AAMI 11135:1994 PDF Download
$54.00Medical Devices – Validation and Routine Control of Ethylene Oxide Sterilization – Includes Errata
standard by Association for the Advancement of Medical Instrumentation, 05/01/1994
Association for the Advancement of Medical Instrumentation
AAMI is the primary source of consensus standards, both national and international, for the medical device industry, as well as practical information, support, and guidance for healthcare technology and sterilization professionals.
Medical Devices – Validation and Routine Control of Ethylene Oxide Sterilization – Includes Errata
standard by Association for the Advancement of Medical Instrumentation, 05/01/1994
Sterilization of Medical Devices – Microbiological Methods – Part 1: Estimation of the Population of Microorganisms on Product
standard by Association for the Advancement of Medical Instrumentation, 09/01/1995
Sterilization of medical devices – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
standard by Association for the Advancement of Medical Instrumentation, 09/01/1998
Active implantable medical devices – Electromagnetic compatibility – EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
standard by Association for the Advancement of Medical Instrumentation, 09/27/2019
Risk management- Part 1: Application of risk management
standard by Association for the Advancement of Medical Instrumentation, 10/16/2000
Cardiovascular implants and artificial organs – Hard shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags, 1ed.
standard by Association for the Advancement of Medical Instrumentation, 03/13/2001
Cardiovascular implants and artificial organs – Cardiopulmonary bypass systems – Arterial blood line filters
standard by Association for the Advancement of Medical Instrumentation, 03/13/2001
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
Medical devices and medical systems-Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE): Part 2-1: Particular requirements for forensic data logging
standard by Association for the Advancement of Medical Instrumentation, 04/22/2022
Standard for Risk Concerns for Interoperable Medical Products (ANSI/AAMI/UL 2800-1-1:2022)
standard by Association for the Advancement of Medical Instrumentation, 06/10/2022
Standard for Interoperable Item Development Life Cycle (ANSI/AAMI/UL 2800-1-2:2022)
standard by Association for the Advancement of Medical Instrumentation, 06/10/2022
Standard for Interoperable Item Integration Life Cycle (ANSI/AAMI/UL 2800-1-3:2022)
standard by Association for the Advancement of Medical Instrumentation, 06/10/2022
Standard for Safety for Medical Device Interoperability (ANSI/AAMI/UL 2800-1:2019)
standard by Association for the Advancement of Medical Instrumentation, 02/25/2019
Standard for Safety for Medical Device Interoperability (ANSI/AAMI/UL 2800-1:2022)
standard by Association for the Advancement of Medical Instrumentation, 06/10/2022
Medical Electrical Equipment, Part 2-2: Particular Requirements for the Safety of High Frequency Surgical Equipment
standard by Association for the Advancement of Medical Instrumentation, 02/07/2007
Autologous Transfusion Devices
standard by Association for the Advancement of Medical Instrumentation, 09/01/1991
Autologous transfusion devices
standard by Association for the Advancement of Medical Instrumentation, 12/06/2005
Autologous transfusion devices
standard by Association for the Advancement of Medical Instrumentation, 08/27/2013
Biological evaluation of medical devices – Part 18: Chemical characterization of materials
standard by Association for the Advancement of Medical Instrumentation, 03/21/2006
AAMI Standards and Recommended Practices – Volume 2.2 – Biomedical Equipment, Part 2: Monitoring and Diagnostic Equipment
standard by Association for the Advancement of Medical Instrumentation, 12/01/1995