International Standard
ISO 80369-3:2016
Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors for enteral applications
Reference number
ISO 80369-3:2016
Edition 1
2016-07
International Standard
Read sample
ISO 80369-3:2016
50731
Published (Edition 1, 2016)
This standard was last reviewed and confirmed in 2023. Therefore this version remains current.
This standard has 1 amendment.

ISO 80369-3:2016

ISO 80369-3:2016
50731
Language
Format
CHF 173
Convert Swiss francs (CHF) to your currency

Abstract

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.

General information

  •  : Published
     : 2016-07
    : International Standard confirmed [90.93]
  •  : 1
     : 39
  • ISO/TC 210
    11.040.25 
  • RSS updates

 Amendments

Amendments are issued when it is found that new material may need to be added to an existing standardization document. They may also include editorial or technical corrections to be applied to the existing document.

Amendment 1

Edition 2019

ISO 80369-3:2016/Amd 1:2019
74038
Language
Format
CHF 18
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Life cycle

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