| ANSI/AAMI/ISO 10993-1:2018 |
Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process |
| ANSI/AAMI/ISO 10993-2:2006(R2014) |
Biological evaluation of medical devices—Part 2: Animal welfare requirements |
| ANSI/AAMI/ISO 10993-3:2014(R2023) |
Biological evaluation of medical devices—Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity |
| ANSI/AAMI/ISO 10993-4:2017 |
Biological evaluation of medical devices—Part 4: Selection of tests for interactions with blood |
| ANSI/AAMI/ISO 10993-5:2009(R2022) |
Biological evaluation of medical devices—Part 5: Tests for in vitro cytotoxicity |
| ANSI/AAMI/ISO 10993-6:2016 |
Biological evaluation of medical devices—Part 6: Tests for local effects after implantation |
| ANSI/AAMI/ISO 10993-9:2009(R2014) |
Biological evaluation of medical devices—Part 9: Framework for identification and quantification of potential degradation products |
| ANSI/AAMI/ISO 10993-10:2010(R2014) |
Biological evaluation of medical devices—Part 10: Tests for irritation and skin sensitization |
| ANSI/AAMI/ISO 10993-11:2017(R2023) |
Biological evaluation of medical devices—Part 11: Tests for systemic toxicity |
| ANSI/AAMI/ISO 10993-12:2012 |
Biological evaluation of medical devices—Part 12: Sample preparation and reference materials |
| ANSI/AAMI/ISO 10993-13-2010(R2019) |
Biological evaluation of medical devices—Part 13: Identification and quantification of degradation products from polymeric devices |
| ANSI/AAMI/ISO 10993-14:2001(R2019) |
Biological evaluation of medical devices—Part 14: Identification and quantification of degradation products from ceramics |
| ANSI/AAMI/ISO 10993-15:2019 |
Biological evaluation of medical devices—Part 15: Identification and quantification of degradation products from metals and alloys |
| ANSI/AAMI/ISO 10993-16:2020(R2022) |
Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables |
| ANSI/AAMI/ISO 10993-17:2002(R2012) |
Biological evaluation of medical devices—Part 17: Establishment of allowable limits for leachable substances |
| AAMI/ISO TIR10993-19:2020 |
Biological evaluation of medical devices—Part 19: Physico-chemical, morphological and topographical characterization of materials |
| AAMI/ISO TIR10993-20:2006 |
Biological evaluation of medical devices—Part 20: Principles and methods for immunotoxicology testing of medical devices |
| ANSI/AAMI/ISO 13022:2012 |
Medical products containing viable human cells—Application of risk management and requirements for processing practices |
| ANSI/AAMI/ISO 14155:2020 |
Clinical investigation of medical devices for human subjects—Good clinical practice |
| AAMI/ISO TIR15499:2017 |
Biological evaluation of medical devices?Guidance on the conduct of biological evaluation within a risk management process |
| ANSI/AAMI/ISO 22442-1:2016 |
Medical devices utilizing animal tissues and their derivatives—Part 1: Application of risk management |
| ANSI/AAMI/ISO 22442-2:2016 |
Medical devices utilizing animal tissues and their derivatives—Part 2: Controls on sourcing, collection and handling |
| ANSI/AAMI/ISO 22442-3:2007(R2016) |
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 |
| ANSI/AAMI/ISO TIR22442-4:2011(R2016) |
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 |
| AAMI/ISO TIR22442-4:2010 |
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 |
| AAMI/ISO TIR37137:2014 |
Cardiovascular biological evaluation of medical devices—Guidance for absorbable implants |
| ANSI/AAMI BE83:2006(R2011) |
Biological evaluation of medical devices—Part 18: Chemical characterization of materials |
| AAMI TIR43:2021 |
Ultrapure dialysis fluid for hemodialysis and related therapies |
| AAMI TIR58:2021 |
Water testing methodologies |
| AAMI TIR72:2017 |
Dialysis fluid chemical composition |
| AAMI TIR77:2018 |
Sorbent-based regenerative hemodialysis systems |
| ANSI/AAMI/ISO 8637-1:2017 |
Extracorporeal systems for blood purification—Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators |
| ANSI/AAMI/ISO 8637-2:2018 |
Extracorporeal systems for blood purification—Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters |
| ANSI/AAMI/ISO 8637-3:2018 |
Extracorporeal systems for blood purification—Part 3: Plasmafilters |
