Publication details
| Publication CODE |
Title |
| NBN EN 60601-2-36:2015 (2015-05) |
MEDICAL ELECTRICAL EQUIPMENT - PART 2-36: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF EQUIPMENT FOR EXTRACORPOREALLY INDUCED LITHOTRIPSY |
| |
| Price Excl. VAT |
Total number of pages, tables and drawings |
|
25.00 €
|
3 P.. |
Description
Applies to basic safety and essential performance of equipment for extracorporeally induced lithotripsy including equipment for other medical applications of therapeutic extracorporeally induced focused pressure pulses.
The applicability of this particular standard is limited to components directly involved in the lithotripsy treatment, such as, but not limited to, the generator of the pressure pulse, patient support device, and their interactions with imaging and monitoring devices.
Other devices, such as patient treatment planning computers, X-ray and ultrasonic devices, are excluded from this standard, because they are treated in other applicable IEC standards.
This particular standard does not apply to ultrasound physiotherapy equipment intended to be used for physiotherapy; abd to ultrasound equipment intended to be used for high intensity therapeutic ultrasound (HITU) and other therapy equipment as described in Annex AA.
This second edition cancels and replaces the first edition.
This edition constitutes a technical revision to align structurally with IEC 60601-1:2005 and its Amendment1:2012.
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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 60601-2-36:2014.
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
Replaces
NBN EN 60601-2-36:1997
|
|
Origin
| Committee |
TC 62/SC 62D
ELECTROMEDICAL EQUIPMENT
|
| Responsible |
De heer VAN HECKE Luk
|
Approval
| BEC Approval |
2014-05-15 |
| NBN Approval |
2015-07-24 |
| Belgian Official Journal |
2015-08-13 |
| Registration |
158294 |
| Numbers identifying the european directives |
93/42/EEC
(Medical devices)
|
| ICS-Code (International Standards Classification) |
11.060.01
|
| NBN Status |
New |
|
| Date of ratification (d.o.r.) |
2014-05-15 |
| Date of availability (d.a.v.) |
2015-05-22 |
| Date of announcement (d.o.a.) |
2015-08-22 |
| Date of publication (d.o.p.) |
2015-11-22 |
| Date of withdrawal former edition (d.o.w.) |
2018-05-22 |
|
Correspondences with international standards
| Relation |
International standard |
Date |
| is identical to |
EN 60601-2-36:2015
|
2015-05-22 |
| is identical to |
IEC 60601-2-36:2014/ed. 2.0
|
2014-04-10 |
Relations to belgian/foreign publications
| Type |
Origin |
Code |
Date |
| Standard |
Belgium |
NBN EN 60601-1-2 |
|
| Standard |
Belgium |
NBN EN 60601-1:2006 |
|
| Standard |
Belgium |
NBN EN 60601-1:2006/A1:2013 |
|
| Standard |
Belgium |
NBN EN 61846:1998 |
|
|
