EN 62353:2008

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.

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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). __________

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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

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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

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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

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INTERNATIONAL ELECTROTECHNICAL COMMISSION ____________
MEDICAL ELECTRICAL EQUIPMENT – RECURRENT TEST AND TEST AFTER REPAIR
OF MEDICAL ELECTRICAL EQUIPMENT
FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with may participate in this preparatory work. International, governmental and non-governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for Standardization (ISO) in accordance with conditions determined by agreement between the two organizations. 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international consensus of opinion on the relevant subjects since each technical committee has representation from all interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any misinterpretation by any end user. 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications transparently to the maximum extent possible in their national and regional publications. Any divergence between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter. 5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any equipment declared to be in conformity with an IEC Publication. 6) All users should ensure that they have the latest edition of this publication. 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and members of its technical committees and IEC National Committees for any personal injury, property damage or other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is indispensable for the correct application of this publication. 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent rights. IEC shall not be held responsible for identifying any or all such patent rights. International Standard IEC 62353 has been prepared by subcommittee 62A: Common aspects of electrical equipment used in medical practice, of IEC technical committee 62: Electrical equipment in medical practice. The text of this standard is based on the following documents: FDIS Report on voting 62A/564/FDIS 62A/572/RVD
Full information on the voting for the approval of this standard can be found in the report on voting indicated in the above table. This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.

62353 © IEC:2007 – 5 –
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. The committee has decided that the contents of this publication will remain unchanged until the maintenance result date indicated on the IEC web site under "http://webstore.iec.ch" in the data related to the specific publication. At this date, the publication will be
• reconfirmed; • withdrawn; • replaced by a revised edition, or • amended.

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MEDICAL ELECTRICAL EQUIPMENT – RECURRENT TEST AND TEST AFTER REPAIR
OF MEDICAL ELECTRICAL EQUIPMENT
1 Scope This International Standard 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". NOTE 1 At this stage, there are no particular requirements. This standard is not suitable to assess whether ME EQUIPMENT or ME SYSTEMS or any other equipment comply with the relevant standards for their design. This standard does not define requirements for REPAIR, exchange of components and MODIFICATION of ME EQUIPMENT or ME SYSTEMS. NOTE 2 All MAINTENANCE, INSPECTION, SERVICING, and REPAIR done in accordance with MANUFACTURER's instructions maintain the conformity to the standard used for the design of the equipment. Otherwise conformity to applicable requirements have to be assessed and verified. 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. This standard is not intended to define time intervals for RECURRENT TESTS. If such intervals are not defined by the MANUFACTURER, Annex F may be used to help establish such intervals.

62353 © IEC:2007 – 7 –
2 Normative references 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. IEC 60364-7-710, Electrical installations of buildings – Part 7-710: Requirements for special installations or locations – Medical locations IEC 60417, Graphical symbols for use on equipment IEC 61010-1, Safety requirements for electrical equipment for measurement, control and laboratory use – Part 1: General requirements IEC 61010-2-010, Safety requirements for electrical equipment for measurement, control and laboratory use – Part 2-010: Particular requirements for laboratory equipment for the heating of materials IEC 61010-031, 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 IEC 61140, Protection against electric shock – Common aspects for installation and equipment IEC 61557-1, Electrical safety in low voltage distribution systems up to 1000 V a.c. and 1500 V d.c. – Equipment for testing, measuring or monitoring of protective measures – Part 1: General requirements 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. NOTE Some of the definitions have to be different than those in IEC 60601-1, as different measuring methods are used. 3.1
ACCESSIBLE CONDUCTIVE PART
part of the ME EQUIPMENT other than an APPLIED PART, which is accessible to the patient, to the operator in contact with the patient or can come in contact with the patient NOTE It is necessary that other accessible parts comply with their respective safety requirements. 3.2
ACCESSORY additional part for use with equipment in order to: – achieve the intended use, – adapt it to some special use, – facilitate its use, – enhance its performance, or – enable its functions to be integrated with those of other equipment [IEC 60601-1:2005, definition 3.3]

