Post on 04-Nov-2019
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AAMI Technical Standards Committees
(Updated April 2018)
I. Anaesthetic and Respiratory .................................................................................................................................................................. 2
II. Active Medical Implants ........................................................................................................................................................................ 4
III. Biological Evaluation of Medical Devices ............................................................................................................................................. 5
IV. Cardiovascular Implants (non-active) and Extracorporeal Systems .................................................................................................... 7
V . Devices for Injection and Transfusion ................................................................................................................................................... 9
VI. Electromedical Devices ..................................................................................................................................................................... 12
VII. General Requirements for Medical Devices ..................................................................................................................................... 16
VIII. Medical Device Connectors ............................................................................................................................................................. 19
IX . Medical Device Software and IT and/or Health Software and HIT ..................................................................................................... 20
X . Sterilization and Infection Prevention – Equipment ............................................................................................................................ 22
XI. Sterilization and Infection Prevention – Hospital Practices and Instructions ...................................................................................... 24
XII. Sterilization and Infection Prevention – Industrial Processes .......................................................................................................... 26
XIII . Tissue Product Safety ..................................................................................................................................................................... 28
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I. Anaesthetic and Respiratory Committee
Code Committee Name Serves as U.S. Mirror Committee
(TAG or U.S. consensus body) for… Scope
AR Anaesthetic and Respiratory Equipment
ISO/TC 121 and related working groups Develops standards for anaesthetic and respiratory equipment and supplies, related devices and supply systems. Parent committee to the Anaesthetic and Respiratory Equipment (AR) working groups to which the standards are balloted. Staff contact: Colleen Elliott celliott@aami.org
AR/WG 01 Anaesthetic Systems ISO/TC 121/SC 1 and related working groups
Develops performance and safety standards for breathing attachments and anaesthetic machines. Staff contact: Colleen Elliott celliott@aami.org
AR/WG 02 Airways and Related Equipment
ISO/TC 121/SC 2 and related working groups (WG 1 through WG 10)
Develops performance and safety standards for laryngoscopic fittings, airway hazards during laser surgery, breathing circuits and tubing, nebulizing systems and components, suction catheters, respiratory therapy tubing and connectors, tracheostomy tubes, tracheal tubes. Staff contact: Colleen Elliott celliott@aami.org
AR/WG 03 Respirator Gas Measurement, Control and Biocompatibility
ISO/TC 121/SC 3/WG 03
ISO/TC 121/SC 3/WG 05
ISO/TC 121/SC 3/WG 13
Develops performance and safety standards related to heat and moisture control, gas flow measurement and control and biocompatibility or respiratory gas pathways. Staff contact: Colleen Elliott celliott@aami.org
AR/WG 04 Anaesthetic Terminology and Semantics
ISO/TC 121/SC 4 and
ISO/TC 121/WG1
Develops standards related to anaesthetic terminology and semantics. Staff contact: Colleen Elliott celliott@aami.org
AR/WG 06 Medical gas systems ISO/TC 121/SC 6
Develops performance and safety standards for medical gas systems. Staff contact: Colleen Elliott celliott@aami.org
AR/WG 08 Suction Devices for Hospital and Emergency Care
ISO/TC 121/SC 8 Develops performance and safety standards for suction devices for hospital and emergency care. Staff contact: Colleen Elliott celliott@aami.org
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I. Anaesthetic and Respiratory Committee
Code Committee Name Serves as U.S. Mirror Committee
(TAG or U.S. consensus body) for… Scope
EV/WG 01 Anesthesia Equipment Working Group
IEC/SC 62D/JWG 2— ISO/TC 121/SC 1 JWG 1
IEC/SC 62A/JWG 5— ISO/TC 121/SC 3 JWG 5
Develops standards dealing with anesthesia workstations and physiologic closed-loop controllers. Staff contact: Hae Choe hchoe@aami.org
EV/WG 09 Lung Ventilators Working Group IEC/SC 62D/JWG 6— ISO/TC 121/SC 1 JWG 6
IEC/SC 62D/JWG 1— ISO/TC 121/SC 3 JWG 1
IEC/SC 62D/JWG 5— ISO/TC 121/SC 3/JWG 10
IEC/SC 62D/JWG 12— ISO/TC 121/SC 3/JWG 12
Develops standards dealing with critical care ventilators, oximeters, respiratory gas monitors, and home respiratory equipment. Staff contact: Hae Choe hchoe@aami.org
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II. Active Medical Implants
Committee Code
Committee Name Serves as U.S. Mirror Committee (TAG or U.S. consensus body) for…
Scope
CI Cochlear Implants Committee ISO TC 150/SC 6/WG 03 Develops performance and safety standards for cochlear implants. Staff contact: Colleen Elliott, celliott@aami.org
IP Implantable Infusion Pumps Committee
ISO/TC 150/SC 6/WG 04 Develops standards that relate to implantable infusion pumps. Staff contact: Jennifer Moyer jmoyer@aami.org
MC Mechanical Circulatory Support Systems Committee
ISO/TC 150/SC 6/WG 06 Develops standards that specify requirements for safety and performance of active implantable circulatory support devices. Staff contact: Cliff Bernier cbernier@aami.org
NS/WG 02 Implantable Neurostimulators Working Group
Develops standards that relate to implantable neurostimulators regardless of therapy type. Staff contact: Jennifer Moyer jmoyer@aami.org.
