BS EN ISO 11608-5:2012
Needle-based injection systems for medical use. Requirements and test methods - Automated functions
Needle-based injection systems for medical use. Requirements and test methods - Automated functions
- Статус документа:
- Отменён
- Формат:
- Электронный (PDF)
- Дата публикации:
- 31 октября 2012 г.
- ICS:
- 11.040.25
- Технический комитет:
- CEN
- SKU:
- BS EN ISO 11608-5:2012
Abstract
1 Scope This part of ISO 11608 specifies requirements and test methods for the automated functions of needle-based injection systems with automated functions ( NIS-AUTO ), for the administration of medicinal products in humans, including but not limited to:
a) drug product preparation (e.g. reconstitution);
b) needle preparation;
c) air removal ;
d) priming ;
e) dose setting;
f) actuation ;
g) needle insertion;
h) injection of the medicinal product;
i) disabling the NIS-AUTO ;
j) needle retraction;
k)<...
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