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3.3
ACCOMPANYING DOCUMENT
document accompanying ME EQUIPMENT, an ME SYSTEM, equipment or an ACCESSORY and containing information for the RESPONSIBLE ORGANIZATION or operator, particularly regarding basic safety and essential performance [IEC 60601-1:2005, definition 3.4] 3.4
APPLIED PART part of ME EQUIPMENT that in normal use necessarily comes into physical contact with the patient for ME EQUIPMENT or an ME SYSTEM to perform its function [IEC 60601-1:2005, definition 3.8] 3.5
APPLIED PART LEAKAGE CURRENT
current flowing from MAINS PARTS and the ACCESSIBLE CONDUCTIVE PARTS of the enclosure to the APPLIED PARTS 3.6
CLASS I term referring to electrical equipment in which protection against electric shock does not rely on basic insulation only, but which includes an additional safety precaution in that means are provided for accessible parts of metal or internal parts of metal to be protectively earthed [IEC 60601-1:2005, definition 3.13] 3.7
CLASS II
term referring to electrical equipment in which protection against electric shock does not rely on basic insulation only, but in which additional safety precautions such as double insulation or reinforced insulation are provided, there being no provision for protective earthing or reliance upon installation conditions NOTE CLASS II ME EQUIPMENT can be provided with a functional earth terminal or a functional earth conductor. [IEC 60601-1:2005, definition 3.14] 3.8
DETACHABLE POWER SUPPLY CORD flexible cord intended to be connected to electrical equipment by means of a suitable appliance coupler for mains supply purposes [IEC 60601-1:2005, definition 3.21] 3.9
EARTH LEAKAGE CURRENT current flowing from the MAINS PART through or across the insulation into the protective earth conductor [IEC 60601-1:2005, definition 3.25]

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3.10
ELECTRICAL SAFETY protection within an equipment which limits the effects of electrical current on a patient, user or other individuals in accordance with IEC 60601-1 NOTE Safety is defined as freedom from unacceptable risk (refer to ISO 14971:2007, definition 2.24). 3.11
EQUIPMENT LEAKAGE CURRENT current flowing from MAINS PARTS to earth via the protective earth conductor and ACCESSIBLE CONDUCTIVE PARTS of the enclosure and APPLIED PARTS
3.12
F-TYPE ISOLATED (FLOATING) APPLIED PART (herein F-TYPE APPLIED PART)
APPLIED PART in which the patient connections are isolated from other parts of the ME EQUIPMENT to such a degree that no current higher than the allowable patient leakage current flows if an unintended voltage originating from an external source is connected to the patient, and thereby applied between the patient connection and earth NOTE F-TYPE APPLIED PARTS are either TYPE BF APPLIED PARTS or TYPE CF APPLIED PARTS. [IEC 60601-1:2005, definition 3.29] 3.13
FUNCTIONAL CONNECTION connection, electrical or otherwise, including those intended to transfer signals, data, power or substances NOTE Connection to a fixed SUPPLY MAINS socket-outlet, whether single or multiple, is not considered to result in a FUNCTIONAL CONNECTION. [IEC 60601-1:2005, definition 3.33] 3.14
INSPECTION combination of all means for verification and assessment of a status quo 3.15
INTERNAL ELECTRICAL POWER SOURCE electrical power source for operating equipment that is a part of the equipment and which produces electrical current from some other form of energy EXAMPLE Chemical, mechanical, solar, or nuclear. NOTE An INTERNAL ELECTRICAL POWER SOURCE can be inside the principal part of equipment, attached to the outside, or contained in a separate enclosure. [IEC 60601-1:2005, definition 3.45] 3.16
MAINS PART electrical circuit that is intended to be connected to the SUPPLY MAINS NOTE 1 The MAINS PART includes all conductive parts that are not separated from the SUPPLY MAINS by at least one means of protection. NOTE 2 For the purpose of this definition, the protective earth conductor is not regarded as a part of the MAINS PART. [IEC 60601-1:2005, definition 3.49]

