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What Did You Miss in 2009?

As 2009 comes to an end, are your AAMI standards and documents up-to-date? Please check the list of collections, individual standards, and popular resources published this year. If you are missing any of these items, click the links below or call 877-249-8226 to order your copy.

To order any of these documents, click the links below or call 877-249-8226.

COLLECTIONS – CDs and Books:

  • AAMI Standards on CD – Complete Collection—This annual subscription of all AAMI standards and guidance documents is the easy and economical way to ensure your collection of AAMI standards are always current. Order Code: STDSCD
  • AAMI Standards on CD – Sterilization Edition—This CD includes every AAMI sterilization standard and guidance document, along with AAMI sterilization articles from BI&T and key FDA and CDC guidance documents. Order Code: STBKCD
  • Sterilization Part 1: Sterilization in Health Care Facilities—The 2009 edition of AAMI’s most popular sterilization book contains 11 standards, including ST65, ST41, TIR34, ST79, and ST79 Amendment 1. Order Code: STBK09-1
  • Sterilization: Part 2: Sterilization Equipment Design and Use—The 2009 edition contains 22 important sterilization standards and guidance documents including ST8, 15882, TIR31, and the 11140. Order Code: STBK09-2
  • Sterilization, Part 3: Industrial Process Control—The 2009 edition of this book contains 37 guidance documents, including new editions of TIR28, TIR14, TIR17665-2, and more. Order code: STBK09-3
  • Medical Equipment Symbols & Safety Signs Clip Art Collection—This CD features high resolution versions of more than 650 standardized symbols for medical equipment. Updated to also include symbols found in ES60601-2-2, RD61, and 60601-2-2. Order Code: SYMBCD
  • Dialysis—The CD format of this collection of AAMI hemodialysis standards and guidance documents was updated to include the 2009 amendments to RD62 and RD52. The Dialysis CD also includes valuable guidance from the FDA and CMS. Order Code: DSBKCD
  • Quality System Collection—New for 2009, this CD contains every AAMI standard for quality systems, medical device software, and human factors; and a wealth of government guidance documents from the FDA and GHTF and quality systems articles from AAMI’s journal. Order Code: AQS-CD
  • AAMI Standards on CD: Biological Evaluation Series—This CD includes all current 10993, 14155, and 22442 standards, including the 2009 editions of 10993-1 and 10993-5. Order Code: BIOTCD
  • The Clinical Engineering Collection on CD—AAMI’s most popular clinical engineering publications are featured on one convenient CD, including the 2009 edition of the Medical Equipment Management Manual. Order Code: CEC
  • Medical Equipment Management Manual, AAMI’s 2009 edition provides up-to-date, essential guidance on how to comply with Joint Commission medical equipment management requirements. Order code: MEMM, MEMMCD, or MEMMSET.
  • AAMI's Benchmarking Solution—This online tool is designed specifically to help clinical engineering departments measure their practices, policies, and procedures against similar departments at other facilities; and share best practices. Order code: ABS.

STANDARDS:

