Content Description

• ANSI/AAMI 2700-1:2019 - Medical Devices and Medical Systems-Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE)-Part 1: General requirements and conceptual model / 2019
• ANSI/AAMI/UL 2800-1-1:2022, Standard for Risk Concerns for Interoperable Medical Products / 2022
• ANSI/AAMI/UL 2800-1-2:2022, Standard for Interoperable Item Development Life Cycle / 2022
• ANSI/AAMI/UL 2800-1-3:2022, Standard for Interoperable Item Integration Life Cycle / 2022
• ANSI/AAMI/UL 2800-1:2022, Standard for Medical Device Interoperability / 2022
• ANSI/AAMI/ISO 5840-1:2015 - Cardiovascular implants-Cardiac valve prostheses-Part 1: General requirements / 2015
• ANSI/AAMI/ISO 5840-2:2015 - Cardiovascular implants-Cardiac valve prostheses-Part 2: Surgically implanted heart valve substitutes / 2015
• ANSI/AAMI/ISO 5840-3:2013 - Cardiovascular implants-Cardiac valve prostheses-Part 3: Heart valve substitutes implanted by transcatheter techniques. / 2013
• ANSI/AAMI/ISO 7198:2016 - Cardiovascular implants-Tubular vascular prostheses / 2016
• ANSI/AAMI/ISO 7199:2016 - Cardiovascular implants and artificial organs-Blood-gas exchangers (oxygenators) / 2016
• ANSI/AAMI/ISO 8637-1:2017, Extracorporeal systems for blood purification-Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators / 2017
• ANSI/AAMI/ISO 8637-2: 2018, Extracorporeal systems for blood purification-Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters / 2018
• ANSI/AAMI/ISO 8637-3:2018,   Extracorporeal systems for blood purification-Part 3: Plasmafilters / 2018
• ANSI/AAMI/ ISO 8638:2010/(R)2015 - Cardiovascular implants and extracorporeal systems-Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters / 2010
• ANSI/AAMI/ISO 10993-2-2006/(R)2014 - Biological evaluation of medical devices-Part 2: Animal welfare requirements / 2006
• ANSI/AAMI/ISO 10993-3:2014 - Biological evaluation of medical devices-Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity / 2014
• ANSI/AAMI/ISO 10993-4:2017, Biological evaluation of medical devices-Part 4: Selection of tests for interactions with blood / 2017
• ANSI/AAMI/ISO 10993-5:2009/(R)2014 - Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity / 2009
• ANSI/AAMI/ISO 10993-6:2016 - Biological evaluation of medical devices-Part 6: Tests for local effects after implantation / 2016
• ANSI/AAMI/ISO 10993-7:2008/(R)2012 - Biological evaluation of medical devices-Part 7: Ethylene oxide sterilization residuals / 2008
• ANSI/AAMI/ISO 10993-9:2009/(R)2014 - Biological evaluation of medical devices, Part 9: Framework for identification and quantification of potential degradation products / 2009
• ANSI/AAMI/ISO 10993-10:2010/(R)2014 - Biological evaluation of medical devices-Part 10: Tests for irritation and skin sensitization / 2010
• ANSI/AAMI/ISO 10993-11:2017, Biological evaluation of medical devices-Part 11: Tests for systemic toxicity / 2017
• ANSI/AAMI/ISO 10993-12:2012 - Biological evaluation of medical devices-Part 12: Sample preparation and reference materials / 2012
• ANSI/AAMI/ISO 10993-13-2010/(R)2014 - Biological evaluation of medical devices-Part 13: Identification and quantification of degradation products from polymeric devices / 2014
• ANSI/AAMI/ISO 10993-14:2001/(R)2011 - Biological evaluation of medical devices-Part 14: Identification and quantification of degradation products from ceramics / 2001
• ANSI/AAMI/ISO 10993-15:2000/(R)2011 - Biological evaluation of medical devices-Part 15: Identification and quantification of degradation products from metals and alloys / 2000
• ANSI/AAMI/ISO 10993-15:2019 Biological evaluation of medical devices-Part 15: Identification and quantification of degradation products from metals and alloys / 2019
• ANSI/AAMI/ISO 10993-16:2017 / 2017
• ANSI/AAMI/ISO 10993-17:2002/(R)2012 - Biological evaluation of medical devices-Part 17: Establishment of allowable limits for leachable substances / 2002
• ANSI/AAMI/ISO 11135:2014 - Sterilization of health care products-Ethylene oxide-Requirements for development, validation and routine control of a sterilization process for medical devices / 2014
• ANSI/AAMI/ISO 11137-1:2006/(R)2015 & A1:2013 & A2:2019 - Sterilization of health care products-Radiation-Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices / 2006
• ANSI/AAMI/ ISO 11137-2: 2013/(R)2019 - Sterilization of health care products-Radiation-Part 2: Establishing the sterilization dose / 2017
• ANSI/AAMI/ISO 11137-3-2017 - Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control / 2017
