A. National Standards Organizations
Acoustical Society of America (ASA)
Acoustical Standards Management Board
American College of Radiology (ACR)
Digital Imaging and Communications Standards Committee
WG 11 Display Function
American Institute of Ultrasound in Medicine (AIUM)
Board of Directors
Standards Committee (Digital Measurement, Doppler, Nomenclature)
American National Standards Institute (ANSI)
Executive Standards Council
Government Members Council
Healthcare Informatics Standards Planning Board
Medical Devices Standards Board (MDSB)
Standards Data and Services Committee (Implementation Team on User Needs)
U.S. National Committee to IEC
American National Standards Institute (Institute of Electrical & Electronic Engineering)
C16 ESD Performance
C63 Electromagnetic Compatibility
C63.19 Task Group on Method of Measurements for Compatibility Between Wireless
Communication Devices and Hearing Aids
SC8 Medical Device EMC Test Methods WG on Ad Hoc EMC Measurement Techniques
American National Standards Institute (Health Physics Society)
N43 Equipment for Non-Medical Radiation Applications
American National Standards Institute (Laser Institute of America)
Z136 Biological Effects of Lasers
Z136 Safe use of Lasers Committee
Z136.4 Laser Control Measurements Subcommittees
American National Standards Institute (Illuminating Engineering Society)
Z311 Photobiological Safety of Lamps and Lighting Systems Subcommittee
American National Standards Institute (Optical Laboratories Association)
Z80 Ophthalmic Standards
Z80.7 Intraocular Lens
Z80 Ophthalmic Standards Subcommittee on Glaucoma Shunts
Z80 Ophthalmic Standards Subcommittee on Ophthalmic Medical Products
American National Standards Institute (Optical Laboratories Association)
Z80 Ophthalmic Standards
Z80.1 Prescription Sunglasses
Z80.7 Intraocular Lens
Z80 Ophthalmic Standards Subcommittee on Ophthalmic Medical Products
American Society for Testing and Materials (ASTM)
Board of Directors
C28 Advanced Ceramics
D11 Rubber
D11.40 Consumer Rubber Products Latex Chemical Sensitivity Task Group
D11.40 Consumer Rubber Products Latex Protein Task Group
E36 Conformity Assessment
E48 Biotechnology
E48.02 Characterization and Identification of Biological Systems Subcommittee
E48.02.03 Task Group on Viruses
F04 Medical & Surgical Materials & Devices
F04 Medical & Surgical Materials & Devices Division I Resources
F04.12 Metallurgical Materials
F04.13 Ceramic Materials
F04.13.05 Calcium Phosphate Coatings (CPC) Crystalline Characterization
F04.13.09 Calcium Phosphate Coatings (CPC) Environmental Stability
F04.14 Composite Materials
F04.15 Material Test Methods
F04.16 Biocompatibility Test Methods
F04.16.01 Biocompatibility Testing Relating to Particulate Implant Debris
F04.16.05 Recovery of Foreign Particulates from Tissue
F04.18 Device Retrieval Analysis
F04.19 Corrosion of Implant Materials
F04 Medical & Surgical Materials & Devices Division II Orthopaedic Devices
F04.21 Osteosynthesis
F04.21.01 Bone Screws
F04.21.02 Bone Screw Testing Methods
F04.21.05 Bone Staples
F04.21.06 Fixation Wires
F04.21.11 Bone Plates
F04.22 Arthroplasty
F04.22.01 Total Hip w/Femoral Stems
F04.22.09 Femoral Stem Test Method
F04.22.10 Hip Wear
F04.25 Spinal Devices
F04 Medical & Surgical Materials & Devices Division III Medical/Surgical Devices
F04.40 Cardiovascular Standards
F04.50 Neurosurgical Standards
F04.65 Medical/Surgical Instruments
F04.65.01 Needle Disposal/Puncture Resistance
F04.80 Cotton Products for Medical Use (formerly D13.56)
F04 Medical & Surgical Materials & Devices Division IV Administrative
F04.90 Executive Subcommittee
F04.93.03 Neurosurgical Implants
F04.95 ISO/TC 168
F04.96 ISO/TC 194
F23 Protective Clothing
F23.40 Biological
