| Publication CODE |
Title |
| NBN EN 60601-2-43:2010 (2010-06) |
MEDICAL ELECTRICAL EQUIPMENT
PART 2-43: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR INTERVENTIONAL PROCEDURES |
| |
| Price Excl. VAT |
Total number of pages, tables and drawings |
|
25.00 €
|
3 P. |
Description
Establishes particular basic safety and essential performance requirements for the design and manufacture of X ray equipment for radioscopically guided interventional procedures. It specifies information which is to be provided with such interventional X-ray equipment for the assistance of the responsible organization and operator in managing the radiation risk and equipment failure risk arising from these procedures which could affect patients or staff. This second edition cancels and replaces the first edition published in 2000. This particular standard has been revised to provide a complete set of safety requirements for X-ray equipment for radioscopically guided interventional procedures, based on the third edition of IEC 60601-1 and relevant collaterals. The present edition is extended to become a system standard for X-ray equipment designed for the use during interventional procedures using X-ray imaging, whether of prolonged or normal duration.
Supersedes EN 60601-2-43:2000 (completely) and EN 60601-2-54:2009 (PR=21882) (partially: interventional aspects of radiography and radioscopy only)
|
| 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.
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:
IEC 60601-2-43:2010.
For the series NBN EN 50XXX, the standards are however complete.
|
EN version
|
FR version
|
DE version
|
|
| Committee |
TC 62/SC 62B
DIAGNOSTIC IMAGING EQUIPMENT
|
| BEC Approval |
2010-06-01 |
| NBN Approval |
2010-08-27 |
| Belgian Official Journal |
2010-10-18 |
| Registration |
107261 |
| Numbers identifying the european directives |
93/42/EEC
(Medical devices)
|
| ICS-Code (International Standards Classification) |
11.040.50
, 37.040.25
|
| NBN Status |
New |
|
| Date of ratification (d.o.r.) |
2010-06-01 |
| Date of availability (d.a.v.) |
2010-06-11 |
| Date of announcement (d.o.a.) |
2010-09-01 |
| Date of publication (d.o.p.) |
2011-03-01 |
| Date of withdrawal former edition (d.o.w.) |
2013-06-01 |
| Date of cessation of conformity (d.o.c.) |
2013-06-01 |
|