• ANSI/AAMI/ISO 11138-1:2017 - Sterilization of health care products-Biological indicators-Part 1: General requirements / 2017
• ANSI/AAMI/ISO 11138-2:2017 - Sterilization of health care products-Biological indicators-Part 2: Biological indicators for ethylene oxide sterilization processes / 2017
• ANSI/AAMI/ISO 11138-3:2017 - Sterilization of health care products-Biological indicators-Part 3: Biological indicators for moist heat sterilization processes / 2017
• ANSI/AAMI/ISO 11138-4:2017 - Sterilization of health care products-Biological indicators-Part 4: Biological indicators for dry heat sterilization processes / 2017
• ANSI/AAMI/ISO 11138-5:2017 - Sterilization of health care products-Biological indicators-Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes / 2017
• ANSI/AAMI/ISO 11138-7:2019 - Sterilization of health care products-Biological indicators-Part 7: Guidance for the selection, use and interpretation of results / 2019
• ANSI/AAMI/ISO 11140-1:2014 - Sterilization of health care products - Chemical indicators - Part 1: General requirements / 2014
• ANSI/AAMI/ISO 11140-3:2007/(R)2015 - Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick steam penetration test / 2007
• ANSI/AAMI/ISO 11140-4:2007/(R)2015 - Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to Bowie and Dick test for detection of steam penetration / 2007
• ANSI/AAMI/ISO 11140-5:2007/(R)2015 - Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick air removal test sheets and packs. / 2007
• ANSI/AAMI/ISO 11607-1:2019 - Packaging for terminally sterilized medical devices- Part 1: Requirements for materials, sterile barrier systems and packaging systems / 2019
• ANSI/AAMI/ISO 11607-2:2019 - Packaging for terminally sterilized medical devices-Part 2: Validation requirements for forming, sealing and assembly processes / 2019
• ANSI/AAMI/ISO 11658:2012 - Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems / 2012
• ANSI/AAMI 11663:2014 - Quality of dialysis fluid for hemodialysis and related therapies / 2014
• ANSI/AAMI/ISO 11737-1:2018 - Sterilization of health care products-Microbiological methods-Part 1: Determination of a population of microorganisms on products / 2018
• ANSI/AAMI/ISO 11737-2:2019 - Sterilization of medical devices-Microbiological methods-Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process / 2019
• ANSI/AAMI/ISO 12417-1:2015 - Cardiovascular implants and extracorporeal systems-Vascular device-drug combination products - Part 1: General requirements / 2015
• ANSI/AAMI/ISO 13022:2012 - Medical products containing viable human cells-Application of risk management and requirements for processing practices / 2012
• ANSI/AAMI/ISO 13408-1:2008/(R)2017 & A1:2013 - Aseptic processing of health care products- Part 1: General requirements (includes Amendment 1). / 2008
• ANSI/AAMI/ISO 13408-2:2018 - Aseptic processing of health care products-Part 2: Sterilizing filtration / 2018
• ANSI/AAMI/ISO 13408-3:2006/(R)2015 - Aseptic processing of health care products-Part 3: Lyophilization / 2006
• ANSI/AAMI/ISO 13408-4-2005/(R)2014 - Aseptic processing of health care products-Part 4: Clean-in-place technologies / 2005
• ANSI/AAMI/ISO 13408-5-2006/(R)2015 - Aseptic processing of health care products-Part 5: Sterilization in place / 2006
• ANSI/AAMI/ISO 13408-6:2005/(R)2013 & A1:2013 - Aseptic processing of health care products - Part 6: Isolator systems / 2005
• ANSI/AAMI/ISO 13408-7:2012/(R)2018 - Aseptic processing of health care products-Part 7: Alternative processes for medical devices and combination products / 2012
• AAMI/ISO 13485:2016 Medical Devices-A Practical Guide, Advice from ISO/TC 210 / 2016
• ANSI/AAMI/ISO 13485:2016/(R)2019 - Medical devices-Quality management systems-Requirements for regulatory purposes / 2016
• ANSI/AAMI 13958:2014 - Concentrates for hemodialysis and related therapies / 2014
• ANSI/AAMI 13959:2014 - Water for hemodialysis and related therapies / 2014
• ANSI/AAMI/ ISO 14117:2019 - Active implantable medical devices-Electromagnetic compatibility-EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices / 2019
• ANSI/AAMI/ISO 14155:2011 - Clinical investigation of medical devices for human subjects. / 2011
• ANSI/AAMI/ISO 14160:2011/(R)2016 - Sterilization of health care products-Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives-Requirements for characterization, development, validation and routine control of a sterilization process for medical devices / 2011
• ANSI/AAMI/ISO 14161-2009/(R)2014 - Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results / 2009
