UNE-EN ISO 11608-3:2022
Current
The latest, up-to-date edition.
Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths (ISO 11608-3:2022, Corrected version 2023-01)
Hardcopy , PDF
English
01-07-2022
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.
| DocumentType |
Standard
|
| Pages |
37
|
| PublisherName |
Asociación Española de Normalización
|
| Status |
Current
|
| Standards | Relationship |
| BS EN ISO 11608-3:2022 | Equivalent |
| I.S. EN ISO 11608-3:2022 | Equivalent |
| DIN EN ISO 11608-3:2022-09 | Equivalent |
| EN ISO 11608-3:2022 | Identical |
| ISO 11608-3:2022 | Identical |
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