GB 12264-1990
Replaced
YY/T 1561-2017
Active
Industry standards-Medicine
YY/T 1561-2017 Tissue engineering medical device products—Remnant α-Gal antigen determination in scaffold materials utilizing animal tissues and their derivatives
YY/T 1561-2017 Tissue engineering medical device products—Remnant α-Gal antigen determination in scaffold materials utilizing animal tissues and their derivatives
Basic Information
Standard Code:
YY/T 1561-2017
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:
2017-03-28
Implement Date:
2018-04-01
Pages:
8 pages
Scope
This standard provides a quantitative detection method for residual α-Gal antigens in animal-derived biomaterials used in the preparation of scaffold materials for tissue engineering medical device products.
This standard is applicable to the detection of α-Gal antigens in various animal-derived biomaterials or their derivatives used in the preparation of scaffold materials for tissue engineering medical device products.
Development Information
Referenced Standards
GB/T 16886.20-2015 Biological evaluation of medical devices—Part 20:Principles and methods for immunotoxicology testing of medical devices
YY/T 0606.25-2014 Tissue engineered medical product—Part 25:Quantification of remnant DNA in biological materials utilizing animal tissues and their derivatives: Fluorescence method
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