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ISO 6507-1:2005
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Metallic materials Vickers hardness test Part 1: Test method |
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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 14155-2:2003
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Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans |
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ISO 6892-1:2016
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Metallic materials Tensile testing Part 1: Method of test at room temperature |
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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 14155-1:2003
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Clinical investigation of medical devices for human subjects Part 1: General requirements |
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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 13356:2015
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Implants for surgery — Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) |
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ISO 14405-2:2011
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Geometrical product specifications (GPS) Dimensional tolerancing Part 2: Dimensions other than linear sizes |
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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 6474-1:2010
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Implants for surgery Ceramic materials Part 1: Ceramic materials based on high purity alumina |
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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 1942:2009
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Dentistry 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 10993-7:2008
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Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals |
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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 5832-2:1999
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Implants for surgery Metallic materials Part 2: Unalloyed titanium |
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ISO 9001:2015
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Quality management systems — Requirements |
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ISO 129-1:2004
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Technical drawings Indication of dimensions and tolerances Part 1: General principles |
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ISO 10993-9:2009
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Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products |
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ISO 14801:2016
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Dentistry Implants Dynamic loading test for endosseous dental implants |
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ISO/TS 11135-2:2008
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Sterilization of health care products Ethylene oxide Part 2: Guidance on the application of ISO 11135-1 |
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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 178:2010
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Plastics Determination of flexural properties |
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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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ISO/TS 22911:2016
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Dentistry Preclinical evaluation of dental implant systems Animal test methods |