| BIOLOGICAL EVALUATION OF MEDICAL DEVICES |
| ANSI/AAMI/ISO 10993–1:2003 |
Part 1: Evaluation and testing, 3ed |
| ANSI/AAMI/ISO 10993–2:2006 |
Part 2: Animal welfare requirements, 2ed |
| ANSI/AAMI/ISO 10993–3:2003 |
Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity, 2ed |
| ANSI/AAMI/ISO 10993–4:2002 and A1:2006 |
Part 4: Selection of tests for interactions with blood, 2ed and 2006 amendment |
| ANSI/AAMI/ISO 10993–5:1999 |
Part 5: Tests for in vitro cytotoxicity, 2ed |
| ANSI/AAMI/ISO 10993–6:2007 |
Part 6: Tests for local effects after implantation, 1ed |
| ANSI/AAMI/ISO 10993–7:1995/(R)2001 |
Part 7: Ethylene oxide sterilization residuals, 2ed |
| ANSI/AAMI/ISO 10993–9:1999/(R)2005 |
Part 9: Framework for identification and quantification of potential degradation products, 2ed |
| ANSI/AAMI BE78:2002 and A1:2006 |
Part 10: Tests for irritation and delayed type hypersensitivity, 2ed (adoption of ISO 10993-10:2002 with national deviation) and 2006 amendment (identical to ISO amendment) |
| ANSI/AAMI/ISO 10993–11:2006 |
Part 11: Tests for systemic toxicity, 2ed |
| ANSI/AAMI/ISO 10993–12:2007 |
Part 12: Sample preparation and reference materials, 3ed |
| ANSI/AAMI/ISO 10993–13:1999/ (R)2004 |
Part 13: Identification and quantification of degradation products from polymeric medical devices, 1ed |
| ANSI/AAMI/ISO 10993–14:2001/(R)2006 |
Part 14: Identification and quantification of degradation products from ceramics, 1ed |
| ANSI/AAMI/ISO 10993–15:2000/(R)2006 |
Part 15: Identification and quantification of degradation products from metals and alloys, 1ed |
| ANSI/AAMI/ISO 10993–16:1997/(R)2003 |
Part 16: Toxicokinetic study design for degradation products and leachables from medical devices, 1ed |
| ANSI/AAMI/ISO 10993-17:2002 |
Part 17: Establishment of allowable limits for leachable substances, 1ed |
| ANSI/AAMI BE83:2006 |
Part 18: Chemical characterization of materials |
| ANSI/AAMI/ISO 14155-1:2003 |
Clinical investigation of medical devices for human subjects—Part 1: General requirements, 1ed |
| ANSI/AAMI/ISO 14155-2:2003 |
Clinical investigation of medical devices for human subjects—Part 2: Clinical investigation plans, 1ed |
| ANSI/AAMI/ISO 22442-1:2007 |
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management, 1ed |
| ANSI/AAMI/ISO 22442-2:2007 |
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling, 1ed |
| ANSI/AAMI/ISO 22442-3:2007 |
Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents, 1ed |
| AAMI TIR19:1998; TIR19/A1:1999 |
Guidance for ANSI/AAMI/ISO 10993–7:1995, Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals, 1ed and Amendment |
| ANSI/AAMI/ISO TIR10993-19:2006 |
Biological evaluation of medical devices - Part 19: Physio-chemical, morphological and topographical characterization of materials, 1ed |
| ANSI/AAMI/ISO TIR10993-20:2006 |
Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices, 1ed |
| BIOMEDICAL EQUIPMENT |
| ANSI/AAMI AT6:2005 |
Autologous transfusion devices, 3ed |
| ANSI/AAMI BF7:1989/(R)2002/(R)2007 |
Blood transfusion micro-filters, 2ed |
| ANSI/AAMI BF64:2002/(R)2007 |
Leukocyte reduction filters, 1ed |
| ANSI/AAMI BP22:1994/(R)2006 |
Blood pressure transducers, 2ed |
| ANSI/AAMI DF80:2003 |
Medical electrical equipment, Part 2-4: Particular requirements for the safety of cardiac defibrillators [including automated external defibrillators], 4ed |
| ANSI/AAMI EC11:1991/(R)2007 |
Diagnostic electrocardiographic devices, 2ed |
| ANSI/AAMI EC12:2000/(R)2005 |
Disposable ECG electrodes, 3ed |
| ANSI/AAMI EC13:2002/(R)2007 |
Cardiac monitors, heart rate meters, and alarms, 3ed |
| ANSI/AAMI EC38:2007 |
Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems, 3ed |
ANSI/AAMI EC53:1995/(R)2001;
EC53/A1:1998/(R)2001 |
ECG cables and leadwires, 1ed and Amendment |
| ANSI/AAMI EC57:1998/(R)2003 |
Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms, 2ed |
| ANSI/AAMI EC71:2001(R)2007 |
Standard communications protocol—Computer assisted electrocardiography, 1ed |
| ANSI/AAMI EQ56:1999/(R):2004 |
Recommended practices for a medical equipment management program, 1ed |
| ANSI/AAMI ID26:2004 |
