ANSI/AAMI/ISO TIR22442-4:2010, 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.   See more information

AAMI TIR43:2011, Ultrapure dialysate for hemodialysis and related therapies. See more information

PDF in Stock; Print in Production ANSI/AAMI HA60601-1-11:2011 (IEC 60601-1-11:2010, MOD), 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 home healthcare environment.    See more information

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.  See more information

ANSI/AAMI/ISO TIR19218-1:2011, Medical devices - Hierarchal coding structure for adverse events - Part 1: Event type codes. See more information

AAMI TIR41:2011, Active implantable medical devices - Guidance for designation of left ventricle and implantable cardioverter defibrillator lead connectors and pulse generator connector cavities for implantable pacemakers and implantable cardioverter defibrillators.   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

ANSI/AAMI/ISO 7199:2009/A1:2012, Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators). Amendment 1.  See more information

ANSI/AAMI/ISO TIR12417:2011, Cardiovascular implants and extracorporeal systems -- Vascular device-drug combination products.  See more information

AAMI TIR30:2011, A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices. See more information

ANSI/AAMI ST67:2011, Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled 'sterile'.  See more information

ANSI/AAMI ST72:2011, Bacterial endotoxin - Test methods, routine monitoring and alternatives to batch testing.   See more information

ANSI/AAMI ST79:2010/A2:2011, Comprehensive guide to steam sterilization and sterility assurance in healthcare facilities, Amendment 2. See more information

ANSI/AAMI/ISO 14160:2011, Sterilization of HC products-Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives-Requirements for characterization, devel, valid, and routine control of a sterilization process for med devices.  See more information

ANSI/AAMI/ISO 20857:2010, Sterilization of health care products - Dry heat: Requirements for the development, validation and routine control of a sterilization process for medical devices. See more information

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