F30 Emergency Medical Services
G03 Durability of Non-Metallic Materials
Association for the Advancement of Medical Instrumentation (AAMI)
Apnea Monitoring Committee
Biological Evaluation Committee
Animal Protection Aspects WG (serves as US sub-TAG for ISO TC 194, WG 03)
Degradation Aspects Related to Biological Testing WG (serves as US sub-TAG for ISO TC 194, WG 02)
Irritation & Sensitization WG (serves as US sub-TAG for ISO TC 194, WG 08)
Sample Preparation & Reference Materials WG (serves as U sub-TAG for ISO TC 194, WG 12)
Systemic Toxicity WG (serves as US sub-TAG for ISO TC 194, WG 07)
Cardiac Valve Prostheses Committee
ECG Committee
Arrhythmia Monitoring WG (serves as US sub-TAG for IEC 62D, WG 02)
Cardiac Monitor WG (serves as US sub-TAG for IEC 62D, WG 04)
Diagnostic Electrocardiograph WG (serves as US sub-TAG for IEC 62D, WG 05)
Electrode WG (serves as US sub-TAG for IEC 62D, WG 06)
Signal Averaging WG (serves as US sub-TAG for IEC 62D, WG 07)
EMC Committee
Electrical Safety Committee
International Standards Committee
Medical Device Software Committee
Neurosurgery Committee
Implantable Neurostimulator WG (serves as US sub-TAG for ISO TC 198, WG 08)
Pacemaker Committee (serves as US sub-TAG for ISO TC 150, SC 2, WG 02, IEC 62D, WG 06)
Standards Board
Sterilization Standards Committee
Microbiological Methods WG (serves as US sub-TAG for ISO TC 198, WG 08)
Returned Devices Decontamination WG (serves as US sub-TAG for ISO TC 198, WG 80)
Reusable Devices Resterilization WG (serves as US sub-TAG for ISO TC 198, WG 81)
Reusable Supplies Decontamination WG (serves as US sub-TAG for ISO TC 198, WG 82)
Sterilization Residuals WG (serves as US sub-TAG for ISO TC 198, WG 63)
Glutaraldehyde & Formaldehyde TG 1 (WG 63)
Terminology WG
Waveform Testing Committee
Association for the Advancement of Rehabilitation Technology (RESNA)
Wheelchairs
SC on Powered Wheelchair EMC
ESD Association
ESD Association's Standards Committee
Institute of Electrical and Electronics Engineers
P1140 Measurement of Electrical & Magnetic Near Fields in Frequency Range of 5Hz & 30MHz
P1140.1 Measurement Techniques for ELF & VLF Magnetic Fields & Electric Fields from
Desktop Computer Displays & Associated Desktop Devices
SCC 28 Sectional Committee on Radiofrequency Radiation Hazards
SC 1 Subcommittee on Instrumentation
SC 2/3 Terminology Standards and Units of Measurement
SC 4 Safety Levels and/or Tolerances with Respect to Personnel
WG 03 High Frequency Effects (From Low Frequencies to and Including the Resonance Region)
Executive Committee
Software Safety Planning Group
Technical Committee on Ultrasonice, Ferroelectrics, and Frequency Control (UFFC)
National Committee for Clinical Laboratory Standards
Area Committee on Automation
Area Committee on Immunology and Ligand Assay
Subcommittee on Digoxin
Area Committee on Microbiology
Subcommitte on Culture Media
Area Committee on Molecular Methods
Subcommittee on Immunohistochemical Procedures
Subcommittee on Molecular Genetics
Subcommittee on Molecular Microbiology
Delegate
Standing Committee
International Relations (ISO TC 212)
Nominating
Standards Management
National Council on Radiation Protection and Measurements
SC 66 Effects of Ultrasound
Underwriters Laboratory (UL)
Medical Industry Standards Group
United States Pharmacopeia
Official CDRH Correspondent
B. International Standards Organizations
Deutsches Institut fur Normung (DIN) - German Institute for Standardization
AAE9 Immunology, Serodiagnostics of Infectious and Immunological Diseases
International Commission on Illumination (CIE)
Div. 6 - Photobiology and Photochemistry
International Electrotechnical Commission
TC 29 Electroacoustics
WG 13 Hearing Aids
