Registration number (WIID)Project No.TitleStatus
28921LVS EN ISO 13485:2003 /AC:2007Medical devices - Quality management systems - Requirements for regulatory purposesAtcelts
33578LVS EN ISO 13485:2003 /AC:2010Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003/Cor 1:2009)Atcelts
24838LVS EN 1041:2008Information supplied by the manufacturer of medical devicesAtcelts
21479LVS EN ISO 14971:2000/A1:2003Medical devices - Application of risk management to medical devices - Amendment 1: Rationale for requirements (ISO 14971:2000/AM1:2003)Atcelts
21072LVS EN ISO 14971:2000/AC:2002Medical devices - Application of risk management to medical devices (ISO 14971:2000)Atcelts
12983CR 14230:2001Global medical device nomenclature for the purpose of regulatory data exchange (identical to ISO/TS 20225:2001)Atcelts
64029EN ISO 13485:2016/AC:2016Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)Atcelts
39825EN ISO 15225:2016Medical devices - Quality management - Medical device nomenclature data structure (ISO/DIS 15225:2015)Atcelts
39370LVS EN ISO 80369-7:2017Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (ISO 80369-7:2016)Atcelts
59550EN ISO 15223-1:2016Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03)Atcelts
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