Publication details
| Publication CODE |
Title |
| NBN EN ISO 80369-6:2016 (2016-04) |
SMALL BORE CONNECTORS FOR LIQUIDS AND GASES in HEALTHCARE APPLICATIONS - PART 6: CONNECTORS FOR NEURAXIAL APPLICATIONS (ISO 80369-6:2016) |
| |
| Price Excl. VAT |
Total number of pages, tables and drawings |
|
25.00 €
|
5 P.. |
Description
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.
|
| Class |
C
|
Available files
ATTENTION: Belgian registered standards (NBN EN or NBN HD) are generally
only available in English or French. Only the cover page is translated
and the document itself is in English or in French.
Very important notice: 98% of the text of the NBN EN 55XXX,
NBN EN 6XXXX comes from the IEC text which is NOT included.
This text can be ordered here:
ISO 80369-6:2016.
For the series NBN EN 50XXX, the standards are however complete.
|
|
|
Status
| Status |
Registered trilingual Belgian standard EN or FR or DE |
| Situation |
Currently active
|
|
Origin
| Committee |
CEN/CLC JTC 3
QUALITY MANAGEMENT AND CORRESPONDING GENERAL ASPECTS FOR MEDICAL DEVICES
|
Approval
| BEC Approval |
2016-02-20 |
| NBN Approval |
2016-05-27 |
| Belgian Official Journal |
2016-06-14 |
| Registration |
176240 |
| Numbers identifying the european directives |
93/42/EEC
(Medical devices)
|
| ICS-Code (International Standards Classification) |
11.040.25
|
| NBN Status |
New |
|
| Date of ratification (d.o.r.) |
2016-02-20 |
| Date of availability (d.a.v.) |
2016-04-13 |
| Date of announcement (d.o.a.) |
2016-07-31 |
| Date of publication (d.o.p.) |
2016-10-31 |
| Date of withdrawal former edition (d.o.w.) |
2016-10-31 |
|
Correspondences with international standards
| Relation |
International standard |
Date |
| is identical to |
EN ISO 80369-6:2016
|
|
| is identical to |
ISO 80369-6:2016/ed. 1.0
|
2016-02-10 |
|
