CENELEC
Project
| Reference | EN 60601-2-47:201X |
|---|---|
| Title | Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems |
| Project Number | 22367 |
| Abstract/Scope | IEC 60601-2-47:2012 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. |
| Status |
Approval stage
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Status
| Current Stage code | 5091 |
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| Current Stage code date | 2011-12-22 |
| Current Stage code deadline | |
| Deadline date for vote |
Legal
| Directive(s) | MDD (93/42/EEC) |
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| Mandate(s) | M/295 |
| Order Voucher |
Details
| IEC Technical Body | IEC/SC 62D |
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| Reference Document | IEC 60601-2-47:2012 (EQV) |
| ICS | 11.040.55 - Diagnostic equipment |
| Keywords | Medical; Ambulatory; Electrocardiograph; Safety |
| Note | Will supersede EN 60601-2-47:2001 |
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| Special National Condition(s) |
Environment
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Clause
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Categories - Aspects
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Product Life Cycle
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Information
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History
Implementation Dates
| date of Ratification (DOR) (1) | 2012-03-22 |
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| date of Availability (DAV) (2) | |
| date of Announcement (DOA) (3) | 2012-06-22 |
| date of Publication (DOP) (4) | 2012-12-22 |
| date of Withdrawal (DOW) (5) | 2015-03-22 |
Relations
| Supersedes | EN 60601-2-47:2001 |
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| Superseded by | |
| Normative reference (6) |
(1) Date of ratification (dor) date when the Technical Board notes the approval of an EN (and HD for CENELEC), from which time the standard may be said to be approved
(2) Date of availability (dav) date when the definitive text in the official language versions of an approved CEN/CENELEC publication is distributed by the Central Secretariat
(3) Date of announcement (doa) latest date by which the existence of an EN (and HD for CENELEC), a TS or a CWA has to be announced at national level
(4) Date of publication (dop) latest date by which an EN has to be implemented at national level by publication of an identical national standard or by endorsement
(5) Date of withdrawal (dow) latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn
(6) This list of normative references is purely indicative. The only official list of normative reference is the list of the published standard.
