IEC 62353:2007

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.

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.

General Information

• Status: Published
• Publication Date: 14-May-2007
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: SC 62A - Common aspects of medical equipment, software, and systems
• Drafting Committee: WG 14 - TC 62/SC 62A/WG 14
• Current Stage: DELPUB - Deleted Publication
• Completion Date: 04-Sep-2014

Relations

• Revised: IEC 62353:2014 - Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
• Effective Date: 05-Sep-2023

Standards Content (Sample)

INTERNATIONAL IEC
STANDARD
CEI
NORME
First edition
INTERNATIONALE
Première édition
2007-05
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
Reference number
Numéro de référence
IEC/CEI 62353:2007
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INTERNATIONAL IEC
STANDARD
CEI
NORME
First edition
INTERNATIONALE
Première édition
2007-05
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
PRICE CODE
XA
CODE PRIX
Commission Electrotechnique Internationale
International Electrotechnical Commission
МеждународнаяЭлектротехническаяКомиссия
For price, see current catalogue
Pour prix, voir catalogue en vigueur

– 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 60601-1:2005.71H46
23HTable E.3 – Allowable values for PATIENT LEAKAGE CURRENTS under the special test
conditions identified in 8.7.4.7 of IEC 60601-1:2005.72H47

– 4 – 62353 © IEC:2007
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
RECURRENT TEST AND TEST AFTER REPAIR
OF MEDICAL ELECTRICAL EQUIPMENT

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