AAMI Technical Standards s (Updated: 1 August 2017) I. Anaesthetic and Respiratory... 2 II. Active Medical Implants... 4 III. Biological Evaluation of Medical Devices... 6 IV. Cardiovascular Implants (non-active) and Extracorporeal Systems... 9 V. Devices for Injection and Transfusion... 11 VI. Electromedical Devices... 15 VII. General Requirements for Medical Devices... 19 VIII. Medical Device Connectors... 22 IX. Medical Device Software and IT and/or Health Software and HIT... 23 X. Sterilization and Infection Prevention Equipment... 26 XI. Sterilization and Infection Prevention Hospital Practices and Instructions... 28 XII. Sterilization and Infection Prevention Processes... 31 XIII. Tissue Product Safety... 33 1
I. Anaesthetic and Respiratory Name Serves as U.S. Mirror 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 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 breathing attachments and anaesthetic machines. Staff contact: Colleen Elliott celliott@aami.org 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 2
I. Anaesthetic and Respiratory Name Serves as U.S. Mirror 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 EV/WG 01 Anesthesia Equipment Working 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 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 3
II. Active Medical Implants Name Serves as U.S. Mirror CI Cochlear Implants 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 ISO/TC 150/SC 6/WG 04 Develops standards that related to implantable infusion pumps. Staff contact: Jennifer Moyer jmoyer@aami.org MC Mechanical Circulatory Support Systems 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 ISO/TC 150/SC 6/WG 05 Develops standards that relate to implantable neurostimulators regardless of therapy type. Staff contact: Jennifer Moyer jmoyer@aami.org. PC Cardiac Rhythm Management Device 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 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 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 Develops methods to assess the safety of MRI and implantable cardiac devices. Staff contact: Jennifer Moyer jmoyer@aami.org 4
II. Active Medical Implants Name Serves as U.S. Mirror TAG 150/SC 6 Active Implantable Medical Devices ISO/TC 150/SC 6 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 5
III. Biological Evaluation of Medical Devices Name Serves as U.S. Mirror BE Biological Evaluation 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 BE/WG 01 Systematic Approach to Biological Evaluation and Terminology ISO/TC 194/WG 01 Working group addressing the systematic approach to biological evaluation and terminology. Staff contact: Amanda Benedict BE/WG 02 Degradation Aspects Related to Biological Testing ISO/TC 194/WG 02 Working group addressing degradation aspects related to biocompatibility testing. Amanda Benedict BE/WG 03 Animal Protection Aspects ISO/TC 194/WG 03 Working group addressing animal protection aspects in biocompatibility evaluation. Staff contact: Amanda Benedict BE/WG 04 Clinical Investigations Working ISO/TC 194/WG 04 Working group addressing biocompatibility related clinical investigations. Staff contact: Amanda Benedict BE/WG 05 Cytotoxicity ISO/TC 194/WG 05 Working group addressing cytotoxicity testing. Staff contact: Amanda Benedict BE/WG 06 Mutagen, Carcinogen, Reproduction toxicity Working ISO/TC 194/WG 06 Working group addressing mutagenicity, carcinogenicity, and reproductive toxicity testing of medical devices. Staff contact: Amanda Benedict 6
III. Biological Evaluation of Medical Devices Name Serves as U.S. Mirror BE/WG 07 Systemic Toxicity ISO/TC 194/WG 07 Working group addressing systemic toxicity testing. Staff contact: Amanda Benedict BE/WG 08 Irritation and Sensitization ISO/TC 194/WG 08 Working group addressing irritation and sensitization testing. Staff contact: Amanda Benedict BE/WG 09 Effects on Blood ISO/TC 194/WG 09 Working group addressing evaluation of the effects on blood. Staff contact: Amanda Benedict BE/WG 10 Implantation ISO/TC 194/WG 10 Working group addressing implantation testing as part of biological evaluation. Staff contact: Amanda Benedict BE/WG 11 Allowable Limits for Leachable Substances ISO/TC 194/WG 11 Working group addressing the determination of allowable limits for leachable substances. Staff contact: Amanda Benedict BE/WG 12 Sample preparation and reference materials Working ISO/TC 194/WG 12 Working group addressing sample preparation and reference materials for biocompatibility testing. Staff contact: Amanda Benedict BE/WG 13 Toxicokinetics Study Design ISO/TC 194/WG 13 Working group addressing toxicokinetics study design. Staff contact: Amanda Benedict BE/WG 14 Material Characterization Working ISO/TC 194/WG 14 Working group addressing material characterization. Staff contact: Amanda Benedict 7
III. Biological Evaluation of Medical Devices Name Serves as U.S. Mirror BE/WG 15 Strategic Approach to Biological Assessment ISO/TC 194/WG 15 Working group addressing strategic approaches to biological assessment. Staff contact: Amanda Benedict BE/WG 16 Pyrogenicity ISO/TC 194/WG 16 Working group addressing pyrogenicity testing and evaluation. Staff contact: Amanda Benedict BE/WG 17 Nanomaterials ISO/TC 194/WG 17 Working group addressing nanomaterials. Staff contact: Amanda Benedict 8
