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YBB 00032003-2015 English PDF
YBB 00032003-2015_English: PDF (YBB00032003-2015)
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YBB 00032003-2015
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Test for Hemolysis
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YBB 00032003-2015
Standards related to:
YBB 00032003-2015
BASIC DATA
Standard ID
YBB 00032003-2015 (YBB00032003-2015)
Description (Translated English)
Test for Hemolysis
Sector / Industry
Medical & Pharmaceutical Packaging Industry Standard
Classification of Chinese Standard
C08
Word Count Estimation
3,39
Date of Issue
2015-08-11
Date of Implementation
2015-12-01
Older Standard (superseded by this standard)
YBB 0003-2003
Regulation (derived from)
China Food & Drug Administration Announcement 2015 No.164
YBB 00032003-2015 YBB NATIONAL STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA Test for Hemolysis Test for Hemolysis This test is a method for measuring the amount of hemoglobin released by red blood cells by directly contacting the test sample with blood, so as to measure the degree of hemolysis in vitro of the test sample. [Preparation prior to the test] COLLECT 20 ml of blood from healthy household-rabbit hearts; ADD 1 ml of 2% potassium oxalate solution, so as to prepare fresh anticoagulant household-rabbit blood. TAKE 8 ml of the fresh anticoagulant household-rabbit blood; and ADD 10 ml of sodium chloride injection to dilute it. [Preparation of the test sample] WEIGH 3 copies of the test sample, 5 g each. Unless otherwise specified, it is generally cut into strips of 0.5 cm X 2 cm. [Test procedure] For the 3 test tubes of the test sample group, ADD 5 g of test sample and 10 ml of sodium chloride injection to each tube. For 3 test tubes of negative control group, ADD 10 ml of sodium chloride injection to each tube. For 3 test tubes of positive control group, ADD 10 ml of purified water to each tube. All the test tubes are placed in a constant temperature water bath at
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