IEC 61010-2-040:2015
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Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials |
ISO 11607-2:2006
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Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes |
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 |
ISO 11737-1:2006
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Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products |
ISO 13485:2016
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Medical devices Quality management systems Requirements for regulatory purposes |
ISO 11140-1:2014
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Sterilization of health care products Chemical indicators Part 1: General requirements |
ISO/TS 11139:2006
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Sterilization of health care products Vocabulary |
ISO 10993-1:2009
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Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
ISO 10012:2003
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Measurement management systems — Requirements for measurement processes and measuring equipment |
ISO 9001:2015
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Quality management systems — Requirements |
IEC 61010-2-043:1997
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Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-043: Particular requirements for dry heat sterilizers using either hot air or hot inert gas for the treatment of medical materials, and for laboratory processes |
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 |
ISO 11138-1:2017
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Sterilization of health care products — Biological indicators — Part 1: General requirements |
ISO 14971:2007
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Medical devices Application of risk management to medical devices |
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/IEC 90003:2014
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Software engineering Guidelines for the application of ISO 9001:2008 to computer software |
ISO 14161:2009
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Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results |
IEC 61010-1:2010+AMD1:2016 CSV
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Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements |
ISO 11138-4:2017
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Sterilization of health care products — Biological indicators — Part 4: Biological indicators for dry heat sterilization processes |
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 |