CENELEC
Project
| Reference | EN 62353:2008 |
|---|---|
| Title | Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment |
| Project Number | 17026 |
| Abstract/Scope | Applies to testing of medical electrical equipment and medical electrical systems, hereafter referred to as me equipment and me systems, or parts of such equipment or systems, which comply with IEC 60601-1, before putting into service, during maintenance, inspection, servicing and after repair or on occasion of recurrent tests to assess the safety of such me equipment or me systems or parts thereof. For equipment not built to IEC 60601-1 these requirements may be used taking into account the safety standards for the design and information in the instructions for use of that equipment. This standard contains tables with allowable values relating to different editions of IEC 60601-1. For the purpose of this standard, the application of measuring methods is independent of the edition according to which the me equipment or me system is designed. This standard contains: - 'general requirements', which contain clauses of general concern, and - 'particular requirements', further clauses handling special types of me equipment or me systems and applying in connection with the 'General requirements'. This standard is also applicable to tests after repair. The testing shall be defined according to the extent of work performed and applicable guidance from the manufacturer. |
| Status |
Published
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Status
| Current Stage code | 6060 |
|---|---|
| Current Stage code date | 2008-01-25 |
| Current Stage code deadline | 2008-08-01 |
| Deadline date for vote |
Legal
| Directive(s) | |
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| Mandate(s) | |
| Order Voucher |
Details
| IEC Technical Body | IEC/SC 62A |
|---|---|
| Reference Document | IEC 62353:2007 (EQV) |
| ICS | 11.040 - Medical equipment |
| Keywords | Medical; Test; Recurrent; After repair test |
| Note | |
| 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) | 2007-09-11 |
|---|---|
| date of Availability (DAV) (2) | 2008-01-25 |
| date of Announcement (DOA) (3) | 2008-01-01 |
| date of Publication (DOP) (4) | 2008-08-01 |
| date of Withdrawal (DOW) (5) | 2010-10-01 |
Relations
| Supersedes | |
|---|---|
| Superseded by | FprEN 62353:2013 |
| Normative reference (6) |
HD 60364-7-710:2012
corr. EN 61010-1:2001 corr. June 2002 EN 61010-2-010:2003 EN 61010-031:2002 EN 61140:2002 EN 61557-1:2007 IEC 60417-DB |
(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.
