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YBB 00022003-2015: Test for Pyrogen
YBB 00022003-2015
YBB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
Test for Pyrogen
[Test procedure] TAKE 3 suitable household-rabbits to measure their normal
body-temperature. Within 15 minutes after the normal body-temperature
conforms to requirements, from the auricular vein, Slowly INJECT the test
solution of which the temperature is lukewarm to about 38 °C. The injection
dose is 10 ml/kg. Then, the body-temperature is measured once every 30
minutes according to the previous method, totaling 6 times. The normal body-
temperature is subtracted from the highest one of the 6 body-temperatures, to
obtain the household-rabbit body-temperature rise (°C). If the temperature of 1
of the 3 household-rabbits is raised by 0.6 °C or higher than 0.6 °C, or the sum
of the 3 household-rabbits’ temperature rises is 1.3 °C or higher than 1.3 °C,
another 5 household-rabbits shall be taken for retest; the test procedure is the
same as above.
[Result judgment] If, among the 3 household-rabbits for the first test, the
temperature rise is lower than 0.6 °C, and the sum of the body-temperature rise
of the 3 household-rabbits is lower than 1.3 °C; or, among the 5 household-
rabbits for the retest, the number of household-rabbits whose body-temperature
is raised by 0.6 °C or higher than 0.6 °C does not exceed 1 household-rabbit,
and the sum of the body-temperature rise of the 8 household-rabbits in the first
test and retest is 3.5 °C or lower than 3.5 °C; then, it is determined that the
pyrogen test of the test sample meets the requirements.
If, among the 3 household-rabbits for the first test, the number of household-
rabbits whose body-temperature is raised by 0.6 °C or higher than 0.6 °C
exceeds 1 household-rabbit; or, among the 5 household-rabbits for the retest,
the number of household-rabbits whose body-temperature is raised by 0.6 °C
or higher than 0.6 °C exceeds 1 household-rabbit; or, the sum of the body-
temperature rise of the 8 household-rabbits in the first test and retest exceeds
3.5 °C; then, it is determined that the pyrogen test of the test sample does not
meet the requirements.
When the temperature rise in these household-rabbits is negative, it is
calculated by 0 °C.