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

 
export to rss fileexport to xls file

CEN/CLC/TC 3 Working Documents

Reference,Title
Downloads
Circulation date
Closing date
  sort down
Voting / Comments
IEC parallel vote
prEN 980:2008 (pr=21716)
Symbols for use in the labelling of medical devices
export to doc file  EN 2008-03-18   Procedure Result No
FprEN 1041:2008 (pr=21910)
Information supplied by the manufacturer of medical devices
export to doc file  EN 2008-06-04   Procedure Result No
prEN 15986:2009 (pr=22621)
Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
export to doc file  EN   Procedure Result No
FprEN ISO 80369-1:2010 (pr=22531)
Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements
export to doc file  EN   Procedure Result Yes
FprEN ISO/IEC 80369-5:2014 (pr=24533)
Small bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications
export to doc file  EN   Procedure Result Yes

export to rss fileexport to xls file

CEN/CLC/TC 3 Documents open for vote

Reference,Title
Downloads
Circulation date
Closing date
  sort down
Type
IEC parallel vote

export to xls file

Other Documents accessible to CEN/CLC/TC 3

Reference,Title
sort upsort down
Downloads
Definitive Text - EN ISO 14971:2000
Medical devices - Application of risk management to medical devices
 
Definitive Text - EN 1041:2008/A1:2013
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 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 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 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 1041:2008
Information supplied by the manufacturer of medical devices
Definitive Text - EN 1041:2008/A1:2013
Information supplied by the manufacturer of medical devices
Definitive Text - EN 1041:2008/A1:2013
Information supplied by the manufacturer of medical devices
Definitive Text - EN ISO 14971:2000/A1:2003
Medical devices - Application of risk management to medical devices
 

Reference
sort upsort down
Circulation date
Reference
Closing date
Participation
This information is accessible for web restricted users


Date period

calendar  
calendar