IV. Cardiovascular Implants (Non-Active) and Extracorporeal Systems Name Serves as U.S. Mirror BF Blood Filter/Cell Salvaging standards related to Blood filtering and transfusion. Staff contact: Cliff Bernier cbernier@aami.org BG Blood/Gas Exchange Device ISO/TC 150/SC 2/WG 04 standards related to Blood/gas exchange devices; oxygenators; extracorporeal perfusion and circulation; cardiopulmonary bypass; ECMO. Staff contact: Cliff Bernier cbernier@aami.org CV Cardiac Valve Prostheses ISO/TC 150/SC 2/WG 01 standards related to Heart valve substitutes; heart valve repair devices. Staff contact: Cliff Bernier cbernier@aami.org DP Medical Device Particulates 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 ISO/TC 150/SC 2/WG 05 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 ISO/TC 150/SC 2 standards related to General technical advice on common cardiovascular implants and extracorporeal systems issues. Staff contact: Cliff Bernier cbernier@aami.org 9
IV. Cardiovascular Implants (Non-Active) and Extracorporeal Systems Name Serves as U.S. Mirror VI Cardiovascular Absorbable Implants ISO/TC 150/SC 2/WG 07 standards related to Absorbable cardiovascular implants. Staff contact: Cliff Bernier cbernier@aami.org VP Vascular Prostheses ISO/TC 150/SC 2/WG 03 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 standards related to Vascular device-drug combination products and local regulatory guidance. Staff contact: Cliff Bernier cbernier@aami.org 10
V. Devices for Injection and Transfusion Name Serves as U.S. Mirror DI Devices for Injection ISO/TC 76 and ISO/TC 84 TC 76: standards related to containers (such as infusion bottles and bags, injection vials, ampoules, glass cylinders, cartridges, prefillable syringes, etc.) application systems (such as giving sets, nonelectrically 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: 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 ISO/TC 76/WG 1 standards related to Soft containers for blood, blood components and parenterals; Infusion, transfusion and blood processing equipment. Staff contact: Cliff Bernier cbernier@aami.org 11
V. Devices for Injection and Transfusion Name Serves as U.S. Mirror DI/WG 02 Rigid Container Systems and Accessories ISO/TC 76/WG 2 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 ISO/TC 76/WG 4 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 ISO/TC 76/WG 5 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 ISO/TC 76/WG 6 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 ISO/TC 84/WG 3 standards related to Syringes for insulin and peninjectors. Staff contact: Cliff Bernier cbernier@aami.org DI/WG 24 Needle Free Injectors Working ISO/TC 84/WG 4 Inactive DI/WG 26 Auto Injectors ISO/TC 84/WG 6 Inactive DI/WG 27 Safety Issues for Needles ISO/TC 84/WG 7 Inactive 12
V. Devices for Injection and Transfusion Name Serves as U.S. Mirror DI/WG 28 Sharps Containers Working ISO/TC 84/WG 8 standards related to Sharps containers. Staff contact: Cliff Bernier cbernier@aami.org DI/WG 29 Catheters ISO/TC 84/WG 9 standards related to Catheters. Staff contact: Cliff Bernier cbernier@aami.org DI/WG 30 Needles ISO/TC 84/WG 10 standards related to Needles. Staff contact: Cliff Bernier cbernier@aami.org DI/WG 31 Syringes ISO/TC 84/WG 11 standards related to Syringes. Staff contact: Cliff Bernier cbernier@aami.org DI/WG 32 Requirements for NIS: Accessibility for Physical Impairments ISO/TC 84/WG 12 standards related to Accessibility for visually impaired. Staff contact: Cliff Bernier cbernier@aami.org DI/WG 33 On-Body Delivery Systems ISO/TC 84/WG 13 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 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 13
VI. Electromedical Devices Name Serves as U.S. Mirror AP Apnea Monitoring Develops reports regarding apnea monitoring by means of thoracic impedance pneumography. Staff contact: Hae Choe hchoe@aami.org BP Blood Pressure Monitoring IEC/SC 62D/JWG22 Develops standards dealing with invasive blood pressure monitoring devices. Staff contact: Hae Choe hchoe@aami.org DF Defibrillator IEC/SC 62D/MT19 Develops standards dealing with cardiac defibrillators and automated external defibrillators. Staff contact: Hae Choe hchoe@aami.org EC ECG 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 Develops standards on aspects of medical equipment management for healthcare technology managers. Staff contact: Amanda Benedict 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 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 IEC/SC 62D/MT16 Develops standard on endoscopic equipment. Staff contact: Hae Choe hchoe@aami.org 14
VI. Electromedical Devices Name Serves as U.S. Mirror EV/WG 05 Hospital Bed IEC/SC 62D ISO/TC 173 JWG 4 EV/WG 06 Clinical Thermometers IEC/SC 62D/JWG 8 ISO/TC 121/SC 1 JWG 6 Develops standards on medical beds and operating tables. Staff contact: Hae Choe hchoe@aami.org 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 IEC/SC 62D/JWG22 Develops standard on transcutaneous partial pressure monitoring equipment. Staff contact: Hae Choe hchoe@aami.org EV/WG 08 Ultrasound 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 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 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 15
