EN 62353:2008

Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment

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.

Medizinische elektrische Geräte - Wiederholungsprüfungen und Prüfung nach Instandsetzung von medizinischen elektrischen Geräten

Appareils électromédicaux - Essai récurrent et essai après réparation d'un appareil électromédical

S'applique aux essais des appareils électromédicaux et aux systèmes électromédicaux ci-après désignés sous le nom d'appareils em et de systèmes em, ou aux parties de ces appareils ou systèmes, satisfaisant à la CEI 60601-1, avant la mise en service, pendant la maintenance, l'inspection, l'entretien courant et après réparation, ou occasionnellement lors d'essais récurrents pour évaluer la sécurité de ces appareils em ou de ces systèmes em ou des parties de ceux-ci. Pour les appareils non construits conformément à la CEI 60601-1, ces exigences peuvent être utilisées en tenant compte des normes de sécurité pour la conception et les informations contenues dans les instructions d'utilisation de ces appareils. La présente norme comprend des tableaux donnant des valeurs admissibles se rapportant aux différentes éditions de la CEI 60601-1. Au sens de la présente norme, l'application des méthodes de mesurage est indépendante de l'édition selon laquelle les appareils em ou les systèmes em sont conçus. Cette norme comprend: - des 'exigences générales', contenant des articles de portée générale, et - des 'exigences particulières', d'autres articles traitant de types spéciaux d'appareils em ou de systèmes em et s'appliquant en conjonction avec les 'exigences générales'. La présente norme s'applique également aux essais après réparation. Les essais doivent être définis selon l'ampleur du travail effectué et selon les directives applicables du fabricant.

Medicinska električna oprema – Ponavljalni preskus in preskus po popravilu medicinske električne opreme (IEC 62353:2007) (IEC 62353:2007)

General Information

• Status: Withdrawn
• Publication Date: 24-Jan-2008
• Withdrawal Date: 30-Sep-2010
• ICS: 11.040 - Medical equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62A - IEC_SC_62A
• Parallel Committee: IEC/SC 62A - IEC_SC_62A
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 09-Oct-2017
• Completion Date: 09-Oct-2017
• Ref Project: SIST EN 62353:2008 - Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment

Relations

• Replaced By: EN 62353:2014 - Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
• Effective Date: 29-Jan-2023

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment (IEC 62353:2007)SRSUDYLOXAppareils électromédicaux - Essai récurrent et essai après réparation d'un appareil électromédical (CEI 62353:2007)Medizinische elektrische Geräte - Wiederholungsprüfungen und Prüfung nach Instandsetzung von medizinischen elektrischen Geräten (IEC 62353:2007)Ta slovenski standard je istoveten z:EN 62353:2008SIST EN 62353:2008en,fr11.040.01ICS:SLOVENSKI
STANDARDSIST EN 62353:200801-april-2008







EUROPEAN STANDARD EN 62353 NORME EUROPÉENNE
EUROPÄISCHE NORM January 2008
CENELEC European Committee for Electrotechnical Standardization Comité Européen de Normalisation Electrotechnique Europäisches Komitee für Elektrotechnische Normung
Central Secretariat: rue de Stassart 35, B - 1050 Brussels
© 2008 CENELEC -
All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 62353:2008 E
ICS 11.040
English version
Medical electrical equipment -
Recurrent test and test after repair of medical electrical equipment (IEC 62353:2007)
Appareils électromédicaux -
Essai récurrent et essai après réparation d'un appareil électromédical (CEI 62353:2007)
Medizinische elektrische Geräte -
Wiederholungsprüfungen und Prüfung nach Instandsetzung von medizinischen elektrischen Geräten (IEC 62353:2007)
This European Standard was approved by CENELEC on 2007-09-11. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CENELEC member into its own language and notified to the Central Secretariat has the same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom.



EN 62353:2008
- 2 -
Foreword The text of document 62A/564/FDIS, future edition 1 of IEC 62353, prepared by SC 62A, Common aspects of electrical equipment used in medical practice, of IEC TC 62, Electrical equipment in medical practice, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 62353 on 2007-09-11. The following dates were fixed: – latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement
(dop)
2008-08-01 – latest date by which the national standards conflicting
with the EN have to be withdrawn
(dow)
2010-10-01 In this standard, the following print types are used: – requirements and definitions: roman type; – informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text of tables is also in a smaller type; – TERMS USED THROUGHOUT THIS STANDARD THAT HAVE BEEN DEFINED IN CLAUSE 3: IN SMALL CAPITALS. The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives, Part 2. For the purposes of this standard, the auxiliary verb: – “shall” means that compliance with a requirement or a test is mandatory for compliance with this standard; – “should” means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this standard; – “may” is used to describe a permissible way to achieve compliance with a requirement or test. An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that there is guidance or rationale related to that item in Annex A.
Annex ZA has been added by CENELEC. __________ Endorsement notice The text of the International Standard IEC 62353:2007 was approved by CENELEC as a European Standard without any modification. In the official version, for Bibliography, the following notes have to be added for the standards indicated: IEC 60335 NOTE
Harmonized in EN 60335 series (partly modified). IEC 60601-1 NOTE
Harmonized as EN 60601-1:2006 (not modified). IEC 60601-1-1 NOTE
Harmonized as EN 60601-1-1:2001 (not modified). IEC 60950 NOTE
Harmonized in EN 60950 series (partly modified). IEC 60950-1 NOTE
Harmonized as EN 60950-1:2006 (modified).



- 3 - EN 62353:2008 IEC 61010 NOTE
Harmonized in EN 61010 series (partly modified). IEC 61557-2 NOTE
Harmonized as EN 61557-2:1997 (not modified).
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