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3.17
MAINS PLUG part, integral with or intended to be attached to a POWER SUPPLY CORD of electrical equipment, to be inserted into a mains socket-outlet [IEC 60601-1:2005, definition 3.50] 3.18
MAINS VOLTAGE voltage of a SUPPLY MAINS between two line conductors of a polyphase system or voltage between the line conductor and the neutral conductor of a single-phase system [IEC 60601-1:2005, definition 3.54] 3.19
MAINTENANCE combination of all technical and administrative means, including supervising ones, to keep or restore a unit in working condition 3.20
MANUFACTURER natural or legal person with responsibility for the design, manufacture, packaging, or labelling of ME EQUIPMENT, assembling an ME SYSTEM, or adapting ME EQUIPMENT or an ME SYSTEM, regardless of whether these operations are performed by that person or on that person's behalf by a third party NOTE 1 ISO 13485 defines "labelling" as written, printed or graphic matter – affixed to a medical device or any of its containers or wrappers, or – accompanying a medical device, related to identification, technical description, and use of the medical device, but excluding shipping documents. In this standard, that material is described as markings and ACCOMPANYING DOCUMENTS. NOTE 2 “Adapting” includes making substantial MODIFICATIONS to ME EQUIPMENT or an ME SYSTEM already in use. NOTE 3 In some jurisdictions, the RESPONSIBLE ORGANIZATION can be considered a MANUFACTURER when involved in the activities described. NOTE 4 Adapted from ISO 14971:2007, definition 2.8. [IEC 60601-1:2005, definition 3.55] 3.21
MEDICAL ELECTRICAL EQUIPMENT ME EQUIPMENT electrical equipment having an APPLIED PART or transferring energy to or from the patient or detecting such energy transfer to or from the patient and which is:
a) provided with not more than one connection to a particular SUPPLY MAINS, and
b) intended by its MANUFACTURER to be used: 1) in the diagnosis, treatment, or monitoring of a patient, or 2) for compensation or alleviation of disease, injury or disability

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NOTE 1 ME EQUIPMENT includes those ACCESSORIES as defined by the MANUFACTURER that are necessary to enable the normal use of the ME EQUIPMENT. NOTE 2 Not all electrical equipment used in medical practice falls within this definition (e.g. in vitro diagnostic equipment). NOTE 3 The implantable parts of active implantable medical devices can fall within this definition, but they are excluded from the scope of IEC 60601-1. [IEC 60601-1:2005, definition 3.63] 3.22
MEDICAL ELECTRICAL SYSTEM ME SYSTEM combination, as specified by its MANUFACTURER, of items of equipment, at least one of which is ME EQUIPMENT to be inter-connected by FUNCTIONAL CONNECTION or by use of a MULTIPLE SOCKET-OUTLET NOTE 1 Equipment, when mentioned in this standard, should be taken to include ME EQUIPMENT. NOTE 2 ME SYSTEM includes those ACCESSORIES as defined by the MANUFACTURER that are necessary to enable the normal use of the ME SYSTEM. [IEC 60601-1:2005, definition 3.64] 3.23
MODIFICATION changing constructional or functional features of ME EQUIPMENT or an ME SYSTEM in a way not described in its ACCOMPANYING DOCUMENTS NOTE This definition may not be confused with “change of ACCESSORIES” because this means changing of ME EQUIPMENT or ME SYSTEMs in a way described in its ACCOMPANYING DOCUMENTS. 3.24
MULTIPLE SOCKET-OUTLET MSO one or more socket-outlets intended to be connected to, or integral with, flexible cables or cords or ME EQUIPMENT for SUPPLY MAINS or equivalent voltage NOTE A MULTIPLE SOCKET-OUTLET can be a separate item or an integral part of equipment. [IEC 60601-1:2005, definition 3.67] 3.25
NON-DETACHABLE POWER SUPPLY CORD POWER SUPPLY CORD fixed to equipment 3.26
NORMAL CONDITION condition in which all means provided for protection against hazards are intact [IEC 60601-1:2005, definition 3.70] 3.27
PATIENT ENVIRONMENT any volume in which intentional or unintentional contact can occur between a patient and parts of the ME EQUIPMENT or ME SYSTEM or between a patient and other persons touching parts of the ME EQUIPMENT or ME SYSTEM NOTE It is difficult to define dimensions for the volume in which diagnosis, monitoring or treatment occurs. The dimensions for the PATIENT ENVIRONMENT given in Figure D.1 have been justified in practice. [IEC 60601-1:2005, definition 3.79]

