GB/T 16886.11-1997
Replaced
T/ZMDS 50003-2026
Active
Group standards
T/ZMDS 50003-2026 Medical device - Validation method for testing software
T/ZMDS 50003-2026 Medical device - Validation method for testing software
Price:
$ 20.00
Basic Information
Standard Code:
T/ZMDS 50003-2026
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Urban transportation facilities
ICS Name:
Integrated medical equipment
Publish Date:
2026-04-07
Implement Date:
2026-05-07
Scope
This document describes the purpose, principles, scope, procedures, re-confirmation conditions, and implementation of software validation for medical device testing, as well as the method of validation documentation. This document applies to the software validation process used for testing in the research and development, production, quality control, and sales stages of medical devices, including purchased off-the-shelf software (OTSS) and ready-to-use software (RUSP). The main technical content of this standard includes validation purposes, validation principles, validation scope, validation procedures, re-validation, and validation documentation. It emphasizes the validation activities for non-self-developed testing software purchased by enterprises to ensure that the testing software meets the requirements of use and regulatory compliance.
Development Information
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