ISO 80369-6:2016 

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

CHF 

Do you need a multi-user copy?

CHF 

Preview

Abstract

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.

Look inside


Additional information

Publication typeInternational Standard
Publication date2016-02-10
Edition1.0
Available language(s)English, French
TC/SCTC 62/SC 62D - Electromedical equipmentrss
ICS11.040.25 - Syringes, needles and catheters
Stability date  2020
Pages45
File size4490 KB

The following test report forms are related:



Share your publications

Learn how to share your publications with your colleagues, using networking options.

Payment information

Our prices are in Swiss francs (CHF). We accept all major credit cards (American Express, Mastercard and Visa), PayPal and bank transfers as form of payment.


Keep in touch

Keep up to date with new publication releases and announcements with our free IEC Just Published email newsletter.

Contact customer services

Please send your enquiry by email or call us on +41 22 919 02 11 between 09:00 – 17:00 CET Monday to Friday.