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ILNAS-EN ISO 11608-3:2022
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05/2022
Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths (ISO 11608-3:2022)
Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths (ISO 11608-3:2022)
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Abstract
This document specifies requirements and test methods for design verification of containers and integrated fluid paths used with Needle-Based Injection Systems (NISs) according to ISO 11608-1.
It is applicable to single and multi-dose containers either filled by the manufacturer (primary container closure) or by the end-user (reservoir) (e.g. cartridges, syringes) and fluid paths that are integrated with the NIS at the point of manufacture.
This document is also applicable to prefilled syringes (see ISO 11040-8) when used with a NIS (see also scope of ISO 11608-1:2022).
This document is not applicable to the following products:
— sterile hypodermic needles;
— sterile hypodermic syringes;
— 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.
Status
| Standard - Active |
Origin
| Technical Committee : |
| CEN/TC 205 : Non-active medical devices |
Implementation
| start of the vote on the project | 20/02/2020 | date of ratification (dor) | 02/01/2022 | |||
| end of the vote on the project | 12/05/2020 | date of anouncement (doa) | 31/08/2022 | |||
| start of the vote on the final project | 07/10/2021 | date of publication (dop) | 30/11/2022 | |||
| end of the vote on the final project | 01/12/2021 | date of withdrawal (dow) | 30/11/2022 |
|
Publication Official Journal
of the Grand-Duchy of Luxembourg |
|
| Reference |
Relations
| Relations to older standards |
| ILNAS-EN ISO 11608-3:2012 |
| Relations to international standards |
| ISO 11608-3:2022 |
| ISO 11608-3 |
International Classification for Standards (ICS codes) :
| 11.040.25 : Syringes, needles and catheters |