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3.28
PATIENT LEAKAGE CURRENT current: – flowing from the patient connections via the patient to earth, or – originating from the unintended appearance of a voltage from an external source on the patient and flowing from the patient via the patient connections of an F-TYPE APPLIED PART to earth [IEC 60601-1:2005, definition 3.80] 3.29
PERMANENTLY INSTALLED term meaning electrically connected to the SUPPLY MAINS by means of a permanent connection that can only be detached by the use of a tool [IEC 60601-1:2005, definition 3.84] 3.30
POWER SUPPLY CORD flexible cord, fixed to or assembled with electrical equipment for connection to SUPPLY MAINS [IEC 60601-12005, definition 3.87] 3.31
PROTECTIVE EARTH RESISTANCE resistance between any ACCESSIBLE CONDUCTIVE PART, which has to be connected for safety purposes to the protective earth terminal, and the − protective connector of the MAINS PLUG, or
− protective connector of the appliance inlet, or − protective conductor permanently connected to the SUPPLY MAINS Resistance between protective connectors at each end of a DETACHABLE POWER SUPPLY CORD 3.32
PUTTING INTO SERVICE first use of the ME EQUIPMENT or ME SYSTEM after setting up at the RESPONSIBLE ORGANIZATION
NOTE This will be the first application of RECURRENT TESTS. 3.33
RECURRENT TEST test, at a defined time interval, carried out for the assessment of safety 3.34
REFERENCE VALUE value documented for the assessment of subsequent measurements 3.35
REPAIR means for reconstitution of a defined condition

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3.36
RESPONSIBLE ORGANIZATION entity accountable for the use and MAINTENANCE of an ME EQUIPMENT or an ME SYSTEM NOTE 1 The accountable entity can be, for example, a hospital, an individual clinician or a layperson. In home use applications, the patient, operator and RESPONSIBLE ORGANIZATION can be one and the same person. NOTE 2 Education and training is included in “use”. [IEC 60601-1:2005, definition 3.101] 3.37
SERVICING combination of all means for maintaining the ME EQUIPMENT or ME SYSTEM within requirements of the MANUFACTURER 3.38
SINGLE FAULT CONDITION
condition in which a single means for reducing a risk is defective or a single abnormal condition is present [IEC 60601-1:2005, definition 3.116] 3.39
SUPPLY MAINS source of electrical energy not forming part of ME EQUIPMENT or ME SYSTEM NOTE This also includes battery systems and converter systems in ambulances and the like. [IEC 60601-1:2005, definition 3.120] 3.40
TOUCH CURRENT leakage current flowing from the enclosure or from parts thereof, excluding patient connections, accessible to any operator or patient in normal use, through an external path other than the protective earth conductor, to earth or to another part of the enclosure NOTE The meaning of this term is the same as that of “ENCLOSURE LEAKAGE CURRENT” in the first and second editions of IEC 60601-1. The term has been changed to align with IEC 60950-1 and to reflect the fact that the measurement now applies also to parts that are normally protectively earthed. [IEC 60601-1:2005, definition 3.129] 3.41
TYPE B APPLIED PART APPLIED PART complying with the specified requirements of IEC 60601-1 to provide protection against electric shock, particularly regarding allowable PATIENT LEAKAGE CURRENT and patient auxiliary current NOTE 1 A TYPE B APPLIED PART is marked with symbol IEC 60417-5840 (2002-10) () or if classified as defibrillation-proof, with symbol IEC 60417-5841 (2002-10) (). NOTE 2 TYPE B APPLIED PARTS are not suitable for direct cardiac application. [IEC 60601-1:2005, definition 3.132, modified]