• ANSI/AAMI/ISO 14708-1:2014 - Implants for surgery-Active implantable medical devices-Part 1: General requirements for safety, marking and for information to be provided by the manufacturer / 2014
• ANSI/AAMI/ISO 14708-3:2017 - Implants for surgery-Active implantable medical devices-Part 3: Implantable neurostimulators / 2017
• ANSI/AAMI/ISO 14708-4:2008/(R)2011 - Implants for surgery-Active implantable medical devices-Part 4: Implantable infusion pumps / 2008
• ANSI/AAMI/ ISO 14708-5: 2010/(R)2015 - Implants for surgery-Active implantable medical devices-Part 5: Circulatory support devices / 2010
• ANSI/AAMI/ISO 14937:2009/(R) 2013 - Sterilization of health care products-General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices / 2009
• ANSI/AAMI/ ISO 14971:2019 - Medical devices-Application of risk management to medical devices / 2019
• ANSI/AAMI/ISO 15223-1:2016 - Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements / 2016
• ANSI/AAMI/ISO 15223-2:2010/(R)2016 - Medical devices - Symbols to be used with medical device labels, labeling, and information to be supplied - Part 2: Symbol development, selection and validation / 2010
• ANSI/AAMI/ISO 15674:2016 - Cardiovascular implants and artificial organs - Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags / 2016
• ANSI/AAMI/ISO 15675:2016 - Cardiovascular implants and artificial organs-Cardiopulmonary bypass systems-Arterial blood line filters / 2016
• ANSI/AAMI/ISO 15676:2016 - Cardiovascular implants and artificial organs-Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO) / 2016
• ANSI/AAMI/ISO 15882:2008/(R)2013 - Sterilization of health care products - Chemical indicators-Guidance for selection, use and interpretation of results. / 2008
• ANSI/AAMI/ISO 16142-1:2016 - Medical devices-Recognized essential principles of safety and performance of medical devices-Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards / 2016
• ANSI/AAMI/ISO 16142-2:2017 - Medical devices-Recognized essential principles of safety and performance of medical devices-Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards / 2017
• ANSI/AAMI/ISO 17664:2017 - Processing of health care products-Information to be provided by the medical device manufacturer for the processing of medical devices / 2017
• ANSI/AAMI/ISO 17665-1:2006/(R)2013 - Sterilization of health care products-Moist Heat-Guidance on the designation of a medical product to a product family and processing category for steam sterilization / 2006
• ANSI/AAMI/ISO 18241:2016 - Cardiovascular implants and extracorporeal systems-Cardiopulmonary bypass systems-Venous bubble traps / 2016
• ANSI/AAMI/ISO 18242:2016 - Cardiovascular implants and extracorporeal systems-Centrifugal blood pumps / 2016
• ANSI/AAMI/ISO 20857:2010/(R)2015 - Sterilization of health care products-Dry heat: Requirements for the development, validation and routine control of a sterilization process for medical devices / 2010
• ANSI/AAMI/ISO 22442-1:2016 - Medical devices utilizing animal tissues and their derivatives-Part 1: Application of risk management. / 2016
• ANSI/AAMI/ISO 22442-2:2016 - Medical devices utilizing animal tissues and their derivatives-Part 2: Controls on sourcing, collection and handling. / 2016
• ANSI/AAMI/ISO 22442-3:2007/(R)2016 - Medical devices utilizing animal tissues and their derivatives-Part 3: Validation of the elimination and/or inactivation of viruses and transimissible spongiform encephalopathy (TSE) agents / 2007
• ANSI/AAMI 23500:2014 - Guidance for the preparation and quality management of fluids for hemodialysis and related therapies. / 2014
• ANSI/AAMI/ISO 25539-1:2017 - Cardiovascular implants- Endovascular devices-Part 1: Endovascular prostheses / 2017
• ANSI/AAMI/ISO 25539-2:2012 - Cardiovascular implants-Endovascular devices-Part 2: Vascular stents / 2012
• ANSI/AAMI/ISO 25539-3:2011/(R)2015 - Cardiovascular implants-Endovascular devices-Part 3: Vena Cava Filters. / 2011
• ANSI/AAMI 26722:2014 - Water treatment equipment for hemodialysis and related therapies / 2014
• ANSI/AAMI/ISO 27185:2012/(R)2017 - Cardiac rhythm management devices-Symbols to be used with cardiac rhythm management device labels, and information to be supplied-General requirements / 2012
• ANSI/AAMI/ISO 27186:2010 - Active implantable medical devices-Four-pole connector system for implantable cardiac rhythm management devices-Dimensional and test requirements / 2010
• ANSI/AAMI/IEC 60601-1-2:2014 - Medical electrical equipment-Part 1-2: General requirements for basic safety and essential performance-Collateral standard: Electromagnetic disturbances - Requirements and tests / 2014
