标准号：ISO 15225-2000
实施状态：作废
中文名称：命名.用于管理资料交流的医疗器械命名系统规范
英文名称：Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange
发布日期：2000-09
被替代标准：ISO 15225-2010
代替标准：ISO/FDIS 15225-1999
采用标准：DIN EN ISO 15225-2000,IDT;DIN EN ISO 15225-2005,IDT;ANSI/AAMI/ISO 15225-2000,IDT;BS EN ISO 15225-2000,IDT;EN ISO 15225-2000,IDT;NF S99-012-2000,IDT;CAN/CSA-ISO 15225-01-2001,IDT;SN EN ISO 15225-2000,IDT;OENORM EN ISO 15225-2000,IDT;OENORM EN ISO 15225-2004,IDT;OENORM EN ISO 15225-2005,IDT;OENORM EN ISO 15225/A2-2005,IDT;UNE-EN ISO 15225-2000,IDT;GOST R ISO 15225-2003,IDT
起草单位：ISO/TC 210
标准简介：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 1: 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.
The requirements contained in this standard are applicable to the development and maintenance of a European nomenclature for medical device identification.
NOTE 2: This European Standard will not include the nomenclature itself. The nomenclature will be supplied as a separate document.
NOTE 3: It is intended to complement the specific requirements of the EC Directives on medical devices in the context of specifying means by which common identification can be achieved between bodies required to exchange data in conformity with the requirements of the Directives.
文件格式：PDF
文件大小：1.11MB
文件页数：34
（以上信息更新时间为：2019-11-23）
ISO 15225-2000 命名.用于管理资料交流的医疗器械命名系统规范.pdf
(1.11 MB)
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