GB 12264-1990
Replaced
YY/T 1435-2016
Active
Industry standards-Medicine
YY/T 1435-2016 Tissue engineering medical device products—Standard guide for characterization of hydrogels
YY/T 1435-2016 Tissue engineering medical device products—Standard guide for characterization of hydrogels
Basic Information
Standard Code:
YY/T 1435-2016
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Extracorporeal circulation, artificial organs, and prosthetic devices
ICS Name:
Surgical implants, prostheses, and orthoses
Publish Date:
2016-07-29
Implement Date:
2017-06-01
Pages:
14 pages
Scope
This standard provides a methodological guide for characterizing the biological properties, formation dynamics, physical and chemical properties, stability, and material transfer of hydrogels in tissue engineering medical device products.
Development Information
Referenced Standards
中华人民共和国药典(2010年版)
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
GB/T 16886.19-2011 Biological evaluation of medical devices—Part 19:Physico-chemical,morphological and topographical characterization of materials
GB/T 16886.19-2022 Biological evaluation of medical devices—Part 19:Physico-chemical,morphological and topographical characterization of materials
YY/T 0606.5-2007 Tissue engineered medical Products—Part 5:Characterization and testing of substrates and scaffolds
YY/T 0606.7-2008 Tissue engineered medical products—Part 7:Chitosan
YY/T 0606.8-2008 Tissue engineered medical products—Part 8:Alginate
YY/T 0606.9-2007 Tissue engineered medical products—Part 9:Sodium hyaluronate
YY/T 0771.1-2020 Medical devices utilizing animal tissues and their derivatives—Part 1:Application of risk management
Related Standards
GB 12279-1990
Replaced
GB 12279-1990 Cardiac valve prostheses general technical specification
GB 12417-1990
Replaced
GB 12417-1990 The general technological conditions of surgical metal implant
GB/T 13461-1992
Replaced
GB/T 13461-1992 Synthetic resin blow knee prostheses
GB/T 14191-1993
Replaced
GB/T 14191-1993 Terminology for prosthetics and orthotics
GB 14722-1993
Replaced