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ISO/DIS 18250-3 : 60.00 (2018)

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ISO/DIS 18250-3 : 60.00 (2018)

MEDICAL DEVICES - CONNECTORS FOR RESERVOIR DELIVERY SYSTEMS FOR HEALTHCARE APPLICATIONS - PART 3: ENTERAL APPLICATIONS

International Organization for Standardization

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Table of Contents

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirement
5 Dimensional requirements for ENTERAL
  feed reservoir CONNECTORS
6 Performance requirements
Annex A (informative) - Rationale and guidance
Annex B (normative) - RESERVIOR CONNECTORS for access port
        on ENTERAL feeding sets and PATIENT interfaces
Annex C (informative) - 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
        RESERVIOR CONNECTORS for ENTERAL APPLICATIONS
ANNEX F (informative) - Summary of RESERVIOR 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
Bibliography
Terminology - Alphabetized index of defined terms
Annex ZA (informative) - Relationship between the document
         and the Essential Requirements of EU Directive 93/42/EEC

Abstract

Defines dimensions and requirements for the design and functional performance of CONNECTORS intended to be used on ENTERAL feed reservoirs.

General Product Information

Document Type Standard
Status Current
Publisher International Organization for Standardization
Committee TC 210