VI. Electromedical Devices Name Serves as U.S. Mirror 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 IEC/SC 62D/MT17 Develops standards for high frequency surgical equipment. Staff contact: Hae Choe hchoe@aami.org ID Infusion Device IEC/SC 62D/MT23 Develops standards related to non-implantable infusion pumps. Staff contact: Jennifer Moyer jmoyer@aami.org II Infant Incubator 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 IEC/SC 62D/MT22 Develops standards related to multi-function patient monitoring equipment. Staff contact: Jennifer Moyer jmoyer@aami.org NS Neurosurgery Provides oversight to the working groups dealing with neurosurgery. Staff contact: Jennifer Moyer jmoyer@aami.org. NS/WG 01 NS/WG 03 Intra-cranial Pressure Devices Transcutaneous Electrical Stimulator Develops standards that relate to devices that are intended to measure intercranial pressure. Staff contact: Jennifer Moyer jmoyer@aami.org Develops standards that establishes certain requirements for portable, battery-powered, transcutaneous electrical nerve stimulators (TENS devices). Staff contact: Jennifer Moyer jmoyer@aami.org 16
VI. Electromedical Devices Name Serves as U.S. Mirror SP Sphygmomanometer IEC/SC 62D/JWG 7 ISO/TC 121/SC 3 JWG 7 Develops standards for automated and nonautomated non-invasive blood pressure monitoring devices. Staff contact: Hae Choe hchoe@aami.org TAG 62D Electromedical Equipment IEC/SC 62D Develops U.S. position for IEC/SC 62D and provides oversight to all of the committees which serve as mirror committeesto the work that is being undertaken by IEC/SC 62D. Staff contact: Hae Choe hchoe@aami.org WV Waveform Testing Develops technical report on acquisition and use of physiologic waveform databases for testing of medical devices. Staff contact: Hae Choe hchoe@aami.org 17
VII. General Requirements for Medical Devices Name Serves as U.S. Mirror (TAG or U.S. consensus body) AL Alarms (Medical Device Alarms) 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 Develops standards and guidance applicable to combination products. Staff contact: Hae Choe hchoe@aami.org EM Electromagnetic Compatibility 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 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 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 18
VII. General Requirements for Medical Devices Name Serves as U.S. Mirror (TAG or U.S. consensus body) QM Quality Management and Corresponding General Aspects for Medical Devices 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 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 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 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 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 19
VII. General Requirements for Medical Devices Name Serves as U.S. Mirror (TAG or U.S. consensus body) 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 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 TAG62 Electrical Equipment in Medical Practice IEC/TC 62 Develops U.S. position for IEC/TC 62. Staff contact: Hae Choe hchoe@aami.org TAG62A 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 20
VIII. Medical Device Connectors Name Serves as U.S. Mirror CN Small Bore Connectors 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 15 Small Bore Connectors Reservoir Delivery Systems ISO/TC 210/WG 5 Develops design standards for connectors for reservoir delivery systems for healthcare applications. Staff contact: Colleen Elliott, celliott@aami.org 21
IX. Medical Device Software and IT and/or Health Software and HIT Name Serves as U.S. Mirror 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 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 Oversight committee for the AAMI software, health information technology, and interoperability working groups. Staff contact: Wil Vargas wvargas@aami.org SM/WG 01 Software 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 22
IX. Medical Device Software and IT and/or Health Software and HIT Name Serves as U.S. Mirror SM/WG 02 Information Technology Networks 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 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 Develops standards on device security as it relates to medical devices. Staff contact: Wil Vargas wvargas@aami.org SM/WG06 Wireless 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 Develops standards relating to software defects. Staff contact: Staff contact: Wil Vargas wvargas@aami.org: 23
