ISO - DIS 11608-3
Needle-based injection systems for medical use — Requirements and test methods — Part 3: NIS containers and integrated fluid paths
|Publication Date:||18 February 2020|
|ICS Code (Syringes, needles and catheters):||11.040.25|
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.
NOTE 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.