ISO 80369-3:2016

Title

Language: EN Small-bore connectors for liquids and gases in healthcare applications -- Part 3: Connectors for enteral applications

Language: FR Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé - Partie 3: Raccords destinés à des applications entérales

Abstract

Language: EN 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.

Language(s)
Language: FR
Edition
1.0
Date of issue
01.07.2016
TC 62/SC 62D
ICS Codes
11.040.25
Publication number
80369
Preview

To use the preview feature, please enable JavaScript in your Browser


Price (excl. VAT)
€ 143,60 (Download and hardcopy)
Delivery format
postal download (39 Pages)

Warenkorb

Back

Legend

Document for download (PDF) PDF document (download version)
ZIP File for download ZIP file (download version)
Shipping item Paper (print version)/shipping item
Adobe DRM ePub File E-book (Adobe DRM ePub)
Storage medium Storage medium
Database Database
Bezugsart Online Viewing access (7-days available online)
Mandatory Standard according current regulation Mandatory Standard according current regulation

This website uses cookies. By continuing to use this website you are giving consent to cookies being used. For information on cookies, please look at our privacy statement.