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I.S. EN 80369-5:2016

I.S. EN 80369-5:2016

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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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Superseded date

24-07-2021

Language(s)

English

Published date

01-01-2017

Publisher

National Standards Authority of Ireland

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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
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

ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications Part 20: Common test methods
EN ISO 5356-1:2015 Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets (ISO 5356-1:2015)
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)
ISO 5356-1:2015 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
ANSI B11 : 2008 GENERAL SAFETY REQUIREMENTS COMMON TO ANSI B11 MACHINES
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
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
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
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
EN ISO 5356-2:2012 Anaesthetic and respiratory equipment - Conical connectors - Part 2: Screw-threaded weight-bearing connectors (ISO 5356-2:2012)
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)
ISO 14971:2007 Medical devices Application of risk management to medical devices
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
ISO 80369-3:2016 Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors for enteral applications

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