<p>This document specifies requirements and test methods for design verification of containers and integrated fluid paths used with Needle-Based Injection Systems (NISs) according to ISO 11608-1.</p>
<p>It is applicable to single and multi-dose containers either filled by the manufacturer (primary container closure) or by the end-user (reservoir) (e.g. cartridges, syringes) and fluid paths that are integrated with the NIS at the point of manufacture.</p>
<p>This document is also applicable to prefilled syringes (see ISO 11040-8) when used with a NIS (see also scope of ISO 11608-1:2022).</p>
<p>This document is not applicable to the following products:</p>
<p>— sterile hypodermic needles;</p>
<p>— sterile hypodermic syringes;</p>
<p>— sterile single-use syringes, with or without needle, for insulin;</p>
<p>— containers that can be refilled multiple times;</p>
<p>— containers intended for dental use;</p>
<p>— catheters or infusion sets that are attached or assembled separately by the user.</p>
Registration number (WIID)
76626
Scope
<p>This document specifies requirements and test methods for design verification of containers and integrated fluid paths used with Needle-Based Injection Systems (NISs) according to ISO 11608-1.</p>
<p>It is applicable to single and multi-dose containers either filled by the manufacturer (primary container closure) or by the end-user (reservoir) (e.g. cartridges, syringes) and fluid paths that are integrated with the NIS at the point of manufacture.</p>
<p>This document is also applicable to prefilled syringes (see ISO 11040-8) when used with a NIS (see also scope of ISO 11608-1:2022).</p>
<p>This document is not applicable to the following products:</p>
<p>— sterile hypodermic needles;</p>
<p>— sterile hypodermic syringes;</p>
<p>— sterile single-use syringes, with or without needle, for insulin;</p>
<p>— containers that can be refilled multiple times;</p>
<p>— containers intended for dental use;</p>
<p>— catheters or infusion sets that are attached or assembled separately by the user.</p>
