GB/T 16886.11-1997
Replaced
YY/T 0618-2017
Active
Industry standards-Medicine
YY/T 0618-2017 Test methods for bacterial endotoxins of medical devices—Routine monitoring and alternatives to batch testing
YY/T 0618-2017 Test methods for bacterial endotoxins of medical devices—Routine monitoring and alternatives to batch testing
Basic Information
Standard Code:
YY/T 0618-2017
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Integrated medical equipment
Publish Date:
2017-02-28
Implement Date:
2018-01-01
Pages:
34 pages
Scope
This standard specifies the basic guidelines for the bacterial endotoxin testing methods applicable to the determination of medical devices, components, or raw materials.
〖HT5"H〗 Note: 〖HTSS〗 Although the scope of this standard is limited to medical devices, the requirements and guidelines provided in this standard may also be applicable to other medical products.
This standard is not applicable to the evaluation of pyrogens other than bacterial endotoxins.
Development Information
Replace the following standards
Referenced Standards
中华人民共和国药典 2015年版
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