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About This Item
Full Description
BS EN 1041:2008 is intended to complement the specific requirements of the cited EU Directives on medical devices by providing guidance on the way that the requirements can be met. If a manufacturer follows BS EN 1041, they will provide a presumption of conformity with the relevant Essential Requirements regarding information to be supplied.
BS EN 1041:2008 does not cover requirements for provision of information for in vitro diagnostic medical devices, which are covered by other labelling standards.
When national transpositions of the Directives specify the means by which information shall be supplied, this standard does not provide derogation from these requirements for that country.
Document History
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BS EN ISO 20417:2021
Medical devices. Information to be supplied by the manufacturer, Incorporating corrigenda May 2021 and May 2022- Most Recent
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BS EN ISO 20417:2021
Medical devices. Information to be supplied by the manufacturer- Historical Version
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BS EN ISO 20417:2021 Draft
Medical devices. Information to be supplied by the manufacturer- Historical Version
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BS EN ISO 20417 Draft
Medical devices. Information to be supplied by the manufacturer- Historical Version
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BS ISO 20417:2021
Medical devices. Information to be supplied by the manufacturer- Historical Version
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BS EN 1041:2008+A1:2013
Information supplied by the manufacturer of medical devices- Historical Version
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BS EN 1041:2008
viewing
Information supplied by the manufacturer of medical devices- Historical Version
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BS 06/30123163 DC
BS EN 1041. Information supplied by the manufacturer with medical devices- Historical Version
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BS EN 1041:1998
Information supplied by the manufacturer with medical devices- Historical Version