GB/T 14233.2-2005 Translated English of Chinese Standard. (GBT 14233.2-2005, GB/T14233.2-2005, GBT14233.2-2005): Test methods for infusion, transfusion, injection equipment for medical use - Part 2: Biological test methods [Buy--download True-PDF in 3-second: https://play.google.com/books > Sign in > This BOOK > "3-dots" > Export > Save as "*.pdf"]https://www.chinesestandard.net, 06/05/2015 - 50 páginas This Part of GB/T 14233 specifies the biological test methods of medical infusion, transfusion and injection equipment. This Part is applicable to medical infusion, transfusion and injection equipment. |
Índice
3 | |
4 | |
5 | |
Sterility Test | 6 |
Bacterial Endotoxin Test | 8 |
Pyrogen Test | 11 |
Acute Systemic Toxicity Test | 13 |
Hemolytic Test | 15 |
Cytotoxicity Test | 17 |
Sensitization Test Maximum Dose Method | 21 |
Intradermal Reaction Test | 23 |
Implantation Test | 24 |
Appendix A Informative Subacute Subchronic Systemic Toxicity Test | 29 |
Appendix B Informative Interaction Test With Blood Devices | 35 |
Informative Preparation of Common Cell Culturing Solution and Culture Solution | 48 |
Palavras e frases frequentes
acceptance judgment index adopted agglutination anticoagulant rabbit blood Appendix of Chinese average coagulation bacterial endotoxin Biological Evaluation biomaterials C3a concentration Calcium chloride Chinese Pharmacopoeia clinically approved coagulation complement system concentration of 9 conducted according control substance cytolysis EDTA electric drying oven ethanol Evaluation of Medical following information group and control hemolysis incomplete freund's adjuvant injection equipment injection with mass intravenous injection leach liquor leaching medium Main Equipment mass concentration Medical Devices medical equipment negative control group observation platelet polypropylene polytetrafluoroethylene Preparation Before Test pressure steam sterilizer production batch pyrogen rattus norvegicus Reagent report The following requirements of GB/T Result judgment selected according serum sodium chloride injection sodium citrate sodium pentobarbital solution preparation method subcutaneous substance and control Tachypleus Amebocyte Lysate temperature test animal test exposure test report Test solution preparation test substance group test substance name thiopental thrombogenesis tissue toxic reaction transfusion and injection vegetable oil vein water bath