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"]

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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.
 

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Índice

Foreword
3
Introduction
4
Scope
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

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