CENELEC
International Standards and Conformity Assessment
for all electrical, electronic and related technologies
CEN/CLC/TC 3 |
Quality management and corresponding general aspects for medical devices |
CEN/CLC/TC 3 Working Documents
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Reference,Title
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Downloads
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Circulation date
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Closing date
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Voting / Comments
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IEC parallel vote
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prEN 980:2008 (pr=21716) Symbols for use in the labelling of medical devices |
 EN |
2008-03-18 | Procedure Result | No | |
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FprEN 1041:2008 (pr=21910) Information supplied by the manufacturer of medical devices |
EN |
2008-06-04 | Procedure Result | No | |
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prEN 15986:2009 (pr=22621) Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates |
EN |
Procedure Result | No | ||
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FprEN ISO 80369-1:2010 (pr=22531) Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements |
EN |
Procedure Result | Yes |
CEN/CLC/TC 3 Documents open for vote
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Reference,Title
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Downloads
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Circulation date
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Closing date
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Type
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IEC parallel vote
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Other Documents accessible to CEN/CLC/TC 3
Reference,Title | Downloads |
|---|---|
Definitive Text - EN ISO 14971:2000 Medical devices - Application of risk management to medical devices | |
Definitive Text - EN 1041:2008 Information supplied by the manufacturer of medical devices | |
Definitive Text - EN ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes | |
Definitive Text - EN ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes | |
Definitive Text - EN ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes | |
Definitive Text - EN 1041:2008 Information supplied by the manufacturer of medical devices | |
Definitive Text - EN 14971:2000/corrigendum Feb. 2002 Medical devices - Application of risk management to medical devices | |
Definitive Text - EN ISO 13485:2003/corrigendum Aug. 2009 Medical devices - Quality management systems - Requirements for regulatory purposes | |
Definitive Text - EN ISO 13485:2003/corrigendum Aug. 2009 Medical devices - Quality management systems - Requirements for regulatory purposes | |
Definitive Text - EN ISO 13485:2003/corrigendum Aug. 2009 Medical devices - Quality management systems - Requirements for regulatory purposes | |
Definitive Text - EN 980:2008 Symbols for use in the labelling of medical devices | |
Definitive Text - EN 980:2008 Symbols for use in the labelling of medical devices | |
Definitive Text - EN 980:2008 Symbols for use in the labelling of medical devices | |
Definitive Text - EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure | |
Definitive Text - EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure | |
Definitive Text - EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates | |
Definitive Text - EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates | |
Definitive Text - EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates | |
Definitive Text - EN 15546-1:2008 Small bore connectors for liquids and gases in healthcare applications - Part 1: General Requirements | |
Definitive Text - EN 15546-1:2008 Small bore connectors for liquids and gases in healthcare applications - Part 1: General Requirements | |
Definitive Text - EN ISO 13485:2012 Medical devices - Quality management systems - Requirements for regulatory purposes | |
Definitive Text - EN ISO 80369-1:2010 Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements | |
Definitive Text - EN 15546-1:2008 Small bore connectors for liquids and gases in healthcare applications - Part 1: General Requirements | |
Definitive Text - EN ISO 14971:2009 Medical devices - Application of risk management to medical devices | |
Definitive Text - EN ISO 14971:2009 Medical devices - Application of risk management to medical devices | |
Definitive Text - EN ISO 14971:2009 Medical devices - Application of risk management to medical devices | |
Definitive Text - EN ISO 13485:2012/AC:2012 Medical devices - Quality management systems - Requirements for regulatory purposes | |
Definitive Text - EN ISO 13485:2012/AC:2012 Medical devices - Quality management systems - Requirements for regulatory purposes | |
Definitive Text - EN ISO 13485:2012/AC:2012 Medical devices - Quality management systems - Requirements for regulatory purposes | |
Definitive Text - EN ISO 14971:2012 Medical devices - Application of risk management to medical devices | |
Definitive Text - EN ISO 14971:2000/A1:2003 Medical devices - Application of risk management to medical devices |
