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

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https://www.chinesestandard.net, May 6, 2015 - Medical - 50 pages
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.
 

Contents

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

Common terms and phrases

About the author (2015)

https://www.chinesestandard.net specializes in providing translation services of all Chinese Standards.

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