I.S. EN ISO 11608-2:2022
Current
The latest, up-to-date edition.
Needle-based injection systems for medical use - Requirements and test methods - Part 2: Double-ended pen needles (ISO 11608-2:2022)
Hardcopy , PDF
English
04-05-2022
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
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Foreword
Introduction
1 Scope
2 Normativereferences
3 Terms and definitions
4 Symbols
5 Requirements
6 Sampling
7 Preconditioning of needles
8 Standard atmosphere and test apparatus.
9 Test methods
10 Packaging
11 Information supplied with the needle(s)
This document specifies requirements and test methods for single-use, double-ended, sterile needles intended to be used with some needle-based injection systems (NISs) that use a non-integrated doubleended needle according to ISO 11608-1
| Committee |
TC 84
|
| DocumentType |
Test Method
|
| Pages |
50
|
| ProductNote |
The date of any NSAIprevious adoption may not matchthe date of its original CEN/CENELEC document.
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
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