ISO 11608-1:2014

Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems

Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems

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Referenced standards

IEC 60068-2-30:2005IEC 60068-2-6:2007IEC 60601-1-2:2007IEC 62366:2007ISO 10993-1:2009ISO 11608-1:2012ISO 11608-2:2012ISO 11608-3:2012ISO 11608-4:2006ISO 11608-5:2012ISO 13485:2003ISO 14253-1:2013ISO 14971:2007ISO/IEC Guide 98-3:2008
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ISO 11608-1:2014

Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems

Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems

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.

Edition2014
Standard Part No1
Published Date2014
Published ByInternational Standardization Organisation
Page Count41