• ANSI/AAMI/IEC 60601-1-2:2014 & A1:2021, Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance—Collateral standard: Electromagnetic disturbances—Requirements and tests / 2021
• ANSI/AAMI/IEC 60601-1-8:2006 & A1:2012 - Medical elelectrical equipment-Part 1-8: General requirements for basic safety and essential performance-Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems / 2006
• ANSI/AAMI/ IEC 60601-1-8:2006 & A1: 2013 & A2:2021, Medical electrical equipment—Part 1-8: General requirements for basic safety and essential performance—Collateral standard: General requirements, test and guidance for alarm systems in medical electrical equipment and medical electrical systems / 2021
• ANSI/AAMI/IEC 60601-1-12:2016 - Medical electrical equipment-Part 1-12: General requirements for basic safety and essential performance-Collateral standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment. / 2016
• ANSI/AAMI/ IEC 60601-1-12:2016 & A1:2021, Medical electrical equipment—Part 1-12: General requirements for basic safety and essential performance— Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in emergency medical services environment / 2021
• ANSI/AAMI/IEC 60601-2-2:2017 - Medical electrical equipment-Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories / 2017
• ANSI/AAMI/IEC 60601-2-4:2010/A1:2018 (Consolidated Text) - Medical electrical equipment-Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators, including Amendment 1 / 2010
• ANSI/AAMI/IEC 60601-2-4:2010/A1:2018 (Redline Version) - Medical electrical equipment-Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators, including Amendment 1 / 2010
• ANSI/AAMI/IEC 60601-2-16:2012 - Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment / 2012
• ANSI/AAMI/IEC 60601-2-16:2012 Red-line Format - Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of hemodialysis, hemodiafiltration and hemofiltration equipment / 2012
• ANSI/AAMI/IEC 60601-2-19:2009/(R)2014 & A1:2016 - Medical Electrical Equipment-Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators / 2009
• ANSI/AAMI/ IEC 60601- 2-20:2009/(R)2014 & A1:2016 - Medical Electrical Equipment-Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators / 2009
• ANSI/AAMI/IEC 60601- 2-21:2009/(R)2014 & A1:2016 - Medical Electrical Equipment-Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers / 2009
• ANSI/AAMI/IEC 60601-2-25:2011/(R)2016 - Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs / 2011
• ANSI/AAMI/IEC 60601-2-27:2011/(R)2016 - Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment / 2011
• ANSI/AAMI/IEC 60601-2-47:2012/(R)2016 - Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems / 2012
• ANSI/AAMI/ IEC 60601- 2-50:2009/(R)2014 & A1:2016 - Medical electrical equipment-Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment / 2009
• ANSI/AAMI/IEC 62304:2006 & A1:2016 - ANSI/AAMI/IEC 62304:2006 & A1:2016 (Consolidated Text)Medical device software-Software life cycle processes / 2006
• ANSI/AAMI/IEC 62304: 2006 & A1:2016 (Redline) - Medical device software-Software life cycle processes / 2006
• ANSI/AAMI/IEC 62366-1:2015 - Medical Devices Part 1: Application of Usability Engineering to Medical Devices / 2015
• ANSI/AAMI/IEC 62366-1:2015/A1:2020, Medical devices-Part 1: Application of usability engineering to medical devices-Amendment 1 / 2020
• ANSI/AAMI/IEC 80001-1:2010 - Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities / 2010
• ANSI/AAMI/ISO 80369-1:2018 - Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements. / 2018
• ANSI/AAMI/ISO 80369-3:2016 - Small-bore connectors for liquids and gases in healthcare applications-Part 3: Connectors for enteral applications. / 2016
• ANSI/AAMI/ ISO 80369-3:2016/A1:2019 - Small-bore connectors for liquids and gases in healthcare applications-Part 3: Connectors for enteral applications-Amendment 1 / 2016
• ANSI/AAMI/ISO 80369-5:2016 - Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications / 2016
• ANSI/AAMI/ISO 80369-6:2016 - Small-bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications / 2016
• ANSI/AAMI/ISO 80369-7:2016 - Small-bore connectors for liquids and gases in healthcare applications-Part 7: Connectors for intravascular or hypodermic applications / 2016
• ANSI/AAMI/ISO 80369-20:2015. - Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods / 2015
• ANSI/AAMI/IEC 80601-2-30:2018 - Medical electrical equipment-Part 2-30: Particular requirements for basic safety and essential performance of automated type non-invasive sphygmomanometers / 2018