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TYPE BF APPLIED PART F-TYPE APPLIED PART complying with the specified requirements of IEC 60601-1 to provide a higher degree of protection against electric shock than that provided by TYPE B APPLIED PARTS
NOTE 1 A TYPE BF APPLIED PART is marked with symbol IEC 60417-5333 (2002-10) () or if classified as defibrillation-proof, with symbol 60417-5334 (2002-10) ( ). NOTE 2 TYPE BF APPLIED PARTS are not suitable for direct cardiac application. [IEC 60601-1:2005, definition 3.133, modified] 3.43
TYPE CF APPLIED PART F-TYPE APPLIED PART complying with the specified requirements of IEC 60601-1 to provide a higher degree of protection against electric shock than that provided by TYPE BF APPLIED PARTS NOTE A TYPE CF APPLIED PART is marked with symbol IEC 60417-5335 (2002-10) () or if classified as defibrillation-proof, with symbol 60417-5336 (2002-10) (). [IEC 60601-1:2005, definition 3.134, modified] 4 Requirements 4.1 * General requirements The following requirements apply to: – tests before PUTTING INTO SERVICE, – RECURRENT TESTS, and – tests after REPAIR. The extent and set of tests shall be chosen to ensure sufficient information and amount of test results for assessment of the safety of the ME EQUIPMENT. Information provided by the MANUFACTURER shall be taken into account (see also 7.9.2.13 of
IEC 60601-1:2005). NOTE 1 The MANUFACTURER has to define in the instructions for use or other ACCOMPANYING DOCUMENTS (e.g. for SERVICING) necessary measurement settings and methods; this may also omit any test. NOTE 2 For ME SYSTEMS, the responsible party, who has assembled the system, will define the necessary measurement settings and methods as required in IEC 60601-1-1. NOTE 3 If no requirements for SERVICING are established by the MANUFACTURER also a RESPONSIBLE ORGANISATION having appropriate expertise may provide requirements for SERVICING. Appropriate expertise includes but is not limited to knowledge and experience with the relevant standards such as IEC 60601-1 including risk management, IEC 60950, IEC 61010 and local regulations. The tests as described in Clause 5 are the basis to define the extent of testing of ME EQUIPMENT or ME SYSTEMs designed and built in compliance with IEC 60601-1. Qualified personnel shall perform these tests. Qualification shall include training on the subject, knowledge, experience and acquaintance with the relevant technologies, standards and local regulations. The personnel assessing the safety shall be able to recognize possible consequences and risks arising from non-conforming equipment.

