ISO/IEC 17025:2005
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General requirements for the competence of testing and calibration laboratories
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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
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ISO/TS 17665-3:2013
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Sterilization of health care products — Moist heat — Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization
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EN 550 : 1994
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STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
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ISO/IEC 17050-1:2004
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Conformity assessment Supplier's declaration of conformity Part 1: General requirements
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ISO 11607-2:2006
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Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
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ISO 11138-3:2017
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Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes
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ISO 15882:2008
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Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results
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ISO 11135:2014
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Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
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EN 285:2015
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Sterilization - Steam sterilizers - Large sterilizers
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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
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ISO 13485:2016
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Medical devices Quality management systems Requirements for regulatory purposes
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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
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EN 14180:2014
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Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
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ISO 11138-2:2017
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Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes
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ISO 18472:2006
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Sterilization of health care products Biological and chemical indicators Test equipment
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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
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EN 552:1994/A2:2000
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STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION
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ISO 8601:2004
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Data elements and interchange formats Information interchange Representation of dates and times
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ISO 20857:2010
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Sterilization of health care products Dry heat Requirements for the development, validation and routine control of a sterilization process for medical devices
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ISO/TS 11139:2006
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Sterilization of health care products Vocabulary
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ISO 11137-3:2017
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Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control
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ISO 11137-2:2013
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Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
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ISO 9001:2015
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Quality management systems — Requirements
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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
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ISO 11138-1:2017
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Sterilization of health care products — Biological indicators — Part 1: General requirements
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ISO 11607-1:2006
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Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
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ISO 14161:2009
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Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results
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ISO 11138-4:2017
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Sterilization of health care products — Biological indicators — Part 4: Biological indicators for dry heat sterilization processes
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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
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EN 1422:2014
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Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
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EN 13060:2014
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Small steam sterilizers
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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
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