Tiêu chuẩn quốc tế
|
Số hiệu
Standard Number
ISO TR 24971:2020
Năm ban hành 2020
Publication date
Tình trạng
A - Còn hiệu lực
Status |
|
Tên tiếng Anh
Title in English Medical devices - Guidance on the application of ISO 14971
|
|
Thay thế cho
Replace |
|
Chỉ số phân loại Quốc tế (ICS)
By field
11.040.01 - Thiết bị y tế nói chung
|
|
Số trang
Page 94
Giá:
Price Liên hệ / Contact us
|
|
Phạm vi áp dụng
Scope of standard This document provides guidance on the development, implementation and maintenance of a risk management system for medical devices according to ISO 14971:2019. The risk management process can be part of a quality management system, for example one that is based on ISO 13485:2016[24], but this is not required by ISO 14971:2019. Some requirements in ISO 13485:2016 (Clause 7 on product realization and 8.2.1 on feedback during monitoring and measurement) are related to risk management and can be fulfilled by applying ISO 14971:2019. See also the ISO Handbook: ISO 13485:2016 - Medical devices - A practical guide[25]. [24] ISO 13485:2016, Medical devices - Quality management systems - Requirements for regulatory purposes [25] ISO Handbook: ISO 13485:2016, Medical devices - A practical guide |