GB/T 16886.11-1997
Replaced
YY/T 1406-2026
Pending
Industry standards-Medicine
YY/T 1406-2026 Medical device software—Guidance on the application of GB/T 42062 to medical device software
YY/T 1406-2026 Medical device software—Guidance on the application of GB/T 42062 to medical device software
Price:
$ 86.00
Basic Information
Standard Code:
YY/T 1406-2026
Standard Type:
Industry standards
Standard Status:
Pending
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Integrated medical equipment
Publish Date:
2026-03-09
Implement Date:
2027-03-01
Pages:
56 pages
Scope
This document provides guidance on applying the requirements contained in GB/T 42062—2022 to the medical device software (standalone software and software components) specified in YY/T 0664—2020. This document does not add or modify the requirements of GB/T 42062—2022 or YY/T 0664—2020.
This document applies to the medical device software specified in YY/T 0664—2020. It also applies to all software in healthcare environments that requires the implementation of a safety risk management process, regardless of whether it is classified as a medical device or not.
This document does not apply to:
——Production or quality management system software;
——Software development tools.
Development Information
Replace the following standards
Referenced Standards
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