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BS EN ISO 80369-3:2016

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

Small-bore connectors for liquids and gases in healthcare applications Connectors for enteral applications
Withdrawn date

03-24-2023

Published date

08-31-2016

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.

This part of ISO80369 specifies 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. NOTE1 Enteral medical devices include enteral feeding sets, enteral drainage sets, enteral syringes, and patient interface devices including access ports. This part of ISO80369 does not specify the dimensions and requirements for the medical devices or accessories that use these connectors. Such requirements are given in particular International Standards for specific medical devices or accessories. This part of ISO80369 does not specify requirements for small-bore connectors that are used for the following: gastric suction-only medical devices; oral-only medical devices; EXAMPLE An oral tip syringe that is not intended to connect to another medical device. It is intended to administer directly to the patient’s mouth. pressurizing and depressurizing the retention mechanism (e.g. balloon) used to hold invasive enteral medical devices in place; medical devices for rectal drainage, rectal administration of medicines or fluid, and any other rectal access medical device; gastrointestinal endoscopy equipment; skin level gastrostomy medical devices. NOTE2 Manufacturers are encouraged to incorporate the small-bore connectors specified in this part of ISO80369 into enteral medical devices or accessories, even if currently not required by the relevant particular medical device standards. It is expected that when the relevant particular medical device standards are revised, requirements for small-bore connectors, as specified in ISO80369, will be included.

Committee
CH/210/5
DevelopmentNote
Supersedes 13/30285694 DC. (08/2016)
DocumentType
Standard
PublisherName
British Standards Institution
Status
Withdrawn
Supersedes

Standards Relationship
ISO 80369-3:2016 Identical
EN ISO 80369-3:2016 Identical

EN 1618 : 1997 CATHETERS OTHER THAN INTRAVASCULAR CATHETERS - TEST METHODS FOR COMMON PROPERTIES
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 10241-2:2012 Terminological entries in standards — Part 2: Adoption of standardized terminological entries
ISO 5356-2:2012 Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors
IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
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 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
EN 1615 : 2000 ENTERAL FEEDING CATHETERS AND ENTERAL GIVING SETS FOR SINGLE USE AND THEIR CONNECTORS - DESIGN AND TESTING
ISO 10241-1:2011 Terminological entries in standards — Part 1: General requirements and examples of presentation
ISO 14971:2007 Medical devices Application of risk management to medical devices
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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