I.S. EN ISO 11608-4:2022
Current
The latest, up-to-date edition.
Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics (ISO 11608- 4:2022)
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 Abbreviated terms
5 General requirements
6 General requirements for testing
7 Identification and marking of NIS-E
8 Protection against electrical hazards
9 Electromagnetic compatibility (EMC)
10 Protection against mechanical hazards
11 Programmable NIS-E.
Annex A (informative) Identification of immunity pass/fail criteria
Annex B (informative) Rationale for using 240 V for testing some requirements
Bibliography
This document specifies requirements and test methods for needle-based injection systems (NISs) containing electronics with or without software (NIS-Es)
| Committee |
ISO/TC 84
|
| DocumentType |
Test Method
|
| Pages |
80
|
| 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 11608-4:2022 | Identical |
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