DSF/PREN ISO 11608-2
Needle-based injection systems for medical use – Requirements and test methods – Part 2: Needles (ISO/DIS 11608-2:2020)
| Organization: | DS |
| Status: | active |
| Page Count: | 31 |
| ICS Code (Syringes, needles and catheters): | 11.040.25 |
scope:
This document specifies requirements, test methods and compatibility requirements for singleuse, double-ended, sterile needles used with needle-based injection systems (NISs) that fulfil the specifications of ISO 11608-1. NOTE - Needles provided by the manufacturer integrated into the fluid path or container are covered in ISO 11608-3, and hypodermic needles provided separately are covered in ISO 7864. This document is not applicable to: - needles for dental use; - pre-filled syringe needles; - needles intended for different routes of administration (e.g. intravenous, intrathecal, intraocular).
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