• ANSI/AAMI/IEC 80601-2-58:2014 - Medical electrical equipment – Part 2-58: Particular requirements for basic safety and essential performance of lens removal and vitrectomy devices for ophthalmic surgery / 2014
• ANSI/AAMI/IEC 80601-2-58:2014 - Medical electrical equipment-Part 2-58: Particular requirements for basic safety and essential performance of lens removal and vitrectomy devices for ophthalmic surgery / 2014
• ANSI/AAMI/ISO 81060-1:2007/(R)2013 - Non invasive sphygmomanometers - Part 1: Requirements and test methods for nonautomated measurement type / 2007
• ANSI/AAMI/ ISO 81060-2:2019 - Non-invasive sphygmomanometers-Clinical investigation of intermittent automated measurement type / 2019
• ANSI/AAMI AT6:2013 - Autologous transfusion devices / 2013
• ANSI/AAMI BE83:2006/(R)2011 - Biological evaluation of medical devices-Part 18: Chemical characterization of materials / 2006
• ANSI/AAMI BF7:2012 - Blood transfusion micro-filters / 2012
• ANSI/AAMI BF64:2012 - Leukocyte reduction filters / 2012
• ANSI/AAMI BP22:1994/(R)2016 - Blood Pressure Transducers / 1994
• ANSI/AAMI CI86:2017 - Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting / 2017
• AAMI CR500:2019 - Basic Introduction to the IEC 60601 Series / 2019
• AAMI CR34971:2022 AAMI Consensus Report: Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning / 2022
• ANSI/AAMI EC12:2000/(R)2015 - Disposable ECG electrodes / 2000
• ANSI/AAMI EC12:2000/(R)2020 Disposable ECG electrodes / 2020
• ANSI/AAMI EC53:2013 - ECG trunk cables and patient leadwires / 2013
• ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires / 2020
• ANSI/AAMI EC57:2012 - Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms / 2012
• ANSI/AAMI EC57:2012/(R)2020, Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms / 2020
• ANSI/AAMI EQ56:2013 - Recommended practice for a medical equipment management program / 2013
• ANSI/AAMI EQ89:2015 - Guidance for the use of medical equipment maintenance strategies and procedures / 2015
• ANSI/AAMI EQ93:2019 - Medical equipment management-Vocabulary used in medical equipment programs / 2019
• ANSI/AAMI ES60601-1:2005/(R)2012, (IEC 60601-1:2005, MOD) - Medical electrical equipment-Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) / 2005
• ANSI/AAMI ES60601-1:2005 & A1:2012 & A2:2021, Medical electrical equipment—Part 1: General requirements for basic safety and essential performance / 2021
• ANSI/AAMI HA60601-1-11:2015 (IEC 60601-1-11:2015, MOD) - MEDICAL ELECTRICAL EQUIPMENT - Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment / 2015
• ANSI/AAMI HA60601-1-11:2015 & A1:2021, Medical electrical equipment—Part 1-11: General requirements for basic safety and essential performance—Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment / 2021
• ANSI/AAMI HE75:2009/(R)2018 - Human factors engineering-Design of medical devices / 2009
• AAMI HIT1000-3(PS):2019 - Safety and effectiveness of health IT software and systems-Part 3: Application of risk management / 2019
• AAMI HIT1000-4 (PS):2020 Safety and effectiveness of health IT software and systems-Part 4: Application of human factors engineering / 2020
• ANSI/AAMI MP80601-249:2020 (IEC 80601-2-49:2020, MOD), Medical electrical equipment-Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors / 2020
• ANSI/AAMI NS4:2013/(R)2017 - Transcutaneous electrical nerve stimulators / 2013
• ANSI/AAMI NS28:1988/(R)2015 - Intracranial pressure monitoring devices / 2015
• ANSI/AAMI PB70:2012 - Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities / 2012
• ANSI/AAMI PB70:2012 Red-Line - Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities / 2012
• ANSI/AAMI PC76:2021, Active implantable medical devices-Requirements and test protocols for safety of patients with pacemakers and ICDs exposed to magnetic resonance imaging / 2021
• ANSI/AAMI RD47:2008/(R)2013 - Reprocessing of hemodialyzers / 2008
• ANSI/AAMI RD47:2020, Reprocessing of hemodialyzers / 2020
• AAMI RT2:2017 - Radiation therapy readiness check / 2017
• AAMI RT3: 2020 Radiation therapy machine characterization / 2020
• ANSI/AAMI/ST8:2013/(R)2018 - Hospital steam sterilizers / 2013
• ANSI/AAMI ST24:1999/(R)2018 - Automatic, general purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities / 1999
• ANSI/AAMI ST40:2004/(R)2018 - Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities / 2004
• ANSI/AAMI ST41:2008/(R)2018 - Ethylene oxide sterilization in health care facilities: Safety and effectiveness / 2008
• ANSI/AAMI ST50:2004/(R)2018 - Dry heat (heated air) sterilizers / 2004