| ANSI/AAMI/ISO 23500-1:2019 |
Preparation and quality management of fluids for haemodialysis and related therapies—Part 1: General requirements |
| ANSI/AAMI/ISO 23500-2:2019 |
Preparation and quality management of fluids for haemodialysis and related therapies—Part 2: Water treatment equipment for haemodialysis applications and related therapies |
| ANSI/AAMI/ISO 23500-3:2019 |
Preparation and quality management of fluids for haemodialysis and related therapies—Part 3: Water for haemodialysis and related therapies |
| ANSI/AAMI/ISO 23500-4:2019 |
Preparation and quality management of fluids for haemodialysis and related therapies—Part 4: Concentrates for haemodialysis and related therapies |
| ANSI/AAMI/ISO 23500-5:2019 |
Preparation and quality management of fluids for haemodialysis and related therapies—Part 5: Quality of dialysis fluid for haemodialysis and related therapies |
| ANSI/AAMI/IEC 60601-2-16:2018 |
Medical electrical equipment—Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment |
| ANSI/AAMI/IEC 60601-2-39:2018 |
Medical electrical equipment—Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment |
| AAMI ACUTE DIALYSIS READINESS HANDBOOK-2021 ED2 |
Acute Dialysis Survey Readiness Handbook, 2nd Edition |
| ANSI/AAMI RD47:2020 |
Reprocessing of hemodialyzers |
| AAMI TIR9:1992(R2019) |
Evaluation of clinical systems for invasive blood pressure monitoring |
| AAMI TIR18:2010 |
Guidance on electromagnetic compatibility of medical devices in healthcare facilities |
| AAMI TIR23:1999(R2019) |
Signal averaging |
| AAMI TIR24:1999(R2019) |
Acquisition and use of physiologic waveform databases for testing of medical devices |
| AAMI TIR44:2012 |
Non-invasive blood pressure motion artifact - Testing and evaluation of NIBP device performance in the presence of motion artifact |
| AAMI TIR60:2014(R2019) |
Common mode rejection in ECG monitoring |
| AAMI TIR61:2014(R2019) |
Generating reports for human factors design validation results for external cardiac defibrillators |
| AAMI TIR62:2014(R2019) |
Generating reports for the purpose of submitting defibrillation waveform data for evaluation |
| AAMI TIR65:2015 |
Sustainability of medical devices-Elements of a responsible product life cycle |
| AAMI TIR66:2017(R2020) |
Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms |
| AAMI TIR71:2017(R2020) |
Guidance for logging of alarm system data |
| AAMI TIR101:2021 |
Fluid delivery performance testing for infusion pumps |
| 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 |
| ANSI/AAMI/IEC 60601-1-2:2014 and A1:2021 (Consolidated Text REDLINE VERSION) |
Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance—Collateral standard: Electromagnetic disturbances—Requirements and tests |
| 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, Amendment 1 |
| ANSI/AAMI/IEC 60601-1-8:2006 and A1: 2013 and A2:2021 (Consolidated Text REDLINE VERSION) |
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 |
| ANSI/AAMI/IEC 60601-1-8:2006 and A1:2012 |
Medical Electrical 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 |
| ANSI/AAMI/IEC 60601-1-8:2006/A2:2021 |
Medical Electrical 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, Amendment 2 |
| 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 |
| ANSI/AAMI/IEC 60601-1-12:2016 and A1:2021 (Consolidated Text REDLINE VERSION) |
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 |
| 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 the emergency medical services environment—Amendment 1 |
| 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 |
| ANSI/AAMI/IEC 60601-2-4:2010 and 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 |
| ANSI/AAMI/IEC 60601-2-4:2010 and 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 |
| ANSI/AAMI/IEC 60601-2-19:2009(R2014) and A1:2016 |
Medical Electrical Equipment—Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators |
| ANSI/AAMI/IEC 60601-2-20:2009(R2014) and A1:2016 |
Medical Electrical Equipment—Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators |
| ANSI/AAMI/IEC 60601-2-20:2009/A1:2016 |
