Cena s DPH / bez DPH
Hlavní stránka>ČSN EN ISO 80369-6 - Konektory s malým vnitřním průměrem pro kapaliny a plyny používané ve zdravotnictví - Část 6: Konektory pro neuraxiální použití
Sponsored link
Vydáno: 01.09.2016
ČSN EN ISO 80369-6 - Konektory s malým vnitřním průměrem pro kapaliny a plyny používané ve zdravotnictví - Část 6: Konektory pro neuraxiální použití

ČSN EN ISO 80369-6

Konektory s malým vnitřním průměrem pro kapaliny a plyny používané ve zdravotnictví - Část 6: Konektory pro neuraxiální použití

Formát
Dostupnost
Cena a měna
Anglicky Tisk
Skladem
495 Kč
Označení normy:ČSN EN ISO 80369-6
Třídící znak:852112
Počet stran:60
Vydáno:01.09.2016
Harmonizace:Norma není harmonizována
Katalogové číslo:500449
Popis

ČSN EN ISO 80369-6

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 I- SO 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.