International Standard ISO 17665 | |
Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices Stérilisation des produits de santé — Chaleur humide — Exigences pour le développement, la validation et le contrôle de routine d’un procédé de stérilisation des dispositifs médicaux Reference number ISO 17665:2024(en) | First edition 2024-03
© ISO 2024
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[1] | ISO 3746, Acoustics — Determination of sound power levels and sound energy levels of noise sources using sound pressure — Survey method using an enveloping measurement surface over a reflecting plane | |
[2] | ISO/TS 5111, Guidance on quality of water for sterilizers, sterilization and washer-disinfectors for health care products | |
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[4] | ISO 9001, Quality management systems — Requirements | |
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[9] | ISO 10993-17, Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances | |
[10] | ISO 11138-7, Sterilization of health care products — Biological indicators — Part 7: Guidance for the selection, use and interpretation of results | |
[11] | ISO 11139:2018, Sterilization of health care products — Vocabulary of terms used in sterilization and related equipment and process standards | |
[12] | ISO 11140-6, Sterilization of health care products — Chemical indicators — Part 6: Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers | |
[13] | ISO 13485:2016, Medical devices — Quality management systems — Requirements for regulatory purposes | |
[14] | ISO 14001, Environmental management systems — Requirements with guidance for use | |
[15] | ISO 14040, Environmental management — Life cycle assessment — Principles and framework | |
[16] | ISO 14644-1, Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness by particle concentration | |
[17] | ISO 14937:2009, 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 | |
[18] | ISO 14971, Medical devices — Application of risk management to medical devices | |
[19] | ISO 15882, Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results | |
[20] | ISO 15883 (all parts), Washer-disinfectors | |
[21] | ISO 17664-1, Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices | |
[22] | ISO 18472, Sterilization of health care products — Biological and chemical indicators — Test equipment | |
[23] | ISO/TS 22421:2021, Sterilization of health care products — Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities | |
[24] | ISO 22442-1, Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management | |
[25] | ISO 22442-2, Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling | |
[26] | ISO 22442-3, Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents | |
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[31] | ANSI/AAMI ST79, Comprehensive guide to steam sterilization and sterility assurance in health care facilities | |
[32] | ANSI/AAMI ST90, Processing of health care products – Quality management systems for processing in health care facilities | |
[33] | EN 285, Sterilization — Steam sterilizers — Large sterilizers | |
[34] | EN 556-1, Sterilization of medical devices — Requirements for medical devices to be designated “STERILE” — Part 1: Requirements for terminally sterilized medical devices | |
[35] | EN 868-2:2017, Packaging for terminally sterilized medical devices — Part 2: Sterilization wrap — Requirements and test methods | |
[36] | EN 868-3:2017, Packaging for terminally sterilized medical devices — Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) — Requirements and test methods | |
[37] | EN 868-4:2017, Packaging for terminally sterilized medical devices — Part 4: Paper bags — Requirements and test methods | |
[38] | EN 868-5:2018, Packaging for terminally sterilized medical devices — Part 5: Sealable pouches and reels of porous materials and plastic film construction — Requirements and test methods | |
[39] | EN 868-8:2018, Packaging for terminally sterilized medical devices — Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 — Requirements and test methods | |
[40] | EN 868-9:2018, Packaging for terminally sterilized medical devices — Part 9: Uncoated nonwoven materials of polyolefines — Requirements and test methods | |
[41] | EN 868-10:2018, Packaging for terminally sterilized medical devices — Part 10: adhesive coated nonwoven materials of polyolefines — Requirements and test methods | |
[42] | EN 13060, Small steam sterilizers | |
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[59] | Parenteral Drug Association. Technical Report No. 1 Revised 2007, Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification, and Ongoing Control, PDA Bethesda, MD, 2007 | |
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[78] | ISO 192532, Sterilization of health care products — Application of ISO/TS 22421 to the requirements for sterilizers used for the terminal sterilization of health care products containing aqueous liquid in sealed containers | |
[79] | ISO 9022-1:2016, Optics and photonics — Environmental test methods — Part 1: Definitions, extent of testing | |
[80] | ISO/TS 16775, Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2 | |
[81] | ANSI/AAMI T8:2013 (R2018), Hospital Steam Sterilizers | |
[82] | ANSI/AAMI ST55:2016 (R2023), Table-Top Steam Sterilizers | |
[83] | JIS T 7322: 2005, High-pressure steam sterilizers for medical use | |
[84] | JIS T 7324:2019, High-pressure steam sterilizers for medical use (small size) |
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