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IEC 60335-2-21 Ed. 5.0 b:2002...
ASTM D4097-19 + Redline Standard...
AAMI GMP1.5GMP Manual 5th edition - Complying with FDA Good Manufacturing Practice requirements: How to develop your Quality Systems ManualHandbook / Manual / Guide by Association for the Advancement of Medical Instrumentation, 02/01/1997
AAMI TIR 13-97Principles of industrial moist heat sterilizationstandard by Association for the Advancement of Medical Instrumentation, 01/01/1997
AAMI CE-293The CE Mark: Understanding the Medical Device DirectiveHandbook / Manual / Guide by Association for the Advancement of Medical Instrumentation, 01/01/1997
Do it by design: An introduction to human factors in medical devicesBook by Association for the Advancement of Medical Instrumentation, 12/01/1996
Current Issues in Medical Device Quality SystemsBook by Association for the Advancement of Medical Instrumentation, 11/01/1996
AAMI SP10-92 Amendment 1Electronic or automated sphygmomanometers, Amendment 1standard by Association for the Advancement of Medical Instrumentation, 01/01/1997
AAMI ST60-96Sterilization of Health Care Products - Chemical Indicators - Part 1: General Requirementsstandard by Association for the Advancement of Medical Instrumentation, 08/01/1996
The Medical Device Directives: A Manufacturers' HandbookBook by Association for the Advancement of Medical Instrumentation, 08/01/1996Gordon R. Higson
AAMI ST58-96Safe Use and Handling of Glutaraldehyde-Based Products in Health Care Facilitiesstandard by Association for the Advancement of Medical Instrumentation, 08/01/1996
AAMI ST33-96Good Hospital Practice: Guidelines for the Selection and Use of Reusable Rigid Sterilization Container Systemsstandard by Association for the Advancement of Medical Instrumentation, 07/01/1996
AAMI ST35-96Good Hospital Practice: Handling and Biological Decontamination of Reusable Medical Devicesstandard by Association for the Advancement of Medical Instrumentation, 04/01/1996
AAMI BG7199Cardiovascular Implants and Artificial Organs - Blood-Gas Exchangers (Oxygenators)standard by Association for the Advancement of Medical Instrumentation, 04/01/1996