Medical electrical equipment, Part 2: Particular requirements for the safety of infusion pumps and controllers, 3ed |
| ANSI/AAMI ID54:1996/(R)2005 |
Enteral feeding set adapters and connectors, 1ed |
| ANSI/AAMI II36:2004 |
Medical electrical equipment, Part 2: Particular requirements for safety of baby incubators, 3ed |
| ANSI/AAMI II51:2004 |
Medical electrical equipment, Part 2: Particular requirements for safety of transport incubators, 2ed |
| AAMI NS4:1986/(R)2002 |
Transcutaneous electrical nerve stimulators, 1ed |
| ANSI/AAMI NS14:1995/(R)2002 |
Implantable spinal cord stimulators, 2ed |
| ANSI/AAMI NS15:1995/(R)2002 |
Implantable peripheral nerve stimulators, 2ed |
| ANSI/AAMI NS28:1988/(R)2006 |
Intracranial pressure monitoring devices, 1ed |
| ANSI/AAMI PB70:2003 |
Liquid barrier performance and classification of protective apparel and drapes in health care facilities, 1ed |
| ANSI/AAMI PAC49:1993/(R)2000 |
Pacemaker emergency intervention system, 1ed |
| ANSI/AAMI PC69:2007 |
Active implantable medical devices — Electromagnetic compatibility — EMC test protocols for implantable cardiac pacemakers and implantable cardioverter defibrillators, 2ed |
| ANSI/AAMI SP10:2002;
SP10 /A1:2003; and
SP10/A2:2006 |
Manual, electronic, or automated sphygmomanometers, 3ed and Amendments 1 and 2 |
| ANSI/AAMI/IEC 60601-2-2:2006 |
Medical electrical equipment, Part 2-2: Particular requirements for the safety of high frequency surgical equipment, 4ed |
ANSI/AAMI/IEC 60601–2–21
& 60601–2–21/A1:2000 |
Medical electrical equipment, Part 2: Particular requirements for the safety of infant radiant warmers, 1ed and Amendment (consolidated copy) |
| ANSI/AAMI/IEC 60601-2-50:2006 |
Medical electrical equipment - Part 2-50: Particular requirements for the safety of infant phototherapy equipment (2006 identical adoption of IEC 2001 standard) |
| ANSI/AAMI/ISO 5840:2005 |
Cardiovascular implants—Cardiac valve prostheses, 4ed |
| ANSI/AAMI/ISO 7198:1998/2001/(R)2004 |
Cardiovascular implants—Tubular vascular prostheses, 3ed |
| ANSI/AAMI/ISO 7199:1996/(R)2002 |
Cardiovascular implants and artificial organs—Blood-gas exchangers (oxygenators), 1ed |
| ANSI/AAMI/ISO 15674:2001 |
Cardiovascular implants and artificial organs—Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags, 1ed |
| ANSI/AAMI/ISO 15675:2001 |
Cardiovascular implants and artificial organs—Cardiopulmonary bypass systems—Arterial line blood filters, 1ed |
| ANSI/AAMI/ISO 25539-1:2003; A1:2005 |
Cardiovascular implants—Endovascular devices—Part 1: Endovascular prostheses, 1ed and Amendment |
ANSI/AAMI/ISO 81060-1:2007 |
Non invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type, 1ed |
| AAMI TIR4:1989 |
Apnea monitoring by means of thoracic impedance pneumography, 1ed |
| AAMI TIR9:1992 |
Evaluation of clinical systems for invasive blood pressure monitoring, 1ed |
| AAMI TIR11:2005 |
Selection and use of protective apparel and surgical drapes in health care facilities, 2ed |
| AAMI TIR21:1998 |
Systems used to forecast remaining pacemaker battery service life, 1ed |
| AAMI TIR23:1999 |
Signal averaging, 1ed |
| AAMI TIR26:2000 |
Ventricular assist and heart replacement systems, 1ed |
| QUALITY MANAGEMENT, GENERAL SAFETY, AND DESIGN |
| ANSI/AAMI ES60601-1:2005 (IEC 60601-1:2005, MOD) |
Medical electrical equipment, Part 1: General requirements for basic safety and essential performance, 1ed |
| AAMI HE48:1993 |
Human factors engineering guidelines and preferred practices for the design of medical devices, 2ed |
| ANSI/AAMI HE74:2001 |
Human factors design process for medical devices, 1ed |
| ANSI/AAMI/IEC 62304:2006 |
Medical device software - Software life cycle processes, 2ed |
| ANSI/AAMI/IEC 60601-1-2:2007 |
Medical electrical equipment, Part 1-2: General requirements for basic safety and essential performance — Collateral standard: Electromagnetic compatibility — Requirements and tests, 2ed |
| ANSI/AAMI/ISO 13485:2003 |
Medical devices — Quality management systems—System requirements for regulatory purposes, 2ed |
| ANSI/AAMI/ISO TIR14969:2004 |
Medical devices — Quality management systems—Guidance on the application of ISO 13485, 2ed |
