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List of Active Documents - By Category

Biological Evaluation

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 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(R2014) 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 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(R2014) Biological evaluation of medical devices, Part 13: Identification and quantification of degradation products from polymeric devices
ANSI/AAMI/ISO 10993-14:2001(R2011) Biological evaluation of medical devices, Part 14: Identification and quantification of degradation products from ceramics
ANSI/AAMI/ISO 10993-15:2000(R2011) Biological evaluation of medical devices, Part 15: Identification and quantification of degradation products from metals and alloys
ANSI/AAMI/ISO 10993-17:2002(R2012) Biological evaluation of medical devices, Part 17: Establishment of allowable limits for leachable substances
AAMI/ISO TIR10993-19:2006 Biological evaluation of medical devices - Part 19: Physio-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 14155:2011 Clinical investigation of medical devices for human subjects
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

Dialysis

AAMI TIR43:2011 Ultrapure dialysate for hemodialysis and related therapies
AAMI TIR58:2014 Water testing methodologies
AAMI TIR72:2017 Dialysis fluid chemical composition
AAMI TIR77:2018 Sorbent-based regenerative hemodialysis systems
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 60601-2-16:2012 Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
ANSI/AAMI/IEC 60601-2-16:2012 Red-Line Includes Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of hemodialysis, hemodiafiltration and hemofiltration equipment and Red-Line format of document showing changes between the current and 2008 version in red and strikethrough
ANSI/AAMI RD47:2020 Reprocessing of hemodialyzers

Electromedical Equipment

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
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 60601-1-8:2006 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 60601-1-12:2016 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 60601-2-2:2017 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/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 AT6:2013 Autologous transfusion devices
ANSI/AAMI BF7:2012 Blood transfusion micro-filters
ANSI/AAMI BF64:2012 Leukocyte reduction filters
ANSI/AAMI/BP22:1994(R2016) Blood pressure transducers
AAMI CR500:2019 Basic Introduction to the IEC 60601 Series
ANSI/AAMI EC12:2000(R2015) Disposable ECG electrodes
ANSI/AAMI EC53:2013 ECG cables and leadwires
ANSI/AAMI EC57:2012 Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms
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/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 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
ANSI/AAMI NS28:1988(R2015) Intracranial pressure monitoring devices

General Aspects of Medical Devices

ANSI/AAMI/ISO 14971:2019 Medical devices—Application of risk management to medical devices
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 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 TIR19218-2:2012 Medical devices - Hierarchical coding structure for adverse events - Part 2: Evaluation codes
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
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/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 EQ56:2013 Recommended practice for a medical equipment management program
ANSI/AAMI EQ89:2015 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 RT3:2020 Radiation therapy machine characterization

HTM

AAMI TIR18:2010 Guidance on electromagnetic compatibility of medical devices in healthcare facilities
AAMI/IEC TIR62354:2015 General testing procedures for medical electrical equipment
ANSI/AAMI EQ56:2013 Recommended practice for a medical equipment management program
ANSI/AAMI EQ89:2015 Guidance for the use of medical equipment maintenance strategies and procedures
AAMI HTM:2019 Healthcare Technology Management Collection

Human Factors

AAMI TIR49:2013(R2020) Design of training and instructional materials for medical devices used in non-clinical environments
AAMI TIR50:2014(R2017) Post-market surveillance of use error management
AAMI TIR51:2014(R2017) Human factors engineering —Guidance for contextual inquiry
AAMI TIR59:2017 Integrating human factors into design controls
ANSI/AAMI/IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices
ANSI/AAMI/IEC 62366-1:2015/A1:2020 Medical devices—Part 1: Application of usability engineering to medical devices—Amendment 1
AAMI/IEC TIR62366-2:2016 Medical devices—Part 2: Guidance on the application of usability engineering to medical devices
ANSI/AAMI HE75:2009(R2018) Human factors engineering - Design of medical devices

Implants and Artificial Organs

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 TIR42:2010 Evaluation of particulates associated with vascular medical devices
ANSI/AAMI/ISO 5840-1:2015 Cardiovascular implants — Cardiac valve prostheses — Part 1: General requirements
ANSI/AAMI/ISO 5840-2:2015 Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted heart valve substitutes
ANSI/AAMI/ISO 5840-3:2013 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
AAMI/ISO TIR12417:2011 Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products
ANSI/AAMI/ISO 12417-1:2015 Cardiovascular implants and extracorporeal systems—Vascular device-drugcombination products—Part 1: General requirements
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 14708-5:2010 Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices
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)
AAMI/ISO TIR17137:2014 Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants
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/ISO 27186:2010 Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements
ANSI/AAMI CI86:2017 Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting

IT- Software- and Wireless

AAMI TIR36:2007 Validation of software for regulated processes
AAMI TIR45:2012(R2018) Guidance on the use of AGILE practices in the development of medical device software
AAMI TIR57:2016 Principles for medical device security—Risk management
AAMI TIR57:2016(R2019) 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 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/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)
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/UL 2800-1:2019 Standard for Safety for Medical Device Interoperability

