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EN 13795-1:2002+A1:2009
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Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Part 1: General requirements for manufacturers, processors and products
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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 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 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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EN 868-5:2009
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Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods
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EN 868-4:2017
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Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
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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 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
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EN 868-6:2017
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Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
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ISO 5636-1:1984
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Paper and board Determination of air permeance (medium range) Part 1: General method
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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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EN 868-2:2017
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Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
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EN 868-3:2017
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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
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AAMI ST65:2008(R2018)
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PROCESSING OF REUSABLE SURGICAL TEXTILES FOR USE IN HEALTH CARE FACILITIES
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ISO 5636-2:1984
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Paper and board — Determination of air permeance (medium range) — Part 2: Schopper method
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ISO 5636-5:2013
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Paper and board — Determination of air permeance (medium range) — Part 5: Gurley method
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ISO 186:2002
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Paper and board — Sampling to determine average quality
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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 10993-1:2009
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Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
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ISO 9001:2015
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Quality management systems — Requirements
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ISO 9000:2015
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Quality management systems — Fundamentals and vocabulary
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EN 868-7:2017
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Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
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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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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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