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CEI EN 80369-5 : 1ED 2017

Current
Current

The latest, up-to-date edition.

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

04-17-2017

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.

Committee
CT 62
DevelopmentNote
Classificazione CEI 62-251. (04/2017) New child AC 2022 is added
DocumentType
Standard
ProductNote
New child AC 2022 is added
PublisherName
Comitato Elettrotecnico Italiano
Status
Current

EN ISO 5356-1:2015 Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets (ISO 5356-1:2015)
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
ISO 5356-2:2012 Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors
ISO 8185:2007 Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems
ASTM D 790 : 2017 : REDLINE Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
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)
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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