X. Sterilization and Infection Prevention Equipment Name Serves as U.S. Mirror PB Protective Barriers (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 ISO/TC 198/WG 04 Develops standards related to biological indicators. Staff contact: Cliff Bernier cbernier@aami.org ST/WG 06 Chemical Indicators Working ISO/TC 198/WG 06 Develops standards related to chemical indicators. Staff contact: Cliff Bernier cbernier@aami.org ST/WG 07 Packaging 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 ISO/TC 198/WG 13 Develops standards and test methods for washerdisinfectors. Staff contact: Jennifer Moyer jmoyer@aami.org ST/WG 43 Hospital Steam Sterilizer Working Develops standards related to the manufacturing of steam sterilizers. Staff contact: Amanda Benedict ST/WG 62 Hospital Ethylene Oxide Sterilizer 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 ST/WG 92 Process Challenge Devices 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 Develops standards related to the manufacturing of rigid sterile barrier systems. Staff contact: Amanda 24
X. Sterilization and Infection Prevention Equipment Name Serves as U.S. Mirror Benedict 25
XI. Sterilization and Infection Prevention Hospital Practices and Instructions Name Serves as U.S. Mirror ST/WG 12 Instructions for Reusable Device Reprocessing 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 40 Steam Sterilization Hospital Practices Develops standards for sterile processing professionals using steam sterilization in health care delivery organizations. Staff contact: Amanda Benedict ST/WG 60 EO Sterilization Hospital Practices Develops standards for sterile processing professionals using EO sterilization in health care delivery organizations. Staff contact: Amanda Benedict ST/WG 61 Chemical Sterilants Hospital Practices Develops standards for sterile processing professionals using chemical sterilants in health care delivery organizations. Staff contact: Amanda Benedict ST/WG 63 Sterilization Residuals Working Develops standards for sterile processing professionals relating to sterilization residuals in health care delivery organizations. Staff contact: Amanda Benedict ST/WG 83 Reusable Surgical Textiles Processing Develops standards and guidance for processing of surgical textiles in health care facilities. Staff contact: Amanda Benedict ST/WG 84 Endoscope Reprocessing Develops guidance on endoscope reprocessing. Staff contact: Amanda Benedict ST/WG 85 Human Factors for Device Develops guidance on human factors engineering as it relates to medical device design and 26
XI. Sterilization and Infection Prevention Hospital Practices and Instructions Name Serves as U.S. Mirror Reprocessing instructions for use. Staff contact: Amanda Benedict ST/WG 86 Quality Systems for Device Reprocessing Develops standards for quality management systems for device reprocessing in health care delivery organizations. Staff contact: Amanda Benedict ST/WG 15 Sterility Assurance Level (SAL) 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 ST/WG 91 Resistometer Develops technical report for test equipment to be used in testing biological and chemical indicators. Staff contact: Cliff Bernier cbernier@aami.org ST/WG 93 ST/WG 95 Cleaning of Reusable Medical Devices Water Quality for Reprocessing Medical Devices Develops guidance on cleaning of medical devices. Staff contact: Amanda Benedict Develops guidance on water quality required for cleaning and reprocessing medical devices. Staff Amanda Benedict ST Sterilization Standards 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 ST/WG 01 Industrial EO sterilization Working ISO/TC 198/WG 01 Develops standards and guidance for ethylene oxide sterilization processes. Staff contact: Cliff Bernier cbernier@aami.org 27
XI. Sterilization and Infection Prevention Hospital Practices and Instructions Name Serves as U.S. Mirror ST/WG 02 Radiation Sterilization Working 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 ISO/TC 198/WG 03 Develops standards and guidance for moist heat sterilization processes. Staff contact: ST/WG 05 Sterilization Terminology Working ISO/TC 198/WG 05 Develops terminology standards and definitions for sterilization processes and equipment. Staff contact: Amanda Benedict ST/WG 08 Microbiological Methods Working 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 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 ISO/TC 198/WG 10 Develops standards for liquid chemical sterilization and processing of medical devices incorporating animal tissue. Staff contact: Amanda Benedict ST/WG 11 General Criteria for Sterilization Processes and Sterilizing Equipment ISO/TC 198/WG 11 Develops standards providing general requirements for sterilization processes not addressed by other sterilization process standards. Staff contact: Amanda Benedict ST/WG 42 Dry Heat Sterilization Working Develops standards and guidance for moist heat sterilization processes. Staff contact: Amanda Benedict 28
XI. Sterilization and Infection Prevention Hospital Practices and Instructions Name Serves as U.S. Mirror ST/WG 96 Compatibility of Materials Subject to Sterilization Develops standards and guidance on the compatibility of various materials (e.g. metals, ceramics, polymers) with different sterilization processes. Staff contact: Amanda Benedict 29
XIII. Tissue Product Safety Name Serves as U.S. Mirror TS Tissue Product Safety ISO/TC 194/SC 1 Develops standards on tissue product safety as it relates to biological evaluation. Staff contact: Amanda Benedict TS/WG 04 TSE Elimination ISO/TC 194/SC 1/WG 04 Develops standards on TSE elimination as it relates to biological evaluation. Staff contact: Amanda Benedict 30