BSI 20/30381877 DC:2020 Edition
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BS EN ISO 11608-2. Needle-based injection systems for medical use. Requirements and test methods – Part 2. Double-ended needles
| Published By | Publication Date | Number of Pages |
| BSI | 2020 | 31 |
This document specifies requirements, test methods and compatibility requirements for single-use, 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:
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needles for dental use;
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pre-filled syringe needles;
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needles intended for different routes of administration (e.g. intravenous, intrathecal, intraocular).
