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ICS:11.080.01
“ISO 11135:2018 Sterilization of health-care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices – Amendment 1: Revision of Annex E, Single batch release” has been added to your cart. View cart
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ISO 22456:2021 Sterilization of healthcare products – Microbiological methods- Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products
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ISO 11140:2022 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
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ISO 19930:2017 Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6
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ISO 25424:2018 Sterilization of health care products – Low temperature steam and formaldehyde – Requirements for development, validation and routine control of a sterilization process for medical devices
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ISO 13408:2021 Aseptic processing of health care products – Part 6: Isolator systems
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ISO 14160:2020 Sterilization of health care products – Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives – Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
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ISO 11138:2019 Sterilization of health care products – Biological indicators – Part 7: Guidance for the selection, use and interpretation of results
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ISO 13408:2005 Aseptic processing of health care products – Part 4: Clean-in-place technologies
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ISO 11135:2018 Sterilization of health-care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices – Amendment 1: Revision of Annex E, Single batch release
0 out of 5CDN $32.00 Add to cart