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<p>This document specifies requirements and test methods for single-use, double-ended, sterile needles intended to be used with some needle-based injection systems (NISs) that use a non-integrated double-ended needle according to ISO 11608-1.</p>
<p>This document is not applicable to the following:</p>
<p>— needles for dental use;</p>
<p>— pre-attached syringe needles;</p>
<p>— hypodermic needles;</p>
<p>— needles intended for different routes of administration (e.g. intravenous, intrathecal, intraocular);</p>
<p>— materials that form the medicinal product contact surfaces of the primary container closure.</p>
<p>However, while this document is not intended to directly apply to these needle products, it does contain requirements and tests methods that can be used to help design and evaluate them.</p>
<p>NOTE Needles provided by the manufacturer integrated into the fluid path or container are covered in ISO 11608‑3, and hypodermic needles provided separately are covered in ISO 7864.</p>
Reģistrācijas numurs (WIID)
70734
Darbības sfēra
<p>This document specifies requirements and test methods for single-use, double-ended, sterile needles intended to be used with some needle-based injection systems (NISs) that use a non-integrated double-ended needle according to ISO 11608-1.</p>
<p>This document is not applicable to the following:</p>
<p>— needles for dental use;</p>
<p>— pre-attached syringe needles;</p>
<p>— hypodermic needles;</p>
<p>— needles intended for different routes of administration (e.g. intravenous, intrathecal, intraocular);</p>
<p>— materials that form the medicinal product contact surfaces of the primary container closure.</p>
<p>However, while this document is not intended to directly apply to these needle products, it does contain requirements and tests methods that can be used to help design and evaluate them.</p>
<p>NOTE Needles provided by the manufacturer integrated into the fluid path or container are covered in ISO 11608‑3, and hypodermic needles provided separately are covered in ISO 7864.</p>
