GB 8662-1988
Replaced
YY/T 1888-2023
Active
Industry standards-Medicine
YY/T 1888-2023 Recombinant humanized collagen protein
YY/T 1888-2023 Recombinant humanized collagen protein
Price:
$ 31.00
Basic Information
Standard Code:
YY/T 1888-2023
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Surgical instruments and materials
Publish Date:
2023-01-18
Implement Date:
2023-07-20
Pages:
17 pages
Scope
This document specifies the quality control, technical requirements, test methods, stability, biological evaluation, and packaging, transportation, and storage of recombinant humanized collagen.
This document is applicable to the quality control of recombinant humanized collagen that does not contain non-human collagen amino acid sequences and is used as a raw material for medical devices.
Note: The samples validated in this document are based on recombinant type III humanized collagen raw materials. For other recombinant humanized collagen raw materials, if applicable, this document can be referenced.
Development Information
Referenced Standards
YY/T 1849-2022 Recombinant collagen protein
中华人民共和国药典
GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing
GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
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GB/T 10160-1995
Abolished
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GB 9706.4-1999
Replaced
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YY 0464-2003
Replaced
YY 0464-2003 Single use hemoperfutor
YY 0054-2003
Replaced