GB/T 14233.2-2005 Test methods for infusion, transfusion, injection equipment for medical use-Part 2: Biological test methods (Text of Document is in English)

01/05/2006

52P

$400.00 USD

Contents
Foreword
Introduction
1 Scope
2 Normative reference
3 Sterility test
4 Bacterial endotoxin test
5 Pyrogen test
6 Acute systemic toxicity
7 Hemolytic test
8 Cytotoxicity test
9 Sensitization test (with the maximum dose method)
10 Intradermal reaction test
Annex A (Informative) Subacute (Subchronic) Systemic Toxicity Test
A.1 Objective
A.2 Reagent
A.3 Main equipment and devices
A.4 Preparations before test
A.5 Testing methods
Annex B (Informative) Test of Interaction with Blood (instrument)
B.1 General Principle
B.2 Test of Internal Venous Thrombosis
B.3 Whole blood clotting time
B.4 Partial thromboplastin time (ptt) test
B.5 Extracorporal spontaneous platelet aggregation test
B.6 Platelet Adhesion Test
B.7 Complement Activation Test
Annex C (Informative) Preparation of Common Solutions and Nutrient Solution of Cell Culture
C.1 Balanced Salt Solution (BBS)
C.2 Digestive Juice
C.3 Methyl Thiazolyl Tetrazolium (MTT) Staining Fluid
C.4 RPMI 1640 Cell Nutrient Solution