AAMI Products
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AAMI TIR65:2015/(R)2022 (PDF)
Sustainability of medical devices—Elements of a responsible product life cycleLEARN 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/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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AAMI TIR17:2017/(R)2020 (PDF)
Compatibility of materials subject to sterilizationLEARN 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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AAMI TIR42:2021 (PDF)
Evaluation of particulate associated with vascular medical devicesLEARN MORE
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AAMI TIR34:2014/(R)2021 (PDF)
Water for the reprocessing of medical devicesLEARN MORE
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AAMI TIR49:2013/(R)2020 (PDF)
Design of training and instructional materials for medical devices used in non-clinical environmentsLEARN MORE
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AAMI CR500:2019 (PDF)
Basic Introduction to the IEC 60601 SeriesLEARN MORE
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AAMI TIR48:2015/(R)2021 (PDF)
Quality Management System (QMS) Recommendations on the Application of the U.S. FDA’s CGMP Final Rule on Combination ProductsLEARN MORE
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ANSI/AAMI ST79:2017/(R)2022 w/ AMDs A1:2020, A2:2020, A3:2020, A4:2020 (PDF)
Comprehensive guide to steam sterilization and sterility assurance in health care facilitiesLEARN MORE
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AAMI TIR12:2020 (PDF)
Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturersLEARN MORE
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AAMI TIR71:2017/(R)2020 (PDF)
Guidance for logging of alarm system dataLEARN MORE
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AAMI TIR59:2017 (PDF)
Integrating human factors into design controlsLEARN MORE
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ANSI/AAMI/ISO 15223-1:2016 [HISTORICAL] (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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ANSI/AAMI HE75:2009/(R)2018 (PDF)
Human factors engineering—Design of medical devicesLEARN MORE
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ANSI/AAMI/ISO 11137-1:2006/(R)2015 & A1:2013 & A2:2019 (PDF)
Sterilization of health care products—Radiation—Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devicesLEARN 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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AAMI TIR57:2016/(R)2023 (PDF)
Principles for medical device security—Risk managementLEARN MORE