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I.S. EN ISO 80369-6:2016

Current

Current

The latest, up-to-date edition.

SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 6: CONNECTORS FOR NEURAXIAL APPLICATIONS (ISO/IEC/DIS 80369-6:2014)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2016

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.


Dates of withdrawal of national standards are available from NSAI.

National Foreword
European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Dimensional requirements for neuraxial SMALL-BORE
  CONNECTORS
6 Performance requirements
Annex A (informative) - Rationale and guidance
Annex B (normative) - SMALL-BORE CONNECTORS for neuraxial
        APPLICATIONS
Annex C (normative) - Reference CONNECTORS for testing
        SMALL-BORE CONNECTORS for neuraxial APPLICATIONS
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 neuraxial APPLICATIONS
Annex F (informative) - Summary of SMALL-BORE CONNECTOR
        design requirements for neuraxial APPLICATIONS
Annex G (informative) - Summary of assessment of the design
        of the SMALL BORE CONNECTORS for neuraxial
        APPLICATIONS
Annex H (normative) - Mechanical tests for verifying
        NON-INTERCONNECTABLE characteristics
Annex I (informative) - Reference to the essential principles
Annex J (informative) - Terminology - alphabetized index
        of defined terms
Bibliography
Annex ZA (informative) - Relationship between this
         European Standard and the Essential
         Requirements of EU Directive 93/42/EEC

Defines requirements for SMALL-BORE CONNECTORS intended to be used for CONNECTIONS in neuraxial APPLICATIONS.

DocumentType
Standard
Pages
66
PublisherName
National Standards Authority of Ireland
Status
Current

Standards Relationship
EN ISO 80369-6 : 2016 COR 2016 Identical
ISO 80369-6:2016 Identical
EN ISO 80369-6:2016 Identical

ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications Part 20: Common test methods
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
ISO 5356-1:2015 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
ISO 3040:2016 Geometrical product specifications (GPS) Dimensioning and tolerancing Cones
ISO 5356-2:2012 Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors
ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
ISO 8185:2007 Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems
ISO/TR 16142:2006 Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
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
ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements
EN 13544-2:2002+A1:2009 Respiratory therapy equipment - Part 2: Tubing and connectors
ASTM D 638 : 2014 : REDLINE Standard Test Method for Tensile Properties of Plastics

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