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
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.
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
Important note : Users cannot be edited or removed once added to your Multi user PDF.Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.