PC Cardiac Rhythm Management Device Committee
ISO/TC 150/SC 6— IEC/SC 62D JWG 1
Develops standards related to the design and safety of implantable cardioverter defibrillators and implantable pacemakers. Staff contact: Jennifer Moyer jmoyer@aami.org
PC WG01 Transvenous Cardiac Leads Working Group
Develops test methods related to transvenous cardiac leads reliability. Staff contact: Jennifer Moyer jmoyer@aami.org
PC WG02 EMC Test Protocols for Pacemakers, ICDs & CRTs Working Group
ISO/TC 150/SC 6— IEC/SC 62D JWG 1
Develops test protocols related to the electromagnetic compatibility of cardiac pacemakers, cardioverter defibrillators and cardiac resynchronization devices. Staff contact: Jennifer Moyer jmoyer@aami.org
PC WG03 Pacemaker and ICD MRI Compatibility Working Group
Develops methods to assess the safety of MRI and implantable cardiac devices. Staff contact: Jennifer Moyer jmoyer@aami.org
TAG 150/SC 6
Active Implantable Medical Devices Committee
ISO/TC 150/SC 6 and ISO/TC 150/SC 6/JWG 2—IEC 62B JWG 1
Develops standards that impact all active implantable devices. Staff contact: Jennifer Moyer jmoyer@aami.org
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III. Biological Evaluation of Medical Devices
Committee Code
Committee Name Serves as U.S. Mirror Committee (TAG or U.S. consensus body) for…
Scope
BE Biological Evaluation Committee ISO/TC 194 Standardization of the approach to biological evaluation of medical and dental materials and devices together with standardization of biological test methods applicable to those materials and devices. Staff contact: Amanda Benedict abenedict@aami.org
BE/WG 01 Systematic Approach to Biological Evaluation and Terminology Working Group
ISO/TC 194/WG 01 Addresses the systematic approach to biological evaluation and terminology. Staff contact: Amanda Benedict abenedict@aami.org
BE/WG 02 Degradation Aspects Related to Biological Testing Working Group
ISO/TC 194/WG 02 Addresses degradation aspects related to biocompatibility testing. Amanda Benedict abenedict@aami.org
BE/WG 03 Animal Protection Aspects Working Group
ISO/TC 194/WG 03 Addresses animal protection aspects in biocompatibility evaluation. Staff contact: Amanda Benedict abenedict@aami.org
BE/WG 04 Clinical Investigations Working Group ISO/TC 194/WG 04 Addresses biocompatibility related clinical investigations. Staff contact: Amanda Benedict abenedict@aami.org
BE/WG 05 Cytotoxicity Working Group ISO/TC 194/WG 05 Addresses cytotoxicity testing. Staff contact: Amanda Benedict abenedict@aami.org
BE/WG 06 Mutagen, Carcinogen, Reproduction toxicity Working Group
ISO/TC 194/WG 06 Addresses mutagenicity, carcinogenicity, and reproductive toxicity testing of medical devices. Staff contact: Amanda Benedict abenedict@aami.org
BE/WG 07 Systemic Toxicity Working Group ISO/TC 194/WG 07 Addresses systemic toxicity testing. Staff contact: Amanda Benedict abenedict@aami.org
BE/WG 08 Irritation and Sensitization Working Group
ISO/TC 194/WG 08 Addresses irritation and sensitization testing. Staff contact: Amanda Benedict abenedict@aami.org
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III. Biological Evaluation of Medical Devices
Committee Code
Committee Name Serves as U.S. Mirror Committee (TAG or U.S. consensus body) for…
Scope
BE/WG 09 Effects on Blood Working Group ISO/TC 194/WG 09 Addresses evaluation of the effects on blood. Staff contact: Amanda Benedict abenedict@aami.org
BE/WG 10 Implantation Working Group ISO/TC 194/WG 10 Addresses implantation testing as part of biological evaluation. Staff contact: Amanda Benedict abenedict@aami.org
BE/WG 11 Allowable Limits for Leachable Substances Working Group
ISO/TC 194/WG 11 Addresses the determination of allowable limits for leachable substances. Staff contact: Amanda Benedict abenedict@aami.org
BE/WG 12 Sample preparation and reference materials Working Group
ISO/TC 194/WG 12 Addresses sample preparation and reference materials for biocompatibility testing. Staff contact: Amanda Benedict abenedict@aami.org
BE/WG 13 Toxicokinetics Study Design Working Group
ISO/TC 194/WG 13 Addresses toxicokinetics study design. Staff contact: Amanda Benedict abenedict@aami.org
BE/WG 14 Material Characterization Working Group
ISO/TC 194/WG 14 Addresses material characterization. Staff contact: Amanda Benedict abenedict@aami.org
BE/WG 15 Strategic Approach to Biological Assessment