Medical electrical equipment—Part 2-20: Particular requirements for the basic safety and essential performance of transport incubators |
| ANSI/AAMI/IEC 60601-2-21:2009(R2014) and A1:2016 |
Medical Electrical Equipment—Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers American National Standard Advancing Safety |
| ANSI/AAMI/IEC 60601-2-21:2009/A1:2016 |
Medical electrical equipment—Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers |
| ANSI/AAMI/IEC 60601-2-25:2011(R2016) |
Medical electrical equipment—Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs |
| ANSI/AAMI/IEC 60601-2-27:2011(R2016) |
Medical electrical equipment—Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment |
| ANSI/AAMI/IEC 60601-2-47:2012(R2016) |
Medical electrical equipment—Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems |
| ANSI/AAMI/IEC 60601-2-50:2009(R2014) and A1:2016 |
Medical electrical equipment—Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment |
| ANSI/AAMI/IEC 60601-2-50:2009/A1:2016 |
Medical electrical equipment—Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment |
| AAMI/IEC TIR61289:2011 |
High frequency surgical equipment—Operation and maintenance |
| AAMI/IEC TIR62296:2009 |
Considerations of unaddressed safety aspects in the Second Edition of IEC 60601-1 and proposals for new requirements |
| 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 |
| AAMI/IEC TIR62354:2015 |
General testing procedures for medical electrical equipment |
| AAMI/IEC TIR62366-2:2016 |
Medical devices—Part 2: Guidance on the application of usability engineering to medical devices |
| 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 |
| 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 |
| ANSI/AAMI/IEC 80601-2-58:2014/A1:2016 |
Amendment 1 to Medical electrical equipment—Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery |
| ANSI/AAMI/IEC 80601-2-77:2020 |
Medical electrical equipment—Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment |
| ANSI/AAMI/IEC 80601-2-78:2020 |
Medical electrical equipment—Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation |
| ANSI/AAMI/ISO 81060-1:2007(R2013) |
Non invasive sphygmomanometers—Part 1: Requirements and test methods for nonautomated measurement type |
| ANSI/AAMI/ISO 81060-2:2019 |
Non-invasive sphygmomanometers—Part 2: Clinical investigation of intermittent automated measurement type |
| ANSI/AAMI/BP22:1994(R2016) |
Blood pressure transducers |
| AAMI CR500:2019 |
Basic Introduction to the IEC 60601 Series |
| ANSI/AAMI EC12:2000(R2020) |
Disposable ECG electrodes |
| ANSI/AAMI EC53:2013(R2020) |
ECG trunk cables and patient leadwires |
| ANSI/AAMI EC57:2012(R2020) |
Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms |
| ANSI/AAMI ES60601-1:2005 and A1:2012 and A2:2021 (Consolidated Text REDLINE VERSION) (IEC 60601-1:2005 MOD) |
Medical electrical equipment—Part 1: General requirements for basic safety and essential performance |
| ANSI/AAMI ES60601-1:2005(R2012) and A1:2012 and C1:2009(R2012) and A2:2010(R2012) (Consolidated Text) |
Medical electrical equipment—Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) |
| ANSI/AAMI ES60601-1:2005/A2:2021 |
Medical electrical equipment—Part 1: General requirements for basic safety and essential performance—Amendment 2 |
| ANSI/AAMI ES60601-1:2005/Amendments |
Medical electrical equipment—Part 1: General requirements for basic safety and essential performance, Amendments |
| 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 home healthcare environment |
| ANSI/AAMI HA60601-1-11:2015 and A1:2021 (Consolidated Text REDLINE VERSION)(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 |
| 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, Amendment 1 |
| ANSI/AAMI MP80601-2-49:2020 (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 |
| ANSI/AAMI NS4:2013(R2017) |
Transcutaneous electrical nerve stimulators |
| AAMI TIR45:2023 |
Guidance on the use of AGILE practices in the development of medical device software |
| AAMI TIR105:2020 |
Risk management guidance for combination products |
| ANSI/AAMI/ISO 14971:2019 |
Medical devices—Application of risk management to medical devices |
| 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 |
