Category: AAMI

Table-Top Steam Sterilizers
standard by Association for the Advancement of Medical Instrumentation, 12/30/2010

Ultrapure dialysate for hemodialysis and related therapies
standard by Association for the Advancement of Medical Instrumentation, 09/23/2011

Guidance on selecting a microbial challenge and inoculation sites for sterilization validation of medical devices
standard by Association for the Advancement of Medical Instrumentation, 09/03/2009

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
standard by Association for the Advancement of Medical Instrumentation, 07/01/2019

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

Current Concepts in Hemodialyzer Reprocessing
standard by Association for the Advancement of Medical Instrumentation, 01/01/1998

Integrating human factors into design controls
standard by Association for the Advancement of Medical Instrumentation, 08/04/2017

Guidance for ANSI/AAMI/ISO 11607, Packaging for terminally sterilized medical devices – Part 1 and Part 2:2006, (now includes 2008 amendment)
standard by Association for the Advancement of Medical Instrumentation, 11/20/2008

Safe Handling and Biological Decontamination of Reusable Medical Devices in Health Care Facilities and in Nonclinical Settings
standard by Association for the Advancement of Medical Instrumentation, 03/17/2003

Comprehensive guide to steam sterilization and sterility assurance in health care facilities (Consolidated text of ST79 and Amendments 1 and 2)
standard by Association for the Advancement of Medical Instrumentation, 07/24/2006

Good Hospital Practice: Steam Sterilization and Sterility Assurance
standard by Association for the Advancement of Medical Instrumentation, 11/02/1993

Application of quality management system concepts to medical device data systems
standard by Association for the Advancement of Medical Instrumentation, 05/23/2012