SIST EN 60601-1-2:2008

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.&Medizinische elektrische Geräte -- Teil 1-2: Allgemeine Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm: Elektromagnetische Verträglichkeit - Anforderungen und PrüfungenAppareils électromédicaux -- Partie 1-2: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Compatibilité électromagnétique - Exigences et essaisMedical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests33.100.01Elektromagnetna združljivost na splošnoElectromagnetic compatibility in general11.040.01Medicinska oprema na splošnoMedical equipment in generalICS:Ta slovenski standard je istoveten z:EN 60601-1-2:2007SIST EN 60601-1-2:2008en,fr,de01-januar-2008SIST EN 60601-1-2:2008SLOVENSKI
STANDARDSIST EN 60601-1-2:2002/A1:2006SIST EN 60601-1-2:20021DGRPHãþD



SIST EN 60601-1-2:2008



EUROPEAN STANDARD EN 60601-1-2 NORME EUROPÉENNE
EUROPÄISCHE NORM July 2007
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
© 2007 CENELEC -
All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-1-2:2007 E
ICS 11.040.01; 33.100.10; 33.100.20 Supersedes EN 60601-1-2:2001 + A1:2006Incorporates corrigendum March 2010
English version
Medical electrical equipment -
Part 1-2: General requirements for basic safety
and essential performance -
Collateral standard: Electromagnetic compatibility -
Requirements and tests (IEC 60601-1-2:2007, modified)
Appareils électromédicaux -
Partie 1-2: Exigences générales
pour la sécurité de base
et les performances essentielles -
Norme collatérale:
Compatibilité électromagnétique -
Exigences et essais (CEI 60601-1-2:2007, modifiée)
Medizinische elektrische Geräte -
Teil 1-2: Allgemeine Festlegungen
für die Sicherheit einschließlich
der wesentlichen Leistungsmerkmale -
Ergänzungsnorm:
Elektromagnetische Verträglichkeit -
Anforderungen und Prüfungen (IEC 60601-1-2:2007, modifiziert)
This European Standard was approved by CENELEC on 2007-04-11. 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.
SIST EN 60601-1-2:2008



EN 60601-1-2:2007
- 2 - Foreword The text of document 62A/560/FDIS, future edition 3 of IEC 60601-1-2, 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 60601-1-2 on 2007-04-11. The following date was fixed: – latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement
– latest date by which the national standards conflicting
with the EN have to be withdrawn
(dop)
(dow)
2008-02-01
2012-06-01 This European Standard supersedes EN 60601-1-2:2001 and its amendment A1:2006.
This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association and covers essential requirements of EC Directive 93/42/EEC. See Annex ZZ. This European Standard constitutes a collateral standard to EN 60601-1:2006, hereafter referred to as the general standard. This EN 60601-1-2 was revised to structurally align it with EN 60601-1:2006 and to implement the decision of IEC SC 62A that the clause numbering structure of collateral standards written to EN 60601-1:2006 would adhere to the form specified in ISO/IEC Directives, Part 2:2004. The principle technical changes are in Clause 4, which now recognizes that there is a general requirement for a risk management process in EN 60601-1:2006. In the 60601 series of publications, collateral standards specify general requirements for safety applicable to – a subgroup of MEDICAL ELECTRICAL EQUIPMENT (e.g. radiological equipment); or – a specific characteristic of all MEDICAL ELECTRICAL EQUIPMENT, not fully addressed in the general standard (e.g. alarm systems). In this collateral standard the following print types are used: − requirements and definitions: in roman type; − test specifications: in italic 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 DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS COLLATERAL STANDARD OR AS NOTES: IN SMALL CAPITALS. NOTE Defined terms are not printed in SMALL CAPITALS in Table 1 through Table 8, in the tables in Annex C and in statements required to appear in the technical description or instructions for use because they are intended for the OPERATOR or RESPONSIBLE ORGANIZATION, who may not be familiar with the defined terms of EN 60601 standards. In referring to the structure of this standard, the term – “clause” means one of the six numbered divisions within the table of contents, inclusive of all subdivisions (e.g. Clause 6 includes Subclauses 6.1, 6.2, etc.); –
“subclause” means a numbered subdivision of a clause (e.g. 6.1, 6.2 and 6.2.1 are all subclauses of Clause 6). SIST EN 60601-1-2:2008



- 3 - EN 60601-1-2:2007 References to clauses within this standard are preceded by the term “Clause” followed by the clause number. References to subclauses within this standard are by number only.
In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of the conditions is true. 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. Clauses, subclauses, items and definitions for which a rationale is provided in informative Annex A are marked with an asterisk (*). Annexes ZA and ZZ have been added by CENELEC. __________ The contents of the corrigendum of March 2010 have been included in this copy. SIST EN 60601-1-2:2008