| 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 |
| AAMI/ISO TIR20416:2020 |
Medical devices—Post-market surveillance for manufacturers |
| AAMI/ISO TIR24971:2020 |
Medical devices—Guidance on the application of ISO 14971 |
| ANSI/AAMI/ISO 25539-3:2011(R2015) |
Cardiovascular implants—Endovascular devices—Part 3: Vena cava filters |
| AAMI TIR34971:2023 |
Application of ISO 14971 to machine learning in artificial intelligence—Guide |
| ANSI/AAMI/ISO 80369-1:2018 |
Small-bore connectors for liquids and gases in healthcare applications—Part 1: General requirements |
| ANSI/AAMI/ISO 80369-3:2016 |
Small-bore connectors for liquids and gases in healthcare applications—Part 3: Connectors for enteral applications |
| 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 |
| ANSI/AAMI/ISO 80369-5:2016 |
Small-bore connectors for liquids and gases in healthcare applications—Part 5: Connectors for limb cuff inflation applications |
| ANSI/AAMI/ISO 80369-6:2016 |
Small-bore connectors for liquids and gases in healthcare applications—Part 6: Connectors for neuraxial applications |
| ANSI/AAMI/ISO 80369-7:2016 |
Small-bore connectors for liquids and gases in healthcare applications—Part 7: Connectors for intravascular or hypodermic applications |
| ANSI/AAMI/ISO 80369-20:2015 |
Small-bore connectors for liquids and gases in healthcare applications—Part 20: Common test methods |
| ANSI/AAMI CN27:2021 |
General requirements for Luer activated valves (LAVs) incorporated into medical devices for intravascular applications |
| ANSI/AAMI EQ89:2015(R2023) |
Guidance for the use of medical equipment maintenance strategies and procedures |
| ANSI/AAMI EQ93:2019 |
Medical equipment management—Vocabulary used in medical equipment programs |
| AAMI RT2:2017 |
Radiation therapy readiness check |
| AAMI RT3:2020 |
Radiation therapy machine characterization |
| AAMI TIR21:2017(R2020) |
Systems used to forecast remaining pacemaker battery service life |
| AAMI TIR41:2011(R2020) |
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 |
| AAMI TIR42:2021 |
Evaluation of particulate associated with vascular medical devices |
| ANSI/AAMI/ISO 5840-1:2022 |
Cardiovascular implants—Cardiac valve prostheses—Part 1: General requirements |
| ANSI/AAMI/ISO 5840-2:2022 |
Cardiovascular implants—Cardiac valve prostheses—Part 2: Surgically implanted heart valve substitutes |
| ANSI/AAMI/ISO 5840-3:2022 |
Cardiovascular implants—Cardiac valve prostheses—Part 3: Heart valve substitutes implanted by transcatheter techniques |
| ANSI/AAMI/ISO 7198:2016 |
Cardiovascular implants and extracorporeal systems—Vascular prostheses—Tubular vascular grafts and vascular patches |
| ANSI/AAMI/ISO 7199:2016 |
Cardiovascular implants and artificial organs—Blood-gas exchangers (oxygenators) |
| ANSI/AAMI/ISO 8638:2010(R2015) |
Cardiovascular implants and extracorporeal systems—Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters |
| AAMI/ISO TIR10974:2018 |
Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device |
| ANSI/AAMI/ISO 11658:2012 |
Cardiovascular implants and extracorporeal systems—Blood/tissue contact surface modifications for extracorporeal perfusion systems |
| 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 |
| 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 |
| ANSI/AAMI/ISO 14708-3:2017 |
Implants for surgery—Active implantable medical devices—Part 3: Implantable neurostimulators |
| ANSI/AAMI/ISO 14708-4:2008(R2011) |
Implants for surgery—Active implantable medical devices—Part 4: Implantable infusion pumps |
| ANSI/AAMI/ISO 15674:2016 |
Cardiovascular implants and artificial organs—Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags |
| ANSI/AAMI/ISO 15675:2016 |
Cardiovascular implants and artificial organs—Cardiopulmonary bypass systems—Arterial blood line filters |
| ANSI/AAMI/ISO 15676:2016 |
Cardiovascular implants and artificial organs—Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO) |
| ANSI/AAMI/ISO 18241:2016 |
Cardiovascular implants and extracorporeal systems—Cardiopulmonary bypass systems - Venous bubble traps |
| ANSI/AAMI/ISO 18242:2016 |
