GB 12264-1990
Replaced
YY/T 0606.3-2007
Active
Industry standards-Medicine
YY/T 0606.3-2007 Tissue engineered medical products—Part 3:General classification
YY/T 0606.3-2007 Tissue engineered medical products—Part 3:General classification
Basic Information
Standard Code:
YY/T 0606.3-2007
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:
2007-01-31
Implement Date:
2008-01-01
Pages:
10 pages
Scope
This part of YY/T 0606 specifies the relevant aspects of the classification standards for tissue engineering medical products, in order to ensure the safety and effectiveness of tissue engineering medical products for patients and users. This part does not include organ and tissue transplantation in the traditional sense, as well as live cell therapy. This part applies to the classification requirements of tissue engineering products, and does not include specific content included in other standards.
Development Information
Same series standard
YY/T 0606.4-2007 Tissue engineered medical product—Part 4:Terminology and classification of skin substitute
YY/T 0606.5-2007 Tissue engineered medical Products—Part 5:Characterization and testing of substrates and scaffolds
YY/T 0606.9-2007 Tissue engineered medical products—Part 9:Sodium hyaluronate
YY/T 0606.12-2007 Tissue engineered medical products—Part 12:Guide for processing cells,tissues,and organs
Referenced Standards
GB/T 16886.9-2001 Biological evaluation of medical devices—Part 9:Framework for identification and quantification of potential degradation products
GB/T 16886.13-2001 Biological evaluation of medical devices—Part 13:Identification and quantification of degradation products from polymeric medical devices
GB/T 16886.14-2003 Biological evaluation of medical devices—Part 14:Identification and quantification of degradation products from ceramics
GB/T 16886.15-2003 Biological eveluation of medical devices—Part 15:Identification and quantification of degradation products from metals and alloys
GB/T 16886.16-2003 Biological evaluation of medical devices—Part 16:Toxicokinetic study design for degradation products and leachables
ISO 14155.1-2003
ISO 14155.2-2003
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