CEN/CLC/TC 3
Registration number (WIID) | Project No. | Title | Status |
---|---|---|---|
33578 | EN ISO 13485:2003/AC:2009 | Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003/Cor 1:2009) | Atcelts |
12987 | CR 13217:1998 | Nomenclature system for medical devices for the purpose of regulatory data exchange - Rationale | Atcelts |
22133 | EN ISO 13485:2003 | Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003) | Atcelts |
21479 | EN ISO 14971:2000/A1:2003 | Medical devices - Application of risk management to medical devices - Amendment 1: Rationale for requirements (ISO 14971:2000/AM1:2003) | Atcelts |
28921 | EN ISO 13485:2003/AC:2007 | Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003) | Atcelts |
40444 | EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices | Atcelts |
24416 | CEN ISO/TR 14969:2005 | Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003 (ISO/TR 14969:2004) | Atcelts |
21072 | EN ISO 14971:2000/AC:2002 | Medical devices - Application of risk management to medical devices (ISO 14971:2000) | Atcelts |
26098 | EN 15546-1:2008 | Small bore connectors for liquids and gases in healthcare applications - Part 1 - General Requirements | Atcelts |
21726 | EN ISO 15225:2000/A1:2004 | Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange - Amendment 1 (ISO 15225:2000/A1:2004) | Atcelts |
Displaying 41-50 of 140 results.