Cardiovascular implants and extracorporeal systems—Centrifugal blood pumps |
| AAMI/ISO TIR21900:2018 |
Guidance for uncertainty analysis regarding the application of ISO/TS 10974 |
| AAMI/ISO TIR23810:2012(R2015) |
Cardiovascular implants and artificial organs—Checklist for preoperative extracorporeal circulation equipment setup |
| ANSI/AAMI/ISO 25539-1:2017 |
Cardiovascular implants—Endovascular devices—Part 1: Endovascular prostheses |
| ANSI/AAMI/ISO 25539-2:2012 |
Cardiovascular implants—Endovascular devices—Part 2: Vascular stents |
| ANSI/AAMI/ISO 27185:2012(R2017) |
Cardiac rhythm management devices—Symbols to be used with cardiac rhythm management device labels, and information to be supplied—General requirements |
| ANSI/AAMI CI86:2017 |
Cochlear implant systems—Requirements for safety, functional verification, labeling and reliability reporting |
| 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 |
| AAMI TIR57:2016 |
Principles for medical device security—Risk management |
| AAMI TIR57:2016(R2023) |
Principles for medical device security—Risk management |
| AAMI TIR69:2017(R2020) |
Risk management of radio-frequency wireless coexistence for medical devices and systems |
| AAMI TIR75:2019 |
Factors to consider when multi-vendor devices interact via an electronic interface: Practical applications and examples |
| AAMI TIR97:2019(R2023) |
Principles for medical device security—Postmarket risk management for device manufacturers |
| 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 |
| ANSI/AAMI 2700-2-1:2022 |
Medical devices and medical systems—Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE): Part 2-1: Particular requirements for forensic data logging |
| ANSI/AAMI/IEC 62304:2006 and A1:2016 (Consolidated Text) |
Medical device software—Software life cycle processes |
| ANSI/AAMI/IEC 62304:2006 and A1:2016 (Redline Format) |
Medical device software—Software life cycle processes |
| ANSI/AAMI/IEC 62304:2006/A1:2015 |
Medical device software—Software life cycle processes |
| ANSI/AAMI/IEC 62304:2006/A1:2016 |
Medical device software—Software life cycle processes |
| ANSI/AAMI/IEC 80001-1:2010 |
Application of risk management for IT Networks incorporating medical devices—Part 1: Roles, responsibilities and activities |
| AAMI/IEC TIR80001-2-1:2012 |
Application of risk management for IT-networks incorporating medical devices—Part 2-1: Step by step risk management of medical IT-networks; Practical applications and examples |
| ANSI/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 |
| AAMI/IEC TIR80001-2-3:2012 |
Application of risk management for IT-networks incorporating medical devices—Part 2-3: Guidance for wireless networks |
| 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 |
| 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 |
| AAMI/ISO TIR 80001-2-6: 2014 |
Application of risk management for ITnetworks incorporating medical—Application guidance—Part 2-6: Guidance for responsibility agreements |
| 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 |
| 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 |
| AAMI/IEC TIR80002-1:2009 |
Medical device software—Part 1: Guidance on the application of ISO 14971 to medical device software |
| AAMI/ISO TIR80002-2:2017 |
Medical device software—Part 2: Validation of software for medical device quality systems |
| 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) |
| ANSI/AAMI HIT1000-1:2022 |
Safety and effectiveness of health IT software and systems—Part 1: Fundamental concepts, principles, and requirements |
| AAMI HIT1000-4(PS):2020 |
Safety and effectiveness of health IT software and systems—Part 4: Application of human factors engineering |
| ANSI/AAMI SW91:2018 |
Classification of defects in health software |
| ANSI/AAMI SW96:2023 |
Standard for medical device security—Security risk management for device manufacturers |
| ANSI/AAMI/UL 2800-1:2022 |
Standard for Medical Device Interoperability |
| ANSI/AAMI/UL 2800-1-1:2022 |
Standard for Risk Concerns for Interoperable Medical Products |
| ANSI/AAMI/UL 2800-1-2:2022 |
Standard for Interoperable Item Development Life Cycle |
| ANSI/AAMI/UL 2800-1-3:2022 |
