AAMI ST59-99

Sterilization of Health Care Products – Biological Indicators – Part 1: General
standard by Association for the Advancement of Medical Instrumentation, 09/01/1999

AAMI ST1137-94

Sterilization of Health Care Products: Requirements for Validation and Routine Control, Radiation Sterilization
standard by Association for the Advancement of Medical Instrumentation, 07/01/1994

AAMI ES60601-1:2005/C1:2009/(R)2012 and A2:2010/(R)2012

ANSI/AAMI ES60601-1:2005, Medical electrical equipment – Part 1: General requirements forbasic safety and essential performance, Amendment 1
Amendment by Association for the Advancement of Medical Instrumentation, 02/09/2006

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  • Comments Off on AAMI ES60601-1:2005/C1:2009/(R)2012 and A2:2010/(R)2012
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AAMI TIR97:2019

Principles for medical device security – Postmarket risk management for device manufacturers
standard by Association for the Advancement of Medical Instrumentation, 09/27/2019

AAMI TIR102:2019

U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems
standard by Association for the Advancement of Medical Instrumentation, 08/30/2019

AAMI TIR51:2014/(R)2017

Human factors engineering – Guidance for contextual inquiry
standard by Association for the Advancement of Medical Instrumentation, 10/24/2014

AAMI STBK13-S

AAMI Sterilization Standards Book Collection: Part 1- Sterilization in Health Care Facilities; Part 2 – Sterilization Equipment; Part 3 – Industrial Process Control
standard by Association for the Advancement of Medical Instrumentation, 01/01/2013

AAMI NS28:1988/(R)2015

Intracranial Pressure Monitoring Devices
standard by Association for the Advancement of Medical Instrumentation, 1988

AAMI TIR17:2017

Compatibility of materials subject to sterilization
standard by Association for the Advancement of Medical Instrumentation, 06/11/2017

AAMI TIR28:2016

Product adoption and process equivalency for ethylene oxide sterilization
standard by Association for the Advancement of Medical Instrumentation, 11/18/2016