EN 60601-1-2:2007
- 4 - Endorsement notice The text of the International Standard IEC 60601-1-2:2007 was approved by CENELEC as a European Standard with agreed common modifications as given below. COMMON MODIFICATIONS Annex A, Subclause 4.2: Replace the last sentence by: These HAZARDS shall be considered in the RISK MANAGEMENT PROCESS. Bibliography Add the following notes for the standards indicated: CISPR 11 + A1 + A2 NOTE Harmonized as EN 55011:2007 (modified) and A2:2007 (not modified). CISPR 24 NOTE Harmonized as EN 55024:1998 (modified). IEC 61000-4-2 + A1 + A2 NOTE Harmonized as EN 61000-4-2:1995 + A1:1998 + A2:2001 (not modified). IEC 61000-4-3 NOTE Harmonized as EN 61000-4-3:2006 (not modified). IEC 61000-4-4 NOTE Harmonized as EN 61000-4-4:2004 (not modified). IEC 61000-4-6 + A1 + A2 NOTE Harmonized as EN 61000-4-6:2007 (not modified). IEC 61326-1 NOTE Harmonized as EN 61326-1:2006 (not modified). ISO 14971 NOTE Harmonized as EN ISO 14971:2000 (not modified). __________ SIST EN 60601-1-2:2008



- 5 - EN 60601-1-2:2007
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 60417 Data base Graphical symbols for use on equipment - -
IEC 60601-1 2005 Medical electrical equipment -
Part 1: General requirements for basic safety and essential performance EN 60601-1 2006
IEC 60601-1-8 2006 Medical electrical equipment -
Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems EN 60601-1-8 2007
IEC 61000-3-2 - 1) Electromagnetic compatibility (EMC) -
Part 3-2: Limits - Limits for harmonic current emissions (equipment input current ≤ 16 A per phase) EN 61000-3-2 2006 2)
IEC 61000-3-3 - 1) Electromagnetic compatibility (EMC) -
Part 3-3: Limits - Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems, for equipment with rated current ≤ 16 A per phase and not subject to conditional connection EN 61000-3-3 + corr. July
1995 2)1997
IEC 61000-4-2 - 1) Electromagnetic compatibility (EMC) -
Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test EN 61000-4-2 1995 2)
IEC 61000-4-3 - 1) Electromagnetic compatibility (EMC) -
Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test EN 61000-4-3 2006 2)
IEC 61000-4-4
- 1) Electromagnetic compatibility (EMC) -
Part 4-4: Testing and measurement techniques - Electrical fast transient/burst immunity test EN 61000-4-4 2004 2)
1) Undated reference.
2) Valid edition at date of issue.
SIST EN 60601-1-2:2008



EN 60601-1-2:2007
- 6 - Publication Year Title EN/HD Year IEC 61000-4-5 - 1) Electromagnetic compatibility (EMC) -
Part 4-5: Testing and measurement techniques - Surge immunity test EN 61000-4-5 2006 2)
IEC 61000-4-6 + A1 + A2 2003 2004 2006 Electromagnetic compatibility (EMC) -
Part 4-6: Testing and measurement techniques - Immunity to conducted disturbances, induced by radio-frequency fields
EN 61000-4-6
2007
IEC 61000-4-8 - 1) Electromagnetic compatibility (EMC) -
Part 4-8: Testing and measurement techniques - Power frequency magnetic field immunity test EN 61000-4-8 1993 2)
IEC 61000-4-11 - 1) Electromagnetic compatibility (EMC) -
Part 4-11: Testing and measurement techniques - Voltage dips, short interruptions and voltage variations immunity tests EN 61000-4-11 2004 2)
CISPR 11 (mod) - 1) Industrial scientific and medical (ISM)
radio-frequency equipment - Electromagnetic disturbance
characteristics - Limits and methods of measurement EN 55011 2007 2)
CISPR 14-1 - 1) Electromagnetic compatibility - Requirements for household appliances, electric tools and similar apparatus -
Part 1: Emission EN 55014-1 2006 2)
CISPR 15 - 1) Limits and methods of measurement of radio disturbance characteristics of electrical lighting and similar equipment EN 55015 2006 2)
CISPR 16-1-2 - 1) Specification for radio disturbance and immunity measuring apparatus and
methods -
Part 1-2: Radio disturbance and immunity measuring apparatus - Ancillary equipment - Conducted disturbances EN 55016-1-2 2004 2)
CISPR 22 (mod) - 1) Information technology equipment - Radio disturbance characteristics - Limits and methods of measurement EN 55022 2006 2)
SIST EN 60601-1-2:2008