| ANSI/AAMI/ISO 14971:2007 |
Medical devices — Application of risk management to medical devices, 3ed |
| ANSI/AAMI/ISO 15223-1:2007 and A1:2008 |
Medical devices — Symbols to be used with medical device labels, labeling, and information to be supplied — Part 1: General requirements, 1ed and 2008 amendment |
| ANSI/AAMI/ISO 15225:2000/(R)2006 and 15525/A1:2004/(R)2006 |
Nomenclature — Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange, 1ed and Amendment |
| AAMI TIR18:1997 |
Guidance on electromagnetic compatibility of medical devices for clinical/biomedical engineers—Part 1: Radiated radio-frequency electromagnetic energy, 1ed |
| AAMI TIR24:1999 |
Acquisition and use of physiologic waveform databases for testing of medical devices, 1ed |
| AAMI TIR32:2004 |
Medical device software risk management, 1ed |
| AAMI TIR36:2007 |
Validation of software for regulated processes , 1ed |
| ANSI/AAMI/IEC TIR60878:2003 |
Graphical symbols for electrical equipment in medical practice, 1ed |
| ANSI/AAMI/IEC TIR62296:2003 |
Considerations of unaddressed safety aspects in the Second Edition of IEC 60601-1 and proposals for new requirements, 1ed |
| ANSI/AAMI/IEC TIR62348:2006 |
Mapping between the clauses of the third edition of IEC 60601-1 and the 1988 edition as amended, 1ed |
| ANSI/AAMI/ISO TIR16142:2005 |
Medical devices—Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices |
| ANSI/AAMI/ISO TIR19218:2005 |
Medical devices - Coding structure for adverse event type and cause, 1ed |
| STERILIZATION |
| ANSI/AAMI ST8:2001 |
Hospital steam sterilizers, 4ed |
| ANSI/AAMI ST24:1999/(R)2005 |
Automatic, general-purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities, 3ed |
| ANSI/AAMI ST35:2003 |
Safe handling and biological decontamination of reusable medical devices in health care facilities and in nonclinical settings, 3ed |
| ANSI/AAMI ST40:2004 |
Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities, 2ed |
| ANSI/AAMI ST41:1999/(R)2005 |
Ethylene oxide sterilization in health care facilities: Safety and effectiveness, 3ed |
| ANSI/AAMI ST50:2004 |
Dry heat (heated air) sterilizers, 2ed |
| ANSI/AAMI ST55:2003 |
Table-top steam sterilizers, 2ed |
| ANSI/AAMI ST58:2005 |
Chemical sterilization and high-level disinfection in health care facilities, 2ed |
| ANSI/AAMI ST63:2002 |
Sterilization of health care products—Requirements for the development, validation and routine control of an industrial sterilization process for medical devices—Dry heat, 1ed |
| ANSI/AAMI ST65:2000 |
Processing of reusable surgical textiles for use in health care facilities, 1ed |
| ANSI/AAMI ST67:2003 |
Sterilization of health care products—Requirements for products labeled ‘sterile’, 1ed |
| ANSI/AAMI ST72:2002 |
Bacterial endotoxins—Test methodologies, routine monitoring and alternatives to batch testing, 1ed |
| ANSI/AAMI ST77:2006 |
Containment devices for reusable medical device sterilization, 1ed |
| ANSI/AAMI ST79:2006 |
Comprehensive guide to steam sterilization and sterility assurance in health care facilities, 1ed |
| ANSI/AAMI ST81:2004 |
Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices, 1ed |
| ANSI/AAMI/ISO 10993–7:1995/(R)2001 |
Biological evaluation of medical devices, Part 7: Ethylene oxide sterilization residuals, 2ed |
| ANSI/AAMI/ISO 11135-1:2007 |
Sterilization of health care products —
Ethylene oxide — Part 1: Requirements
for development, validation, and routine
control of a sterilization process for
medical devices, 4ed |
| ANSI/AAMI/ISO 11137-1:2006 |
Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ANSI/AAMI/ISO 11137-2:2006 |
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose |
| ANSI/AAMI/ISO 11137-3:2006 |
Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects |
| ANSI/AAMI/ISO 11138-1:2006 |
Sterilization of health care products - Biological indicators - Part 1: General requirements, 2ed |
| ANSI/AAMI/ISO 11138-2:2006 |
Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes, 3ed |
| ANSI/AAMI/ISO 11138-3:2006 |
Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes |
| ANSI/AAMI/ISO 11138-4:2006 |
Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes |
