I.S. EN ISO 80369-7:2021
Current
The latest, up-to-date edition.
Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
Hardcopy , PDF
English
16-06-2021
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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 General requirements
5 Dimensional requirements for Luer connectors
6 Performance requirements
Annex A (informative) Rationale and guidance
Annex B (normative) Luer connectors
Annex C (normative) Reference connectors
Annex D (informative) Assessment of medical devices and their attributes with connections within this application
Annex E (informative) Summary of the usability requirements for Luer connectors for intravascular or hypodermic applications
Annex F (informative) Summary of Luer connector design requirements for intravascular or hypodermic applications
Annex G (informative) Summary of assessment of the design of the Luer connector for intravascular or hypodermic applications
Annex H (informative) Reference to the essential principles
Annex I (informative) Reference to the general safety and performance requirements
Annex J (informative) Terminology — Alphabetized index of defined terms
Bibliography
This document specifies dimensions and requirements for the design and functional performance of small-bore connectors intended to be used for connections in intravascular applications or hypodermic connections in hypodermic applications of medical devices and accessories.
| Committee |
TC 210
|
| DocumentType |
Standard
|
| Pages |
64
|
| 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 80369-7:2021 | Identical |
| EN ISO 80369-7:2021 | Identical |
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