• ANSI/AAMI ST55:2016 - Table-top Steam Sterilizers / 2016
• ANSI/AAMI ST58:2013/(R)2018 - Chemical sterilization and high-level disinfection in health care facilities / 2013
• ANSI/AAMI ST65:2008/(R)2018 - Processing of reusable surgical textiles for use in health care facilities / 2008
• ANSI/AAMI ST67:2019 - Sterilization of health care products-Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled “sterile” / 2019
• ANSI/AAMI ST72:2019, Bacterial endotoxins-Test methods, routine monitoring, and alternatives to batch testing / 2019
• ANSI/AAMI ST77:2013/(R)2018 - Containment devices for reusable medical device sterilization / 2013
• ANSI/AAMI ST79:2017 - Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities / 2017
• ANSI/AAMI ST90:2017 - Processing of health care products - Quality management systems for processing in health care facilities / 2017
• ANSI/AAMI ST91:2015 - Flexible and semi-rigid endoscope processing in healthcare facilities / 2015
• ANSI/AAMI ST91:2021, Flexible and semi-rigid endoscope processing in health care facilities / 2021
• AAMI ST98:2022, Cleaning validation of health care products—Requirements for development and validation of a cleaning process for medical devices / 2022
• ANSI/AAMI ST15883-1:2009/(R)2014 &A1:2014&A2:2012 - (Consolidated Text) (ISO 15883-1:2006, MOD) Washer-disinfectors-Part 1: General requirements, terms and definitions and tests / 2009
• ANSI/AAMI ST15883-2:2013/(R)2015 (ISO 15883-2:2006 MOD) - Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. / 2013
• ANSI/AAMI ST15883-3:2012/(R)2015 - Washer-disinfectors, Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers / 2012
• ANSI/AAMI SW91:2018 - Classification of defects in health software / 2018
• AAMI TIR9:1992/(R)2019 - Evaluation of clinical systems for invasive blood pressure monitoring / 1992
• AAMI TIR11:2005/(R)2015 - Selection and use of protective apparel and surgical drapes in health care facilities / 2005
• AAMI TIR12:2010 - Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers / 2010
• AAMI TIR12:2010 Red-line Format - Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers / 2010
• AAMI TIR12:2020, Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers / 2020
• AAMI TIR14:2016 - Contract sterilization using ethylene oxide / 2016
• AAMI TIR15:2016 - Physical aspects of ethylene oxide sterilization / 2016
• AAMI TIR16:2017 - Microbiological aspects of ethylene oxide sterilization / 2017
• AAMI TIR17:2017 - Compatibility of materials subject to sterilization / 2017
• AAMI TIR18:2010 - Guidance on electromagnetic compatibility of medical devices in healthcare facilities / 2010
• AAMI TIR21:2017 - Systems used to forecast remaining pacemaker battery service life / 2017
• AAMI TIR21: 2017/(R)2020, Systems used to forecast remaining pacemaker battery service life / 2020
• AAMI TIR23:1999/(R)2019 - Signal averaging / 1999
• AAMI TIR24:1999/(R)2019 - Acquisition and use of physiologic waveform databases for testing of medical devices / 1999
• AAMI TIR28:2016 - Product adoption and process equivalence for ethylene oxide sterilization / 2016
• AAMI TIR29:2012/(R)2017 - Guide for process characterization and control in radiation sterilization of medical devices / 2012
• AAMI TIR30:2011/(R)2016 - A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices / 2011
• AAMI TIR31:2008 - Process challenge devices/test packs for use in health care facilities / 2008
• AAMI TIR34: 2014/(R)2017 - Water for the reprocessing of medical devices / 2014
• AAMI TIR35:2016 - Sterilization of health care products-Radiation sterilization-Alternative sampling plans for verification dose experiments and sterilization dose audits / 2016
• AAMI TIR36:2007 - Validation of software for regulated processes / 2007
• AAMI TIR37:2013 - Sterilization of health care products-Radiation-Guidance on sterilization of biologics and tissue-based products / 2013
• AAMI TIR38:2019 - Medical device safety assurance case guidance / 2019
• AAMI TIR39:2009/(R)2017 - Technical Information Report Guidance on selecting a microbial challenge and inoculation sites for sterilization validation of medical devices / 2009
• AAMI TIR40:2018 - Sterilization of health care products-Radiation-Guidance on dose setting utilizing a Modified Method 2 / 2018
• AAMI TIR41:2011/(R)2017 - Active Implantable Medical Devices-Guidance for Designation of Left Ventricle and Implantable Cardioverter Defibrillator Lead Connectors and Pulse Generator Connector Cavities for Implantable Pacemakers and Implantable Cardioverter Defibrillators / 2011
