AAMI STBK13-3 – Sterilization, Part 3: Industrial Process Control, 2013 Edition

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