  • ANSI/AAMI/IEC TIR80002-1:2009, Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software Order Code: 8000201 or 8000201-PDF (Coming Soon. Call and place your order today.)
  • 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 Order Code: 14937 or 14937-PDF (Coming Soon. Call and place your order today.)
  • 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 Order Code: 1173702 or 1173702-PDF (Coming Soon. Call and place your order today.)
  • AAMI TIR15:2009, Physical aspects of ethylene oxide sterilization Order Code: TIR15 or TIR15-PDF (Coming Soon. Call and place your order today.)
  • AAMI TIR40:2009, Sterilization of health care products - Radiation - Guidance on dose setting utilizing a Modified Order Code: TIR40 or TIR40-PDF (Coming Soon. Call and place your order today.)
  • ANSI/AAMI/ISO 13485:2003/(R)2009, Medical devices — Quality management systems — Requirements for regulatory purposes Order Code: 13485 or 13485-PDF
  • ANSI/AAMI/ISO 10993-1:2009, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process Order Code: 1099301 or 1099301-PDF
  • AAMI TIR39:2009, Guidance on selecting a microbial challenge and inoculation sites for sterilization validation of health care products Order Code: TIR39 or TIR39-PDF
  • ANSI/AAMI PB70:2003/(R)2009, Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities Order Code: PB70 or PB70-PDF
  • ANSI/AAMI PB70:2003/(R)2009, Desempeño impermeable y clasificación de vestimenta y lencería protectoras utilizadas en instituciones de salud Spanish Translation Order Code: PB70-SP-PDF
  • ANSI/AAMI/ISO 14161:2009, Sterilization of health care products — Biological indicators — Guidance for the selection, use and interpretation of results Order Code: 14161 or 14161-PDF
  • ANSI/AAMI/ISO 14161:2009, Sterilization of health care products — Biological indicators — Guidance for the selection, use and interpretation of results Red-line Format Order Code: 14161-RD-PDF
  • ANSI/AAMI/ISO 81060-2:2009, Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type Order Code: 8106002 or 8106002-PDF
  • ANSI/AAMI ST15883-1:2009 (ISO 15883-1:2006, MOD), Washer-disinfectors — Part 1: General requirements, terms and definitions and tests Order Code: TIR39 or TIR39-PDF
  • ANSI/AAMI HE74:2001/(R)2009, Human factors design process for medical devices Order Code: HE724 or HE74-PDF
  • ANSI/AAMI/ISO 25539-1:2003/(R)2009, Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses Order Code: 2553901 or 2553901-PDF
  • ANSI/AAMI/ISO 25539-1:2003/A1:2005/(R)2009, Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses Amendment 1: Test methods Order Code: 2553901-A or 2553901-A-PDF
  • ANSI/AAMI/ISO 10993-3-2003/(R)2009, Biological evaluation of medical devices, Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity Order Code: 1099303 or 1099303-PDF
  • AAMI NS4:1986/(R)2009, Transcutaneous electrical nerve stimulators Order Code: NS4 or NS4-PDF
  • ANSI/AAMI ID26:2004/(R)2009, Medical electrical equipment — Part 2: Particular requirements for the safety of infusion pumps and controllers Order Code: ID26 or ID26-PDF
  • ANSI/AAMI ST:24:1999/(R)2009, Automatic, general purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities Order Code: ST24 or ST24-PDF
  • ANSI/AAMI/ISO 14708-3:2008, Implants for surgery — Active implantable medical devices —
    Part 3: Implantable neurostimulators     Order Code: 1470803 or 1470803-PDF
  • ANSI/AAMI/ISO 14708-4:2008, Implants for surgery — Active implantable medical devices—
    Part 4: Implantable infusion pumps     Order Code: 1470804 or 1470804-PDF
  • ANSI/AAMI ST79:2006/A2:2009, Comprehensive guide to steam sterilization and sterility assurance in health care facilities, Amendment 2 (Check here to determine what you need to update your copy of ST79.)
  • ANSI/AAMI ST79:2006 & 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) Order Code: ST79 or ST79-PDF
  • ANSI/AAMI/ISO 10993-5:2009, Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity Order Code: 1099305 or 1099305-PDF
  • 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 Order Code: 1766502 or 1766502-PDF
