Category: AAMI

Disposable ECG electrodes
standard by Association for the Advancement of Medical Instrumentation, 01/06/2005

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

Washer-disinfectors – Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. (ISO 15883-2:2006, MOD)
standard by Association for the Advancement of Medical Instrumentation, 12/03/2012

Comprehensive guide to steam sterilization and sterility assurance in health care facilities
standard by Association for the Advancement of Medical Instrumentation, 07/24/2006

Blood transfusion micro-filters
standard by Association for the Advancement of Medical Instrumentation, 11/30/2012

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

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

Periodic review of ANSI/AAMI ST40:2004, Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities (Reaffirmed 2010)
standard by Association for the Advancement of Medical Instrumentation, 10/07/2004

Sterilization of health care products – Radiation sterilization – Product adoption and alternative sampling plans for verification dose experiments and sterilization dose audits
standard by Association for the Advancement of Medical Instrumentation, 06/05/2016

Washer-disinfectors, Part 1: General requirements, terms and definitions and tests (Includes Amendment 2, 2012)
standard by Association for the Advancement of Medical Instrumentation, 09/15/2009