CENELEC
Project
| Reference | EN 60601-2-47:2001 |
|---|---|
| Title | Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems |
| Project Number | 7365 |
| Abstract/Scope | Specifies the particular safety requirements for ambulatory electrocardiographic systems. 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. The systems may first record and store the ECG and analyse it later on a separate unit, or record and analyse the ECG simultaneously. The type of storage media used is irrelevant with regard to this standard; 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. |
| Status |
Published
|
Status
| Current Stage code | 6060 |
|---|---|
| Current Stage code date | 2001-10-26 |
| Current Stage code deadline | 2002-07-01 |
| Deadline date for vote |
Legal
| Directive(s) | MDD (93/42/EEC) |
|---|---|
| Mandate(s) | M/023; M/432 |
| Order Voucher | BC/CLC/93-01 |
Details
| IEC Technical Body | IEC/SC 62D |
|---|---|
| Reference Document | IEC 60601-2-47:2001 (EQV) |
| ICS | 11.040.55 - Diagnostic equipment |
| Keywords | Medical equipment; Ambulatory; Electrocardiograph; Essential performance; Safety |
| Note | EN following parallel vote |
| A-Deviation(s) | |
| 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) | 2001-10-01 |
|---|---|
| date of Availability (DAV) (2) | 2001-10-26 |
| date of Announcement (DOA) (3) | 2002-01-01 |
| date of Publication (DOP) (4) | 2002-07-01 |
| date of Withdrawal (DOW) (5) | 2004-10-01 |
Relations
| Supersedes | |
|---|---|
| Superseded by | FprEN 60601-2-47:2011 |
| Normative reference (6) |
EN 60529:1991
corr. May 1993 EN 60601-1:1990 corr. July 1994 A11:1993 A12:1993 A13:1996 EN 60601-2-25:1995 EN 60601-2-27:1994 |
(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.
