GB/T 16886.11-1997
Replaced
YY/T 1775.1-2021
Active
Industry standards-Medicine
YY/T 1775.1-2021 Biological evaluation of absorbable medical devices—Part 1:Guidance for absorbable implants
YY/T 1775.1-2021 Biological evaluation of absorbable medical devices—Part 1:Guidance for absorbable implants
Basic Information
Standard Code:
YY/T 1775.1-2021
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Integrated medical equipment
Publish Date:
2021-03-09
Implement Date:
2022-04-01
Pages:
12 pages
Scope
This part of YY/T 1775 specifies general guidelines for the biological evaluation of absorbable implants to support the safety evaluation of absorbable implants.
This part is applicable to the evaluation of absorbable implants during the risk assessment process based on GB/T 16886.
Note: Absorbable implants are designed to degrade, so their degradation products will be released into the patient's body. This is a fundamental difference between such products and other medical devices that are not intended to be absorbed by the patient's body.
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