Publication CODE |
Title |
NBN EN 60601-2-18:2015 (2015-10) |
MEDICAL ELECTRICAL EQUIPMENT - PART 2-18: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ENDOSCOPIC EQUIPMENT |
|
Price Excl. VAT |
Total number of pages, tables and drawings |
25.00 €
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4 P.. |
Description
Establishes particular basic safety and essential performance requirements for endoscopic equipment. The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operation of endoscopic equipment. IEC 60601-2-18:2009 amends and supplements IEC 60601-1:2005.
This edition cancels and replaces the Previous edition.
This edition constitutes a technical revision and has been aligned or harmonized with IEC 60601-1:2005.
The main changes with respect to the previous edition include:
- alignment of requirements with IEC 60601-1:2005;
- inclusion of essential performance requirements;
- the inclusion of energized endoscopes and energized endotherapy devices used through second and subsequent punctures within the scope of the standard;
- reference to IEC 60601-2-2 for the dielectric strength testing of HF energized endotherapy devices, rather than defining different tests.
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Class |
C
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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 60601-2-18:2009.
For the series NBN EN 50XXX, the standards are however complete.
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DE version
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EN version
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FR version
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Committee |
CLC TC 62
ELECTRICAL EQUIPMENTS IN MEDICAL PRACTICE
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Responsible |
De heer VAN HECKE Luk
|
BEC Approval |
2015-09-15 |
NBN Approval |
2015-11-30 |
Belgian Official Journal |
2016-02-02 |
Registration |
159740 |
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.) |
2015-09-15 |
Date of availability (d.a.v.) |
2015-10-23 |
Date of announcement (d.o.a.) |
2015-12-15 |
Date of publication (d.o.p.) |
2016-06-15 |
Date of withdrawal former edition (d.o.w.) |
2018-09-15 |
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