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1. Fragments:
Not more than 5 fragments shall be found for every 100
penetrations on the antibiotics-stopper.
Not more than 20 fragments of diameter equal to or greater
than 50 ?m shall be found for every 10 penetrations on the
infusion-stopper.
2. Hardness:
The hardness shall fulfill the demand expounded by the user.
Generally, the hardness of the infusion stopper and the ?
20 series is Shore 50??; the hardness of the ?13 series
is Shore 55??.
3. Spike penetration force:
The force needed to penetrate the stopper of the antibiotic-
bottle shall not exceed 10N.
The force needed to penetrate the stopper of the infusion -
bottle shall not exceed 80N, and the average value shall be
less than 75N. No stopper shall be pushed into the bottle
during piercing.
4. The seal-ability and self-seal-ability:
The antibiotic-stopper shall be closed with the bottle; and
shall be sealed by itself in the course of three times
penetrating.
When the spike penetrate the infusion-stopper, complete
penetration shall be able to be achieved; under the weight
weighing 0.5kg effecting, no shall the spike be pulled out
from the stopper during 4 hour; nor signs of leakage shall
appear on the part that be penetrated during this time
period.
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