1 Scope
This part of ISO 11608 specifies requirements and test methods for single-use, double-ended, sterile needles for needle-based injection systems (NISs) that fulfil the specifications of ISO 11608-1.
It is not applicable to:
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— needles for dental use;
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— pre-filled syringe needles;
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— needles pre-assembled by the manufacturer;
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— needles not requiring assembly or attachment to the NIS.