ISO/TC 194/WG 15 Addresses strategic approaches to biological assessment. Staff contact: Amanda Benedict abenedict@aami.org
BE/WG 16 Pyrogenicity Working Group ISO/TC 194/WG 16 Addresses pyrogenicity testing and evaluation. Staff contact: Amanda Benedict abenedict@aami.org
BE/WG 17 Nanomaterials Working Group ISO/TC 194/WG 17 Addresses nanomaterials. Staff contact: Amanda Benedict abenedict@aami.org
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IV. Cardiovascular Implants (Non-Active) and Extracorporeal Systems
Committee Code
Committee Name Serves as U.S. Mirror Committee (TAG or U.S. consensus body) for…
Scope
BF Blood Filter/Cell Salvaging Committee
Develops essential performance and safety standards related to Blood filtering and transfusion. Staff contact: Cliff Bernier cbernier@aami.org
BG Blood/Gas Exchange Device Committee
ISO/TC 150/SC 2/WG 04 Develops essential performance and safety standards related to Blood/gas exchange devices; oxygenators; extracorporeal perfusion and circulation; cardiopulmonary bypass; ECMO. Staff contact: Cliff Bernier cbernier@aami.org
CO Cardiac Occluders Committee ISO/TC 150/SC 2/WG 08 Develops essential performance and safety standards related to cardiac occluders. Staff contact: Cliff Bernier cbernier@aami.org
CV Cardiac Valve Prostheses Committee ISO/TC 150/SC 2/WG 01 Develops essential performance and safety standards related to Heart valve substitutes; heart valve repair devices. Staff contact: Cliff Bernier cbernier@aami.org
DP Medical Device Particulates Committee
Develops essential performance and safety standards related to Vascular exposure to particles arising from the manufacturing environment for vascular medical devices and from the use of vascular medical devices. Staff contact: Cliff Bernier cbernier@aami.org
RD Renal Disease and Detoxification Committee
ISO/TC 150/SC 2/WG 05 Develops essential performance and safety standards related to Hemodialysis and related therapies equipment; dialysis fluid quality, preparation, and management. Staff contact: Cliff Bernier cbernier@aami.org
TAG 150/SC 2
Cardiovascular Implants and Extracorporeal Systems Committee
ISO/TC 150/SC 2 Develops essential performance and safety standards related to General technical advice on common cardiovascular implants and extracorporeal systems issues. Staff contact: Cliff Bernier cbernier@aami.org
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IV. Cardiovascular Implants (Non-Active) and Extracorporeal Systems
Committee Code
Committee Name Serves as U.S. Mirror Committee (TAG or U.S. consensus body) for…
Scope
VI Cardiovascular Absorbable Implants Committee
ISO/TC 150/SC 2/WG 07 Develops essential performance and safety standards related to Absorbable cardiovascular implants. Staff contact: Cliff Bernier cbernier@aami.org
VP Vascular Prostheses Committee ISO/TC 150/SC 2/WG 03 Develops essential performance and safety standards related to Vascular and endovascular prostheses including stents and vena cava filters. Staff contact: Cliff Bernier cbernier@aami.org
VP/WG 01 Vascular Device/Drug Combination Products
ISO/TC 150/SC 2/WG 06 Develops essential performance and safety standards related to Vascular device-drug combination products and local regulatory guidance. Staff contact: Cliff Bernier cbernier@aami.org
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V. Devices for Injection and Transfusion
Committee Code
Committee Name Serves as U.S. Mirror Committee (TAG or U.S. consensus body)
for…
Scope
DI Devices for Injection Committee ISO/TC 76 and ISO/TC 84 TC 76: Develops essential performance and safety standards related to containers (such as infusion bottles and bags, injection vials, ampoules, glass cylinders, cartridges, pre-fillable syringes, etc.) application systems (such as giving sets, non-electrically driven portable infusion devices, blood collection systems, etc.) and accessories for infusion, transfusion, injection and blood processing in blood banks, terms, definitions, requirements and test methods for these devices, specifications and test methods for quality and performance of their materials and components (such as elastomeric closures, caps and ports, pipettes, etc.) and quality management systems for primary packaging materials.
TC84: Develops essential performance and safety standards related to performance of metered devices and supplies intended for administration of medicinal products, and standardization of syringes, needles, and intravascular catheters.
