SSH EN ISO 11608-1:2015

Sisteme injeksioni me gjilpërë për përdorim mjekësor - Kërkesat dhe metodat e testimit - Pjesa 1: Sisteme injeksioni me gjilpërë (ISO 11608-1:2014)

Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2014)

Scope

ISO 11608-1:2014 specifies requirements and test methods for needle-based injection systems (NISs) intended to be used with needles and with replaceable or non-replaceable containers. Containers covered in ISO 11608-1:2014 include single- and multi-dose syringe-based and cartridge-based systems, filled either by the manufacturer or by the end-user.

Related directives

Directives related to this standards.