BS EN ISO 11608-3. Needle-based injection systems for medical use. Requirements and test methods Part 3. NIS containers and integrated fluid paths
|Standard number:||20/30382352 DC|
|Status:||Draft for Comment|
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.
Prefilled syringes (ISO 11040-8) are included in the scope when used with a NIS; see also scope of ISO 11608-1:20xx.
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.