Appendix G

Standards Organizations

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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

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Continue on to Appendix H.