Standard for Interoperable Item Integration Life Cycle |
| AAMI TIR31:2008 |
Process challenge devices/test packs for use in health care facilities |
| AAMI TIR39:2009(R2022) |
Guidance on selecting a microbial challenge and inoculation sites for sterilization validation of medical devices |
| AAMI TIR55:2014(R2017) |
Human factors engineering for processing medical devices |
| ANSI/AAMI/ISO 11138-1:2017(R2024) |
Sterilization of health care products—Biological indicators—Part 1: General requirements |
| ANSI/AAMI/ISO 11138-2:2017(R2024) |
Sterilization of health care products—Biological indicators—Part 2: Biological indicators for ethylene oxide sterilization processes |
| ANSI/AAMI/ISO 11138-3:2017(R2024) |
Sterilization of health care products—Biological indicators—Part 3: Biological indicators for moist heat sterilization processes |
| ANSI/AAMI/ISO 11138-4:2017(R2024) |
Sterilization of health care products—Biological indicators—Part 4: Biological indicators for dry heat sterilization processes |
| ANSI/AAMI/ISO 11138-5:2017(R2024) |
Sterilization of health care products—Biological indicators—Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes |
| ANSI/AAMI/ISO 11138-7:2019 |
Sterilization of health care products—Biological indicators—Part 7: Guidance for the selection, use and interpretation of results |
| ANSI/AAMI/ISO 11140-1:2014 |
Sterilization of health care products—Chemical indicators—Part 1: General requirements |
| ANSI/AAMI/ISO 11140-3: 2007(R2015) |
Sterilization of health care products—Chemical indicators—Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test |
| ANSI/AAMI/ISO 11140-4:2007(R2015) |
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 |
| ANSI/AAMI/ISO 11140-5:2007(R2015) |
Sterilization of health care products—Chemical indicators—Part 5: Class 2 indicators for Bowie and Dick air removal test sheets and packs |
| ANSI/AAMI/ISO 11607-1:2019 |
Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| ANSI/AAMI/ISO 11607-2:2019 |
Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processes |
| AAMI/ISO TIR16775:2023 |
Packaging for terminally sterilized medical devices—Guidance on the application of ISO 11607-1 and ISO 11607-2 |
| ANSI/AAMI/ISO TIR19024:2016 |
Evaluation of CPB devices relative to their capabilities of reducing the transmition of gaseous microemboli (GME) to a patient during cardiopulmonary bypass |
| ANSI/AAMI ST8:2013(R2018) |
Hospital steam sterilizers |
| ANSI/AAMI ST24:1999(R2018) |
Automatic, general purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities |
| ANSI/AAMI ST50:2004(R2018) |
Dry heat (heated air) sterilizers |
| ANSI/AAMI ST55:2016(R2023) |
Table-top steam sterilizers |
| ANSI/AAMI ST77:2013(R2018) |
Containment devices for reusable medical device sterilization |
| ANSI/AAMI ST15883-1:2009(R2014) (ISO 15883-1:2006 MOD) |
Washer-disinfectors—Part 1: General requirements, terms and definitions and tests |
| ANSI/AAMI ST15883-1: 2009(R2023) and A1:2014 and A2:2012 (Consolidated Text) (ISO 15883-1:2006 MOD) |
Washer-disinfectors—Part 1: General requirements, terms and definitions and tests |
| ANSI/AAMI ST15883-2:2013(R2023) (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. |
| ANSI/AAMI ST15883-3:2012(R2023) |
Washer-disinfectors—Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers |
| AAMI TIR11:2005(R2021) |
Selection and use of protective apparel and surgical drapes in health care facilities |
| AAMI TIR63:2014(R2023) |
Management of loaned critical and semi-critical medical devices that require sterilization or high-level disinfection |
| AAMI TIR67:2018(R2022) |
Promoting safe practices pertaining to the use of sterilant and disinfectant chemicals in health care facilities |
| AAMI TIR68:2018(R2022) |
Low and intermediate-level disinfection in healthcare settings for medical devices and patient care equipment and sterile processing environmental surfaces |
| AAMI TIR79:2018 |
ST79 Self-assessment for health care facilities |
| AAMI TIR99:2024 |
Processing of dilators, transesophageal and ultrasound probes in health care facilities |
| ANSI/AAMI/ISO 18472:2022 |
Sterilization of health care products—Biological and chemical indicators—Test equipment |
