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Publication details

Publication CODE Title
NBN EN 60601-2-47:2015 (2015-05) MEDICAL ELECTRICAL EQUIPMENT - PART 2-47: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS
 
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Description
Concerns the basic safety and essential performance of AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS. It amends and supplements the general standard IEC 60601-1 (third edition 2005). The requirements of this particular standard take priority over those of the general standard. Within the scope of this standard are systems of the following types: a) systems that provide continuous recording and continuous analysis of the ECG allowing full re-analysis giving essentially similar results. b) systems that provide continuous analysis and only partial or limited recording not allowing a full re-analysis of the ECG. The safety aspects of this standard apply to all types of systems falling in one of the above- mentioned categories. If the AMBULATORY ELECTROCARDIOGRAPHIC SYSTEM offers automatic ECG analysis, minimal performance requirements for measurement and analysis functions apply. MEDICAL ELECTRICAL EQUIPMENT covered by IEC 60601-2-25 and IEC 60601-2-27 are excluded from the scope of this standard. This standard does not apply to systems that do not continuously record and analyse the ECG (for example, 'intermittent event recorders'). This second edition cancels and replaces the first edition published in 2001. It constitutes a technical revision. This edition was revised to align structurally with the 2005 edition of IEC 60601-1.
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 60601-2-47:2012. For the series NBN EN 50XXX, the standards are however complete.

EN version
DE version
FR version
Status
Status Registered trilingual Belgian standard EN or FR or DE
Situation Currently active
Replaces  NBN EN 60601-2-47:2001
Origin
Committee TC 62/SC 62D
ELECTROMEDICAL EQUIPMENT
Responsible De heer VAN HECKE Luk
Approval
BEC Approval 2015-04-14
NBN Approval 2015-07-24
Belgian Official Journal 2015-08-13
Registration 158296
Numbers identifying the european directives 93/42/EEC  (Medical devices)
ICS-Code (International Standards Classification) 11.040.55
NBN Status New
Date of ratification (d.o.r.) 2015-04-14
Date of availability (d.a.v.) 2015-05-22
Date of announcement (d.o.a.) 2015-07-14
Date of publication (d.o.p.) 2016-01-14
Date of withdrawal former edition (d.o.w.) 2018-04-14
Correspondences with international standards
Relation International standard Date
is identical to EN 60601-2-47:2015 2015-05-22
is identical to IEC 60601-2-47:2012/ed. 2.0 2012-02-16
Relations to belgian/foreign publications
Type Origin Code Date
Standard Belgium NBN EN 60601-1-2:2007