Staff contact: Cliff Bernier cbernier@aami.org
DI/WG 01 Soft Containers for Blood; Blood Processing Equipment Working Group
ISO/TC 76/WG 1 Develops essential performance and safety standards related to Soft containers for blood, blood components and parenterals; Infusion, transfusion and blood processing equipment. Staff contact: Cliff Bernier cbernier@aami.org
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V. Devices for Injection and Transfusion
Committee Code
Committee Name Serves as U.S. Mirror Committee (TAG or U.S. consensus body)
for…
Scope
DI/WG 02 Rigid Container Systems and Accessories Working Group
ISO/TC 76/WG 2 Develops essential performance and safety standards related to Rigid container systems and related accessories for parenterals and injectables. Staff contact: Cliff Bernier cbernier@aami.org
DI/WG 04 Elastomeric Parts, Components and Packaging Working Group
ISO/TC 76/WG 4 Develops essential performance and safety standards related to Elastomeric parts and components and related secondary packaging components. Staff contact: Cliff Bernier cbernier@aami.org
DI/WG 05 Blood Collection Systems Working Group
ISO/TC 76/WG 5 Develops essential performance and safety standards related to Blood collecting systems for diagnostic use. Staff contact: Cliff Bernier cbernier@aami.org
DI/WG 06 Primary Packaging Materials for Medicinal Products Working Group
ISO/TC 76/WG 6 Develops essential performance and safety standards related to Primary packaging materials for medicinal products. Staff contact: Cliff Bernier cbernier@aami.org
DI/WG 23 Syringes for Insulin and Pen Injectors Working Group
ISO/TC 84/WG 3 Develops essential performance and safety standards related to Syringes for insulin and pen-injectors. Staff contact: Cliff Bernier cbernier@aami.org
DI/WG 24 Needle Free Injectors Working Group ISO/TC 84/WG 4 Inactive
DI/WG 26 Auto Injectors Working Group ISO/TC 84/WG 6 Inactive
DI/WG 27 Safety Issues for Needles Working Group
ISO/TC 84/WG 7 Inactive
DI/WG 28 Sharps Containers Working Group ISO/TC 84/WG 8 Develops essential performance and safety standards related to Sharps containers. Staff contact: Cliff Bernier cbernier@aami.org
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V. Devices for Injection and Transfusion
Committee Code
Committee Name Serves as U.S. Mirror Committee (TAG or U.S. consensus body)
for…
Scope
DI/WG 29 Catheters Working Group ISO/TC 84/WG 9 Develops essential performance and safety standards related to Catheters. Staff contact: Cliff Bernier cbernier@aami.org
DI/WG 30 Needles Working Group ISO/TC 84/WG 10 Develops essential performance and safety standards related to Needles. Staff contact: Cliff Bernier cbernier@aami.org
DI/WG 31 Syringes Working Group ISO/TC 84/WG 11 Develops essential performance and safety standards related to Syringes. Staff contact: Cliff Bernier cbernier@aami.org
DI/WG 32 Requirements for NIS: Accessibility for Physical Impairments Working Group
ISO/TC 84/WG 12 Develops essential performance and safety standards related to Accessibility for visually impaired. Staff contact: Cliff Bernier cbernier@aami.org
DI/WG 33 On-Body Delivery Systems Working Group
ISO/TC 84/WG 13 Develops essential performance and safety standards related to Bolus injection. Staff contact: Cliff Bernier cbernier@aami.org
DI/WG 34 Needle-based injection system (NIS) - Electrotechnical requirements and test methods
ISO/TC 84/WG 14 Develops essential performance and safety standards related to Electrotechnical requirements and test methods for Needle-based injection systems. Staff contact: Cliff Bernier cbernier@aami.org
DI/WG 35 Device Change Management ISO/TC 84/WG 15 Develops guidelines for device change management. Staff contact: Cliff Bernier cbernier@aami.org
DI/WG 36 Drug Delivery System Requirements for Paedriatics and Other Demographics
ISO/TC 84/WG 16 Develops essential performance and safety standards for drug delivery systems for paedriatrics and other demographics. Staff contact: Cliff Bernier cbernier@aami.org
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VI. Electromedical Devices
Committee Code Committee Name Serves as U.S. Mirror Committee (TAG or U.S. consensus body)
for…
Scope
AP Apnea Monitoring Committee Develops reports regarding apnea monitoring by means of thoracic impedance pneumography. Staff contact: Hae Choe hchoe@aami.org
BP Blood Pressure Monitoring Committee
IEC/SC 62D/JWG22 Develops standards dealing with invasive blood pressure monitoring devices. Staff contact: Hae Choe hchoe@aami.org
DF Defibrillator Committee IEC/SC 62D/MT19 Develops standards dealing with cardiac defibrillators and automated external defibrillators. Staff contact: Hae Choe hchoe@aami.org
EC ECG Committee IEC/SC 62D/JWG22 Develops standards dealing with diagnostic, cardiac, and ambulatory electrocardiographic (ECG) monitoring equipment as well as the cables and leadwires, arrhythmia monitoring and electrodes used in electrocardiographs. Staff contact: Hae Choe hchoe@aami.org
EQ Medical Equipment Management Committee
Develops standards on aspects of medical equipment management for healthcare technology managers. Staff contact: Patrick Bernat pbernat@aami.org or Joe Lewelling jlewelling@aami.org
EV/WG 02 Electroencephalographs Equipment IEC/SC 62D/JWG22 Develops standard on electroencephalographs. Staff contact: Hae Choe hchoe@aami.org
EV/WG 03 EMG and Evoked Response Equipment Working Group
