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AAMI CR500:2019

Basic Introduction to the IEC 60601 Series
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AAMI TIR102:2019

U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems
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AAMI TIR18:2010

Guidance on electromagnetic compatibility of medical devices in healthcare facilities
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AAMI TIR28:2016 (PDF)

Product adoption and process equivalence for ethylene oxide sterilization
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AAMI TIR29:2012/(R)2017 (PDF)

Guide for process characterization and control in radiation sterilization of medical devices
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AAMI TIR30:2011/(R)2016 (PDF)


A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices
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AAMI TIR42:2010

Evaluation of particulates associated with vascular medical devices
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AAMI TIR44:2012

Non-invasive blood pressure motion artifact - Testing and evaluation of NIBP device performance in the presence of motion artifact
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AAMI TIR48:2015

Quality Management System (QMS) Recommendations on the Application of the U.S. FDA's CGMP Final Rule on Combination Products
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AAMI TIR97:2019

Principles for medical device security—Postmarket risk management for device manufacturers
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AAMI/IEC TIR62296:2009

Considerations of Unaddressed Safety Aspects in the Second Edition of IEC 60601-1 and Proposals for New Requirements
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AAMI/ISO DTIR20416:2020 Preorder

Medical devices—Post-market surveillance for manufacturers
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AAMI/ISO TIR10974:2018 (PDF)

Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device.
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AAMI/ISO TIR17137:2014 (PDF)

Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants
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Acquisition Guide for Clinical Technology Equipment

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Acquisition Guide for Clinical Technology Equipment

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ANSI/AAMI 2700-1:2019

Medical Devices and Medical Systems—Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE)—Part 1: General requirements and conceptual model
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ANSI/AAMI CI86:2017 (PDF)

Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting
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ANSI/AAMI EQ56:2013

Recommended practice for a medical equipment management program
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ANSI/AAMI HA60601-1-11:2015 (IEC 60601-1-11:2015, MOD)

MEDICAL ELECTRICAL EQUIPMENT - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
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