya
Wilbon (ODE)

SC on Antimycobacterial Susceptibility Testing Cathy Nutter (ODE)
Roxanne Shively (OIVD)

SC on Antiviral Susceptibility Testing D. Kathleen Wright (OIVD) Marilyn
Lightfoote (OST)

Sally Selepak (OIVD)

SC on Culture Media Roxanne Shively (ODE) Victoria Hitchins (OST)

SC on Methods of Antimicrobial Susceptibiity Tonja Wilbon (ODE)

Testing of Human Mycoplasma

SC on Parasitology Thomas Simms (OIVD) Roxanne Shively (ODE)

SC on Viral Culture D. Kathleen Wright (OIVD)

[Area Committee on Molecular Methods]{.underline} Larry Bockstahler
(OST) Michele Schoonmaker (OIVD)

> SC on Fluorescence In Situ Hybridization (FISH) Geretta Wood (ODE)
> Louise Magruder (OIVD)

Methods for Medical Genetics

SC on Genotyping Kathleen Whitaker (OIVD)

SC on Microassays Joseph Hackett (ODE)

SC on Molecular Diagnostic Methods for Roxanne Shively (OIVD)

Infectious Diseases

SC on Nucleic Acid Sequencing Maria Chan (ODE) Kathleen Whitaker (OIVD)

SC on PCR-Based Assays in Molecular Ginette Michaud (OIVD) Maria Chan
(ODE)

Hematology

SC on Quantitative Molecular Diagnostics for vacant Kathleen Whitaker
(OIVD)

Infectious Diseases

SC on Sample Collection Roxanne Shively (ODE)

**N**ational **C**ouncil on **R**adiation **P**rotection &
**M**easurements

SC 66 Effects of Ultrasound Melvin Stratmeyer (OST) Gerald Harris (OST)

**N**ational **E**lectrical **M**anufacturers **A**ssociation

Digital Imaging and Communications Standards Loren Zaremba (ODE) Kish
Chakrabarti (OHIP)

Committee

WG 11 Display Function Robert Jennings (OST) Kish Chakrabarti (OHIP)

WG 15 Digital Mammography Kish Chakrabarti (OHIP)

NMR Technical Committee Loren Zaremba (ODE) William Maloney (OC)

**N**ational **F**ire **P**rotection **A**ssociation

Committee on Hyperbaric & Hypobaric Facilities Christy Foreman (ODE)
Joanna Weitershausen (ODE)

Laser Fire Protection Committee Jerome Dennis (OC)

**R**ehabilitation **E**ngineering and Assistive Technology **S**ociety
of **N**orth **A**merica

Wheelchairs Committee Laurel S. Mendelson (OHIP) Donald M. Witters (OST)

SC on Powered Wheelchair EMC Donald Witters (OST)

The **S**ociety of **A**utomotive **E**ngineers

G-10 Aerospace Behavioral Engineering

Technology Committee

G-10L Aircraft Internal Environment (Radiation) L. Dale Smith (OC)

**U**nited **S**tates **P**harmacopoeia

Official CDRH Correspondent Robert Gottesman (OST)

ACR - American College of Radiology

ADA - American Dental Association

ASA - Acoustical Society of America

ASQC - American Society of Quality Control

HPS - Health Physics Society

IEEE - Institute of Electrical and Electronic Engineers

IES - Illuminating Engineering Society

INMM - Institute of Nuclear Materials Management

LIA - Laser Institute of America

NAPM - National Association of Photographic Manufacturers, Inc.

NEMA - National Electrical Manufacturers Association

OLA - Optical Laboratories Association

SAE - The Society of Automotive Engineers, International