CEN Standards Collection 263/370: CEN CLC TC 3 - QM & Cor. Gen. Aspects For Med. Dev.

[BornToSin]

full list:

EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
CR 13217:1998 Nomenclature system for medical devices for the purpose of regulatory data exchange - Rationale
EN ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
CR 13825:2000 Luer connectors - A report to CEN chef from the CEN forum task group "Luer fittings"
CEN/CLC/TR 14060:2014 Medical device traceability enabled by unique device identification (UDI)
CEN ISO/TR 14969:2005 Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003 (ISO/TR 14969:2004)
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
CEN/TR 15133:2005 Nomenclature - Collective terms and codes for groups of medical devices
EN ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2012)
EN ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016)
EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
EN ISO 80369-1:2010 Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2010)
EN ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods (ISO 80369-20:2015)


missing:
EN ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
CEN/CLC/TR 14060:2014 Medical device traceability enabled by unique device identification (UDI)
CEN/TR 15133:2005 Nomenclature - Collective terms and codes for groups of medical devices
EN ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016)



linkz:

[link Point to another website Only the registered members can access]
or

[link Point to another website Only the registered members can access]

[BornToSin]

update:

EN ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) - added missing standard
EN ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016) - added missing standard
EN ISO 80369-6:2016 Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications (ISO 80369-6:2016) - added new standard

missing list:

CEN/CLC/TR 14060:2014 Medical device traceability enabled by unique device identification (UDI)
CEN/TR 15133:2005 Nomenclature - Collective terms and codes for groups of medical devices


new links:

[link Point to another website Only the registered members can access]
or

[link Point to another website Only the registered members can access]

[BornToSin]

new missing list:

CEN/CLC/TR 14060:2014 Medical device traceability enabled by unique device identification (UDI)
CEN/TR 15133:2005 Nomenclature - Collective terms and codes for groups of medical devices
EN ISO 80369-3:2016 Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications (ISO 80369-3:2016)


fresh links:

[link Point to another website Only the registered members can access]
or

[link Point to another website Only the registered members can access]

[BornToSin]

still same missing list:

CEN/CLC/TR 14060:2014 Medical device traceability enabled by unique device identification (UDI)
CEN/TR 15133:2005 Nomenclature - Collective terms and codes for groups of medical devices
EN ISO 80369-3:2016 Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications (ISO 80369-3:2016)

updated links:

[link Point to another website Only the registered members can access]
or

[link Point to another website Only the registered members can access]

[BornToSin]

update:

EN ISO 80369-3:2016 Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications (ISO 80369-3:2016) - added missing standard

missing list :

CEN/CLC/TR 14060:2014 Medical device traceability enabled by unique device identification (UDI)
CEN/TR 15133:2005 Nomenclature - Collective terms and codes for groups of medical devices
EN 80369-5:2016 Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications


new links:

[link Point to another website Only the registered members can access]
or

[link Point to another website Only the registered members can access]

[BornToSin]

update:

added missing/new:

EN ISO 13485:2016/AC:2016 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
CEN/TR 15133:2005 Nomenclature - Collective terms and codes for groups of medical devices
EN ISO 15223-1:2016 Medical devices - Symbols to be used with medical device labels* labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016)
EN 80369-5:2016 Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications


the only 1 missing now is:

CEN/CLC/TR 14060:2014 Medical device traceability enabled by unique device identification (UDI)


the link:

[link Point to another website Only the registered members can access]

[BornToSin]

update:

BQ or EN or missing

CR 13217:1998 Nomenclature system for medical devices for the purpose of regulatory data exchange - Rationale
CR 13825:2000 Luer connectors - A report to CEN chef from the CEN forum task group "Luer fittings"
CEN ISO/TR 14969:2005 Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003 (ISO/TR 14969:2004)
EN ISO 15223-1:2016 Medical devices - Symbols to be used with medical device labels* labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016)
EN ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016)
EN ISO 80369-1:2010 Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2010)
EN ISO 80369-3:2016 Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications (ISO 80369-3:2016)
EN 80369-5:2016 Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications
EN 80369-5:2016/AC:2017-02 Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications
EN ISO 80369-6:2016 Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications (ISO 80369-6:2016)


the missing are:

CEN/CLC/TR 14060:2014 Medical device traceability enabled by unique device identification (UDI)
EN ISO 80369-7:2017 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (ISO 80369-7:2016* Corrected version 2016-12-01)

[link Point to another website Only the registered members can access]