Name: CEI UNI EN/ISO 80369-7 : 1ED 2017
Brand: CEI

SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 7: CONNECTORS FOR INTRAVASCULAR OR HYPODERMIC APPLICATIONS

Published date

19-12-2017

Publisher

Comitato Elettrotecnico Italiano

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.

Committee	CT 62
DevelopmentNote	Classificazione CEI 62-253. (12/2017)
DocumentType	Standard
PublisherName	Comitato Elettrotecnico Italiano
Status	Current

Standards	Relationship
UNI CEI EN ISO 80369-7 : 2017	Identical
EN ISO 80369-7:2017	Identical
ISO 80369-7:2016	Identical

ISO 80369-20:2015	Small-bore connectors for liquids and gases in healthcare applications Part 20: Common test methods
ISO 80369-6:2016	Small bore connectors for liquids and gases in healthcare applications — Part 6: Connectors for neuraxial applications
ASTM D 790 : 2017 : REDLINE	Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
ISO 80369-1:2010	Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirements
ISO 14971:2007	Medical devices Application of risk management to medical devices
ASTM D 638 : 2014 : REDLINE	Standard Test Method for Tensile Properties of Plastics