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CEI UNI EN ISO 80369-3 : 2017

Current

Current

The latest, up-to-date edition.

SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 3: CONNECTORS FOR ENTERAL APPLICATIONS

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2017

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
        principles
Annex I (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

Defines the dimensions and requirements for the design and functional performance of small-bore connectors intended to be used for connections on enteral medical devices and accessories.

Committee
CT 62
DevelopmentNote
Classificazione CEI 210-214. (02/2017)
DocumentType
Standard
Pages
54
PublisherName
Comitato Elettrotecnico Italiano
Status
Current

Standards Relationship
UNI CEI EN ISO 80369-3 : 2016 Identical
EN ISO 80369-3:2016 Identical
ISO 80369-3:2016 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 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications Part 7: Connectors for intravascular or hypodermic applications
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

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