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 languagesale 10% offe-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 languagesale 10% offe-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 languagesale 10% offe-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 languagesale 10% offe-Library read for1 day