标准号：ISO/TR 14969-2004
实施状态：作废
中文名称：医疗装置.质量管理系统.ISO 13485-2003应用指南
英文名称：Medical devices - Quality mangement systems - Guidance on the application of ISO 13485: 2003
发布日期：2004-10
被替代标准：ISO 13485-2016
代替标准：ISO 14969-1999
采用标准：DIN-Fachbericht CEN ISO/TR 14969-2005,IDT;CEN ISO/TR 14969-2005,IDT;CEN ISO/TR 14969-2005,IDT;TR Q 14969-2007,IDT;CAN/CSA-ISO/TR 14969-05-2005,IDT;UNE-CEN ISO/TR 14969 IN-2006,IDT;GOST R ISO/TR 14969-2007,IDT
起草单位：ISO/TC 210
标准简介：This Technical Report provides guidance for the application of the requirements for quality management
systems contained in ISO 13485. It does not add to, or otherwise change, the requirements of ISO 13485.
This Technical Report does not include requirements to be used as the basis of regulatory inspection or
certification assessment activities.
NOTE The terms “should”, “can” and “might” within this Technical Report are used as follows. “Should” is used to
indicate that, amongst several possibilities to meet a requirement in ISO 13485, one is recommended as being particularly
suitable, without mentioning or excluding others, or that a certain course of action is preferred but not necessarily required.
“Can” and “might” are used to indicate possibilities or options. These terms do not indicate requirements.
This guidance can be used to better understand the requirements of ISO 13485 and to illustrate some of the
variety of methods and approaches available for meeting the requirements of ISO 13485.
文件格式：PDF
文件大小：2.35MB
文件页数：84
（以上信息更新时间为：2019-11-22）
ISO_TR 14969-2004 医疗装置.质量管理系统.ISO 13485-2003应用指南.pdf
(2.35 MB)
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