Hivatkozási szám

MSZ EN ISO 80369-6:2016

Dokumentumazonosító

163639

Cím

Egészségügyben használatos, kis belső átmérőjű csatlakozók folyadékokhoz és gázokhoz. 6. rész: Csatlakozók gerincközeli alkalmazásokhoz (ISO 80369-6:2016, 2016. 11. 15-ei helyesbített változat)

Angol cím

Small bore connectors for liquids and gases in healthcare applications. Part 6: Connectors for neuraxial applications (ISO 80369-6:2016, Corrected version 2016.11. 15.)

Alkalmazási terület

This part of ISO 80369 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 smallbore connectors intended for use with neuraxial application medical devices or accessories, which do not comply with this part of ISO 80369.

ICS

11.040.25 Fecskendők, tűk és katéterek

Műszaki Bizottság

A szabvány nyelve

angol

Az érvényesség kezdete

2016-09-01

Forrás

idt EN ISO 80369-6:2016; idt ISO 80369-6:2016

Előd

Utód

Módosítás

SZK-közlemények

2017/02: Helyesbítés

Kapcsolódó európai jogszabály

93/42/EGK A TANÁCS 93/42/EGK IRÁNYELVE (1993. június 14.) az orvostechnikai eszközökről (MDV93)

A szabvány

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