ISO/TR 24971:2013
医疗器械.ISO 14971标准的应用导则
Medical devices - Guidance on the application of ISO 14971
ISO/TR 24971:2013 发布历史
ISO/TR 24971:2013由国际标准化组织 IX-ISO 发布于 2013-07-01。
ISO/TR 24971:2013 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: 11.040.01 医疗设备综合。
ISO/TR 24971:2013的历代版本如下：
- 2020年 ISO/TR 24971:2020 医疗器械ISO 14971应用指南
- 2013年 ISO/TR 24971:2013 医疗器械.ISO 14971标准的应用导则
This Technical Report provides guidance in addressing specific areas of ISO 14971 when implementing risk management. The guidance is intended to assist manufacturers and other users of the standard to: —understand the role of international product safety and process standards in risk management; —develop the policy for determining the criteria for risk acceptability; —incorporate production and post-production feedback loop into risk management; — differentiate between "information for safety" and "disclosure of residual risk"; and —evaluate overall residual risk.
