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ICS:11.040.01
Showing 1–9 of 31 results
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ISO 62366:2015 Medical devices – Part 1: Application of usability engineering to medical devices
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ISO 19244:2014 Guidance on transition periods for standards developed by ISO/TC 84 – Devices for administration of medicinal products and catheters
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ISO 80002:2014 Medical device software – Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
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ISO 20069:2019 Guidance for assessment and evaluation of changes to drug delivery systems
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ISO 80001:2016 Application of risk management for IT-networks incorporating medical devices – Part 2-8: Application guidance – Guidance on standards for establishing the security capabilities identified in IEC 80001-2-2
CDN $441.00 Add to cart -
ISO 62304:2015 Medical device software – Software life cycle processes – Amendment 1
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ISO 80001:2012 Application of risk management for IT-networks incorporating medical devices – Part 2-2: Guidance for the communication of medical device security needs, risks and controls
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ISO 15378:2017 Primary packaging materials for medicinal products – Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
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ISO 63:2019 Guide to the development and inclusion of aspects of safety in International Standards for medical devices
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