AAMI STBK13-3
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This collection of 38 documents has been updated to include nine new/ revised standards. It features new guidance for sterilization of single-use medical devices incorporating materials of animal origins (14160), requirements for products labeled “sterile” (ST67), dry heat sterilization of health care products (20857), radiation (11137-2), and more.
Whether using in-house or contract facilities, manufacturers that ship their products sterile should not be without this book.
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
- 14160 Sterilization of single-use medical devices incorporating materials of animal origin – Validation and routine control of sterilization by liquid chemical sterilants
- 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 the population of microorganisms on products
- 11737-2 Sterilization of medical devices – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation, and maintenance 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
- 20857 Sterilization of health care products-Dry heat: Requirements for the development, validation and routine control of a sterilization process for medical devices
- 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 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
- TIR29 Guide for process control in radiation sterilization
- TIR17 Compatibility of materials subject to sterilization
- 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 Aseptic processing of health care products – Part 2: Filtration
- 13408-3 Aseptic processing of health care products – Part 3: Lyophilization
- 13408-4 Aseptic processing of health care products – Part 4: Clean-in-place technologies
- 13408-5 Aseptic processing of health care products – Part 5: Sterilization in place
- 13408-6 Aseptic processing of health care products – Part 6: Isolator systems
- 13408-7 Aseptic processing of health care products – Part 7: Alternative processes for medical devices and combination products
Product Details
- Published:
- 2013
