GB/T 16886.11-1997
Replaced
T/CAMDI 040-2026
Active
Group standards
T/CAMDI 040-2026 Additive manufacturing-Special requirements of quality management system for metal medical devices
T/CAMDI 040-2026 Additive manufacturing-Special requirements of quality management system for metal medical devices
Price:
$ 20.00
Basic Information
Standard Code:
T/CAMDI 040-2026
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Orthopaedic surgery, orthopaedic instruments
ICS Name:
Integrated medical equipment
Publish Date:
2026-01-06
Implement Date:
2026-01-06
Scope
This document specifies the special requirements for the production quality management system of metal medical devices produced by additive manufacturing processes. This document applies to the production quality management system for metal medical devices processed by laser selective melting or electron beam selective melting processes.
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