EN 62353:2008
(Main)Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
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
Relations
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.
- 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). IEC 61557-2:2007 has been harmonized as EN 61557-2:2007 (not modified). IEC 61557-4 NOTE
Harmonized as EN 61557-4:1997 (not modified). IEC 61557-4:2007 has been harmonized as EN 61557-4:2007 (not modified). IEC 62020 NOTE
Harmonized as EN 62020:1998 (not modified). ISO 13485 NOTE
Harmonized as EN ISO 13485:2003 (not modified). ISO 14971 NOTE
Harmonized as EN ISO 14971:2007 (not modified). __________
- 4 -
Annex ZA
(normative)
Normative references to international publications with their corresponding European publications
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
NOTE
When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD applies.
Publication Year Title EN/HD Year
IEC 60364-7-710 -1) Electrical installations of buildings -
Part 7-710: Requirements for special installations or locations - Medical locations - -
IEC 60417 Data-base Graphical symbols for use on equipment - -
IEC 61010-1
-1) Safety requirements for electrical equipment for measurement, control, and
laboratory use -
Part 1: General requirements EN 61010-1 + corr. June
20012) 2002
IEC 61010-2-010 -1) Safety requirements for electrical equipment for measurement, control, and
laboratory use -
Part 2-010: Particular requirements for laboratory equipment for the heating of material EN 61010-2-010 20032)
IEC 61010-031 -1) Safety requirements for electrical equipment for measurement, control and laboratory use - Part 031: Safety requirements for hand-held probe assemblies for electrical measurement and test EN 61010-031 20022)
IEC 61140 -1) Protection against electric shock - Common aspects for installation and equipment EN 61140 20022)
IEC 61557-1 -1) Electrical safety in low voltage distribution systems up to 1 000 V a.c. and 1 500 V d.c. - Equipment for testing, measuring or monitoring of protective measures -
Part 1: General requirements EN 61557-1 20072)
1) Undated reference. 2) Valid edition at date of issue.
INTERNATIONAL STANDARD IECCEI NORME INTERNATIONALE62353First editionPremière édition2007-05 Medical electrical equipment – Recurrent test and test after repair
of medical electrical equipment Appareils électromédicaux – Essai récurrent et essai après réparation
d’un appareil électromédical For price, see current cataloguePour prix, voir catalogue en vigueur PRICE CODE CODE PRIX XA Commission Electrotechnique InternationaleInternational Electrotechnical Commission
– 2 – 62353 © IEC:2007
CONTENTS FOREWORD.4
1 Scope.6 2 Normative references.7 3 Terms and definitions.7 4 Requirements.14 4.1 * General requirements.14 4.2 Testing before PUTTING INTO SERVICE, after MODIFICATIONS, and after REPAIR.15 4.3 * RECURRENT TEST.16 5 * Tests.16 5.1 General.16 5.2 Visual INSPECTION.16 5.3 Measurements.17 5.4 Functional test.29 6 Results of test and evaluation.30 6.1 Reporting of results.30 6.2 Evaluation.30
Annex A (informative)
General guidance and rationale.31 Annex B (informative)
Sequence of testing.38 Annex C (normative)
Requirements for the measurement equipment and for measurement circuits for PROTECTIVE EARTH RESISTANCE and leakage currents.41 Annex D (informative)
PATIENT ENVIRONMENT.44 Annex E (informative) Allowable values for leakage currents from IEC 60601-1.45 Annex F (informative)
Testing intervals.48 Annex G (informative)
Example of test documentation.49
Bibliography.50
Index of defined terms.51
Figure 1 – Measuring circuit for the measurement of PROTECTIVE EARTH RESISTANCE in ME EQUIPMENT that is disconnected from the SUPPLY MAINS.18 Figure 2 – Measuring circuit for the measurement of PROTECTIVE EARTH RESISTANCE in ME EQUIPMENT or ME SYSTEM, which for functional reasons cannot be disconnected from SUPPLY MAINS, or in ME EQUIPMENT or ME SYSTEM permanently connected to mains.19 Figure 3 – Measuring circuit for the measurement of EQUIPMENT LEAKAGE CURRENT – alternative method.22 Figure 4 – Measuring circuit for the measurement of EQUIPMENT LEAKAGE CURRENT– direct method.23 Figure 5 – Measuring circuit for the measurement EQUIPMENT LEAKAGE CURRENT
– differential method.24
62353 © IEC:2007 – 3 –
Figure 6 – Measuring circuit for the measurement of APPLIED PART LEAKAGE CURRENT
“F-TYPE APPLIED PART” – alternative method.25 Figure 7 – Measuring circuit for the measurement of APPLIED PART LEAKAGE CURRENT
– MAINS VOLTAGE on F-TYPE APPLIED PART – direct method.26 Figure 8 – Measuring circuit for the measurement of APPLIED PART LEAKAGE CURRENT for equipment with an INTERNAL ELECTRICAL POWER SOURCE – direct method.26 Figure 9 – Measuring circuit for the measurement of the insulation resistance
between MAINS PART and protective earth for CLASS I equipment and
between MAINS PART and (non-earthed) ACCESSIBLE CONDUCTIVE PARTS for CLASS I and CLASS II equipment.28 Figure 10 – Measuring circuit for measurement of the insulation resistance between MAINS PART and APPLIED PARTS which make a patient connection.28 Figure 11 – Measuring circuit for measurement of the insulation resistance between F-TYPE APPLIED PARTS which make a patient connection and
protective earth for CLASS I equipment and between F-TYPE APPLIED PARTS
which make a patient connection and (non-earthed) ACCESSIBLE CONDUCTIVE PARTS
for CLASS I and CLASS II equipment.29 Figure B.1 – Sequence of testing.38 Figure B.2 – Measurement of leakage currents (CLASS I ME EQUIPMENT).39 Figure B.3 – Measurement of leakage currents (CLASS II ME EQUIPMENT and ACCESSIBLE CONDUCTIVE PARTS of CLASS I ME EQUIPMENT, which are not connected to protective earth).40 Figure C.1 – Example of a measuring device and its frequency characteristics.43 Figure D.1 – Example of PATIENT ENVIRONMENT.44 Figure G.1 – Example of test documentation.65H49
17HTable 1 – Legends of symbols.66H20 18HTable 2 – Allowable values for leakage currents.67H27 19HTable A.1 – Addressees and their possible interest in this standard.68H31 20HTable A.2 – Reasons for choosing different measuring methods.69H35 21HTable E.1 – Allowable values for continuous leakage currents from IEC 60601-1:1988.70H45 22HTable E.2 – Allowable values for TOUCH CURRENTS, EARTH LEAKAGE CURRENTS, PATIENT LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS under NORMAL CONDITION and SINGLE FAULT CONDITION from IEC 60601-1:2005.
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.