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.
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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
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