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
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