I.S. EN ISO 80369-6:2016
Current
The latest, up-to-date edition.
Hardcopy , PDF
English
01-01-2016
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.
National Foreword
European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Dimensional requirements for neuraxial SMALL-BORE
CONNECTORS
6 Performance requirements
Annex A (informative) - Rationale and guidance
Annex B (normative) - SMALL-BORE CONNECTORS for neuraxial
APPLICATIONS
Annex C (normative) - Reference CONNECTORS for testing
SMALL-BORE CONNECTORS for neuraxial APPLICATIONS
Annex D (informative) - Assessment of MEDICAL DEVICES
and their attributes with CONNECTIONS within this
APPLICATION
Annex E (informative) - Summary of the usability requirements
for SMALL-BORE CONNECTORS for neuraxial APPLICATIONS
Annex F (informative) - Summary of SMALL-BORE CONNECTOR
design requirements for neuraxial APPLICATIONS
Annex G (informative) - Summary of assessment of the design
of the SMALL BORE CONNECTORS for neuraxial
APPLICATIONS
Annex H (normative) - Mechanical tests for verifying
NON-INTERCONNECTABLE characteristics
Annex I (informative) - Reference to the essential principles
Annex J (informative) - Terminology - alphabetized index
of defined terms
Bibliography
Annex ZA (informative) - Relationship between this
European Standard and the Essential
Requirements of EU Directive 93/42/EEC
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