ÍST EN ISO 80369-6:2025

Staða:

Gildistaka - 12.9.2025

Íslenskt heiti:

Smávíddartengi fyrir vökva og lofttegundir í lækningatækjum – Hluti 6: Tengi til nota við mænudeyfingu

Enskt heiti:

Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neural applications (ISO 80369-6:2025)

Tengdur staðall:

ISO 80369-6:2025

Tækninefnd:

CEN/CLC/JTC 3

ICS flokkur:

11.040

Auglýst:

12.9.2025

Umfang (scope):

NOTE         Clause A.2 contains guidance or rationale for this clause. This document specifies requirements for small-bore connectors intended to be used for connections in neural applications. This document does not specify requirements for the medical devices or accessories that use these connectors. Such requirements are given in particular standards for specific medical devices or accessories.
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* Mynd sem fylgir ÍST EN ISO 80369-6:2016

ÍST EN ISO 80369-6:2016

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 neura
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