CENELEC
Project
| Reference | EN 60601-2-51:2003 |
|---|---|
| Title | Medical electrical equipment - Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs |
| Project Number | 14389 |
| Abstract/Scope | Establishes particular requirements, in addition to the requirements of EN 60601-2-25, for the safety, including essential performance of recording and analysing single channel and multichannel electrocardiographs. These requirements shall apply particularly to - recording electrocardiographs; - electrocardiographs which are part of other medical electrical equipment, for example exercise testing systems, if this equipment is used to record ECGs for diagnostic purposes; - electrocardiographs which are used as output units for ECG data base management systems or electrocardiographs which are used as output units located at other places than the recording unit; - analysing electrocardiographs, systems, and computing devices which by means of electronic data processing and pattern recognition derive measurements (e.g. intervals and amplitudes) and diagnostic statements from the ECG; - those parts of patient monitors or other specialised electrocardiographs that are capable of performing the functions of the analysing electrocardiographs. |
| Status |
Published
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Status
| Current Stage code | 6060 |
|---|---|
| Current Stage code date | 2003-07-31 |
| Current Stage code deadline | 2003-04-01 |
| Deadline date for vote |
Legal
| Directive(s) | MDD (93/42/EEC) |
|---|---|
| Mandate(s) | M/432 |
| Order Voucher |
Details
| IEC Technical Body | IEC/SC 62D |
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| Reference Document | IEC 60601-2-51:2003 (EQV) |
| ICS | 11.040.55 - Diagnostic equipment |
| Keywords | Medical equipment; Recording; Analyse; Single/multi channel; Electrocardiograph |
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History
Implementation Dates
| date of Ratification (DOR) (1) | 2003-04-01 |
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| date of Availability (DAV) (2) | 2003-07-31 |
| date of Announcement (DOA) (3) | 2003-07-01 |
| date of Publication (DOP) (4) | 2004-02-01 |
| date of Withdrawal (DOW) (5) | 2006-04-01 |
Relations
| Supersedes | |
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| Superseded by | |
| Normative reference (6) | CSE working group recommendation:1985 ANSI/AAMI EC11:1991 IEEE Computer Society Press:1990, 1991, 1992 ISO 1000:1992 ENV 1064:1991 EN 60601-1:1990 corr. July 1994 A1:1993 A2:1995 A11:1993 A12:1993 A13:1996 EN 60601-1-4:1996 EN 60601-2-25:1995 A1:1999 |
(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.
