20/30382352 DC

This standard 20/30382352 DC BS EN ISO 11608-3. Needle-based injection systems for medical use. Requirements and test methods is classified in these ICS categories:

• 11.040.25 Syringes, needles and catheters

This document specifies requirements and test methods for design verification of containers and integrated fluid paths to be used with Needle-Based Injection Systems (NIS) that fulfil the requirements of ISO 11608-1 (and other subparts as appropriate). It is applicable to single and multi-dose containers (either filled by the manufacturer [primary container closure] or by the end-user [reservoir]) and fluid paths that are integrated with the NIS at the point of manufacture.

Products excluded from scope are:

• sterile hypodermic needles for single use;

• sterile hypodermic syringes for single use;

• 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.