Governance & Resilience Standards > Medical Devices

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BS EN 1041:2008+A1:2013 1.

BS EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices

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ISBN: 9780580808739Publication Status: Active
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BS EN 60601-1:2006+A12:2014 2.

BS EN 60601-1:2006+A12:2014 Medical electrical equipment. General requirements for basic safety and essential performance

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ISBN: 9780580883187Publication Status: Active
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BS EN 60601-1-2:2015 3.

BS EN 60601-1-2:2015 Medical electrical equipment. General requirements for basic safety and essential performance. Collateral Standard. Electromagnetic disturbances. Requirements and tests

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ISBN: 9780580580604Publication Status: Active
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BS EN ISO 11607-1:2017 4.

BS EN ISO 11607-1:2017 Packaging for terminally sterilized medical devices. Requirements for materials, sterile barrier systems and packaging systems

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ISBN: 9780580964336Publication Status: Active
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BS EN ISO 11607-2:2017 5.

BS EN ISO 11607-2:2017 Packaging for terminally sterilized medical devices. Validation requirements for forming, sealing and assembly processes

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ISBN: 9780580964343Publication Status: Active
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BS EN ISO 13485:2016 6.

BS EN ISO 13485:2016 Medical devices. Quality management systems. Requirements for regulatory purposes

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ISBN: 9780580938092Publication Status: Active
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BS EN ISO 13485:2016 7.

BS EN ISO 13485:2016 Medical devices. Quality management systems. Requirements for regulatory purposes

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ISBN: 9780580967702Publication Status: Active
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BS EN ISO 13485:2016 - TC 8.

BS EN ISO 13485:2016 - TC Tracked Changes. Medical devices. Quality management systems. Requirements for regulatory purposes

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ISBN: 9780539038224Publication Status: Active
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BS EN ISO 14971:2012 9.

BS EN ISO 14971:2012 Medical devices. Application of risk management to medical devices

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ISBN: 9780580799525Publication Status: Active
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BS EN ISO 15223-1:2016 - TC 10.

BS EN ISO 15223-1:2016 - TC Tracked Changes. Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirements

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ISBN: 9780539038262Publication Status: Active
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