EN ISO 80369-3:2016

European foreword
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

ISO 80369-3:2016 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.NOTE 1 Enteral medical devices include enteral feeding sets, enteral drainage sets, enteral syringes, and patient interface devices including access ports.It 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.It 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.NOTE 2 Manufacturers are encouraged to incorporate the small-bore connectors specified in ISO 80369-3 :2016 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 ISO 80369, will be included.