AAMI ST55-1997

Table-Top Steam Sterilizers
standard by Association for the Advancement of Medical Instrumentation, 04/01/1997

AAMI BIOT9-S

Biological Evaluation of Medical Devices, Three-Book Set
standard by Association for the Advancement of Medical Instrumentation, 01/01/1999

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 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 TIR 25

Chemical Indicators – Guidance for the Selection, Use, and Interpretation of Results in Health Care Facilities
standard by Association for the Advancement of Medical Instrumentation, 08/28/2000

AAMI TIR 15843

Sterilization of health care products-Radiation sterilization-Product families, sampling plans for verification dose experiments and sterilization dose audits, and frequency of sterilization dose audits
standard by Association for the Advancement of Medical Instrumentation, 01/01/2001