This part of YY/T 0606 specifies relevant aspects of the classification standards for tissue engineered medical products to ensure the safety and effectiveness of tissue engineered medical products for patients and users. This section does not include organ and tissue transplantation and living cell therapy in the traditional sense. This section applies to the classification requirements for tissue engineering products and does not include specific content included in other standards.
YY/T 0606.3-2007 Referenced Document
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
GB/T 16886.9-2001 Biological evaluation of medical devices-Part 9:Framework for identification and quantification of potential degradation product
YY/T 0606.3-2007 history
2007YY/T 0606.3-2007 Tissue engineered medical products.Part 3:General classification