YY 0954-2015 Translated English of Chinese Standard. YY0954-2015: Nonactive surgical implants - Type I collagen implants - Specific requirementshttps://www.chinesestandard.net, 24.12.2016 - 28 sivua 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. |
Sisältö
| 3 | |
APPENDIXA Normative Determination of collagen content | 17 |
Normative Trace element analysis | 24 |
Yleiset termit ja lausekkeet
0.01 mol/L hydrochloric accordance with 13.4 acid hydrolyzate amino acid analyzer applicable Bacterial endotoxin content Biological evaluation Bovine serum albumin bromophenol blue calculated in accordance China volume Clinical evaluation collagen concentration reach 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 heavy metals calculated hydrolysis tube hydroxyproline injection instrument instruction manual L-hydroxyproline reference substance 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 utilizing animal tissue volume reach volumetric flask YY/T