IEC/SC 62D/MT26 Develops standard on electromyographs and evoked response equipment. Staff contact: Hae Choe hchoe@aami.org
EV/WG 04 Electro-optical Equipment Working Group
IEC/SC 62D/MT16 Develops standard on endoscopic equipment. Staff contact: Hae Choe hchoe@aami.org
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VI. Electromedical Devices
Committee Code Committee Name Serves as U.S. Mirror Committee (TAG or U.S. consensus body)
for…
Scope
EV/WG 05 Hospital Bed Working Group IEC/SC 62D — ISO/TC 173 JWG 4
Develops standards on medical beds and operating tables. Staff contact: Hae Choe hchoe@aami.org
EV/WG 06 Clinical Thermometers IEC/SC 62D/JWG 8 — ISO/TC 121/SC 1 JWG 6
Develops standards on clinical thermometers and screening thermographs for human febrile temperature screening. Staff contact: Hae Choe hchoe@aami.org
EV/WG 07 Transcutaneous Partial Pressure Monitoring Equipment Working Group
IEC/SC 62D/JWG22 Develops standard on transcutaneous partial pressure monitoring equipment. Staff contact: Hae Choe hchoe@aami.org
EV/WG 08 Ultrasound Working Group IEC/SC 62D/JWG38
IEC/SC 62D/MT24
Develops standards on ultrasound physiotherapy equipment, extracorporeally induced lithotripsy, and high intensity therapeutic ultrasound. Staff contact: Hae Choe hchoe@aami.org
EV/WG 10 Short-wave & Microwave Therapy Equipment
IEC/SC 62D/MT 18 Develops standards on short-wave therapy and microwave therapy equipment. Staff contact: Hae Choe hchoe@aami.org
EV/WG 11 Ionized Gas Coagulation Equipment
IEC/SC 62D/WG34 Develops standard for ionized gas coagulation equipment. Staff contact: Hae Choe hchoe@aami.org
EV/WG 12 Luminaires Working Group IEC/SC 62D/MT27 Develops standard on surgical luminaires and luminaires for diagnosis. Staff contact: Hae Choe hchoe@aami.org
EV/WG 13 Lens Removal and Vitrectomy Devices Working Group
IEC/SC 62D — ISO/TC 172/SC 7 JWG 9
Develops standard for lens removal and vitrectomy devices. Staff contact: Hae Choe hchoe@aami.org
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VI. Electromedical Devices
Committee Code Committee Name Serves as U.S. Mirror Committee (TAG or U.S. consensus body)
for…
Scope
EV/WG 14 Photodynamic Therapy and Diagnostic Equipment
IEC/SC 62D/WG 33 Develops standard for photodynamic therapy and diagnostic equipment. Staff contact: Hae Choe hchoe@aami.org
HF High Frequency Therapeutic Device Committee
IEC/SC 62D/MT17 Develops standards for high frequency surgical equipment. Staff contact: Hae Choe hchoe@aami.org
ID Infusion Device Committee IEC/SC 62D/MT23 Develops standards related to non-implantable infusion pumps. Staff contact: Jennifer Moyer jmoyer@aami.org
II Infant Incubator Committee IEC/SC 62D/MT21 Develops standards for pediatric medical equipment such as incubators, radiant warmers, and phototherapy equipment. Staff contact: Hae Choe hchoe@aami.org
MP Multiparameter Patient Monitoring Equip Committee
IEC/SC 62D/MT22 Develops standards related to multi-function patient monitoring equipment. Staff contact: Jennifer Moyer jmoyer@aami.org
NS Neurosurgery Committee Provides oversight to the working groups dealing with neurosurgery. Staff contact: Jennifer Moyer jmoyer@aami.org.
NS/WG 01 Intra-cranial Pressure Devices Working Group
Develops standards that relate to devices that are intended to measure intercranial pressure. Staff contact: Jennifer Moyer jmoyer@aami.org
NS/WG 03 Transcutaneous Electrical Stimulator Working Group
Develops standards that establishes certain requirements for portable, battery-powered, transcutaneous electrical nerve stimulators (TENS devices). Staff contact: Jennifer Moyer jmoyer@aami.org
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VI. Electromedical Devices
Committee Code Committee Name Serves as U.S. Mirror Committee (TAG or U.S. consensus body)
for…
Scope
SP Sphygmomanometer Committee IEC/SC 62D/JWG 7— ISO/TC 121/SC 3 JWG 7
Develops standards for automated and non-automated non-invasive blood pressure monitoring devices. Staff contact: Hae Choe hchoe@aami.org
TAG 62D Electromedical Equipment Committee
IEC/SC 62D Develops U.S. position for IEC/SC 62D and provides oversight to all of the committees which service as mirror committees to the work that is being undertaken by IEC/SC 62D. Staff contact: Hae Choe hchoe@aami.org
WV Waveform Testing Committee Develops technical report on acquisition and use of physiologic waveform databases for testing of medical devices. Staff contact: Hae Choe hchoe@aami.org
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VII. General Requirements for Medical Devices
Committee Code
Committee Name Serves as U.S. Mirror Committee (TAG or U.S. consensus body)
for…
Scope
AL Alarms (Medical Device Alarms) Committee
IEC/SC 62A/JWG 2— ISO/TC 121/SC 3 JWG 2
Develops standards on auditory and visual alarm signals for medical equipment. Staff contact: Jennifer Moyer jmoyer@aami.org
CP Combination Products Committee Develops standards and guidance applicable to combination products. Staff contact: Hae Choe hchoe@aami.org
EM Electromagnetic Compatibility Committee
IEC/SC 62A/MT23 Develops general electromagnetic compatibility requirements for medical electrical equipment, taking into consideration the special needs of medical practice. Staff contact: Hae Choe hchoe@aami.org
ES Electrical Safety Committee
