ISO 15883-1:2006
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Washer-disinfectors Part 1: General requirements, terms and definitions and tests |
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 |
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 |
ISO 15883-6:2011
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Washer-disinfectors — Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment |
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 15883-3:2006
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Washer-disinfectors Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers |
ISO/TS 16775:2014
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Packaging for terminally sterilized medical devices Guidance on the application of ISO 11607-1 and ISO 11607-2 |
ISO 25424:2009
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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/TS 15883-5:2005
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Washer-disinfectors Part 5: Test soils and methods for demonstrating cleaning efficacy |
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 |
ISO 15883-4:2008
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Washer-disinfectors Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes |
ISO 10993-7:2008
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Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals |
AAMI TIR 12 : 2010
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DESIGNING, TESTING, AND LABELING REUSABLE MEDICAL DEVICES FOR REPROCESSING IN HEALTH CARE FACILITIES: A GUIDE FOR MEDICAL DEVICE MANUFACTURERS |
EN 16442:2015
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Controlled environment storage cabinet for processed thermolabile endoscopes |
ISO 15883-7:2016
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Washer-disinfectors — Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment |
ISO 14971:2007
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Medical devices Application of risk management to medical devices |
ISO 7000:2014
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Graphical symbols for use on equipment Registered symbols |
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 |
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. |
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 |
ISO 15223:2000
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Medical devices Symbols to be used with medical device labels, labelling and information to be supplied |