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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 15883-1:2006
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Washer-disinfectors Part 1: General requirements, terms and definitions and tests
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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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IEC 60068-2-27:2008
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Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock
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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 10993-13:2010
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Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
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ISO 7151:1988
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Surgical instruments Non-cutting, articulated instruments General requirements and test methods
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ISO 11737-2:2009
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Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
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ISO 11737-1:2006
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Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products
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ISO 15883-3:2006
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Washer-disinfectors Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers
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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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ISO/TR 14969:2004
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Medical devices Quality management systems Guidance on the application of ISO 13485: 2003
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ISO 4957:1999
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Tool steels
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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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IEC 60068-2-31:2008
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Environmental testing - Part 2-31: Tests - Test Ec: Rough handling shocks, primarily for equipment-type specimens
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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 10993-14:2001
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Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics
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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
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ISO 11140-1:2014
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Sterilization of health care products Chemical indicators Part 1: General requirements
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ISO 10993-18:2005
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Biological evaluation of medical devices Part 18: Chemical characterization of materials
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ISO/TS 10993-19:2006
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Biological evaluation of medical devices Part 19: Physico-chemical, morphological and topographical characterization of materials
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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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IEC 60068-2-47:2005
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Environmental testing - Part 2-47: Test - Mounting of specimens for vibration, impact and similar dynamic tests
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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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ISO 8601:2004
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Data elements and interchange formats Information interchange Representation of dates and times
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ISO 13408-1:2008
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Aseptic processing of health care products — Part 1: General requirements
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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 10993-12:2012
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Biological evaluation of medical devices Part 12: Sample preparation and reference materials
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ISO 10993-7:2008
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Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
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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 80000-1:2009
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Quantities and units — Part 1: General
|
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ISO 7153-1:2016
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Surgical instruments Materials Part 1: Metals
|
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ISO 7740:1985
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Instruments for surgery Scalpels with detachable blades Fitting dimensions
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ISO 8319-2:1986
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Orthopaedic instruments — Drive connections — Part 2: Screwdrivers for single slot head screws, screws with cruciate slot and cross-recessed head screws
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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 14155:2011
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Clinical investigation of medical devices for human subjects Good clinical practice
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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 14971:2007
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Medical devices Application of risk management to medical devices
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ISO 7000:2014
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Graphical symbols for use on equipment Registered symbols
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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 15223-1:2016
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Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
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ISO 15883-2:2006
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Washer-disinfectors Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.
|
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ISO 17664:2017
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Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
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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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