I.S. EN ISO 80369-7:2017 COR 2017
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 7: CONNECTORS FOR INTRAVASCULAR OR HYPODERMIC APPLICATIONS (ISO 80369-7:2016, CORRECTED VERSION 2016-12-01)
Hardcopy , PDF
English
04-07-2017
01-02-2019
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Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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National Foreword
European foreword
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) - Terminology - Alphabetized index
of defined terms
Bibliography
Annex ZA (informative) - Relationship between this
European standard and the essential
requirements of Directive 93/42/EEC [OJ L 169]
aimed to be covered
Defines 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.
| DevelopmentNote |
Supersedes I.S. EN 1707 & I.S. EN 20594-1. (06/2017)
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| DocumentType |
Standard
|
| Pages |
0
|
| PublisherName |
National Standards Authority of Ireland
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| Status |
Superseded
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| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| EN ISO 80369-7:2017 | Identical |
| ISO 80369-7:2016 | Identical |
| BS EN ISO 80369-7 : 2017 COR 2017 | Equivalent |