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Access new AAMI standards even faster! Instead of waiting for an update — download important new standards before they are published at NO ADDITIONAL CHARGE from the Standards on CD Subscribers-Only Area.

Standards Available for Download:

• ANSI/AAMI/ ISO 15223-1: 2007/(R)2012 and A1:2008/ (R)2012 Medical devices — Symbols to be used with medical device labels, labeling, and information to be supplied — Part 1: General requirements (Jan 2012)
• ANSI/AAMI/IEC 60601- 1-2:2007/ (R)2012 Medical electrical equipment — Part 1-2: General requirements for basic safety and essential performance — Collateral standard: Electromagnetic compatibility — Requirements and tests (Jan 2012)
• ANSI/AAMI ID54:1996/ (R)2012 Enteral feeding set adapters and connectors (Jan 2012)
• ANSI/AAMI ES60601-1:2005/(R)2012 and C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment — Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD). (Jan 2012)
• ANSI/AAMI BP22:1994/ (R)2011 Blood pressure transducers (Jan 2012)
• ANSI/AAMI/ ISO 13408- 1:2008/ (R)2011 Aseptic processing of health care products — Part 1: General requirements (Jan 2012)
• ANSI/AAMI ST72:2011 Bacterial endotoxins — Test methods, routine monitoring, and alternatives to batch testing Red-line Format (Jan 2012)
• ANSI/AAMI ST72:2011 Bacterial endotoxins — Test methods, routine monitoring, and alternatives to batch testing (Jan 2012)
• AAMI TIR30:2011 A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices Red-line Format (Jan 2012)
• ANSI/AAMI/ ISO 14155:2011 Clinical investigation of medical devices for human subjects – Good clinical practice (Jan 2012)
• ANSI/AAMI HA60601-1- 11:2011 MEDICAL ELECTRICAL EQUIPMENT – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2010, MOD) (Dec 2011)
• ANSI/AAMI/ISO 10993-14:2001/(R)2011 Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics (Dec 2011)
• ANSI/AAMI/ISO 10993-15:2000/(R)2011 Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys (Dec 2011)
• ANSI/AAMI/ISO 11737-1:2006/(R)2011Sterilization of health care products— Microbiological methods—Part 1: Determination of the population of microorganisms on product (Dec 2011)
• ANSI/AAMI/ISO 14708-3:2008/(R)2011 Implants for surgery—Active implantable medical devices—Part 3: Implantable neurostimulators (Dec 2011)
• ANSI/AAMI/ISO 14708-4:2008/(R)2011 Implants for surgery—Active implantable medical devices—Part 4: Implantable infusion pumps (Dec 2011)
• ANSI/AAMI/ISO 22442-1:2007/(R)2011 Medical devices utilizing animal tissues and their derivatives—Part 1: Application of risk management (Dec 2011)
• ANSI/AAMI/ISO 22442-2:2007/(R)2011 Medical devices utilizing animal tissues and their
  derivatives — Part 2: Controls on sourcing, collection and handling (Dec 2011)
• ANSI/AAMI/ISO 22442-3:2007/(R)2011 Medical devices utilizing animal tissues and their
  derivatives—Part 3: Validation of the elimination and/ or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (Dec 2011)
• ANSI/AAMI BF7:1989/ (R)2011 Blood transfusion microfilters (Dec 2011)
• ANSI/AAMI BF64:2002/(R)2011 Leukocyte reduction filters (Dec 2011)
• ANSI/AAMI BE83:2006/(R)2011 Biological evaluation of medical devices—Part 18: Chemical characterization of materials (Dec 2011)
• ANSI/AAMI/ ISO TIR 19218-1:2011 Medical devices — Hierarchal coding structure for adverse events — Part 1: Event-type codes (November 2011)
• ANSI/AAMI/ISO TIR 22442-4: 2010 Medical devices utilizing animal tissues and their derivatives — Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes (November 2011)
• AAMI TIR43: 2011 Ultrapure dialysate for hemodialysis and related therapies (November 2011)

Anything above this point was added after the 2011.2 version was issued.

• ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 (Consolidated Text) Comprehensive guide to steam sterilization and sterility assurance in health care facilities (October 2011)
• ANSI/AAMI ST79:2010/A2:2011, Comprehensive guide to steam sterilization and sterility assurance in health care facilities (2011 amendment only) (October 2011)
• AAMI TIR30:2011 A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices (September 2011)
• ANSI/AAMI/ISO 27186:2010 Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements (September 2011)
• ANSI/AAMI/IEC 60601-2-27:2011 Medical electrical equipment — Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment (September 2011)
• ANSI/AAMI ST67:2011 Sterilization of health care products — Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled “sterile” (August 2011)
• ANSI/AAMI/ISO TIR12417:2011 Cardiovascular implants and extracorporeal systems – Vascular device-drug combination products (July 2011)
• ANSI/AAMI/ISO 23500:2011 Guidance for the preparation and quality management of fluids for hemodialysis and related therapies (June 2011)
• ANSI/AAMI/ISO 13959:2009 Water for hemodialysis and related therapies (June 2011)
• ANSI/AAMI/ISO 13958:2009 Concentrates for hemodialysis and related therapies (June 2011)
• ANSI/AAMI/ISO 26722:2009 Water treatment equipment for hemodialysis applications and related therapies (June 2011)
• ANSI/AAMI AT6:2005/(R)2011 Autologous transfusion devices (May 2011)
• ANSI/AAMI/ISO 14155:2011 Clinical investigation of medical devices for human subjects – Good clinical practice (March 2011)
• ANSI/AAMI ST55:2010 Table-top steam sterilizers (March 2011)

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