- 7 - EN 60601-1-2:2007 Annex ZZ (informative)
Coverage of Essential Requirements of EC Directives This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association and within its scope the standard covers all relevant essential requirements as given in Annex I of the EC Directive 93/42/EEC. Compliance with this standard provides one means of conformity with the specified essential requirements of the Directive concerned. WARNING: Other requirements and other EC Directives may be applicable to the products falling within the scope of this standard. ___________
SIST EN 60601-1-2:2008



SIST EN 60601-1-2:2008



IEC 60601-1-2Edition 3.0 2007-03INTERNATIONAL STANDARD NORME INTERNATIONALEMedical electrical equipment –
Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests
Appareils électromédicaux – Partie 1-2: Exigences générales pour la sécurité de base et les performances essentielles – Norme collatérale: Compatibilité électromagnétique –
Exigences et essais
INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE XFICS 11.040.01;
33.100.10;
33.100.20 PRICE CODECODE PRIXISBN 2-8318-9050-0SIST EN 60601-1-2:2008



– 2 – 60601-1-2 © IEC:2007 CONTENTS FOREWORD.5 INTRODUCTION.8
1 Scope, object and related standards.10 1.1 * Scope.10 1.2 Object.10 1.3 Related standards.10 2 Normative references.10 3 Terms and definitions.12 4 General requirements.15 4.1 General requirements for ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT
and ME SYSTEMS.15 4.2 * SINGLE FAULT CONDITION for ME EQUIPMENT.16 5 Identification, marking and documents.16 5.1 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts.16 5.2 ACCOMPANYING DOCUMENTS.17 6 ELECTROMAGNETIC COMPATIBILITY.39 6.1 EMISSIONS.39 6.2 IMMUNITY.42
Annex A (informative)
General guidance and rationale.58 Annex B (informative)
Guide to marking and labelling requirements
for ME EQUIPMENT and ME SYSTEMS.88 Annex C (informative)
Example completion of Table 1 through Table 8.91 Annex D (informative)
Guidance in classification according to CISPR 11.103 Annex E (informative)
Guidance in the application of IEC 60601-1-2 to particular standards.106 Annex F (informative)
ELECTROMAGNETIC ENVIRONMENTS.109 Annex G (informative)
Guidance for determining if electrical equipment that is not ME EQUIPMENT and that is used in an ME SYSTEM is exempt from the EMC testing requirements of this collateral standard.110 Annex H (informative)
Mapping between the elements of the second edition of IEC 60601-1-2 as amended and IEC 60601-1-2:2007.112
Bibliography.120
Index of defined terms used in this collateral standard.121
Figure 1 – Instructions for completing Table 1 for CISPR 11 ME EQUIPMENT and ME SYSTEMS.21 Figure 2 – Instructions for completing Table 1 for CISPR 14 and CISPR 15 ME EQUIPMENT.22 Figure 3 – Instructions for completing Table 2.25 Figure 4 – Instructions for completing Table 3 and Table 5 for LIFE-SUPPORTING ME EQUIPMENT and ME SYSTEMS.31 SIST EN 60601-1-2:2008