  • 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 Order Code: 601202 or 601202-PDF
  • ANSI/AAMI RD52:2004 (incl A1 through A4), Dialysate for hemodialysis (consolidated text with Amendments 1 through 4 included) Order Code: RD52 or RD52-PDF
  • ANSI/AAMI RD52:2004/A3:2009 and A4:2009, Dialysate for hemodialysis, Amendments 3 and 4 Order Code: RD52-A-PDF (FREE Download)
  • AAMI TIR28:2009, Product adoption and process equivalence for ethylene oxide sterilization Order Code: TIR28 or TIR28-PDF
  • ANSI/AAMI/ISO 7199:2009, Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) Order Code: 7199 or 7199-PDF
  • ANSI/AAMI/ISO 15675:2009, Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems - Arterial blood line filter Order Code: 15675 of 15675-PDF
  • ANSI/AAMI/ISO 15674:2009, Cardiovascular implants and artificial organs - Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags Order Code: 15674 of 15674-PDF
  • AAMI TIR14:2009, Contract sterilization using ethylene oxide Order Code: TIR14 or TIR14-PDF
  • ANSI/AAMI RD62:2006 (incl A1), Water treatment equipment for hemodialysis applications Order Code: RD62 or RD62
  • ANSI/AAMI RD62:2006/A1:2009, Water treatment equipment for hemodialysis applications, Amendment 1 - 4.2.6, Deionization Order Code: RD62-A-PDF (FREE Download)
  • 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 Order Code: 601250 or 601250-PDF
  • ANSI/AAMI/IEC TIR62296:2009, Considerations of unaddressed safety aspects in the Second Edition of IEC 60601-1 and proposals for new requirements Order Code: 62296 or 62296-PDF
  • ANSI/AAMI/IEC 60601-2-19:2009, Medical electrical equipment - Part 2-19: Particular requirements for basic safety and essential performance of baby incubators Order Code: 601219 or 601219-PDF
  • ANSI/AAMI/IEC 60601-2-20:2009, Medical electrical equipment - Part 2-20: Particular requirements for basic safety and essential performance of transport incubators Order Code: 601220 or 601220-PDF
  • 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 Order Code: 601221 or 601221-PDF
  • ANSI/AAMI ST65:2008, Processing of reusable surgical textiles for use in health care facilities Order Code: ST65 or ST65-PDF
  • 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 Order Code: 601258 or 601258-PDF
  • ANSI/AAMI ST8:2008, Hospital steam sterilizers Order Code: ST8 or ST8-PDF
  • ANSI/AAMI/ISO 10993-04:2002/(R)2009, Biological evaluation of medical devices, Part 4: Selection of tests for interactions with blood Order Code: 1099304 or 1099304-PDF
  • ANSI/AAMI/ISO 10993-16:1997/(R)2009, Biological evaluation of medical devices, Part 16: Toxicokinetic study design for degradation products and leachables from medical devices Order Code: 1099316 or 1099316-PDF
  • ANSI/AAMI EQ56:1999/(R)2008, Recommended practices for a medical equipment management program Order Code: EQ56 or EQ56-PDF
  • ANSI/AAMI/ISO 13408-1:2008, Aseptic processing of health care products - Part 1: General requirements Order Code: 1340801 or 1340801-PDF
  • ANSI/AAMI/ISO 13408-2:2003, Aseptic processing of health care products - Part 2: Filtration Order Code: 1340802 or 1340802-PDF
  • ANSI/AAMI/ISO 13408-3:2006, Aseptic processing of health care products - Part 3: Lyophilization Order Code: 1340803 or 1340803-PDF
  • ANSI/AAMI/ISO 13408-4:2005, Aseptic processing of health care products - Part 4: Clean-in-place technologies Order Code: 1340804 or 1340804-PDF
  • ANSI/AAMI/ISO 13408-5:2006, Aseptic processing of health care products - Part 5: Sterilization in place Order Code: 1340805 or 1340805-PDF
  • ANSI/AAMI/ISO 13408-6:2005, Aseptic processing of health care products - Part 6: Isolator systems Order Code: 1340806 or 1340806-PDF
  • AAMI TIR31:2008, Process challenge devices/test packs for use in health care facilities Order Code: TIR31 or TIR31-PDF
  • ANSI/AAMI/ISO 10993-7:2008, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals 1099307 or 1099307-PDF
  • ANSI/AAMI/ISO 15882:2008, Sterilization of health care products - Chemical indicators - Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results Order Code: 15882 or 15882-PDF

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