Category: AAMI

AAMI

AAMI ST55:2016

AAMI ST55:2016

Table-Top Steam Sterilizers
standard by Association for the Advancement of Medical Instrumentation, 11/01/2016

AAMI TIR48:2015

AAMI TIR48:2015

Quality Management System (QMS) Recommendations on the Application of the U.S. FDA's CGMP Final Rule on Combination Products
standard by Association for the Advancement of Medical Instrumentation, 08/14/2015

AAMI ES60601-1:2005

AAMI ES60601-1:2005

Medical electrical equipment, Part 1: General requirements for basic safety and essential performance
standard by Association for the Advancement of Medical Instrumentation, 02/09/2006

AAMI TIR66:2017/(R)2020

AAMI TIR66:2017/(R)2020

Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms
standard by Association for the Advancement of Medical Instrumentation, 02/28/2017

AAMI ST79:2010 and A1:2010

AAMI ST79:2010 and A1:2010

Comprehensive guide to steam sterilization and sterility assurance in health care facilities
standard by Association for the Advancement of Medical Instrumentation, 09/04/2010

The Quality System Compendium: CGMP Requirements and Industry Practice, Third Edition

The Quality System Compendium: CGMP Requirements and Industry Practice, Third Edition

Book by Association for the Advancement of Medical Instrumentation, 03/01/2015

Dialysis Water and Dialysate Recommendations: A User Guide

Dialysis Water and Dialysate Recommendations: A User Guide

Book by Association for the Advancement of Medical Instrumentation, 05/01/2014

AAMI HE75:2009/(R)2018

AAMI HE75:2009/(R)2018

Human factors engineering – Design of medical devices
standard by Association for the Advancement of Medical Instrumentation, 10/21/2009

AAMI ES60601-1:2005/A1:2012 & C1:2009/(R)2012 & A2:2010/(R)2012

AAMI ES60601-1:2005/A1:2012 & C1:2009/(R)2012 & A2:2010/(R)2012

ANSI/AAMI ES60601-1:2005, Medical electrical equipment – Part 1: General requirements forbasic safety and essential performance, Amendment 1 (2012
Amendment by Association for the Advancement of Medical Instrumentation, 02/09/2006

AAMI MP80601-2-49:2020

AAMI MP80601-2-49:2020

Medical electrical equipment – Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors
standard by Association for the Advancement of Medical Instrumentation, 03/24/2020