TC 61 Safety of Household and Similar Electrical Appliances
WG 16 Ultraviolet Radiation
SC 61B Safety of Household Microwave Ovens
TC 62 Electrical Equipment in Medical Practice
WG 02 Safety of Computer Systems Used in Medical Electrical Equipment
SC 62A Common Aspects of Electrical Equipment Used in Medical Practice TAG
Secretary's Advisory Group
WG 01 Safety
WG 13 Electromagnetic Compatibility
WG 15 Risk Management
WG 16 Electric Shock
WG 17 Mechanical Hazards
WG 18 Overheating and Fire and Additional Hazards (combined WG 18 & 19)
WG 20 Environmental Protection
SC 62B Diagnostic Imaging Equipment TAG
WG 15 High Voltage Generators
WG 19 Mammographic Anti-Scatter Grids & Mammographic Cassettes
WG 22 Ultrasound Diagnostic Equipment
WG 24 Safety of X-ray Equipment for Interventional Procedures
SC 62C Equipment Radiotherapy, Nuclear Medicine and Radiation Dosimetry TAG
WG 03 Performance of Dosimeters
SC 62D Electromedical Equipment TAG
WG 01 Diagnostics, Electrocardiographs (ECG)
WG 01 Diagnostics, Ultrasonic Medical Diagnostic Equipment
WG 02 Therapy and Surgery Equipment, Ultrasound Therapy sub-TAG
WG 06 Cardiac Pacemakers
WG 11 Extracorporeal Shock Wave Lithotripsy Equipment sub-TAG
TC 65A Systems Aspects
WG 09 Safe Software
WG 10 Functional Safety of Programmable Electronic Systems
TC 77 Electromagnetic Compatibility
TC 87 Ultrasonics
WG 08 Ultrasonic Field Measurements
WG 12 Ultrasound Exposure Parameters
U.S. Coordinating Committee on Electromagnetic Compatibility
International Organization for Standardization
TC 056 Dependability
WG 03 Equipment Reliability Verification
TC 150 Implants for Surgery
SC 1 Materials
SC 2 Cardiovascular Implants TAG
WG 01 Cardiac Valves
WG 02 Cardiac Pacemakers
WG 04 Blood Oxygenators
WG 05 Retrieval and Analysis of Implants
SC 3 Neurological Implants
SC 4 Bone and Joint Replacements
WG 02 Knee Wear
TC 172 Optics and Optical Instruments
SC 7 Ophthalmic, Optics and Instruments
WG 06 Ophthalmic Optical Instruments and Test Methods
WG 07 Ophthalmic Implants (formerly ANSI Viscosurgical Devices SC)
SC 9 Electro-optical Systems
WG 01 Terminology and Test Methods for Lasers
WG 02 Interfaces and System for Medical Applications
WG 03 Safety
WG 04 Laser Systems for Medical Applications
WG 05 Laser Systems for General Applications
WG 06 Optical Components and Their Test Methods
WG 07 Electro-optical Systems Other Than Lasers
TC 173 Technical Systems and Aids for Disabled or Handicapped Persons
SC 1 Wheelchairs
WG 01 Test Methods
WG 09 Determination of the Performance of Stand-up Type Wheelchairs
WG 10 Requirements and Test Methods for Electromagnetic Compatibility of Powered
Wheelchairs and Motorized Scooters
TC 194 Biological Evaluation of Medical Devices
WG 02 Degradation Aspects Related to Biological Testing Ceramics Task Force
WG 02 Degradation Aspects Related to Biological Testing Polymers Task Force
WG 02 Degradation Aspects Related to Biological Testing sub-TAG
WG 03 Animal Protection Aspects sub-TAG
WG 07 Systemic Toxicity sub-TAG
WG 08 Irritation, Sensitization
WG 11 Ethylene Oxide & Other Sterilization Residues (Joint TC 194 - TC 198)
WG 12 Sample Preparation and Reference Materials
WG 13 Toxicokinetic Study
WG 14 Material Characterization
WG 15 Strategic Approach to Biological Assessment
TC 198 Sterilization of Health Care Products
WG 04 Biological Indicators sub-TAG
WG 08 Microbiological Methods sub-TAG
WG 11 General Sterilization Criteria
TC 210 General Aspects of Health Care Products Quality Systems
WG 02 General Aspects Stemming from the Application of Quality Principles to Medical
Devices
WG 04 Application of Risk Management to Medical Devices
International Society of Blood Transfusion
Automation and Data Processing Working Group
