ISO 80369-6:2016

Title

Language: EN Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications

Language: FR Raccords de petite taille pour liquides et gaz utilisés dans les domaine de la santé - Partie 6: Raccords destinés à des applications en contact avec le système nerveux (neuraxiales)

Abstract

Language: EN ISO 80369-6:2016 specifies requirements for small-bore connectors intended to be used for connections in neuraxial applications. Neuraxial applications involve the use of medical devices intended to administer medications to neuraxial sites, wound infiltration anaesthesia delivery, and other regional anaesthesia procedures or to monitor or remove cerebro-spinal fluid for therapeutic or diagnostic purposes. NOTE 1 Sites for the neuraxial application include the spine, intrathecal or subarachnoid space, ventricles of the brain, and the epi-, extra-, or peri-dural space. Neuraxial application anaesthetics can be administered regionally affecting a large part of the body, such as a limb, and include plexus blocks, such as the branchial plexus blocks or single nerve blocks. Neuraxial application procedures include continuous infusion of wounds with local anaesthetic agents. NOTE 2 For the purposes of this part of ISO 80369, local anaesthesia injected hypodermically is not considered a neuraxial application. EXAMPLES Intended administration includes intrathecal chemotherapy, local anaesthetics, radiological contrast agents, antibiotics, analgesics. This part of ISO 80369 specifies dimensions and requirements for the design and functional performance of these small-bore connectors intended to be used with medical devices. This part of ISO 80369 does not specify 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. NOTE 3 Manufacturers are encouraged to incorporate the small-bore connectors specified in this part of ISO 80369 into medical devices, medical systems, 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 this part of ISO 80369, will be included. Furthermore, it is recognized that standards need to be developed for many medical devices used for neuraxial applications. NOTE 4 ISO 80369-1:2010, 5.8, specifies alternative methods of compliance with ISO 80369-1:2010, for small-bore connectors intended for use with neuraxial application medical devices or accessories, which do not comply with this part of ISO 80369.

Language(s)
Language: FR
Edition
1.0
Date of issue
10.02.2016
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)
€ 150,50 (Download and hardcopy)
Delivery format
postal download (45 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