| Publication CODE |
Title |
| NBN EN 60601-2-45:2011 (2011-03) |
MEDICAL ELECTRICAL EQUIPMENT
PART 2-45: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MAMMOGRAPHIC X-RAY EQUIPMENT AND MAMMOGRAPHIC STEREOTACTIC DEVICES |
| |
| Price Excl. VAT |
Total number of pages, tables and drawings |
|
25.00 €
|
5 P. |
Description
Applies to the basic safety and essential performance of mammographic x-ray equipment and mammographic stereotactic devices, hereafter also referred to as ME equipment.
Note 1: this includes mammographic x-ray equipment using integrated digital x-ray image receptors or integrated storage phosphor subsystems.
Excluded from the scope of this document are:
- reconstructive tomography modes of operation;
- diagnostic consoles;
- picture archiving and communication systems (pacs);
- non-integrated storage phosphor readers;
- hard copy cameras;
- films, screens and cassettes;
- computer aided detection (cad);
- devices for performing core biopsy and other biopsy instruments;
- modes of operation intended to demonstrate local contrast medium uptake (contrast enhanced digital mammography);
If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant.
Note 2: IEC60601-2-7:1998 and IEC60601-2-32 are not part of the 3rd edition scheme for ammographic x-ray equipment and mammographic stereotactic devices.
|
| 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 60601-2-45:2011.
For the series NBN EN 50XXX, the standards are however complete.
|
EN version
|
FR version
|
DE version
|
|
| Status |
Registered trilingual Belgian standard EN or FR or DE |
| Situation |
Currently active
Replaces
NBN EN 60601-2-45:2001
|
|
| Committee |
TC 62/SC 62B
DIAGNOSTIC IMAGING EQUIPMENT
|
| BEC Approval |
2011-03-17 |
| NBN Approval |
2011-05-20 |
| Belgian Official Journal |
2011-07-14 |
| Registration |
116062 |
| Numbers identifying the european directives |
93/42/EEC
(Medical devices)
|
| ICS-Code (International Standards Classification) |
11.040.50
|
| NBN Status |
Adapted |
|
| Date of ratification (d.o.r.) |
2011-03-17 |
| Date of availability (d.a.v.) |
2011-03-18 |
| Date of announcement (d.o.a.) |
2011-06-17 |
| Date of publication (d.o.p.) |
2011-12-17 |
| Date of withdrawal former edition (d.o.w.) |
2014-03-17 |
|
