I.S. EN 80369-5:2016

Superseded

SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 5: CONNECTORS FOR LIMB CUFF INFLATION APPLICATIONS

Available format(s)

Hardcopy , PDF

Superseded date

07-24-2021

Language(s)

English

Published date

01-01-2017

Publisher

National Standards Authority of Ireland

Preview

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

National Foreword
FOREWORD
INTRODUCTION
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Dimensional requirements for
  sphygmomanometer and cuff SMALL-BORE CONNECTORS
6 Performance requirements
Annex A (informative) - Rationale and guidance
Annex B (normative) - SMALL-BORE CONNECTORS for
        the limb cuff inflation APPLICATION
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
        limb cuff inflation APPLICATIONS
Annex F (informative) - Summary of SMALL-BORE
        CONNECTOR design requirements for limb cuff
        inflation APPLICATIONS
Annex G (informative) - Summary of assessment
        of the design of the CONNECTORS for limb cuff
        inflation APPLICATION
Annex H (informative) - Obsolete limb cuff inflation
        CONNECTOR
Annex I (informative) - Air leakage by pressure decay
        TEST METHOD
Annex J (informative) - Resistance to separation from
        axial load TEST METHOD
Annex K (informative) - Reference to the essential principles
Index of defined terms
Bibliography
Annex ZA (normative) - Normative references to
         international publications with their
         corresponding European publications
Annex ZZ (informative) - Relationship between this
         European standard and the essential
         requirements of Directive 93/42/EEC
         [OJ L 169] aimed to be covered

Defines dimensions and requirements for the design and functional performance of SMALL-BORE CONNECTORS intended to be used for CONNECTIONS in limb cuff inflation APPLICATIONS of MEDICAL DEVICES and ACCESSORIES.

DevelopmentNote	2016 Edition issued incorporating corrigendum 2017. (05/2017)
DocumentType	Standard
Pages	104
PublisherName	National Standards Authority of Ireland
Status	Superseded
SupersededBy	I.S. EN 80369-5:2016 + COR 2017

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ISO 81060-1:2007	Non-invasive sphygmomanometers — Part 1: Requirements and test methods for non-automated measurement type
EN ISO 80369-1:2010	Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2010)
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ANSI B11 : 2008	GENERAL SAFETY REQUIREMENTS COMMON TO ANSI B11 MACHINES
ISO 3040:2016	Geometrical product specifications (GPS) Dimensioning and tolerancing Cones
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CR 13825:2000	Luer connectors - A report to CEN chef from the CEN forum task group "Luer fittings"
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
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IEC 80601-2-30:2009+AMD1:2013 CSV	Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
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ISO 80369-1:2010	Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirements
EN ISO 14971:2012	Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
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EN ISO 8185:2009	Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems (ISO 8185:2007)
ISO 594-2:1998	Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings
ISO 594-1:1986	Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements
ASTM D 638 : 2014 : REDLINE	Standard Test Method for Tensile Properties of Plastics
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