Registration number (WIID)Project No.TitleStatus
64861LVS CEN/TR 17223:2018Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices RegulationAtcelts
12988EN 980:2003Graphical symbols for use in the labelling of medical devicesAtcelts
21726EN ISO 15225:2000/A1:2004Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange - Amendment 1 (ISO 15225:2000/A1:2004)Atcelts
39366LVS EN ISO 80369-6:2016Small bore connectors for liquids and gases in healthcare applications – Part 6: Connectors for neuraxial applications (ISO 80369-6:2016, Corrected version 2016-11-15)Atcelts
64029LVS EN ISO 13485:2016/AC:2017Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)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
21072LVS EN ISO 14971:2000/AC:2002Medical devices - Application of risk management to medical devices (ISO 14971:2000)Atcelts
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
24838LVS EN 1041:2008Information supplied by the manufacturer of medical devicesAtcelts
12983CR 14230:2001Global medical device nomenclature for the purpose of regulatory data exchange (identical to ISO/TS 20225:2001)Atcelts
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