| ANSI/AAMI/ISO 11138-5:2006 |
Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes |
| ANSI/AAMI/ISO 11140-1:2005 |
Sterilization of health care products - Chemical indicators - Part 1: General requirements, 2ed |
| ANSI/AAMI/ISO 11140-3:2007 |
Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick steam penetration test |
| ANSI/AAMI/ISO 11140-4:2007 |
Sterilization of health care products — Chemical indicators — Part 4: Class 2 indicators as an alternative for Bowie and Dick test for detection of steam penetration |
| ANSI/AAMI/ISO 11140-5:2007 |
Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for Bowie and Dick air removal test sheets and packs, 2ed |
| ANSI/AAMI/ISO 11607-1:2006 |
Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging, 3ed |
| ANSI/AAMI/ISO 11607-2:2006 |
Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes, 1ed |
| ANSI/AAMI/ISO 11737–1:2006 |
Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products, 2ed |
| ANSI/AAMI/ISO 11737–2:1998 |
Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the validation of a sterilization process, 1ed |
| ANSI/AAMI/ISO 11737–3:2004 |
Sterilization of medical devices — Microbiological methods—Part 3: Guidance on evaluation and interpretation of bioburden data, 1ed |
| ANSI/AAMI/ISO 14160:1998 |
Sterilization of single-use medical devices incorporating materials of animal origin — Validation and routine control of sterilization by liquid chemical sterilants, 1ed |
| ANSI/AAMI/ISO 14161:2000 |
Sterilization of health care products — Biological indicators — Guidance for the selection, use, and interpretation of results, 2ed |
| ANSI/AAMI/ISO 14937:2000 |
Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process, 1ed |
| ANSI/AAMI/ISO 15882:2003 |
Chemical indicators — Guidance on the selection, use, and interpretation of results, 3ed |
| ANSI/AAMI/ISO 17665-1:2006 |
Sterilization of health care products — Moist heat — Part 1 Requirements for the development, validation and routine control of a sterilization process for medical devices, 3ed |
| ANSI/AAMI/ISO 18472:2006 |
Sterilization of health care products — Biological and chemical indicators — Test equipment, 1ed |
| AAMI TIR12:2004 |
Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for device manufacturers, 2ed |
| AAMI TIR13:1997 |
Principles of industrial moist heat sterilization, 1ed |
| AAMI TIR14:1997; TIR14/A1:2004 |
Contract sterilization for ethylene oxide, 1ed and Amendment |
| AAMI TIR15:1997 |
Ethylene oxide sterilization equipment, process considerations and pertinent calculations, 1ed |
| AAMI TIR16:2000 |
Process development and performance qualification for ethylene oxide sterilization — Microbiological aspects, 1ed |
| AAMI TIR17:1997 |
Radiation sterilization — Material qualification, 1ed |
| AAMI TIR19:1998; TIR19/A1:1999 |
Guidance for ANSI/AAMI/ISO 10993–7:1995, Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals, 1ed and Amendment |
| AAMI TIR20:2001 |
Parametric release for ethylene oxide sterilization, 1ed |
| AAMI TIR22:2007 |
Guidance for ANSI/AAMI/ISO 11607, Packaging for terminally sterilized medical devices, Part 1 and Part 2:2006, 2ed |
| AAMI TIR28:2001 |
Product adoption and process equivalency for ethylene oxide sterilization, 1ed |
| AAMI TIR29:2002 |
Guide for process control in radiation sterilization, 1ed |
| AAMI TIR30:2003 |
A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices, 1ed |
| AAMI TIR31:2003 |
Process challenge devices/test packs for use in healthcare facilities, 1ed |
| AAMI TIR33:2005 |
Sterilization of health care products — Radiation — Substantiation of a selected sterilization dose - Method VDmax, 1ed |
| AAMI TIR34:2007 |
Water for the reprocessing of medical devices, 1ed |
| AAMI TIR35:2006 |
Sterilization of health care products — Radiation sterilization — Alternative sampling plans for verification dose experiments and sterilization dose audits, 1ed |
| AAMI TIR37:2007 |
Sterilization of health care
products — Radiation —
Guidance on sterilization of
human tissue-based products, 1ed |
| ANSI/AAMI/ISO TIR11139:2006 |
Sterilization of health care products —Vocabulary, 2ed |