60601-1-2 © IEC:2007 – 3 –
Figure 5 – Instructions for completing Table 4 and Table 6 for ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING.32 Figure A.1 – Example of cable arrangement for radiated IMMUNITY test.86 Figure A.2 – Examples showing maximum dimension for ME EQUIPMENT with one and with two cables.87 Figure G.1 – Procedure for determining if electrical equipment that is not ME EQUIPMENT and that is used in an ME SYSTEM is exempt from the EMC testing requirements of this collateral standard.111
Table 1 – Guidance and MANUFACTURER’S declaration – ELECTROMAGNETIC EMISSIONS – for all ME EQUIPMENT and ME SYSTEMS.20 Table 2 – Guidance and MANUFACTURER’S declaration []– electromagnetic IMMUNITY – for all ME EQUIPMENT and ME SYSTEMS.24 Table 3 – Guidance and MANUFACTURER’S declaration – electromagnetic IMMUNITY – for LIFE-SUPPORTING ME EQUIPMENT and ME SYSTEMS.27 Table 4 – Guidance and MANUFACTURER’S declaration – electromagnetic IMMUNITY – for ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING.28 Table 5 – Recommended separation distances between portable and mobile RF communications equipment and the ME EQUIPMENT or ME SYSTEM – for LIFE-SUPPORTING ME EQUIPMENT and ME SYSTEMS.29 Table 6 – Recommended separation distances between portable and mobile RF communications equipment and the ME EQUIPMENT or ME SYSTEM – for ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING.30 Table 7 – Guidance and MANUFACTURER’S declaration – electromagnetic IMMUNITY – for LIFE-SUPPORTING ME EQUIPMENT and ME SYSTEMS that are specified
for use only in a shielded location.36 Table 8 – Guidance and MANUFACTURER’S declaration – electromagnetic IMMUNITY – for ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING and are specified
for use only in a shielded location.37 Table 9 – Modulation frequency, PHYSIOLOGICAL SIMULATION FREQUENCY,
and OPERATING FREQUENCY.46 Table 10 – IMMUNITY TEST LEVELS for voltage dips.55 Table 11 – IMMUNITY TEST LEVEL for voltage interruption.55 Table B.1 – Marking on the outside of ME EQUIPMENT, ME SYSTEMS or their parts.88 Table B.2 – ACCOMPANYING DOCUMENTS, instructions for use.89 Table B.3 – ACCOMPANYING DOCUMENTS, technical description.90 Table C.1 – Example (1) of completed Table 1.91 Table C.2 – Example (2) of completed Table 1.92 Table C.3 – Example (3) of completed Table 1.93 Table C.4 – Example of completed Table 2.94 Table C.5 – Example (1) test, IMMUNITY and COMPLIANCE LEVELS.95 Table C.6 – Example of completed Table 3.96 Table C.7 – Example of completed Table 5.97 Table C.8 – Example of completed Table 4.98 Table C.9 – Example of completed Table 6.99 Table C.10 – Example (2) test, IMMUNITY and COMPLIANCE LEVELS.99 SIST EN 60601-1-2:2008



– 4 – 60601-1-2 © IEC:2007 Table C.11 – Example of completed Table 7.100 Table C.12 – Example (3) test, IMMUNITY and COMPLIANCE LEVELS.101 Table C.13 – Example of completed Table 8.102 Table F.1 – ELECTROMAGNETIC ENVIRONMENTS.109 Table H.1 – Mapping between the elements of the eecond edition of IEC 60601-1-2 as amended and IEC 60601-1-2:2007.112
SIST EN 60601-1-2:2008



60601-1-2 © IEC:2007 – 5 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION ____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 1-2: General requirements for basic safety
and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests
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 60601-1-2 has been prepared by IEC subcommittee 62A: Common aspects of electrical equipment used in medical practice, of IEC technical committee 62: Electrical equipment in medical practice. This third edition constitutes a collateral standard to IEC 60601-1: Medical electrical equipment – Part 1: General requirements for safety and essential performance hereafter referred to as the general standard. This document cancels and replaces the second edition of IEC 60601-1-2, and constitutes a technical revision. SIST EN 60601-1-2:2008



– 6 – 60601-1-2 © IEC:2007 This edition of IEC 60601-1-2 was revised to structurally align it with the 2005 edition of IEC 60601-1 and to implement the decision of IEC subcommittee 62A that the clause numbering structure of collateral standards written to IEC 60601-1:2005 would adhere to the form specified in ISO/IEC Directives, Part 2:2004. The principle technical changes are in Clause 4, which now recognizes that there is a general requirement for a risk management process in IEC 60601-1:2005. The text of this standard is based on the following documents: FDIS Report on voting 62A/560/FDIS 62A/567/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. In the 60601 series of publications, collateral standards specify general requirements for safety applicable to: – a subgroup of MEDICAL ELECTRICAL EQUIPMENT (e.g. radiological equipment); or – a specific characteristic of all MEDICAL ELECTRICAL EQUIPMENT, not fully addressed in the general standard (e.g. alarm systems). In this collateral standard, the following print types are used: – requirements and definitions: roman type. – test specifications: italic 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 DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS COLLATERAL STANDARD OR AS NOTED: SMALL CAPITALS. NOTE Defined terms are not printed in SMALL CAPITALS in Table 1 through Table 8, in the tables in Annex C and in statements required to appear in the technical description or instructions for use because they are intended for the OPERATOR or RESPONSIBLE ORGANIZATION, who may not be familiar with the defined terms of IEC 60601 standards. In referring to the structure of this standard, the term – “clause” means one of the six numbered divisions within the table of contents, inclusive of all subdivisions (e.g. Clause 6 includes 6.1, 6.2, etc.); – “subclause” means a numbered subdivision of a clause (e.g. 6.1, 6.2 and 6.2.1 are all subclauses of Clause 6). References to clauses within this standard are preceded by the term “Clause” followed by the clause number. References to subclauses within this standard are by number only. In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true
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