IEC/SC 62A Develops standards that test medical electrical equipment and specifies general testing requirements. Staff contact: Hae Choe hchoe@aami.org
HA Home Use and EMS Environment IEC/SC 62A/JWG 6— ISO/TC 121/SC 6 JWG 6
Develops standards and guidance documents that provide information on design, maintenance, and use of medical devices and systems intended for the non-clinical environment in order to continually improve safety and usability. Staff contact: Jennifer Moyer jmoyer@aami.org
HE Human Factors Engineering Committee
IEC/SC 62A/JWG4— ISO/TC 210/JWG 3
Develops general requirements and guidance on a usability-engineering process for improving the safety of medical devices and combinations of medical devices. Staff contact: Jennifer Moyer jmoyer@aami.org
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VII. General Requirements for Medical Devices
Committee Code
Committee Name Serves as U.S. Mirror Committee (TAG or U.S. consensus body)
for…
Scope
QM Quality Management and Corresponding General Aspects for Medical Devices Committee
ISO/TC 210 Develops standards for quality management and corresponding general aspects for medical devices. Staff contact: Wil Vargas wvargas@aami.org
QM/WG 01 Application of Quality Systems to Medical Devices Working Group
ISO/TC 210/WG 01 Develops standards for a quality management system that can be used by an organization involved in stages of the life-cycle of a medical device. Staff contact: Wil Vargas wvargas@aami.org
QM/WG 02 General Aspects Stemming from the Application of Quality Principles to Medical Devices Working Group
ISO/TC 210/WG 02 Develops standards and guides that can be used in the assessment of conformity of medical devices to the recognized essential principles that when met, indicate a medical device is safe and performs as intended. Staff contact: Wil Vargas wvargas@aami.org
QM/WG 03 Symbols & Nomenclature for Medical Devices Working Group
ISO/TC 210/WG 03 Develops standards for symbols used in medical device labelling that convey information on the safe and effective use of medical devices. Staff contact: Wil Vargas wvargas@aami.org
QM/WG 04 Application of Risk Management to Medical Devices Working Group
ISO/TC 210— IEC/SC 62A JWG 1
Develops standards and guidance that specify a process for a manufacturer to identify the hazards associated with medical devices to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. Staff contact: Wil Vargas wvargas@aami.org
QM/WG 06 Application of post market surveillance systems to medical devices
ISO/TC 210/WG 06 Develops standards and guidance that assist medical device manufacturers to collect and analyze experience gained with their devices after placing on the market, and identify ways to use the data. Staff contact: Wil Vargas wvargas@aami.org
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VII. General Requirements for Medical Devices
Committee Code
Committee Name Serves as U.S. Mirror Committee (TAG or U.S. consensus body)
for…
Scope
RB Robotics ISO/TC 299 – IEC/SC 62A JWG 9
ISO/TC 299 – IEC/SC 62D JWG35
ISO/TC 299 – IEC/SC 62D JWG36
Develops standards and guidance which deal with robotic equipment with medical implications. Staff contact: Hae Choe hchoe@aami.org
SU Sustainability Committee Develops standards and guidance on sustainability as it relates to medical device development with regard to the triple bottom line: economy, environment, society. Staff contact: Cliff Bernier cbernier@aami.org
TAG 62 Electrical Equipment in Medical Practice Committee
IEC/TC 62 Develops U.S. position for IEC/TC 62. Staff contact: Hae Choe hchoe@aami.org
TAG 62A Common aspects of electrical equipment used in medical practice
IEC/SC 62A Develops U.S. position for IEC/SC 62A and working groups/maintenance teams/joint working groups under this subcommittee. Staff contact: Hae Choe hchoe@aami.org
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VIII. Medical Device Connectors
Committee Code
Committee Name Serves as U.S. Mirror Committee (TAG or U.S. consensus body) for…
Scope
CN Small Bore Connectors Committee ISO/TC 210— IEC/SC 62D JWG 4
Develops design standards for small-bore connectors for healthcare applications. Staff contact: Colleen Elliott celliott@aami.org
CN/WG 01 Luer Activated Valves Working Group Develops standards for luer activated valves/needle free connectors. Staff contact: Colleen Elliott celliott@aami.org
CN/WG 15 Small Bore Connectors Reservoir Delivery Systems Working Group
ISO/TC 210/WG 5 Develops design standards for connectors for reservoir delivery systems for healthcare applications. Staff contact: Colleen Elliott celliott@aami.org
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IX. Medical Device Software and IT and/or Health Software and HIT
Committee Code
Committee Name Serves as U.S. Mirror Committee (TAG or U.S. consensus body) for…
Scope
AAMI/UL 2800
Interoperability Coordinates the activity for the development of a family of standards focused on component safety and security requirements for plug-and-play interoperability with medical devices. Staff contact: Wil Vargas wvargas@aami.org
HIT Health IT Committee Addresses safety, effectiveness, and security of health software and health IT. Staff contact: Joe Lewelling jlewelling@aami.org
HIT/WG 01 Health IT Risk Management Addresses risk management for the health IT sociotechnical system. Staff contact: Joe Lewelling jlewelling@aami.org
