BS EN ISO 11608-5:2012 PDF

Needle-based injection systems for medical use. Requirements and test methods - Automated functions

Название (английский):

BS EN ISO 11608-5:2012

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

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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;

BS EN ISO 11608-5:2012 PDF

Abstract

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Abstract

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