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BS EN ISO 80369-3 : 2016

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BS EN ISO 80369-3 : 2016

SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 3: CONNECTORS FOR ENTERAL APPLICATIONS (ISO 80369-3:2016)

British Standards Institution

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Table of Contents

Foreword<br>Introduction<br>1 Scope<br>2 Normative references<br>3 Terms and definitions<br>4 General requirements<br>5 Dimensional requirements for ENTERAL<br>&nbsp;&nbsp;SMALL-BORE CONNECTORS<br>6 Performance requirements<br>Annex A (informative) - Rationale and guidance<br>Annex B (normative) - ENTERAL SMALL-BORE<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;CONNECTORS<br>Annex C (normative) - Reference CONNECTORS<br>Annex D (informative) - Assessment of MEDICAL<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;DEVICES and their attributes with<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;CONNECTIONS within this APPLICATION<br>Annex E (informative) - Summary of the usability<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;requirements for SMALL-BORE<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;CONNECTORS for ENTERAL applications<br>Annex F (informative) - Summary of SMALL-BORE<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;CONNECTOR criteria and requirements for<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;ENTERAL APPLICATIONS<br>Annex G (informative) - Summary of assessment of<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;the design of the CONNECTORS for ENTERAL<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;APPLICATIONS<br>Annex H (informative) - Reference to the essential<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;principles<br>Annex I (informative) - Terminology - Alphabetized<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;index of defined terms<br>Bibliography<br>Annex ZA (informative) - Relationship between this<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;document and the Essential Requirements of<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;EU Directive 93/42/EEC

Abstract

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.

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Document Type Standard
Status Current
Publisher British Standards Institution
Committee CH/210/5
Supersedes
  • 13/30285694 DC : 0