HIT/WG 02 Health IT Quality Systems Addresses quality systems for the health IT sociotechnical system. Staff contact: Joe Lewelling jlewelling@aami.org
HIT/WG 03 Health IT Usability Addresses usability for the health IT sociotechnical system. . Staff contact: Joe Lewelling jlewelling@aami.org
HIT/WG 04 Health IT Safety ISO/TC 215— IEC/SC 62A JWG 7
Coordinates the US input and US adoption of international standards for health software and health IT. Joe Lewelling jlewelling@aami.org
SM Software and Information Technology Committee
Oversight committee for the AAMI software, health information technology, and interoperability working groups. Staff contact: Wil Vargas wvargas@aami.org
SM/WG 01 Software Working Group ISO/TC 210— IEC/SC 62A JWG 2 (IEC/SC 62A JWG 3)
Develops standards and guidance on medical device software. Staff contact: Wil Vargas wvargas@aami.org
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IX. Medical Device Software and IT and/or Health Software and HIT
Committee Code
Committee Name Serves as U.S. Mirror Committee (TAG or U.S. consensus body) for…
Scope
SM/WG 02 Information Technology Networks Working Group
ISO/TC 215— IEC/SC 62A JWG 7
Oversees US adoption of the IEC 80001 series of standards and guides on the application of risk management for IT-networks incorporating medical devices. Staff contact: Joe Lewelling jlewelling@aami.org
SM/WG03 Interoperability Working Group Addresses hazardous situations that may arise from a lack of interoperability, which includes but is not limited to the inability to communicate or an attempt to integrate systems which were not intended to be integrated. Staff contact: Wil Vargas wvargas@aami.org
SM/ WG05 Device Security Working Group Develops standards on device security as it relates to medical devices. Staff contact: Wil Vargas wvargas@aami.org
SM/WG06 Wireless Working Group Develops standards on wireless issues as they relate to medical devices. Staff contact: Staff contact: Wil Vargas wvargas@aami.org:
SM/WG08 Software Defect Classification Working Group
Develops standards relating to software defects. Staff contact: Staff contact: Wil Vargas wvargas@aami.org:
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X. Sterilization and Infection Prevention – Equipment Committee
Code Committee Name Serves as U.S. Mirror Committee
(TAG or U.S. consensus body) for… Scope
PB Protective Barriers Committee (surgical gowns and drapes)
Develops performance standards for surgical gowns and drapes. Staff contact: Colleen Elliott, celliott@aami.org
ST/WG 04 Biological Indicators Working Group ISO/TC 198/WG 04 Develops standards related to biological indicators. Staff contact: Cliff Bernier cbernier@aami.org
ST/WG 06 Chemical Indicators Working Group ISO/TC 198/WG 06 Develops standards related to chemical indicators. Staff contact: Cliff Bernier cbernier@aami.org
ST/WG 07 Packaging Working Group ISO/TC 198/WG 07 Develops standards related to packaging for terminally sterilized medical devices. Staff contact: Hae Choe hchoe@aami.org
ST/WG 13 Washer Disinfectors Working Group ISO/TC 198/WG 13 Develops standards and test methods for washer-disinfectors. Staff contact: Jennifer Moyer jmoyer@aami.org
ST/WG 43 Hospital Steam Sterilizer Working Group
Develops standards related to the manufacturing of steam sterilizers. Staff contact: Amanda Benedict abenedict@aami.org
ST/WG 62 Hospital Ethylene Oxide Sterilizer Working Group
Develops performance and safety standards for large (> 2 cu. ft. chamber) and small steam sterilizers utilized in health care facilities to sterilize reusable medical devices. Staff contact: Amanda Benedict abenedict@aami.org
ST/WG 91 Resistometer Working Group Develops standards for test equipment to be used in testing biological and chemical indicators. Staff contact: Cliff Bernier cbernier@aami.org
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X. Sterilization and Infection Prevention – Equipment Committee
Code Committee Name Serves as U.S. Mirror Committee
(TAG or U.S. consensus body) for… Scope
ST/WG 92 Process Challenge Devices Working Group
Develops technical report for process challenge devices/test packs used in healthcare facilities. Staff contact: Hae Choe hchoe@aami.org
ST/WG 94 Rigid Sterilization Container Systems Working Group
Develops standards related to the manufacturing of rigid sterile barrier systems. Staff contact: Amanda Benedict abenedict@aami.org
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XI. Sterilization and Infection Prevention – Hospital Practices and Instructions
Committee Code
Committee Name Serves as U.S. Mirror Committee (TAG or U.S. consensus body) for…
Scope
ST/WG 12 Instructions for Reusable Device Reprocessing Working Group
ISO/TC 198/WG 12 Develops standards for the development, validation or verification and provision of instructions for processing medical devices in health care facilities. Staff contact: Jennifer Moyer jmoyer@aami.org
ST/WG 15 Sterility Assurance Level (SAL) Working Group
ISO/TC 198/WG 15 Develops standards addressing the assurance of sterility in the processing of health care products to be labelled "sterile". Staff contact: Amanda Benedict abenedict@aami.org
ST/WG 40 Steam Sterilization Hospital Practices Working Group
Develops standards for sterile processing professionals using steam sterilization in health care delivery organizations. Staff contact: Amanda Benedict abenedict@aami.org
ST/WG 60 EO Sterilization Hospital Practices Working Group
