Recent Files in the Subscriber Area

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• ANSI/AAMI RD5:2003/(R)2008 Hemodialysis systems
• ANSI/AAMI RD52:2004 and ANSI/AAMI RD52:2004/A1:2007 & A2:2007 Dialysate for hemodialysis
• ANSI/AAMI RD52:2004/A1:2007 & A2:2007 Dialysate for hemodialysis, Amendment 1 - Annex C: Special considerations for home hemodialysis and Amendment 2 - Annex D: Self-assessment of compliance with recommendations for dialysate preparation
• AAM TIR36:2007 Validation of software for regulated processes
• ANSI/AAMI EC13:2002/(R)2007 Cardiac monitors, heart rate meters, and alarms
• AAM TIR34:2007 Water for the reprocessing of medical devices
• ANSI/AAMI/ISO 22442-1:2007 Medical devices utilizing animal tissues and their derivatives— Part 1: Application of risk management
• ANSI/AAMI/ISO 22442-2:2007 Medical devices utilizing animal tissues and their derivatives—Part 2: Controls on sourcing, collection and handling
• ANSI/AAMI/ISO 22442-3:2007 Medical devices utilizing animal tissues and their derivatives—Part 3: Controls on sourcing, collection and handling
• ANSI/AAMI/ISO EC13:2002/(R)2007 Cardiac monitors, heart rate meters, and alarms
• ANSI/AAMI/ISO 10993-12:2007 Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
• AAMI TIR37:2007 Sterilization of health care products — Radiation — Guidance on sterilization of human tissue-based products
• ANSI/AAMI PC69:2007 Active implantable medical devices — Electromagnetic compatibility — EMC test protocols for implantable cardiac pacemakers and implantable cardioverter defibrillators
• ANSI/AAMI/ISO 15223-1:2007 Medical devices — Symbols to be used with medical device labels, labeling, and information to be supplied — Part 1: General requirements
• ANSI/AAM/ ISO 14971:2007 Medical devices- Application of risk management to medical devices (with errata incorporated)
• ANSI/AAMI/ISO 10993-6:2007 Biological evaluation of medical devices — Part 6: Tests for local effects after implantation
• ANSI/AAMI BF64: 2002/(R)2007 Leukocyte reduction filters
• ANSI/AAMI BF7:1989 (R)2002/(R)2007 Blood transfusion micro-filters
• ANSI/AAMI/ISO 11135-1:2007 Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices
• ANSI/AAMI RD17:2007 Cardiovascular implants and artificial organs — Extracorporeal blood circuit for hemodialyzers, hemodiafilters, and hemofilters
• ANSI/AAMI RD16:2007 Cardiovascular implants and artificial organs — Hemodialyzers, hemodiafilters, hemofilters, and hemoconcentrators
• ANSI/AAMI/ISO 11140-3:2007 Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
• ANSI/AAMI/IEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance -Collateral standard: Electromagnetic compatibility - Requirements and tests
• AAMI TIR22:2007 Guidance for ANSI/AAMI/ISO 11607, Packaging for terminally sterilized medical devices - Part 1 and Part 2:2006
• ANSI/AAMI/IEC 60601-2-2: 2006 Medical electrical equipment, Part 2-2: Particular requirements for the safety of high frequency surgical equipment
• ANSI/AAMI RD61:2006 Concentrates for Hemodialysis
• ANSI/AAMI/IEC 60601-2-50:2006 Medical electrical equipment, Part 2-50: Particular requirements for the safety of infant phototherapy equipment
• ANSI/AAM BE78:2002 & A1/2006 Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity
• ANSI/AAMI/ISO 14971:2007 Medical devices - Application of risk management to medical devices (Final Draft Standard Version)
• ANSI/AAMI RD62:2006 Water treatment equipment for hemodialysis applications
• ANSI/AAMI ST77:2006 Containment devices for reusable medical device sterilization
• AAMI TIR35:2006 Sterilization of healthcare products - Radiation sterilization - Alternative sampling plans for verification dose experiments and sterilization dose audits.
• ANSI/AAMI/ISO 10993-11:2006 Biological evaluation of medical devices-Part 11: Tests for systemic toxicity
• AAMI TIR33:2005 Sterilization of health care products - Radiation -Substantiation of a selected sterilization dose - Method VDmax
• ANSI/AAMI/ISO 10993-2:2006 Biological evaluation of medical devices-Part 2: Animal welfare requirements
• ANSI/AAMI/ISO 17665-1:2006 Sterilization of health care products - Moist heat-Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices
• ANSI/AAMI/ISO 10993-4:2002/A1:2006 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood, Amendment 1 (Identical to ISO 10993-4 2002/Amendment 1:2006)
• AAMI TIR20, Parametric Release for Ethylene Oxide Sterilization (This file replaces the TIR20 file on the 2006.2 version of the CD, which mistakenly included the preview edition of the document.)
  
• ANSI/AAMI/IEC TIR62348:2006, Mapping between the clauses of the third edition of IEC 60601-1 and the 1988 edition as amended
• ANSI/AAMI/IEC 62304:2006, Medical device software-Software life cycle processes

• ANSI/AAMI/ISO 11138-1:2006, Sterilization of health care products - Biological indicators - Part 1: General requirements, 2ed

• ANSI/AAMI/ISO 11138-2:2006, Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes, 3ed
• ANSI/AAMI/ISO 11138-3:2006, Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
• ANSI/AAMI/ISO 11138-4:2006, Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes
• ANSI/AAMI/ISO 11138-5:2006, Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
• ANSI/AAMI/ISO 11137-2:2006, Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
• ANSI/AAMI/ISO TIR10993-19:2006, Biological evaluation of medical devices - Part 19: Physico-chemical, morphological, and topographical characterization of materials
• ANSI/AAMI/ISO TIR10993-20:2006, Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices
• ANSI/AAMI ST79:2006, Comprehensive guide to steam sterilization and sterility assurance in health care facilities
• ANSI/AAMI/ISO 18472:2006, Sterilization of health care products - Biological and chemical indicators - Test equipment
• ANSI/AAMI BE83:2006, Biological evaluation of medical devices - Part 18:Chemical characterization of materials
• ANSI/AAMI/ISO 11137-1:2006, Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices
• ANSI/AAMI/ISO 11137-3:2006, Sterilization of health care products - Radiation - Part 3:Guidance on dosimetric aspects
• ANSI/AAMI AT6:2005, Autologous transfusion devices
• ANSI/AAMI/ ISO 11737-1:2006, Sterilization of health care products - Microbiological methods - Part 1: Determination of the population of microorganisms on product
• ANSI/AAMI/ ISO 11607-1:2006, Packaging for terminally sterilized medical devices-Part 1: Requirements for materials, sterile barrier systems, and packaging systems
• ANSI/AAMI/ ISO 11607-2:2006, Packaging for terminally sterilized medical devices-Part 2: Validation requirements for forming, sealing, and assembly processes
• ANSI/AAMI/ ISO TIR11139:2006, Sterilization of health care products-Vocabulary
• ANSI/AAMI/ ES60601-1:2005, Medical equipment-Part 1: General requirements for basic safety and essential performance
• ANSI/AAMI/ISO TIR16142:2005, Medical devices — Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
• ANSI/AAMI ST58:2005, Chemical sterilization and high-level disinfection in healthcare facilities
• AAMI TIR11:2005, Selection and use of protective apparel and surgical drapes in health care facilities

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