Publication details
| Publication CODE |
Title |
| NBN EN 60601-2-63:2015 (2015-05) |
MEDICAL ELECTRICAL EQUIPMENT - PART 2-63: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL EXTRA-ORAL X-RAY EQUIPMENT |
| |
| Price Excl. VAT |
Total number of pages, tables and drawings |
|
25.00 €
|
4 P.. |
Description
Applies to the basic safety and essential performance of dental extra-oral X-ray equipment, hereafter also called ME equipment. The scope includes ME systems containing such ME equipment.
This particular standard has been prepared to provide, based on IEC 60601-1:2005 and its collaterals, a complete set of basic safety and essential performance requirements for dental extra-oral x-ray equipment.
While the previously existing standards for such equipment were dedicated to components and subsystems, this particular standard addresses the system level of dental extra-oral x-ray equipment. Components and their functions are addressed as far as necessary.
The scope of this standard is restricted to X-ray equipment where:
- the x-ray tube assembly contains the high-voltage transformer assembly; and
- the geometrical relations between the X-ray source, the anatomical object being imaged in the patient, and the X-ray image receptor, are preset in the design and cannot be arbitrarily altered by the operator during intended use.
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| 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:
IEC 60601-2-63:2012.
For the series NBN EN 50XXX, the standards are however complete.
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EN version
|
DE version
|
FR version
|
|
Status
| Status |
Registered trilingual Belgian standard EN or FR or DE |
| Situation |
Currently active
|
|
Origin
| Committee |
TC 62/SC 62B
DIAGNOSTIC IMAGING EQUIPMENT
|
Approval
| BEC Approval |
2012-10-24 |
| NBN Approval |
2015-07-24 |
| Belgian Official Journal |
2015-08-13 |
| Registration |
158300 |
| Numbers identifying the european directives |
93/42/EEC
(Medical devices)
|
| ICS-Code (International Standards Classification) |
11.040.50
|
| NBN Status |
New |
|
| Date of ratification (d.o.r.) |
2012-10-24 |
| Date of availability (d.a.v.) |
2015-05-29 |
| Date of announcement (d.o.a.) |
2015-08-29 |
| Date of publication (d.o.p.) |
2015-11-29 |
| Date of withdrawal former edition (d.o.w.) |
2018-05-29 |
|
Correspondences with international standards
| Relation |
International standard |
Date |
| is identical to |
EN 60601-2-63:2015
|
2015-05-29 |
| is identical to |
IEC 60601-2-63:2012/ed. 1.0
|
2012-09-19 |
Relations to belgian/foreign publications
| Type |
Origin |
Code |
Date |
| Standard |
Foreign |
IEC/PAS 61910-1:2007 |
|
| Document |
Foreign |
IEC/TR 60788:2004 |
|
| Standard |
Belgium |
NBN EN 60336 |
|
| Standard |
Belgium |
NBN EN 60601-1-2:2007 |
|
| Standard |
Belgium |
NBN EN 60601-1-3:2008 |
|
| Standard |
Belgium |
NBN EN 60601-2-29:2008 |
|
| Standard |
Belgium |
NBN EN 60601-2-54:2009 |
|
|
