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    • Medical equipment in general
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    ISO 10993-2:1992

    Biological evaluation of medical devices Part 2: Animal welfare requirements

    International Organization for Standardization

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    ISO 9918:1993

    Capnometers for use with humans; requirements

    International Organization for Standardization

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    ISO 11135:1994

    Medical devices - Validation and routine control of ethylene oxide sterilization

    International Organization for Standardization

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    ISO 14155:1996

    Clinical investigation of medical devices

    International Organization for Standardization

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    ISO 11197:1996

    Medical electrical equipment - Particular requirements for safety of medical supply units

    International Organization for Standardization

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    ISO 13485:1996

    Quality systems - Medical devices - Particular requirements for the application of ISO 9001

    International Organization for Standardization

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    ISO 13488:1996

    Quality systems - Medical devices - Particular requirements for the application of ISO 9002

    International Organization for Standardization

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    ISO 10993-16:1997

    Biological evaluation of medical devices Part 16: Toxicokinetic study design for degradation products and leachables

    International Organization for Standardization

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    ISO/TR 15223:1998

    Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied

    International Organization for Standardization

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    ISO 14971-1:1998

    Medical devices - Risk management Part 1: Application of risk analysis

    International Organization for Standardization

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