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CEN/CLC/TC 3

Quality management and corresponding general aspects for medical devices
 
 
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CEN/CLC/TC 3 Work programme

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Current Code
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Document
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Fcst. voting date
EN 1041:2008/FprA1 (pr=24447)
Information supplied by the manufacturer of medical devices
5021  2012-09-192013-01-112013-06-10 
FprEN ISO 15223-1:2012 (pr=22485)
Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
5021  2009-06-092012-02-242012-04-23 
prEN ISO/IEC 80369-3 (pr=24534)
Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications
1099  2012-11-062012-11-06  
prEN ISO/IEC 80369-5 (pr=24533)
Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications
1099  2012-11-062012-11-06  
prEN ISO/IEC 80369-6 (pr=24535)
Small-bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications
1099  2012-11-062012-11-06  
prEN ISO/IEC 80369-7 (pr=24536)
Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors with 6% (Luer) taper for intravascular or hypodermic applications
1099  2012-11-062012-11-06  

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CEN/CLC/TC 3 Publications

Reference, Title
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Publication date
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EN 1041:2008 (pr=21910)
Information supplied by the manufacturer of medical devices		2008-08-06 export to doc file  EN  DE
EN 15986:2011 (pr=22621)
Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates		2011-03-04 export to doc file  EN  FR  DE
EN 980:2008 (pr=21716)
Symbols for use in the labelling of medical devices		2008-05-21 export to doc file  EN  FR  DE
EN ISO 13485:2012 (pr=24011)
Medical devices - Quality management systems - Requirements for regulatory purposes		2012-02-17 export to doc file  EN
EN ISO 13485:2012/AC:2012 (pr=24183)
Medical devices - Quality management systems - Requirements for regulatory purposes		2012-07-06 export to doc file  EN  FR  DE
EN ISO 14971:2012 (pr=24225)
Medical devices - Application of risk management to medical devices		2012-07-06 export to doc file  EN
EN ISO 15225:2010 (pr=21816)
Medical devices - Quality management - Medical device nomenclature data structure		2010-05-07 export to doc file  EN  FR
EN ISO 80369-1:2010 (pr=22531)
Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements		2010-12-17 export to doc file  EN

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CEN/CLC/TC 3 Maintenance cycle

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Technical Comittee
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Project in progress
EN 1041:2008 (pr=21910)
Information supplied by the manufacturer of medical devices		2008-08-062013-08-062016-08-06CEN/CLC/TC 3 
EN 15986:2011 (pr=22621)
Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates		2011-03-042016-03-042019-03-04CEN/CLC/TC 3 
EN 980:2008 (pr=21716)
Symbols for use in the labelling of medical devices		2008-05-212009-06-042012-06-04CEN/CLC/TC 3FprEN ISO 15223-1:2012
EN ISO 13485:2012 (pr=24011)
Medical devices - Quality management systems - Requirements for regulatory purposes		2012-02-17 2020-02-17CEN/CLC/TC 3 
EN ISO 13485:2012/AC:2012 (pr=24183)
Medical devices - Quality management systems - Requirements for regulatory purposes		2012-07-062017-07-062020-07-06CEN/CLC/TC 3 
EN ISO 14971:2012 (pr=24225)
Medical devices - Application of risk management to medical devices		2012-07-06 2020-07-06CEN/CLC/TC 3 
EN ISO 15225:2010 (pr=21816)
Medical devices - Quality management - Medical device nomenclature data structure		2010-05-07 2018-05-07CEN/CLC/TC 3 
EN ISO 80369-1:2010 (pr=22531)
Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements		2010-12-17 2018-12-17CEN/CLC/TC 3 

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TC 3 Project files


CEN/CLC/TC 3 TC/SC in figures

Current Stage
Year
Year -1
Year -2
Year -3
Year -4
Year >5
Committee stage040000
Approval stage110000
Published031202
Withdrawn000014

CEN/CLC/TC 3 Figures overall

Total publications
 32
Published in last 3 years
 7
Total work in progress
 15
Total proposals
 0
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CEN/CLC/TC 3 Environment

Reference
Clause
Categories - Aspects
Product Life Cycle
Information
Confirmed
EN ISO 14971:2000 (pr=14053)
Medical devices - Application of risk management to medical devices		 All Others Manufacturing B2B N
EN ISO 14971:2000/A1:2003 (pr=14750)
Medical devices - Application of risk management to medical devices		 All Others Use B2B N

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CEN/CLC/TC 3 EU Directive(s)

Reference
Stage code
Directive
OJ Status
OJ Reference
Mandate
EN 1041:2008/FprA1 (pr=24447)
Information supplied by the manufacturer of medical devices		 5021 93/42/EEC
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices		 NEW
90/385/EEC
Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices		 NEW
EN ISO 13485:2012 (pr=24011)
Medical devices - Quality management systems - Requirements for regulatory purposes		 6060 98/79/EC
Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices		 LEG
90/385/EEC
Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices		 LEG
93/42/EEC
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices		 LEG
EN ISO 14971:2012 (pr=24225)
Medical devices - Application of risk management to medical devices		 6060 98/79/EC
Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices		 LEG
90/385/EEC
Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices		 LEG
93/42/EEC
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices		 LEG
EN 15986:2011 (pr=22621)
Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates		 6060 93/42/EEC
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices		 NOJ
EN ISO 80369-1:2010 (pr=22531)
Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements		 6060 93/42/EEC
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices		 NPB
prEN ISO/IEC 80369-3 (pr=24534)
Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications		 1099 93/42/EEC
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices		 NEW
prEN ISO/IEC 80369-5 (pr=24533)
Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications		 1099 93/42/EEC
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices		 NEW
prEN ISO/IEC 80369-6 (pr=24535)
Small-bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications		 1099 93/42/EEC
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices		 NEW
prEN ISO/IEC 80369-7 (pr=24536)
Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors with 6% (Luer) taper for intravascular or hypodermic applications		 1099 93/42/EEC
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices		 NEW

 
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