AAMI Products
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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 equipmentLEARN MORE
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ANSI/AAMI/ISO 15675:2016 (PDF)
Cardiovascular implants and artificial organs—Cardiopulmonary bypass systems—Arterial blood line filtersLEARN MORE
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ANSI/AAMI/ISO 15223-2:2010/(R)2016 (PDF)
Medical devices—Symbols to be used with medical device labels, labeling and information to be supplied—Part 2: Symbol development, selection and validationLEARN MORE
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ANSI/AAMI/ISO 15676:2016 (PDF)
Cardiovascular implants and artificial organs—Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)LEARN MORE
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ANSI/AAMI/ISO 15223-1:2016 (PDF)
Medical devices—Symbols to be used with medical device labels, labelling and information to be supplied—Part 1: General requirementsLEARN MORE
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AAMI/ISO TIR80002-2:2017 (PDF)
Medical device software—Part 2: Validation of software for medical device quality systemsLEARN MORE
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AAMI/ISO TIR24971:2020 (PDF)
Medical devices—Guidance on the application of ISO 14971LEARN MORE
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AAMI/ISO TIR20416:2020 (PDF)
Medical devices—Post-market surveillance for manufacturersLEARN MORE
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ANSI/AAMI/ISO 13485:2016/(R)2019 (PDF)
Medical devices—Quality management systems—Requirements for regulatory purposesLEARN MORE -
ANSI/AAMI/ISO 11737-2:2019 (PDF)
Sterilization of medical devices—Microbiological methods—Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization processLEARN MORE
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AAMI/ISO 13485:2016, A Practical Guide (PDF)
Medical Devices—A Practical Guide, Advice from ISO/TC 210LEARN MORE
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AAMI/IEC TIR80002-3:2016 (PDF)
Medical Device Software—Part 3: Process reference model of medical device software life cycle processes (IEC 62304)LEARN MORE
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AAMI/IEC TIR80002-1:2009 (PDF)
Medical device software—Part 1: Guidance on the application of ISO 14971 to medical device softwareLEARN MORE
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ANSI/AAMI/ISO 11737-1:2018 (PDF)
Sterilization of health care products—Microbiological methods—Part 1: Determination of a population of microorganisms on productsLEARN MORE
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ANSI/AAMI/ISO 11607-2:2019 (PDF)
Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processesLEARN MORE
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ANSI/AAMI/ISO 11607-1:2019 (PDF)
Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems and packaging systemsLEARN MORE
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AAMI TIR97:2019 (PDF)
Principles for medical device security—Postmarket risk management for device manufacturersLEARN MORE
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ANSI/AAMI HE75:2009/(R)2018 (PDF)
Human factors engineering—Design of medical devicesLEARN MORE
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AAMI TIR69:2017/(R)2020 (PDF)
Risk management of radio-frequency wireless coexistence for medical devices and systemsLEARN MORE
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AAMI TIR71:2017/(R)2020 (PDF)
Guidance for logging of alarm system dataLEARN MORE