Standards

ANSI/AAMI/ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity. See more information

PDF in Stock; Print in Production ANSI/AAMI ES60601-1:2005/C1:2009, Medical electrical equipment, Part 1: General requirements for basic safety and essential performance, Amendment C1.  See more information

ANSI/AAMI HE75:2009, Human factors engineering - Design of medical devices. See more information

ANSI/AAMI/IEC 60601-2-2:2009, Medical electrical equipment - Part 2-2: Particular requirements for basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories.  See more information

PDF in Stock; Print in Production ANSI/AAMI/IEC 80601-2-30:2009, Medical electrical equipment - Part 2-30: Particular requirements for basic safety and essential performance of automated type non-invasive sphygmomanometers. See more information

PDF in Stock; Print in Production ANSI/AAMI/IEC TIR80002-1:2009, Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software. See more information

ANSI/AAMI/ISO 81060-2:2009, Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type. See more information

ANSI/AAMI/ISO 14708-3:2008, Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators. See more information

ANSI/AAMI/ISO 14708-4:2008, Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pumps. See more information

AAMI TIR15:2009, Physical aspects of ethylene oxide sterilization. See more information

AAMI TIR16:2009, Microbiological aspects of ethylene oxide sterilization.   See more information

AAMI TIR39:2009, Guidance on selecting a microbial challenge and inoculation sites for sterilization validation of health care products. See more information

AAMI TIR40:2009, Sterilization of health care products - Radiation - Guidance on dose setting utilizing a Modified Method 2.  See more information

ANSI/AAMI ST15883-1:2009 (ISO 15883-1:2006, MOD), Washer-disinfectors, Part 1: General requirements, terms and definitions and tests. See more information

ANSI/AAMI ST79:2006 and A1:2008, A2:2009, Comprehensive guide to steam sterilization and sterility assurance in health care facilities (Consolidated text of ST79 and Amendments 1 and 2). See more information

ANSI/AAMI ST79:2006/A2:2009, Comprehensive guide to steam sterilization and sterility assurance in health care facilities, Amendment 2. See more information

PDF in Stock; Print in Production ANSI/AAMI/ISO 11737-2:2009, Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process. See more information

ANSI/AAMI/ISO 14161:2009, Sterilization of health care products - Biological indicators - Guidance for the selection, use, and interpretation of results. See more information

PDF in Stock; Print in Production ANSI/AAMI/ISO 14937:2009, Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices. See more information

ANSI/AAMI/ISO TIR17665-2:2009, Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ANSI/AAMI/ISO 17665-1. See more information

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