Develops standards for sterile processing professionals using EO sterilization in health care delivery organizations. Staff contact: Amanda Benedict abenedict@aami.org
ST/WG 61 Chemical Sterilants Hospital Practices Working Group
Develops standards for sterile processing professionals using chemical sterilants in health care delivery organizations. Staff contact: Amanda Benedict abenedict@aami.org
ST/WG 63 Sterilization Residuals Working Group
Develops standards for sterile processing professionals relating to sterilization residuals in health care delivery organizations. Staff contact: Amanda Benedict abenedict@aami.org
ST/WG 83 Reusable Surgical Textiles Processing Working Group
Develops standards and guidance for processing of surgical textiles in health care facilities. Staff contact: Amanda Benedict abenedict@aami.org
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XI. Sterilization and Infection Prevention – Hospital Practices and Instructions
Committee Code
Committee Name Serves as U.S. Mirror Committee (TAG or U.S. consensus body) for…
Scope
ST/WG 84 Endoscope Reprocessing Working Group
Develops guidance on endoscope reprocessing. Staff contact: Amanda Benedict abenedict@aami.org
ST/WG 85 Human Factors for Device Reprocessing Working Group
Develops guidance on human factors engineering as it relates to medical device design and instructions for use. Staff contact: Amanda Benedict abenedict@aami.org
ST/WG 86 Quality Systems for Device Reprocessing Working Group
Develops standards for quality management systems for device reprocessing in health care delivery organizations. Staff contact: Amanda Benedict abenedict@aami.org
ST/WG 93 Cleaning of Reusable Medical Devices Working Group
Develops guidance on cleaning of medical devices. Staff contact: Amanda Benedict abenedict@aami.org
ST/WG 95 Water Quality for Reprocessing Medical Devices
Develops guidance on water quality required for cleaning and reprocessing medical devices. Staff Amanda Benedict abenedict@aami.org
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XII. Sterilization and Infection Processes – Industrial Processes
Committee Code
Committee Name Serves as U.S. Mirror Committee (TAG or U.S. consensus body) for…
Scope
ST Sterilization Standards Committee ISO/TC 198 Provides administrative guidance over the AAMI sterilization standards program and U.S. participation in ISO/TC 198, Sterilization of health care products. Staff contact: Amanda Benedict abenedict@aami.org
ST/WG 01 Industrial EO sterilization Working Group
ISO/TC 198/WG 01 Develops standards and guidance for ethylene oxide sterilization processes. Staff contact: Cliff Bernier cbernier@aami.org
ST/WG 02 Radiation Sterilization Working Group ISO/TC 198/WG 02 Develops standards and guidance for radiation sterilizations processes. Staff contact: Colleen Elliott celliott@aami.org
ST/WG 03 Industrial Moist Heat Sterilization Working Group
ISO/TC 198/WG 03 Develops standards and guidance for moist heat sterilization processes. Staff contact: abenedict@aami.org
ST/WG 05 Sterilization Terminology Working Group
ISO/TC 198/WG 05 Develops terminology standards and definitions for sterilization processes and equipment. Staff contact: Amanda Benedict abenedict@aami.org
ST/WG 08 Microbiological Methods Working Group
ISO/TC 198/WG 08 Develops microbiological methods and standards used in sterilization processing. Staff contact: Jennifer Moyer jmoyer@aami.org
ST/WG 09 Aseptic Processing Working Group ISO/TC 198/WG 09 Develops standards for aseptic processing of healthcare products as a production process. Staff contact: Jennifer Moyer jmoyer@aami.org
ST/WG 10 Liquid Chemical Sterilization Working Group
ISO/TC 198/WG 10 Develops standards for liquid chemical sterilization and processing of medical devices incorporating animal tissue. Staff contact: Amanda Benedict abenedict@aami.org
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XII. Sterilization and Infection Processes – Industrial ProcessesCommittee
Code Committee Name Serves as U.S. Mirror Committee
(TAG or U.S. consensus body) for… Scope
ST/WG 11 General Criteria for Sterilization Processes and Sterilizing Equipment Working Group
ISO/TC 198/WG 11 Develops standards providing general requirements for sterilization processes not addressed by other sterilization process standards. Staff contact: Amanda Benedict abenedict@aami.org
ST/WG 42 Dry Heat Sterilization Working Group Develops standards and guidance for moist heat sterilization processes. Staff contact: Amanda Benedict abenedict@aami.org
ST/WG 96 Compatibility of Materials Subject to Sterilization Working Group
Develops standards and guidance on the compatibility of various materials (e.g. metals, ceramics, polymers) with different sterilization processes. Staff contact: Amanda Benedict abenedict@aami.org
ST/WG 16 Vaporized Hydrogen PeroxideSterilization
ISO/TC 198/WG 16 Develops standards and guidance for vaporized hydrogen peroxide sterilization processes. Staff contact: Amanda Benedict abenedict@aami.org
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XIII. Tissue Product SafetyCommittee
Code Committee Name Serves as U.S. Mirror Committee
(TAG or U.S. consensus body) for… Scope
TS Tissue Product Safety Committee ISO/TC 194/SC 1 Develops standards on tissue product safety as it relates to biological evaluation. Staff contact: Amanda Benedict abenedict@aami.org