GB/T 16886.11-1997
Replaced
YY/T 1437-2023
Active
Industry standards-Medicine
YY/T 1437-2023 Medical devices—Guidance on the application of GB/T 42062
YY/T 1437-2023 Medical devices—Guidance on the application of GB/T 42062
Price:
$ 100.00
Basic Information
Standard Code:
YY/T 1437-2023
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Integrated medical equipment
Publish Date:
2023-06-20
Implement Date:
2024-07-01
Pages:
76 pages
Scope
This document provides guidelines for developing, implementing, and maintaining a medical device risk management system in accordance with GB/T 42062—2022.
The risk management process can be an integral part of a quality management system (for example, a system based on GB/T 42061—2022 [15]), but this is not a requirement in GB/T 42062—2022. Certain requirements related to risk management in GB/T 42061—2022 (Chapter 7 "Product Realization" and 8.2.1 "Feedback") can be achieved by applying GB/T 42062—2022, as described in YY/T 0595—2020 [17].
Development Information
Replace the following standards
Referenced Standards
Adopt standards
ISO/TR 24971:2020
Related Standards
GB/T 16886.3-1997
Replaced
GB/T 16886.3-1997 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity
GB/T 16886.6-1997
Replaced
GB/T 16886.6-1997 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation
GB/T 16886.1-2001
Replaced
GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing
GB/T 16886.13-2001
Replaced
GB/T 16886.13-2001 Biological evaluation of medical devices—Part 13:Identification and quantification of degradation products from polymeric medical devices
GB/T 16886.7-2001
Replaced