BSI 20/30381874 DC:2020 Edition

This document specifies requirements and test methods for Needle-Based Injection Systems (NISs) for single-patient use intended to deliver discrete volumes (bolus) of medicinal product, through needles or soft cannulas for intradermal, subcutaneous and/or intramuscular delivery, incorporating pre-filled or user-filled, replaceable or non-replaceable containers.

Stand-alone prefilled syringes defined by ISO 11040-8 are not covered by this document (see exclusions below). However, when the prefilled syringes are provided to the user with an integrated addition, certain portions of the ISO 11608 series apply as follows:

• prefilled syringes that are provided to the user with an integrated electronic addition (e.g. electronic dose counter) are covered by relevant requirements of ISO 11608-4, but only to assess the function, feature or performance of the “addition” not the prefilled syringe;

• prefilled syringes that are provided to the user with an integrated addition that provides an automated function (e.g. an automated inserter that inserts to a predetermined insertion depth or needle safety device) are covered by relevant requirements of ISO 11608-5, but only to assess the function, feature or performance of the “addition” (as integrated into the NIS) not the prefilled syringe.

It is important to note that other functions and characteristics of the prefilled syringe, such as dose accuracy, are subject to the requirements (delivered volume) in ISO 11040-8 and not this document, unless the addition impacts the delivery function (e.g. a mechanism that intends to restrict or stop the plunger movement, which would limit the dose delivered). In that case, the system is completely covered by this document and applicable requirements of the ISO 11608 series.

Excluded from the scope are:

• stand-alone prefilled syringes defined by ISO 11040-8 (with noted exceptions above);

• toxicity (biocompatibility) of materials that form the medicinal product contact surfaces of the primary container closure;

• NISs that provide continuous delivery and require a delivery rate clinically specified in the medicinal product labelling or determined by a physician based on clinical relevance (i.e. medication efficacy) as would be the case with insulin patch pumps or traditional infusion pumps (e.g. IEC 60601-2-24, ISO 28620) associated with continuous delivery of medicinal products (e.g. insulin);

• containers that can be refilled multiple times;

• needle-free injectors;

• requirements relating to methods or equipment associated with user filling of containers unless they are dedicated accessories;

• NISs intended for dental use;

• syringes and needles which are not intended for use in a NIS;

• NISs intended for different routes of administration (e.g. intravenous, intrathecal, intraocular).