AAMI STBK13-3

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