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ANSI/AAMI/ISO 11138-5:2017 (PDF)

Sterilization of health care products—Biological indicators—Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
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ANSI/AAMI/ISO 11607-1:2006/(R)2015 (PDF)

Packaging for terminally sterilized medical devices • Part 1: Requirements for materials, sterile barrier systems, and packaging systems
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ANSI/AAMI/ISO 11737-2-2009/(R)2014

Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
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ANSI/AAMI/ISO 12417-1:2015 (PDF)

Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements
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ANSI/AAMI/ISO 14708-3:2017 (PDF)

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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.
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ANSI/AAMI/ISO 15674:2016 (PDF)

Cardiovascular implants and artificial organs - Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
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ANSI/AAMI/ISO 15675:2016 (PDF)

Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems - Arterial blood line filters
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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)
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AAMI/ISO TIR16142-1:2016

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
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ANSI/AAMI/ISO 16142-2:2017 (PDF)

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
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ANSI/AAMI/ISO 17664:2017 (PDF)

Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices.

Supersedes ST81
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ANSI/AAMI/ISO 18241:2016 (PDF)

Cardiovascular implants and extracorporeal systems - Cardiopulmonary bypass systems - Venous bubble traps
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ANSI/AAMI/ISO 22442-1:2016 (PDF)

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management.
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ANSI/AAMI/ISO 25539-2:2012


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ANSI/AAMI/ISO 25539-2:2012 (PDF)


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ANSI/AAMI/ISO 25539-3:2011/(R)2015

Cardiovascular implants - Endovascular devices - Part 3: Vena Cava Filters.
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ANSI/AAMI/ISO 26782:2015 & Cor.1:2015 (Consolidated Txt) PDF

Anaesthetic and respiratory equipment — Spirometers intended for the measurement of time forced expired volumes in humans
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ANSI/AAMI/ISO 27186:2010

Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements.
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ANSI/AAMI/ISO 5367:2015 PDF

Anaesthetic and respiratory equipment—Breathing sets and connectors
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