GB/T 16886.11-1997
Replaced
T/CAMDI 026-2024
Active
Group standards
T/CAMDI 026-2024 Additive manufacturing and special requirements for quality management systems of personalized medical devices
T/CAMDI 026-2024 Additive manufacturing and special requirements for quality management systems of personalized medical devices
Price:
$ 20.00
Basic Information
Standard Code:
T/CAMDI 026-2024
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
-
ICS Name:
Integrated medical equipment
Publish Date:
2024-04-23
Implement Date:
2024-05-01
Pages:
12 pages
Scope
Main technical content: This document specifies the special requirements for quality management of personalized medical devices produced by additive manufacturing processes. This document is applicable to additive manufacturing personalized medical devices, including additive manufacturing customized medical devices and additive manufacturing patient-matched medical devices.
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