CENELEC - Standards Development - List of Technical Bodies - CEN/CLC/TC 3

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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prEN ISO 13485:2014 (pr=24989)
Medical devices - Quality management systems - Requirements for regulatory purposes
4021  2013-08-082014-02-212014-07-20 
CLC/FprTR 14060:2014 (pr=25147)
Medical device traceability enabled by unique device identification (UDI)
5021  2013-10-292014-01-242014-04-23 
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 15225 (pr=24990)
Medical devices - Quality management - Medical device nomenclature data structure
1099  2013-08-082013-02-14  
prEN ISO 80369-1 (pr=24992)
Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2010)
1099  2013-08-082013-07-05  
prEN ISO 80369-2 (pr=24988)
Small bore connectors for liquids and gases in healthcare applications - Part 2 - Connectors for respiratory applications
1099  2013-08-082008-04-23  
prEN ISO/IEC 80369-3:2013 (pr=24534)
Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications
4021  2012-11-062013-08-092014-01-08 
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
5060  2012-11-062014-04-142014-05-05 
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 80369-7:2013 (pr=24536)
Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors with 6% (Luer) taper for intravascular or hypodermic applications
4021  2012-11-062013-07-122013-10-11 
prEN ISO/IEC 80369-20:2013 (pr=24991)
Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods (ISO/DIS 80369-20:2013)
4021  2013-08-082013-08-232014-01-22 

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CEN/CLC/TC 3 Publications

Reference, Title
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Downloads
EN 1041:2008 (pr=21910)
Information supplied by the manufacturer of medical devices
2008-08-06 export to doc file  EN  DE
EN 1041:2008/A1:2013 (pr=24447)
Information supplied by the manufacturer of medical devices
2013-09-27 export to doc file  EN  FR  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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EN 1041:2008 (pr=21910)
Information supplied by the manufacturer of medical devices
2008-08-062013-08-062016-08-06CEN/CLC/TC 3 
EN 1041:2008/A1:2013 (pr=24447)
Information supplied by the manufacturer of medical devices
2013-09-272018-09-272021-09-27CEN/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 2014-12-09CEN/CLC/TC 3prEN ISO 13485:2014
EN ISO 13485:2012/AC:2012 (pr=24183)
Medical devices - Quality management systems - Requirements for regulatory purposes
2012-07-062011-12-092014-12-09CEN/CLC/TC 3prEN ISO 13485:2014
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 2016-02-14CEN/CLC/TC 3prEN 15225
EN ISO 80369-1:2010 (pr=22531)
Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements
2010-12-17 2016-07-05CEN/CLC/TC 3prEN ISO 80369-1

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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 stage021001
Enquiry stage130000
Approval stage201000
Published013122
Withdrawn000005

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/A1:2013 (pr=24447)
Information supplied by the manufacturer of medical devices
6060 93/42/EEC
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
NOJ
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
NOJ
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
prEN ISO 13485:2014 (pr=24989)
Medical devices - Quality management systems - Requirements for regulatory purposes
4021 93/42/EEC
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
NEW
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
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
CLC/FprTR 14060:2014 (pr=25147)
Medical device traceability enabled by unique device identification (UDI)
5021 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
NOJ
93/42/EEC
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
NOJ
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 80369-1 (pr=24992)
Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2010)
1099 93/42/EEC
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
NEW
prEN ISO 80369-2 (pr=24988)
Small bore connectors for liquids and gases in healthcare applications - Part 2 - Connectors for respiratory applications
1099 93/42/EEC
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
NEW
prEN ISO/IEC 80369-3:2013 (pr=24534)
Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications
4021 93/42/EEC
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
NEW
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
5060 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 80369-7:2013 (pr=24536)
Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors with 6% (Luer) taper for intravascular or hypodermic applications
4021 93/42/EEC
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
NEW
prEN ISO/IEC 80369-20:2013 (pr=24991)
Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods (ISO/DIS 80369-20:2013)
4021 93/42/EEC
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
NEW