| ANSI/AAMI PB70:2022 |
Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities |
| ANSI/AAMI ST40:2004(R2018) |
Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities |
| ANSI/AAMI ST41:2008(R2018) |
Ethylene oxide sterilization in health care facilities: Safety and effectiveness |
| ANSI/AAMI ST58:2013(R2018) |
Chemical sterilization and high-level disinfection in health care facilities |
| ANSI/AAMI ST65:2008(R2018) |
Processing of reusable Surgical textiles for use in health care facilities |
| ANSI/AAMI ST79:2017 |
Comprehensive guide to steam sterilization and sterility assurance in health care facilities |
| ANSI/AAMI ST79:2017 Amendments A1:2020 and A2:2020 and A3:2020 and A4:2020 |
Comprehensive guide to steam sterilization and sterility assurance in health care facilities |
| ANSI/AAMI ST79:2017 and 2020 Amendments A1-A2-A3-A4 (Consolidated Text) |
Comprehensive guide to steam sterilization and sterility assurance in health care facilities |
| ANSI/AAMI ST90:2017(R2024) |
Processing of health care products—Quality management systems for processing in health care facilities |
| ANSI/AAMI ST91:2021 |
Flexible and semi-rigid endoscope processing in health care facilities |
| ANSI/AAMI ST98:2022 |
Cleaning validation of health care products—Requirements for development and validation of a cleaning process for medical devices |
| ANSI/AAMI ST108:2023 |
Water for the processing of medical devices |
| AAMI TIR12:2020(R2023) |
Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers |
| AAMI TIR14:2016(R2020) |
Contract sterilization using ethylene oxide |
| AAMI TIR15:2016(R2020) |
Physical aspects of ethylene oxide sterilization |
| AAMI TIR16:2023 |
Microbiological aspects of ethylene oxide sterilization |
| AAMI TIR17:2017(R2023) |
Compatibility of materials subject to sterilization |
| AAMI TIR28:2016(R2020) |
Product adoption and process equivalence for ethylene oxide sterilization |
| AAMI TIR29:2012(R2017) |
Guide for process characterization and control in radiation sterilization of medical devices |
| AAMI TIR35:2016(R2021) |
Sterilization of health care products—Radiation sterilization—Product adoption and alternative sampling plans for verification dose experiments and sterilization dose audits |
| AAMI TIR40:2018(R2022) |
Sterilization of health care products—Radiation—Guidance on dose setting utilizing a Modified Method 2 |
| AAMI TIR52:2014(R2022) |
Environmental monitoring for terminally sterilized healthcare products |
| AAMI TIR56:2013(R2020) |
Guidance for the development, validation and routine control of an ethylene oxide sterilization process utilizing flexible bag systems for the sterilization of medical devices |
| AAMI TIR74:2016(R2021) |
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 |
| AAMI TIR76:2021 |
Sterilization of health care products—Radiation—Substantiation of a selected sterilization dose at a specified sterility assurance level: Method VDmaxSD-S |
| AAMI TIR100:2021 |
End-to-end microbiological quality and sterility assurance |
| AAMI TIR104:2022 |
Guidance on transferring health care products between radiation sterilization sources |
| AAMI TIR106:2024 |
Microbiological methods—Understanding and use of product bioburden data |
| ANSI/AAMI/ISO 10993-7:2008(R2012) |
Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals |
| 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 |
| ANSI/AAMI/ISO 11135:2014/A1:2018 |
Sterilization of health-care products—Ethylene oxide—Requirements for the development, validation and routine control of a sterilization process for medical devices—Amendment 1: Revision of Annex E, Single batch release |
| ANSI/AAMI/ISO 11137-1:2006(R2015) A2:2019 |
Sterilization of health care products—Radiation—Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices—Amendment 2: Revision to 4.3.4 and 11.2 |
| ANSI/AAMI/ISO 11137-1: 2006(R2015) and A1:2013 and A2:2019 (Consolidated Text) |
Sterilization of health care products—Radiation—Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices |
| ANSI/AAMI/ISO 11137-2:2013(R2019) |
Sterilization of health care products—Radiation—Part 2: Establishing the sterilization dose |
