YY 0954-2015: Translated English of Chinese Standard. YY0954-2015: Nonactive surgical implants - Type I collagen implants - Specific requirements
https://www.chinesestandard.net, 2016 M12 24 - 28 pages
This standard specifies the specific requirements for injectable collagen implants (abbreviated as implants) which are prepared from purified (noncross-linked) type I collagen as a starting material.
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APPENDIXA Normative Determination of collagen content
Normative Trace element analysis
accordance with 13.4 acid hydrolyzate acid of volume amino acid analyzer applicable Bacterial endotoxin content Biological evaluation Bovine serum albumin bromophenol blue calculated in accordance China volume Clinical evaluation collagen content collagen implants Collagen reference substance collagenase digestion solution Coomassie Brilliant Blue decolorization Determination devices utilizing animal elastin evaluation of medical FOLLOW the methods glacial acetic acid guaranteed reagent hydrochloric heavy metals calculated hydrolysis tube hydroxyproline injection instrument instruction manual L-hydroxyproline reference substance Medical devices utilizing melting point method of Appendix methods as specified mol/L hydrochloric acid molybdenum nitric acid optical density People's Republic Pharmacopoeia preclinical evaluation prefilled syringes YBB protein impurity content provisions reference substance solution Republic of China requirements in Chapter results shall comply Rotary evaporator SDS-PAGE Sirius red Sodium citrate buffer sodium hydroxide specified in Appendix sterile temperature test methods test solution total amount Trace elements Tryptophan type I collagen volume reach volumetric flask YY/T