| Publication CODE |
Title |
| NBN EN 45502-2-3:2010 (2010-02) |
ACTIVE IMPLANTABLE MEDICAL DEVICES
PART 2-3: PARTICULAR REQUIREMENTS FOR COCHLEAR AND AUDITORY BRAINSTEM IMPLANT SYSTEMS |
| |
| Price Excl. VAT |
Total number of pages, tables and drawings |
|
70.00 €
|
45 P ; 3 TAB ; 8 FIG. |
Description
Specifies requirements that are applicable to those active implantable medical devices that are intended to treat hearing impairment via electrical stimulation of the auditory pathways. Devices which treat hearing impairment via means other than electrical stimulation are not covered by this Standard.
The tests that are specified in EN 45502 are type tests and are to be carried out on samples of a device to show compliance.
Is also applicable to non-implantable parts and accessories of the devices.
The electrical characteristics of the implantable part shall be determined by either the appropriate method detailed in this particular standard or by any other method demonstrated to have an accuracy equal to, or better than, the method specified. In the case of dispute, the method detailed in this particular standard shall apply.
|
| Class |
C74
(EQUIPMENT USING ELECTRICAL POWER RADIOLOGY AND SIMILAR ELECTRICAL APPLIANCES AND THEIR ACCESSORIES)
|
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.
|
EN version
|
FR version
|
DE version
|
|
| Status |
Registered trilingual Belgian standard EN or FR or DE |
| Situation |
Currently active
|
|
| Committee |
JWGAIMD
See TC 62WGXA1 (field of TC 62)
|
| BEC Approval |
2010-02-01 |
| NBN Approval |
2010-03-19 |
| Belgian Official Journal |
2010-05-05 |
| Registration |
105821 |
| Numbers identifying the european directives |
90/385/EEC
(Active implantable medical devices)
|
| ICS-Code (International Standards Classification) |
11.040.40
|
| NBN Status |
New |
|
| Date of ratification (d.o.r.) |
2010-02-01 |
| Date of availability (d.a.v.) |
2010-02-19 |
| Date of announcement (d.o.a.) |
2010-08-01 |
| Date of publication (d.o.p.) |
2011-02-01 |
| Date of withdrawal former edition (d.o.w.) |
2013-02-01 |
|
