Customer Support: 131 242

  • There are no items in your cart
We noticed you’re not on the correct regional site. Switch to our AMERICAS site for the best experience.
Dismiss alert

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

View more information
$181.69
Including GST where applicable

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.

Need help?
Call us on 131 242, then click here to start a Screen Sharing session
so we can help right away! Learn more