BSI 20/30382352 DC 2020
$13.70
BS EN ISO 11608-3. Needle-based injection systems for medical use. Requirements and test methods – Part 3. NIS containers and integrated fluid paths
| Published By | Publication Date | Number of Pages |
| BSI | 2020 | 34 |
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:
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sterile hypodermic needles for single use;
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sterile hypodermic syringes for single use;
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sterile single-use syringes, with or without needle, for insulin;
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containers that can be refilled multiple times;
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containers intended for dental use;
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catheters or infusion sets that are attached or assembled separately by the user.
