International Standard
ISO 80369-6:2016
Small bore connectors for liquids and gases in healthcare applications — Part 6: Connectors for neuraxial applications
Reference number
ISO 80369-6:2016
Edición 1
2016-03
International Standard
Vista previa
ISO 80369-6:2016
50734
No disponible en español
Publicado (Edición 1, 2016)

ISO 80369-6:2016

ISO 80369-6:2016
50734
Idioma
Formato
CHF 173
Convertir Franco suizo (CHF) a tu moneda

Resumen

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.

Informaciones generales

  •  : Publicado
     : 2016-03
     : 2016-11
     : 2016-11
    : Norma Internacional para revisar [90.92]
  •  : 1
     : 45
  • ISO/TC 210
    11.040.25 
  • RSS actualizaciones

Próxima versión en desarrollo

Draft International Standard
ISO/DIS 80369-6
Small bore connectors for liquids and gases in healthcare applications — Part 6: Connectors for neural applications
Reference number
ISO/DIS 80369-6
Edición 1
Draft
International Standard

ISO/DIS 80369-6

Small bore connectors for liquids and gases in healthcare applications

Part 6: Connectors for neural applications

ISO/DIS 80369-6

ISO/DIS 80369-6
85462
Idioma
Formato
CHF 63
Convertir Franco suizo (CHF) a tu moneda

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