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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 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 15510:2014
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Stainless steels Chemical composition |
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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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ASTM A 959 : 2016 : REDLINE
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Standard Guide for Specifying Harmonized Standard Grade Compositions for Wrought Stainless Steels |
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ISO 15730:2000
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Metallic and other inorganic coatings — Electropolishing as a means of smoothing and passivating stainless steel |
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ISO 5832-3:2016
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Implants for surgery Metallic materials Part 3: Wrought titanium 6-aluminium 4-vanadium alloy |
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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 7405:2008
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Dentistry Evaluation of biocompatibility of medical devices used in dentistry |
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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 18472:2006
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Sterilization of health care products Biological and chemical indicators Test equipment |
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ISO 16061:2015
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Instrumentation for use in association with non-active surgical implants General requirements |
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ISO 1942:2009
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Dentistry Vocabulary |
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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 5832-2:1999
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Implants for surgery Metallic materials Part 2: Unalloyed titanium |
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ISO 7153-1:2016
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Surgical instruments Materials Part 1: Metals |
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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 14971:2007
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Medical devices Application of risk management to medical devices |
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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 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 1043-1:2011
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Plastics — Symbols and abbreviated terms — Part 1: Basic polymers and their special characteristics |
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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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SAC GB/T 20878 : 2007
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STAINLESS AND HEAT-RESISTING STEELS - DESIGNATION AND CHEMICAL COMPOSITION |
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EN 10088-1:2014
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Stainless steels - Part 1: List of stainless steels |