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Each individual equipment of an ME SYSTEM which has its own connection to SUPPLY MAINS, or which can be connected/disconnected from SUPPLY MAINS without the use of a tool, shall be tested individually. Additionally the ME SYSTEM as a whole shall be tested to avoid a situation where aging of individual equipment can result in unacceptable values. An ME SYSTEM that is connected with a MULTIPLE SOCKET-OUTLET to SUPPLY MAINS shall be treated during the tests like a single item of equipment. If the ME SYSTEM, or a part of it, is connected to SUPPLY MAINS via a separating transformer, the transformer has to be included in the measurements. In ME SYSTEMS, where more than one ME EQUIPMENT are interconnected by data cables or other means, e.g. by electrically conducting mountings or cooling water pipes, the testing of PROTECTIVE EARTH RESISTANCE shall be performed on every single equipment. If items of ME EQUIPMENT, which are combined into an ME SYSTEM by FUNCTIONAL CONNECTION, cannot be tested separately for technical reasons, the complete ME SYSTEM shall be tested. ACCESSORIES of the ME EQUIPMENT, which can affect the safety of the equipment under test or the results of the measurements, shall be included in the tests. ACCESSORIES included in the tests shall be documented. All DETACHABLE POWER SUPPLY CORDS, which are available ready for use, shall be inspected and the PROTECTIVE EARTH RESISTANCE shall be measured according to 5.3.2. All tests shall be performed in such manner that no hazards arise for testing personnel, patients or other individuals.
If not otherwise stated, all values for current and voltage are the r.m.s. values of an alternating, direct or composite voltage or current. 4.2 Testing before PUTTING INTO SERVICE, after MODIFICATIONS, and after REPAIR Before first time operation as intended: – of new or modified ME EQUIPMENT or ME SYSTEMS, – of ME EQUIPMENT or ME SYSTEMS not yet tested according to Clause 5, or – of REPAIRED ME EQUIPMENT or ME SYSTEMS, the applicable tests as listed in Clause 5 shall be performed. The results of these measurements are the “REFERENCE VALUE” and shall be documented together with the measuring method, as a reference for future measurements. After any REPAIR and/or MODIFICATION of the ME EQUIPMENT, conformity to the applicable requirements of the standards used for the design of the equipment shall be assessed and verified. This shall be done by a qualified and authorized individual. The extent of testing according to this standard shall take into account the kind of REPAIR or MODIFICATION.

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4.3 * RECURRENT TEST The applicable tests as listed in Clause 5 shall be used for RECURRENT TEST. The values found in these tests shall be documented together with the measuring method and shall be assessed. The values measured shall not exceed the acceptable limit as defined in Table 2 or the tables in Annex E. If the measured values are between 90 % and 100 % of the acceptable limit, previously measured values (REFERENCE VALUE) shall be taken into consideration for the assessment of the ELECTRICAL SAFETY of the ME EQUIPMENT or the ME SYSTEM. If such previous data values are not available, reduced intervals between upcoming RECURRENT TESTS shall be taken into account. ME SYSTEMS shall be visually inspected to determine whether the configuration is still the same as at the time of the last INSPECTION, or whether units of the ME SYSTEM have been exchanged, added or removed. Such changes shall be documented, as well as any changing of the configuration of ME SYSTEM, and will void the validity of previous REFERENCE VALUES. Measurement results/values measured after changes of the ME SYSTEM shall be documented as REFERENCE VALUES. 5 * Tests 5.1 General Prior to testing, consult the ACCOMPANYING DOCUMENTS to identify the MANUFACTURER’S MAINTENANCE recommendations including any special conditions and precautions that shall be taken into account. NOTE The recommended sequence of the tests to be performed is defined in Figure B.1. The tests may be performed at the ambient temperature, humidity and atmospheric pressure as present at the site of testing. Requirements for supply voltage as defined in IEC 60601-1 do not have to be fulfilled. 5.2 Visual INSPECTION Covers and housings shall be opened only: – if required in the ACCOMPANYING DOCUMENT of the ME EQUIPMENT or ME SYSTEM, or – if required in this standard, or – if there is an indication of inadequate safety. Special attention shall be paid to the following: – all fuses accessible from the outside are complying with the data given by the MANUFACTURER (rated current, characteristics), – safety related marking, labels and labelling is legible and complete, – the integrity of mechanical parts, – any damage or contamination, – assess the relevant ACCESSORIES together with the ME EQUIPMENT or ME SYSTEM (e.g. detachable or fixed POWER SUPPLY CORDS, patient leads, tubing), – the required documentation is present and reflects the current revision of the ME EQUIPMENT or ME SYSTEM.

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After testing, REPAIR or adjustment, check that the ME EQUIPMENT or ME SYSTEM is restored to the conditions necessary for normal use before being returned into service. 5.3 Measurements 5.3.1 General For requirements for the measuring device, see Annex C. Before testing, the ME EQUIPMENT or ME SYSTEM shall, if possible, be disconnected from the SUPPLY MAINS. If not possible, special measures shall be taken to prevent hazards for the personnel performing the tests and m
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