CEN/TC 257/SC 1 - Nomenclature for medical devices
To draft a detailed nomenclature, including terms and associated codings, to support WI 00257006 (mandate BC/CEN/94/20.9). The nomenclature system shall be in accordance with the requirements of prEN 1874. It shall comprise a three layer structure ("category", "generic group" and "device type"). The nomenclature shall be based on existing widely used systems, such as ECRI and N NKKN.
Nomenclature for medical devices
To draft a detailed nomenclature, including terms and associated codings, to support WI 00257006 (mandate BC/CEN/94/20.9). The nomenclature system shall be in accordance with the requirements of prEN 1874. It shall comprise a three layer structure ("category", "generic group" and "device type"). The nomenclature shall be based on existing widely used systems, such as ECRI and N NKKN.
General Information
No scope available
- Standard18 pagesEnglish languagee-Library read for1 day
This European Standard specifies requirements and guidance for the construction of a nomenclature for medical devices in order to facilitate co-operation and exchange of regulatory data on an international level between interested parties such as: Regulatory Authorities, Manufacturers, Suppliers, Health Care Providers, and End Users. NOTE: This European Standard includes guidelines for a minimum data set and its structure. These guidelines are provided for system designers setting up databases utilizing the nomenclature system described herein.
- Amendment6 pagesEnglish languagee-Library read for1 day
This European Standard specifies requirements and guidance for the construction of a nomenclature for medical devices in order to facilitate co-operation and exchange of regulatory data on an international level between interested parties such as: Regulatory Authorities, Manufacturers, Suppliers, Health Care Providers, and End Users. NOTE: This European Standard includes guidelines for a minimum data set and its structure. These guidelines are provided for system designers setting up databases utilizing the nomenclature system described herein.
- Amendment5 pagesEnglish languagee-Library read for1 day
This European Standard specifies requirements and guidance for the construction of a nomenclature for medical devices in order to facilitate co-operation and exchange of regulatory data on an international level between interested parties such as: Regulatory Authorities, Manufacturers, Suppliers, Health Care Providers, and End Users. NOTE: This European Standard includes guidelines for a minimum data set and its structure. These guidelines are provided for system designers setting up databases utilizing the nomenclature system described herein.
- Standard26 pagesEnglish languagee-Library read for1 day
Frequently Asked Questions
CEN/TC 257/SC 1 is a Subcommittee within the European Committee for Standardization (CEN). It is named "Nomenclature for medical devices" and is responsible for: To draft a detailed nomenclature, including terms and associated codings, to support WI 00257006 (mandate BC/CEN/94/20.9). The nomenclature system shall be in accordance with the requirements of prEN 1874. It shall comprise a three layer structure ("category", "generic group" and "device type"). The nomenclature shall be based on existing widely used systems, such as ECRI and N NKKN. This committee has published 4 standards.
CEN/TC 257/SC 1 develops CEN standards. The scope of work includes: To draft a detailed nomenclature, including terms and associated codings, to support WI 00257006 (mandate BC/CEN/94/20.9). The nomenclature system shall be in accordance with the requirements of prEN 1874. It shall comprise a three layer structure ("category", "generic group" and "device type"). The nomenclature shall be based on existing widely used systems, such as ECRI and N NKKN. Currently, there are 4 published standards from this subcommittee.
The European Committee for Standardization (CEN) is a public standards organization that brings together the national standardization bodies of 34 European countries. CEN provides a platform for developing European Standards (ENs) and other technical documents in relation to various products, materials, services, and processes, supporting the European Single Market.
A Subcommittee (SC) in CEN operates under a Technical Committee and focuses on a specific subset of the TC's scope. Subcommittees develop standards and technical specifications in their specialized area, reporting to their parent Technical Committee. They may also have working groups for detailed technical work.