AAMI
Association for the Advancement of Medical Instrumentation 1988 – 2024
Showing 129–144 of 342 results
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AAMI TIR10974 2018
AAMI/ISO TIR10974:2018 – Assessment of the safety of magnetic resonance imaging for patients with an…
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AAMI ST41 2008 RA 2018
ANSI/AAMI ST41:2008/(R)2018 – Ethylene oxide sterilization in health care facilities: Safety and effectiveness Published By…
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AAMI 11135 2014
ANSI/AAMI/ISO 11135:2014 – Sterilization of health care products-Ethylene oxide-Requirements for development, validation and routine control…
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AAMI TIR16775 2014
AAMI/ISO TIR16775:2014 – Packaging for terminally sterilized medical devices – Guidance on the application of…
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AAMI ST15883 1 2009 RA 2014 A4 2014 A2 2012
ANSI/AAMI ST15883-1:2009/(R)2014 &A1:2014&A2:2012 – (Consolidated Text) (ISO 15883-1:2006, MOD) Washer-disinfectors-Part 1: General requirements, terms and…
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AAMI ST58 2013 RA 2018
ANSI/AAMI ST58:2013/(R)2018 – Chemical sterilization and high-level disinfection in health care facilities Published By Publication…
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AAMI TIR48 2015
AAMI TIR48:2015 – Quality Management System (QMS) Recommendations on the Application of the U.S. FDA’s…
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AAMI TIR57 2016 RA 2019
AAMI TIR57:2016/(R)2019 – Principles for medical devices security-Risk management Published By Publication Date Number of…
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AAMI TIR102 2019
AAMI TIR102:2019 – U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in…
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AAMI TIR36 2007
AAMI TIR36:2007 – Validation of software for regulated processes Published By Publication Date Number of…
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AAMI TIR80002 2 2017
AAMI/ISO TIR80002-2:2017 – Medical device software-Part 2: Validation of software for medical device quality systems…
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AAMI TIR80001 2 7 2014
AAMI/IEC TIR80001-2-7:2014 – Application of risk management for IT-networks incorporating medical devices-Part 2-7: Application guidance-Guidance…
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AAMI 62304 2006 RL(Redline)
ANSI/AAMI/IEC 62304: 2006 & A1:2016 (Redline) – Medical device software-Software life cycle processes Published By…
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AAMI CI86 2017
ANSI/AAMI CI86:2017 – Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting…
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AAMI 27186 2010
ANSI/AAMI/ISO 27186:2010 – Active implantable medical devices-Four-pole connector system for implantable cardiac rhythm management devices-Dimensional…
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AAMI 25539 2 2012
ANSI/AAMI/ISO 25539-2:2012 – Cardiovascular implants-Endovascular devices-Part 2: Vascular stents Published By Publication Date Number of…