AAMI STBK10-2

The 2010 edition of this sterilization collection for manufacturers and users of sterilization equipment includes 23 AAMI standards and guidance documents. It features recently released guidance on biological indicators (14161) and washer-disinfectors (ST15883-1). Additional guidance documents cover biological indicators (11138 series), packaging (11607 series), EO sterilizers, dry heat sterilizers, table-top steam sterilizers, and more.

Contents

• 11138-1 Sterilization of health care product – Biological indicators – Part 1: General requirements, 2nd edition
• 11138-2 Sterilization of health care products – Biological indicators – Part 2: Biological indicators for ethylene oxide sterilization processes, 3rd edition
• 11138-3 Sterilization of health care products – Biological indicators – Part 3: Biological indicators for moist heat sterilization processes, 1st edition
• 11138-4 Sterilization of health care products – Biological indicators – Part 4: Biological indicators for dry heat sterilization processes, 1st edition
• 11138-5 Sterilization of health care products – Biological indicators – Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes, 1st edition
• 18472 Sterilization of health care products – Biological and chemical indicators – Test equipment, 1st edition
• 14161 Sterilization of health care products – Biological indicators – Guidance for the selection, use, and interpretation of results, 2nd edition
• 15882 Chemical indicators – Guidance for the selection, use, and interpretation of results, 3rd edition
• TIR31 Process challenge devices/test packs for use in health care facilities, 1st edition
• 11140-1 Sterilization of health care products-Chemical indicators – Part 1: General requirements
• 11140-3 Sterilization of health care products-Chemical indicators – Part 3: Class 2 indicator systems for use in the Bowie and Dick steam penetration test
• 11140-4 Sterilization of health care products-Chemical indicators – Part 4: Class 2 indicators as an alternative to Bowie and Dick test for detection of steam penetration
• ST8 Hospital steam sterilizers, 5th edition
• ST24 Automatic, general-purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities, 3rd edition
• ST50 Dry heat (heated air) sterilizers, 2nd edition
• ST55 Table-top steam sterilizers, 2nd edition
• 11607-1 Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems, and packaging, 3ed
• 11607-2 Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing, and assembly processes, 1ed
• TIR22 Guidance for ANSI/AAMI/ISO 11607, Packaging for terminally sterilized medical devices, 1st edition and amendment
• ST15883-1 Washer-disinfectors, Part 1: General requirements, terms and definitions and tests
• ST77 Containment devices for reusable medical device sterilization
• TIR11139 Sterilization of health care products – Vocabulary, 2nd edition

Published:

2010

Part of:

AAMI STBK10-S/STBKCD