• AAMI TIR42:2010 - Evaluation of particulates associated with vascular medical devices / 2010
• AAMI TIR42:2021, Evaluation of particulae associated with vascular medical devices / 2021
• AAMI TIR43:2011 - Ultrapure dialysate for hemodialysis and related therapies / 2011
• AAMI TIR43:2021, Ultrapure dialysis fluid for hemodialysis and related therapies / 2021
• AAMI TIR44:2012 - Technical Information Report Non-invasive blood pressure motion artifact - Testing and evaluation of NIBP device performance in the presence of motion artifact / 2012
• AAMI TIR45:2012/(R)2018 - Guidance on the use of AGILE practices in the development of medical device software / 2012
• AAMI TIR48:2015 - Quality Management System (QMS) Recommendations on the Application of the U.S. FDA\'s CGMP Final Rule on Combination Products / 2015
• AAMI TIR48:2015/(R)2021 Quality Management System (QMS) Recommendations on the Application of the U.S. FDA’s CGMP Final Rule on Combination Products / 2021
• AAMI TIR49:2013 - Design of training and instructional materials for medical devices used in non-clinical environments / 2013
• AAMI TIR49: 2013/(R)2020, Design of training and instructional materials for medical devices used in non-clinical environments / 2020
• AAMI TIR50:2014/(R)2017 - Post-market surveillance of use error management / 2014
• AAMI TIR51:2014/(R)2017 - Human factors engineering-Guidance for contextual inquiry / 2014
• AAMI TIR52:2014/(R)2017 - Environmental monitoring for terminally sterilized healthcare products / 2014
• AAMI TIR55:2014/(R)2017 - Human factors engineering for processing medical devices / 2014
• AAMI TIR57:2016/(R)2019 - Principles for medical devices security-Risk management / 2016
• AAMI TIR58:2014 - Water testing methodologies / 2014
• AAMI TIR59:2017 - Integrating human factors into design controls / 2017
• AAMI TIR60:2014/(R)2019 - Common mode rejection in ECG monitoring / 2014
• AAMI TIR61:2014/(R)2019 - Generating reports for human factors design validation results for external cardiac defibrillator / 2014
• AAMI TIR62:2014/(R)2019 - Generating reports for the purpose of submitting defibrillation waveform data for evaluation / 2014
• AAMI TIR63: 2014/(R)2017 - Management of loaned critical and semi-critical medical devices that require sterilization or high-level disinfection / 2014
• AAMI TIR65:2015 - Technical Information Report Sustainability of medical devices - Elements of a responsible product life cycle / 2015
• AAMI TIR66:2017 - Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms / 2017
• AAMI TIR66: 2017/(R)2020, Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms / 2020
• AAMI TIR67:2018 - Promoting safe practices pertaining to the use of sterilant and disinfectant chemicals in health care facilities / 2018
• AAMI TIR68:2018 - Low and intermediate-level disinfection in healthcare settings for medical devices and patient care equipment and sterile processing environmental surfaces / 2018
• AAMI TIR69:2017 - Risk management of radio-frequency wireless coexistence for medical devices and systems / 2017
• AAMI TIR71:2017 - Guidance for logging of alarm system data / 2017
• AAMI TIR72:2017 - Dialysis fluid chemical composition / 2017
• AAMI TIR74: 2016 - Change summary for ISO 11135:2014, Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices / 2016
• AAMI TIR75:2019 - Factors to consider when multi-vendor devices interact via an electronic interface: Practical applications and examples / 2019
• AAMI TIR77:2018 - Sorbent-based regenerative hemodialysis systems / 2018
• AAMI TIR97:2019 - Principles for medical device security-Postmarket risk management for device manufacturers / 2019
• AAMI TIR100:2021, End-to-end microbiological quality and sterility assurance / 2021
• AAMI TIR102:2019 - U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems / 2019
• AAMI TIR105:2020 Risk management guidance for combination products / 2020
• AAMI/ISO TIR10974:2018 - Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device. / 2018
• ANSI/AAMI/ISO TIR10993-19:2006 - Biological evaluation of medical devices-Part 19: Physio-chemical, morphological and topographical characterization of materials / 2006
• ANSI/AAMI/ISO TIR10993-20:2006 - Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices / 2006
• AAMI/ISO TIR13004:2013/(R)2016 - Sterilization of health care products-Radiation-Substantiation of a selected sterilization dose: Method VDmaxSD / 2013
• AAMI/ISO TIR16775:2014 - Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 / 2014
