AAMI STBK10-3

This collection of 37 documents was updated in late 2010 to include nine new/ revised standards. It features new guidance for ethylene oxide, radiation, biological indicators, validation and control of a sterilization process, and test methodologies.

Contents

• 14937 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
• 14161 Sterilization of health care products -Biological indicators -Guidance for the selection, use, and interpretation of results
• 15882 Sterilization of health care products -Chemical indicators -Guidance for selection, use and interpretation of results
• 11737-1 Sterilization of medical devices -Microbiological methods -Part 1: Determination of a population of microorganisms on products
• 11737-2 Sterilization of medical devices -Microbiological methods -Part 2: Tests of sterility performed in the validation of a sterilization process
• ST72 Bacterial endotoxin-Test methodologies, routine monitoring and alternatives to batch testing
• 17665-1 Sterilization of health care products -Moist heat -Part 1 Requirements for the development, validation and routine control of a sterilization process for medical devices
• 17665-2 Sterilization of health care products -Moist heat -Part 2: Guidance on the application of ANSI/AAMI/ISO 17665-1
• 11135-1 Sterilization of health care products -Ethylene oxide -Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
• TIR11135-2 Sterilization of health care products -Ethylene oxide -Part 2: Guidance on the application of ANSI/AAMI/ISO 11135-1
• TIR14 Contract sterilization using ethylene oxide
• TIR15 Physical aspects of ethylene oxide sterilization
• TIR16 Microbiological aspects of ethylene oxide sterilization
• TIR28 Product adoption and process equivalence for ethylene oxide sterilization
• 10993-7 Biological evaluation of medical devices -Part 7: Ethylene oxide sterilization residuals
• 11137-1 Sterilization of health care products -Radiation -Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
• 11137-2 Sterilization of health care products -Radiation -Part 2: Establishing the sterilization dose
• 11137-3 Sterilization of health care products -Radiation -Part 3: Guidance on dosimetric aspects
• TIR33 Sterilization of health care products -Radiation sterilization -Substantiation of a selected sterilization dose -Method VDmax
• TIR35 Sterilization of health care products -Radiation sterilization -Alternative sampling plans for verification dose experiments and sterilization dose audits
• TIR37 Sterilization of health care products –Radiation –Guidance on sterilization of human tissue-based products
• TIR40 Sterilization of health care products –Radiation –Guidance on dose setting utilizing a Modified Method 2
• TIR17 Compatibility of materials subject to sterilization
• 14160 Sterilization of single-use medical devices incorporating materials of animal origin -Validation and routine control of sterilization by liquid chemical sterilants
• ST63 Sterilization of health care products –Requirements for the development, validation and routine control of an industrial sterilization process for medical devices–Dry heat
• TIR11139 Sterilization of health care products -Vocabulary
• ST67 Sterilization of medical devices-Requirements for products labeled “STERILE”
• 11607-1 Packaging for terminally sterilized medical devices -Part 1: Requirements for materials, sterile barrier systems and packaging
• 11607-2 Packaging for terminally sterilized medical devices -Part 2: Validation requirements for forming, sealing and assembly processes
• TIR22 Guidance for ANSI/AAMI/ISO 11607, Packaging for terminally sterilized medical devices -Part 1 and Part 2:2006
• 13408-1 Aseptic processing of health care products -Part 1: General requirements
• 13408-2 ANSI/AAMI/ISO 13408-2:2003, Aseptic processing of health care products -Part 2: Filtration
• 13408-3 ANSI/AAMI/ISO 13408-3:2006, Aseptic processing of health care products -Part 3: Lyophilization
• 13408-4 ANSI/AAMI/ISO 13408-4:2005, Aseptic processing of health care products -Part 4: Clean-in-place technologies
• 13408-5 ANSI/AAMI/ISO 13408-5:2006, Aseptic processing of health care products -Part 5: Sterilization in place
• 13408-6 ANSI/AAMI/ISO 13408-6:2005, Aseptic processing of health care products -Part 6: Isolator systems

Part of:

AAMI STBK10-S/STBKCD