GB/T 16886.11-1997
Replaced
T/CSYLQX 0001-2025
Active
Group standards
T/CSYLQX 0001-2025 The Credit Evaluation Standards for Medical Device Business Enterprises
T/CSYLQX 0001-2025 The Credit Evaluation Standards for Medical Device Business Enterprises
Price:
$ 20.00
Basic Information
Standard Code:
T/CSYLQX 0001-2025
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
\nRadioactive source
ICS Name:
Integrated medical equipment
Publish Date:
2025-11-01
Implement Date:
2025-12-01
Scope
This document is applicable to the credit evaluation of medical device operating enterprises (excluding retail, chain, and online operating enterprises). This document establishes the general requirements for the credit evaluation of medical device operating enterprises, the evaluation index system, sets out the scoring rules for the evaluation indicators, describes the rules for forming the evaluation results, and stipulates the requirements for the organization and implementation of the evaluation activities, as well as for management and improvement.
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