• AAMI/ISO TIR17137:2014 - Cardiovascular implants and extracorporeal systems-Cardiovascular absorbable implants / 2014
• ANSI/AAMI/ISO TIR17665-2:2009/(R)2016 - Technical Information Report Sterilization of health care products – Moist Heat – Part 2: Guidance on the application of ANSI/AAMI/ISO 17665-1 / 2009
• AAMI/ISO TIR17665-3:2014/(R)2016 - Sterilization of health care products-Moist Heat-Guidance on the designation of a medical product to a product family and processing category for steam sterilization / 2014
• ANSI/AAMI/ISO TIR19024:2016 - Evaluation of CPB devices relative to their capabilities of reducing the transmission of gaseous microemboli (GME) to a patient during cardiopulmonary bypass / 2016
• AAMI/ISO TIR20416:2020, Medical devices-Post-market surveillance for manufacturers / 2020
• AAMI/ISO TIR21900:2018 - Guidance for uncertainty analysis regarding the application of ISO/TS 10974 / 2018
• AAMI/ISO TIR22442-4:2011/(R)2016 - Medical devices utilizing animal tissues and their derivatives-Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes / 2011
• AAMI/ISO TIR23810: 2012/(R)2015 - Cardiovascular implants and artificial organs - Checklist for preoperative extracorporeal circulation equipment setup / 2012
• AAMI/ISO TIR24971:2013/(R)2016 - Medical devices-Guidance on the application of ISO 14971 / 2013
• AAMI/ISO TIR24971:2020 Medical devices- Guidance on the application of ISO 14971 / 2020
• ANSI/AAMI/ISO TIR37137:2014 - Cardiovascular biological evaluation of medical devices-Guidance for absorbable implants / 2014
• AAMI/IEC TIR60878:2015 - Graphic symbols for electrical equipment in medical practice / 2015
• AAMI/IEC TIR61289:2011 - High frequency surgical equipment - Operation and maintenance / 2011
• AAMI/IEC TIR62296:2009 - Considerations of Unaddressed Safety Aspects in the Second Edition of IEC 60601-1 and Proposals for New Requirements / 2009
• ANSI/AAMI/IEC TIR62348:2012 - Assessment of the impact of the most significant changes in Amendment 1 to IEC 60601-1:2005 and mapping of the clauses of IEC 60601-1:2005 to the previous edition / 2012
• AAMI/IEC TIR62354:2015 - General testing procedures for medical electrical equipment / 2015
• AAMI/IEC TIR62366-2:2016 - Medical Devices Part 2: Guidance on the Application of Usability Engineering to Medical Devices. / 2016
• AAMI/IEC TIR80001-2-1:2012 - Application of risk management for IT-networks incorporating medical device-Part 2-1: Step by step risk management of medical IT-networks; Practical applications and examples / 2012
• AAMI/IEC TIR80001-2-2:2012 - Application of risk management for IT-networks incorporating medical devices-Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls / 2012
• AAMI/IEC TIR80001-2-3:2012 - Application of risk management for IT-networks incorporating medical devices-Part 2-3: Guidance for wireless networks / 2012
• AAMI/IEC TIR80001-2-4:2012 - Application of risk management for IT-networks incorporating medical devices-Part 2-4: General implementation guidance for healthcare delivery organizations. / 2012
• AAMI/IEC TIR80001-2-5:2014 - Application of risk management for IT-networks incorporating medical devices-Part 2-5: Application guidance - Guidance for distributed alarm systems / 2014
• AAMI/IEC TIR80001-2-6:2014 - Application of risk management for IT-networks incorporating medical-Application guidance-Part 2-6: Guidance for responsibility agreements / 2014
• AAMI/IEC TIR80001-2-7:2014 - Application of risk management for IT-networks incorporating medical devices-Part 2-7: Application guidance-Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1 / 2014
• AAMI/IEC TIR80001-2-8:2016 - Application of risk management for IT networks incorporating medical devices. Part 2-8: Application guidance - guidance on standards for establishing the security capabilities identified in IEC 80001-2-2 / 2016
• AAMI/IEC TIR80002-1:2009 - Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software / 2009
• AAMI/ISO TIR80002-2:2017 - Medical device software-Part 2: Validation of software for medical device quality systems / 2017
• AAMI/IEC TIR80002-3: 2016 - Technical Information Report Medical Device Software - Part 3: Process reference model of medical device software life cycle processes (IEC 62304) / 2016
• ANSI/AAMI/IEC 62366-1: 2015+AMD1:2020 (Consolidated Text), Medical devices-Part 1: Application of usability engineering to medical devices, including Amendment 1 / 2020
• ANSI/AAMI/UL 2800-1:2019 - Standard for Safety for Medical Device Interoperability / 2019

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