Publication details
| Publication CODE |
Title |
| NBN EN 60601-2-5:2015 (2015-10) |
MEDICAL ELECTRICAL EQUIPMENT - PART 2-5: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ULTRASONIC PHYSIOTHERAPY 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 ultrasonic physiotherapy equipment employing a single plane unfocused circular transducer per treatment head, producing static beams perpendicular to the face of the treatment head.
This standard can also be applied to ultrasonic physiotherapy equipment used for compensation or alleviation of disease, injury or disability.
This third edition cancels and replaces the second edition published in 2000.
This edition constitutes a technical revision. The numbering was revised to agree with IEC 60601-1:2005 (third edition). Beyond this, essential performance characteristics are defined in 201.4.3.101, guidance on maintenance is added in 201.7.9.2.1, a new requirement regarding dielectric withstand was added in 201.8.8.3.
The clause on transducer surface temperature rise, 201.11, has been modified to allow for simulated use conditions. Measurements of ultrasound-related parameters are now referenced to IEC 61689:2007 (second edition). The most important change in the ultrasound-related parameters is the definition of effective radiating area, 201.3.207. This change will also affect the value of the effective intensity and its uncertainty.
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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 60601-2-5:2009.
For the series NBN EN 50XXX, the standards are however complete.
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DE version
|
EN version
|
FR version
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|
Status
| Status |
Registered trilingual Belgian standard EN or FR or DE |
| Situation |
Currently active
Replaces
NBN EN 60601-2-5:2001
|
|
Origin
| Committee |
TC 62/SC 62D
ELECTROMEDICAL EQUIPMENT
|
| Responsible |
De heer VAN HECKE Luk
|
Approval
| BEC Approval |
2015-09-15 |
| NBN Approval |
2015-11-30 |
| Belgian Official Journal |
2016-02-02 |
| Registration |
159739 |
| Numbers identifying the european directives |
93/42/EEC
(Medical devices)
|
| ICS-Code (International Standards Classification) |
11.040.60
|
| 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 |
|
Correspondences with international standards
| Relation |
International standard |
Date |
| is identical to |
EN 60601-2-5:2015
|
2015-10-23 |
| is identical to |
IEC 60601-2-5:2009/ed. 3.0
|
2009-07-30 |
Relations to belgian/foreign publications
| Type |
Origin |
Code |
Date |
| Standard |
Belgium |
NBN EN 60601-1-2:2007 |
|
| Standard |
Belgium |
NBN EN 61689:2007 |
|
| Standard |
Belgium |
NBN EN 62127-1:2007 |
|
| Standard |
Belgium |
NBN EN 62127-2:2007 |
|
|
