I.S. EN ISO 11608-1:2022
Current
The latest, up-to-date edition.
Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2022)
Hardcopy , PDF
English
15-06-2022
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 Normative references
3 Terms and definitions
4 Symbols
5 Requirements
6 Reagent and apparatus
7 Assessment of dose accuracy and other primary functions
8 Preparation and operation of NISs
9 Test case matrix
10 Testing procedures
11 Inspection
12 Information supplied with the NIS
Annex A (informative) Testing rationale
Annex B (normative) One- and two-sided tolerance limit factors, k (for normally distributed
data)
Annex C (informative) Biological evaluation according to ISO 10993-1
Annex D (informative) Functional stability
Annex E (normative) Instructions for use, marking and age warning
Annex F (informative) Rationale for recommended sample sizes
Annex G (informative) Considerations for assessing impact on primary functions due to
exposure to or contact with medicinal product
Annex H (informative) Introduction of primary functions
Bibliography
This document specifies requirements and test methods for Needle-Based Injection Systems (NISs) for single-patient use intended to deliver discrete volumes (bolus) of medicinal product, which can be delivered through needles or soft cannulas for intradermal, subcutaneous and/or intramuscular delivery, incorporating pre-filled or user-filled, replaceable or non-replaceable containers.
| Committee |
ISO/TC 84
|
| DocumentType |
Standard
|
| Pages |
90
|
| ProductNote |
The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 11608-1:2022 | Identical |
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