Standards

ANSI/AAMI RD52:2004 (incl A1 through A4), Dialysate for hemodialysis (consolidated text with Amendments 1 through 4 included).  See more information

ANSI/AAMI RD52:2004/A3:2009, Dialysate for hemodialysis, Amendment 3 - Annex E: Acute dialysis.  See more information

ANSI/AAMI RD52:2004/A4:2009, Dialysate for hemodialysis, Amendment 4 - Annex C: Special considerations for home hemodialysis, C.5.5 Deionization.   See more information

ANSI/AAMI RD62:2006/A1:2009, Water treatment equipment for hemodialysis applications, Amendment 1 - 4.2.6, Deionization.  See more information

ANSI/AAMI/IEC 60601-2-19:2009, Medical electrical equipment - Part 2-19: Particular requirements for basic safety and essential performance of baby incubators.  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

ANSI/AAMI/IEC 60601-2-20:2009, Medical electrical equipment - Part 2-20: Particular requirements for basic safety and essential performance of transport incubators. See more information

ANSI/AAMI/IEC 60601-2-21:2009, Medical electrical equipment - Part 2-21: Particular requirements for basic safety and essential performance of infant radiant warmers. See more information

ANSI/AAMI/IEC 60601-2-50:2009, Medical electrical equipment - Part 2-50: Particular requirements for basic safety and essential performance of infant phototherapy equipment. See more information

ANSI/AAMI/IEC 80601-2-58:2008, Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal and vitrectomy devices for ophthalmic surgery.   See more information

ANSI/AAMI/IEC TIR62296:2009, Considerations of unaddressed safety aspects in the Second Edition of IEC 60601-1 and proposals for new requirements. See more information

ANSI/AAMI/ISO 15674:2009, Cardiovascular implants and artificial organs - Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags.   See more information

ANSI/AAMI/ISO 15675:2009, Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems - Arterial blood line filters.  See more information

ANSI/AAMI/ISO 7199:2009, Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators).  See more information

AAMI TIR14:2009, Contract sterilization using ethylene oxide. See more information

AAMI TIR22:2007/A1:2008, Guidance for ANSI/AAMI/ISO 11607, Packaging for terminally sterilized medical devices - Part 1 and Part 2:2006, Amendment 1. See more information

AAMI TIR28:2009, Product adoption and process equivalence for ethylene oxide sterilization. See more information

AAMI TIR31:2008, Process challenge devices/test packs for use in health care facilities. See more information

ANSI/AAMI ST65:2008, Processing of reusable surgical textiles for use in health care facilities. See more information

ANSI/AAMI ST8:2008, Hospital steam sterilizers. See more information

ANSI/AAMI/ISO 10993-7:2008, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals. See more information

ANSI/AAMI/ISO 13408-1:2008, Aseptic processing of health care products - Part 1: General requirements. See more information

ANSI/AAMI/ISO 13408-2:2003, Aseptic processing of health care products - Part 2: Filtration. See more information

ANSI/AAMI/ISO 13408-3:2006, Aseptic processing of health care products - Part 3: Lyophilization. See more information

ANSI/AAMI/ISO 13408-4:2005, Aseptic processing of health care products - Part 4: Clean-in-place technologies. See more information

ANSI/AAMI/ISO 13408-5:2006, Aseptic processing of health care products - Part 5: Sterilization in place. See more information

ANSI/AAMI/ISO 13408-6:2005, Aseptic processing of health care products - Part 6: Isolator systems. See more information

ANSI/AAMI/ISO 15882:2008, Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results. 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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