Quality Systems/Regulatory Affairs

AAMI TIR38:2019 Medical device safety assurance case guidance
AAMI TIR48:2015 Quality Management System (QMS) Recommendations on the Application of the U.S. FDA’s CGMP Final Rule on Combination Products
AAMI TIR102:2019 U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems
AAMI/ISO 13485:2016 Medical Devices—A Practical Guide, Advice from ISO/TC 210

Sterilization-Equipment

AAMI TIR28:2016 Product adoption and process equivalence for ethylene oxide sterilization
AAMI TIR31:2008 Process challenge devices/test packs for use in health care facilities
AAMI TIR39:2009(R2017) 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
AAMI TIR56:2013(R2016) Guidance for the development, validation and routine control of an ethylene oxide sterilization process utilizing flexible bag systems for the sterilization of medical devices
ANSI/AAMI/ISO 11138-1:2017 Sterilization of health care products—Biological indicators—Part 1: General requirements
ANSI/AAMI/ISO 11138-2:2017 Sterilization of health care products—Biological indicators—Part 2: Biological indicators for ethylene oxide sterilization processes
ANSI/AAMI/ISO 11138-3:2017 Sterilization of health care products—Biological indicators—Part 3: Biological indicators for moist heat sterilization processes
ANSI/AAMI/ISO 11138-4:2017 Sterilization of health care products—Biological indicators—Part 4: Biological indicators for dry heat sterilization processes
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
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 TIR16775:2014 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
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
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/ISO 80369-3:2016 Small-bore connectors for liquids and gases in healthcare applications—Part 3: Connectors for enteral applications
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 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(R2014) and A1:2014 and A2:2012 (Consolidated Text) Washer-disinfectors—Part 1: General requirements, terms and definitions and tests
ANSI/AAMI ST15883-2:2013/(R2015) (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(R2015) (ISO 15883-3:2006 MOD) Washer-disinfectors, Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers

Sterilization-Hospital

AAMI TIR11:2005(R2015) Selection and use of protective apparel and surgical drapes in health care facilities
AAMI TIR12:2010 Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers
AAMI TIR12:2010 Red-line Includes Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers and red-line format of document showing changes between the current and 2004 version in red and strikethrough
AAMI TIR30:2011 Red-line Includes a compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices and red-line format of document showing changes between the current and 2003 version in red and strikethrough
AAMI TIR30:2011(R2016) A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices
AAMI TIR34:2014(R2017) Water for the reprocessing of medical devices
AAMI TIR63:2014(R2017) Management of loaned critical and semi-critical medical devices that require sterilization or high-level disinfection
AAMI TIR67:2018 Promoting safe practices pertaining to the use of sterilant and disinfectant chemicals in health care facilities
AAMI TIR68:2018 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
ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
ANSI/AAMI PB70:2012 Red-Line 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 ST90:2017 Processing of health care products—Quality management systems for processing in health care facilities
ANSI/AAMI ST91:2015 Flexible and semi-rigid endoscope processing in health care facilities

Sterilization-Industrial

AAMI TIR14:2016 Contract sterilization using ethylene oxide (Revision of AAMI TIR14:2009)
AAMI TIR15:2016 Physical aspects of ethylene oxide sterilization
AAMI TIR16:2017 Microbiological aspects of ethylene oxide sterilization
AAMI TIR17:2017 Compatibility of materials subject to sterilization
AAMI TIR22:2007 and AAMI TIR22:2007/A1:2008 Guidance for ANSI/AAMI/ISO 11607, Packaging for terminally sterilized medical devices-Part 1 and Part 2:2006
AAMI TIR29:2012(R2017) Guide for process characterization and control in radiation sterilization of medical devices
AAMI TIR35:2016 Sterilization of health care products— Radiation sterilization— Product adoption and alternative sampling plans for verification dose experiments and sterilization dose audits
AAMI TIR37:2013 Sterilization of health care products-Radiation-Guidance on sterilization of biologics and tissue-based products
AAMI TIR40:2018 Sterilization of health care products—Radiation—Guidance on dose setting utilizing a Modified Method 2
AAMI TIR52:2014(R2017) Environmental monitoring for terminally sterilized healthcare products
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
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 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 Sterilization of health care products—Radiation—Part 3: Guidance on dosimetric aspects of development, validation and routine
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 11737-1:2018 Sterilization of health care products—Microbiological methods—Part 1: Determination of a population of microorganisms on products
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 TIR13004:2013(R2016) Sterilization of health care products - Radiation - Substantiation of a 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 17664:2017 Processing of health care products—Information to be provided by the medical device manufacturer for the processing of 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
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
ANSI/AAMI ST67:2011(R2017) 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

Symbols

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
ANSI/AAMI/ISO 15223-2:2010(R2016) Medical devices—Symbols to be used with medical device labels, labeling, and information to be supplied—Part 2: Symbol development, selection and validation
AAMI/IEC TIR60878:2015 Graphical symbols for electrical equipment in medical practice