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. 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. 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). This document is not applicable to the following products: — sterile hypodermic needles; — sterile hypodermic syringes; — sterile single-use syringes, with or without needle, for insulin; — containers that can be refilled multiple times; — containers intended for dental use; — catheters or infusion sets that are attached or assembled separately by the user.
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.
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.
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).
This document is not applicable to the following products:
— sterile hypodermic needles;
— sterile hypodermic syringes;
— sterile single-use syringes, with or without needle, for insulin;
— containers that can be refilled multiple times;
— containers intended for dental use;
— catheters or infusion sets that are attached or assembled separately by the user.
<p>This part of ISO 11608 specifies the functional and design considerations for containers to be used with</p> <p>needle-based injection systems (NIS) that fulfil the specifications of ISO 11608-1. It is applicable to single and</p> <p>multi-dose containers (either filled by the manufacturer or by the end-user) which can be provided to the enduser</p> <p>integrated in the NIS or assembled with the NIS at the time of use.</p> <p>This part of ISO 11608 includes specifications and test methods to describe and evaluate cartridges for use</p> <p>in NIS with pen needles (as defined in ISO 11608-2) and outlines design considerations for other potential</p> <p>containers, including syringes to be used with a NIS.</p> <p>This part of ISO 11608 is not applicable to cartridges intended for dental use.</p> <p>Syringes and needles that are sold separately and not intended for use in a NIS are outside the scope of this</p> <p>part of ISO 11608.</p> <p>NOTE See ISO 7864 (needles), ISO 8537 (insulin syringes) and ISO 7886-1 (manual syringes).</p>
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