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Standards Available for Download:
- ANSI/AAMI/IEC 60601-2-2:2009 Medical electrical equipment — Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgery equipment and high frequency surgical accessories
- AAMI TIR28:2009 Product adoption and process equivalence for ethylene oxide sterilization
- ANSI/AAMI RD52:2004, Dialysate for hemodialysis (consolidated text with Amendments 1 through 4 included)
- ANSI/AAMI RD52:2004/ A3:2009 & A4:2009 Amendment 3—Annex E: Special considerations for acute hemodialysis and Amendment 4 — Annex C: Special considerations for home hemodialysis, C.5.C Deionization
- ANSI/AAMI/ISO 15675:2009 Cardiovascular implants and artificial organs — Cardiopulmonary bypass systems — Arterial blood line filters
- ANSI/AAMI/ISO 15674:2009 Cardiovascular implants and artificial organs — Hard shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
- AAMI TIR14:2009 Contract sterilization using ethylene oxide
- ANSI/AAMI RD62:2006 and ANSI/AAMI RD62:2006/A1:2009 Water treatment equipment for hemodialysis applications
- ANSI/AAMI RD62:2006/A1:2009 Water treatment equipment for hemodialysis applications
- ANSI/AAMI/ISO 7199:2009 Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators)
- ANSI/AAMI/IEC 60601-2-50:2009 Medical Electrical Equipment — Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
- ANSI/AAMI/IEC TIR62296:2009 Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for new requirements
- ANSI/AAMI/IEC 60601-2-19:2009 Medical Electrical Equipment — Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
- ANSI/AAMI/IEC 60601-2-20:2009 Medical Electrical Equipment — Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
- ANSI/AAMI/IEC 60601-2-21:2009 Medical Electrical Equipment — Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
- ANSI/AAMI/ISO 11137-2:2006 (Corrected 21 April 2009) Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
- ANSI/AAMI ST65:2008 Processing of reusable surgical textiles for use in health care facilities
- ANSI/AAMI/IEC 80601-2-58:2008 Medical Electrical Equipment —Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices
- ANSI/AAMI ST8:2008 Hospital steam sterilizers
- ANSI/AAMI/ISO 10993-4:2002/(R)2009 & A1:2006/(R)2009 Biological evaluation of medical devices — Part 4: Selection of tests for interaction with blood
- ANSI/AAMI/ISO 10993-16:1997/(R)2009Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables from medical devices
- ANSI/AAMI/ISO 10993-7:2008 Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
- ANSI/AAMI/ISO 13408-1:2008 Aseptic processing of health care products — Part 1: General requirements
- ANSI/AAMI/ISO 13408-2:2003 Aseptic processing of health care products — Part 2: Filtration
- ANSI/AAMI/ISO 13408-3:2006 Aseptic processing of health care products — Part 3: Lyophilization
- ANSI/AAMI/ISO 13408-4:2005 Aseptic processing of health care products — Part 4: Clean-in-place technologies
- ANSI/AAMI/ISO 13408-5:2006 Aseptic processing of health care products — Part 5: Sterilization in place
- ANSI/AAMI/ISO 13408-6:2005 Aseptic processing of health care products — Part 6: Isolator systems
- ANSI/AAMI/ISO 15882:2008 Sterilization of health care products — Chemical indicators— Guidance for selection, use and interpretation of results
- AAMI TIR31:2008 Process challenge devices/ test packs for use in health care facilities
- 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
- AAMI TIR22:2007 and AAMI TIR22:2007/ A1:2008 Guidance for ANSI/AAMI/ISO 11607, Packaging for terminally sterilized medical devices — Part 1 and Part 2:2006
- ANSI/AAMI/ISO 14155-1:2003/(R)2008 Clinical investigation of medical devices for human subjects — Part 1: General requirements
- ANSI/AAMI/ISO 14155-2:2003/(R)2008 Clinical investigation of medical devices for human subjects— Part 2: Clinical investigation plans
- ANSI/AAMI/ISO 14160:1998/(R)2008 Sterilization of single-use medical devices incorporating materials of animal origin — Validation and routine control of sterilization by liquid chemical sterilants
- ANSI/AAMI SP10:2002/A1:2003/(R)2008 Amendment 1 to ANSI/AAMI SP10:2002, Manual, electronic, or automated sphygmomanometers
- ANSI/AAMI SP10:2002/(R)2008 & ANSI/AAMI SP10:2002/A1:2003/(R)2008 &
ANSI/ AAMI SP10:2002/A2:2006/(R)2008 Manual, electronic, or automated sphygmomanometer - ANSI/AAMI ST55:2003/(R)2008 Table-top steam sterilizers
- ANSI/AAMI ST67:2003/(R)2008 Sterilization of health care products — Requirements for products labeled “STERILE”
- ANSI/AAMI/ISO EC57:1998/(R) 2008 Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms
- ANSI/AAMI EC53A:1998/(R)2008 Amendment 1 to ANSI/AAMI EC53: 1995, American National Standard for ECG cables and leadwires
- ANSI/AAMI EC53:1995/(R)2008 ECG cables and leadwires
- ANSI/AAMI/ISO 10993-17:2002/(R)2008 Biological evaluation — Part 17: Methods for the establishment of allowable limits for leachable substances
- ANSI/AAMI BE78:2002/(R)2008 Biological evaluation of medical devices — Part 10: Tests for irritation and delayed-type hypersensitivity
- ANSI/AAMI BE78:2002 /A1:2006(R)2008 Biological evaluation of medical devices — Part 10: Tests for irritation and delayed-type hypersensitivity (identical adoption of ISO 10993-10:2002/ Amendment 1:2006)
- ANSI/AAMI/ISO TIR11135-2:2008, Sterilization of health care products— Ethylene oxide — Part 2: Guidance on the application of ANSI/ AAMI/ ISO 11135-1
- AAMI TIR17:2008, Compatibility of materials subject to sterilization
- ANSI/AAMI/ISO 25539-2:2008, Cardiovascular implants — Endovascular devices — Part 2: Vascular stents
- ANSI/AAMI ST79:2006 and A1:2008, Comprehensive guide to steam sterilization and sterility assurance in health care facilities (Consolidated text of ST79 and Amendment 1)
- ANSI/AAMI ST79:2006/A1:2008, Comprehensive guide to steam sterilization and sterility assurance in health care facilities, Amendment 1
- ANSI/AAMI ST41:2008, Ethylene oxide sterilization in health care facilities: Safety and effectiveness
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