Publication details
| Publication CODE |
Title |
| NBN EN 60601-2-25:2015 (2015-10) |
MEDICAL ELECTRICAL EQUIPMENT - PART 2-25: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROCARDIOGRAPHS |
| |
| Price Excl. VAT |
Total number of pages, tables and drawings |
|
25.00 €
|
4 P.. |
Description
Applies to the basic safety and essential performance of electrocardiographs intended by themselves or as a part of a medical electrical system, for the production of electrocardiogram reports for diagnostic purposes. The equipment intended for use under extreme or uncontrolled environmental conditions outside the hospital environment or physician's office, such as in ambulances and air transport, shall comply with this particular standard. Additional standards may apply to Medical electrical equipment for those environments of use. Not included within the scope of this particular standard are:
a) the part of Medical electrical equipment that provides vectorcardiographic loops;
b) ambulatory electrocardiographic medical electrical equipment covered by IEC 60601-2-47 where not intended for obtaining electrocardiogram reports for diagnostic purposes;
c) cardiac monitors covered by IEC 60601-2-27 where not intended for obtaining electrocardiographic reports for diagnostic purposes.
This second edition cancels and replaces the first edition of IEC 60601-2-25, published in 1993 and the first edition of IEC 60601-2-51, published in 2003.
Updating the particular standards to refer to the third edition of the general standard provided the opportunity to merge the first editions of IEC 60601-2-25 and IEC 60601-2-51 into one standard. Reformatting and technical changes were both made. This second edition of IEC 60601-2-25 constitutes a technical revision of both those standards.
|
| 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 60601-2-25:2011.
For the series NBN EN 50XXX, the standards are however complete.
|
DE version
|
EN version
|
FR version
|
|
Status
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 |
159742 |
| Numbers identifying the european directives |
93/42/EEC
(Medical devices)
|
| ICS-Code (International Standards Classification) |
11.040.55
, 11.040.99
|
| 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 60601-2-25:2015
|
2015-10-23 |
| is identical to |
IEC 60601-2-25:2011/ed. 2.0
|
2011-10-19 |
Relations to belgian/foreign publications
| Type |
Origin |
Code |
Date |
| Standard |
Belgium |
NBN EN 60601-1-2:2007 |
|
| Standard |
Belgium |
NBN EN 60601-2-2:2009 |
|
|
