AAMI BIOT7

September 11, 2020 By No Comments

AAMI BIOT7

September 11, 2020 By No Comments

AAMI Standards and Recommended Practices – Volume 4: Biological Evaluation of Medical Devices
standard by Association for the Advancement of Medical Instrumentation, 04/01/1997

Medical electrical equipment, Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
standard by Association for the Advancement of Medical Instrumentation, 02/09/2006

Medical electrical equipment-Part 2-4: Particular requirements for the safety of cardiac defibrillators (including automate dexternal defibrillators)
standard by Association for the Advancement of Medical Instrumentation, 03/12/2004

Physical aspects of ethylene oxide sterilization
standard by Association for the Advancement of Medical Instrumentation, 11/18/2016

Book by Association for the Advancement of Medical Instrumentation, 07/01/1991

Systems Used to Forecast Remaining Pacemaker Battery Service Life
standard by Association for the Advancement of Medical Instrumentation, 06/11/2017

AAMI STBK13-S

September 11, 2020 By No Comments

AAMI STBK13-S

September 11, 2020 By No Comments

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

Basic Introduction to the IEC 60601 Series
standard by Association for the Advancement of Medical Instrumentation, 12/18/2019

Electrical Safety Manual, 2008 Edition
Handbook / Manual / Guide by Association for the Advancement of Medical Instrumentation, 01/01/2008

Product adoption and process equivalency for ethylene oxide sterilization
standard by Association for the Advancement of Medical Instrumentation, 03/17/2009

AAMI EQ56-99

September 11, 2020 By No Comments

AAMI EQ56-99

September 11, 2020 By No Comments

Recommended Practice for a Medical Equipment Management Program
standard by Association for the Advancement of Medical Instrumentation, 05/25/1999

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