ISO 11137-1:2006
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Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
ISO 5636-3:2013
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Paper and board — Determination of air permeance (medium range) — Part 3: Bendtsen method |
ISO 11138-3:2017
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Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes |
EN 285:2015
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Sterilization - Steam sterilizers - Large sterilizers |
ISO/TS 17665-2:2009
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Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1 |
ISO 14937:2009
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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 |
AAMI ST46 : 4ED 2002
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STEAM STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES |
ISO 11140-3:2007
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Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test |
EN 14180:2014
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Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing |
ISO 11138-2:2017
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Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes |
ISO 11135-1:2007
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Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
ISO 11140-1:2014
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Sterilization of health care products Chemical indicators Part 1: General requirements |
ISO 18472:2006
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Sterilization of health care products Biological and chemical indicators Test equipment |
ISO 5636-5:2013
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Paper and board — Determination of air permeance (medium range) — Part 5: Gurley method |
ISO 11140-4:2007
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Sterilization of health care products — Chemical indicators — Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration |
ISO 8601:2004
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Data elements and interchange formats Information interchange Representation of dates and times |
ISO/TS 11139:2006
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Sterilization of health care products Vocabulary |
EN 15424:2007
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Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices |
ISO 9001:2015
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Quality management systems — Requirements |
ISO 11140-5:2007
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Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for Bowie and Dick-type air removal tests |
ISO/TS 11135-2:2008
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Sterilization of health care products Ethylene oxide Part 2: Guidance on the application of ISO 11135-1 |
ISO 14161:2009
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Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results |
ISO 11138-5:2017
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Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes |
ISO 17665-1:2006
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Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |