ISO/TR 14969-2004
医疗装置.质量管理系统.ISO 13485-2003应用指南
Medical devices - Quality mangement systems - Guidance on the application of ISO 13485: 2003
ISO/TR 14969-2004 发布历史
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.
ISO/TR 14969-2004由国际标准化组织 IX-ISO 发布于 2004-10。
ISO/TR 14969-2004 在中国标准分类中归属于: C30 医疗器械综合，在国际标准分类中归属于: 03.120.10 质量管理和质量保证,11.040.01 医疗设备综合。
ISO/TR 14969-2004的历代版本如下：
- 2004年10月 ISO/TR 14969-2004 医疗装置.质量管理系统.ISO 13485-2003应用指南
ISO/TR 14969-2004 医疗装置.质量管理系统.ISO 13485-2003应用指南 由 ISO 14969-1999 变更而来。
ISO/TR 14969-2004 医疗装置.质量管理系统.ISO 13485-2003应用指南 于 2016-03-01 变更为 ISO 13485-2016 医疗器械.质量管理体系.管理用途的要求。
- 标准号
- ISO/TR 14969-2004
- 发布日期
- 2004年10月
- 实施日期
- 废止日期
- 无
- 中国标准分类号
- C30
- 国际标准分类号
- 03.120.10;11.040.01
- 发布单位
- 国际标准化组织
- 代替标准
- ISO 13485-2016
- 被代替标准
- ISO 14969-1999
- 适用范围
- 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.