Standards

ANSI/AAMI/ISO 10993-16:2010, Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables. See more information

ANSI/AAMI/ISO 10993-9:2009, Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products. See more information

ANSI/AAMI/ISO 8638:2010, Cardiovascular implants and artificial organs - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters.  See more information

AAMI TIR18:2010, Guidance on electromagnetic compatibility of medical devices in healthcare facilities. See more information

ANSI/AAMI ES60601-1:2005/A2:2010, Medical electrical equipment, Part 1: General requirements for basic safety and essential performance, Amendment A2.   See more information

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

ANSI/AAMI/IEC TIR62354:2009, General testing procedures for medical electrical equipment.  See more information

ANSI/AAMI/ISO 14708-5:2010, Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices. See more information

ANSI/AAMI/ISO 27186:2010, Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements.  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 TIR40:2009, Sterilization of health care products - Radiation - Guidance on dose setting utilizing a Modified Method 2.  See more information

ANSI/AAMI ST79:2010, Comprehensive guide to steam sterilization and sterility assurance in health care facilities. See more information

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