GB/T 16886.11-1997
Replaced
T/CAMDI 073-2021
Active
Group standards
T/CAMDI 073-2021 Medical electron beam powder bed fusion additive manufacturing equipment for medical devices
T/CAMDI 073-2021 Medical electron beam powder bed fusion additive manufacturing equipment for medical devices
Price:
$ 20.00
Basic Information
Standard Code:
T/CAMDI 073-2021
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Integrated medical equipment
Publish Date:
2021-08-11
Implement Date:
2021-08-12
Scope
Main technical content: This standard specifies the definitions and terminology, technical requirements, test methods, and requirements for marking, labeling, and packaging of electron beam powder bed fusion additive manufacturing equipment for medical devices. This standard applies to electron beam powder bed fusion additive manufacturing equipment (hereinafter referred to as equipment) used in the research and development and manufacturing of medical devices. The medical devices manufactured include, but are not limited to, personalized medical implants, standardized batch implants, and auxiliary tools used in the medical field.
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