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ICS:11.040.01

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    ISO 62366:2020 Medical devices – Part 1: Application of usability engineering to medical devices – Amendment 1

    CDN $203.00
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    ISO 80001:2017 Application of risk management for IT-networks incorporating medical devices – Part 2-9: Application guidance – Guidance for use of security assurance cases to demonstrate confidence in IEC/TR 80001-2-2 security capabilities

    CDN $441.00
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    ISO 20417:2021 Medical devices – Information to be supplied by the manufacturer

    CDN $351.00
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    ISO 62304:2006 Medical device software – Software life cycle processes

    CDN $644.00
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    ISO 20416:2020 Medical devices – Post-market surveillance for manufacturers

    CDN $312.00
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    ISO 80001:2021 Application of risk management for IT-networks incorporating medical devices – Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software

    CDN $441.00
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    ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes

    CDN $312.00
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    ISO 15223:2010 Medical devices – Symbols to be used with medical device labels, labelling, and information to be supplied – Part 2: Symbol development, selection and validation

    CDN $173.00
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    ISO 80001:2014 Application of risk management for IT-networks incorporating medical devices – Part 2-5: Application guidance – Guidance for distributed alarm systems

    CDN $441.00
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