| ANSI/AAMI/ISO 11137-3:2017(R2023) |
Sterilization of health care products—Radiation—Part 3: Guidance on dosimetric aspects of development, validation and routine control |
| AAMI/ISO TIR11137-4:2022(R2023) |
Sterilization of health care products—Radiation—Part 4: Guidance on process control |
| ANSI/AAMI/ISO 11138-8:2023 |
Sterilization of health care products—Biological indicators—Part 8: Method for validation of a reduced incubation item for a biological indicator |
| ANSI/AAMI/ISO 11737-1:2018 |
Sterilization of health care products—Microbiological methods—Part 1: Determination of a population of microorganisms on products |
| ANSI/AAMI/ISO 11737-1:2018/A1:2021 |
Sterilization of health care products—Microbiological methods—Part 1: Determination of a population of microorganisms on products; AMENDMENT 1 |
| 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 |
| ANSI/AAMI/ISO 13004:2022 |
Sterilization of health care products—Radiation—Substantiation of selected sterilization dose: Method VDmaxSD |
| ANSI/AAMI/ISO 13408-1:2008(R2011)/A1:2013 |
Aseptic processing of health care products—Part 1: General requirements—Amendment 1 |
| ANSI/AAMI/ISO 13408-1:2008(R2017) and A1:2013 |
Aseptic processing of health care products—Part 1: General requirements (includes Amendment 1) |
| ANSI/AAMI/ISO 13408-2:2018 |
Aseptic processing of health care products—Part 2: Sterilizing filtration |
| ANSI/AAMI/ISO 13408-3:2006(R2015) |
Aseptic processing of health care products—Part 3: Lyophilization |
| ANSI/AAMI/ISO 13408-4:2005(R2014) |
Aseptic processing of health care products—Part 4: Clean-in-place technologies |
| ANSI/AAMI/ISO 13408-5:2006(R2015) |
Aseptic processing of health care products—Part 5: Sterilization in place |
| ANSI/AAMI/ISO 13408-6:2005(R2013) and A1:2013 |
Aseptic processing of health care products—Part 6: Isolator systems. (Includes Amendment 1) |
| ANSI/AAMI/ISO 13408-6:2005/A1:2013 |
Aseptic processing of health care products—Part 6: Isolator systems—Amendment 1 |
| ANSI/AAMI/ISO 13408-7:2012(R2018) |
Aseptic processing of health care products—Part 7: Alternative processes for medical devices and combination products |
| ANSI/AAMI/ISO 14160:2011(R2016) |
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 |
| ANSI/AAMI/ISO 14937:2009(R2013) |
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 |
| ANSI/AAMI/ISO 15882:2008(R2013) |
Sterilization of health care products—Chemical indicators—Guidance for selection, use and interpretation of results |
| ANSI/AAMI/ISO 17664-1:2022 |
Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices—Part 1: Critical and semi-critical medical devices |
| ANSI/AAMI/ISO 17664-2:2022 |
Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices—Part 2: Non-critical medical devices |
| ANSI/AAMI/ISO 17665-1:2006(R2013) |
Sterilization of health care products—Moist heat—Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ANSI/AAMI/ISO TIR17665-2:2009(R2016) |
Technical Information Report Sterilization of health care products—Moist Heat—Part 2: Guidance on the application of ANSI/AAMI/ISO 17665-1 |
| AAMI/ISO TIR17665-2:2009 |
Sterilization of health care products—Moist heat—Part 2: Guidance on the application of ANSI/AAMI/ISO 17665-1 |
| AAMI/ISO TIR17665-3:2014 |
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 |
| AAMI/ISO TIR17665-3:2014(R2016) |
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 |
| ANSI/AAMI/ISO 20857:2010(R2015) |
Sterilization of health care products—Dry heat—Requirements for the development, validation and routine control of a sterilization process for medical devices |
| AAMI/ISO TIR21387:2023 |
Sterilization of health care products—Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release |
| AAMI/ISO TIR22456:2022 |
Sterilization of health care products—Microbiological methods—Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products |
| ANSI/AAMI ST67:2019 |
Sterilization of health care products—Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled “sterile” |
| ANSI/AAMI ST72:2019 |
Bacterial endotoxins—Test methods, routine monitoring, and alternatives to batch testing |
