I.S. EN ISO 80369-3:2016
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 ENTERAL
SMALL-BORE CONNECTORS
6 Performance requirements
Annex A (informative) - Rationale and guidance
Annex B (normative) - ENTERAL SMALL-BORE
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 SMALL-BORE
CONNECTORS for ENTERAL applications
Annex F (informative) - Summary of SMALL-BORE
CONNECTOR criteria and requirements for
ENTERAL APPLICATIONS
Annex G (informative) - Summary of assessment of
the design of the CONNECTORS for ENTERAL
APPLICATIONS
Annex H (informative) - Reference to the essential
(informative) - Terminology - Alphabetized
index of defined terms
Bibliography
Annex ZA (informative) - Relationship between this
document and the Essential Requirements of
EU Directive 93/42/EEC
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