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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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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 17665-1:2006/(R) 2013

Sterilization of health care products - Moist heat - Part 1 Requirements for the development, validation and routine control of a sterilization process for medical devices.
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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 20857:2010/(R)2015

Sterilization of health care products - Dry heat: Requirements for the development, validation and routine control of a sterilization process for medical devices.
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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 22442-2:2016 (PDF)

Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling.
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ANSI/AAMI/ISO 22442-3:2007/(R)2016

Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transimissible spongiform encephalopathy (TSE) agents
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ANSI/AAMI/ISO 25539-1:2017 (PDF)

Cardiovascular implants— Endovascular devices—Part 1: Endovascular prostheses
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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 5367:2015 PDF

Anaesthetic and respiratory equipment—Breathing sets and connectors
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ANSI/AAMI/ISO 5841-2:2014

Implants for surgery â?? Cardiac pacemakers â?? Part 2: Reporting of clinical performance of populations of pulse generators or leads
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ANSI/AAMI/ISO 5841-3:2013/(R)2018 (PDF)

Implants for surgery—Cardiac pacemakers—Part 3: Low-profile connectors (IS-1) for implantable pacemakers
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ANSI/AAMI/ISO 7198:2016 (PDF)

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