IEC 60601-1-2
Edition 4.0 2014-02
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 1-2: General requirements for basic safety and essential performance –
Collateral Standard: Electromagnetic disturbances – Requirements and tests
Appareils électromédicaux –
Partie 1-2: Exigences générales pour la sécurité de base et les performances
essentielles – Norme collatérale: Perturbations électromagnétiques – Exigences
et essais
IEC 60601-1-2:2014-02(en-fr)
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IEC 60601-1-2
Edition 4.0 2014-02
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 1-2: General requirements for basic safety and essential performance –
Collateral Standard: Electromagnetic disturbances – Requirements and tests
Appareils électromédicaux –
Partie 1-2: Exigences générales pour la sécurité de base et les performances
essentielles – Norme collatérale: Perturbations électromagnétiques – Exigences
et essais
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
XD
ICS 11.040.01, 33.100.10, 33.100.20
PRICE CODE
CODE PRIX
ISBN 978-2-8322-1413-8
® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
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– 2 – 60601-1-2 © IEC:2014
CONTENTS
CONTENTS ............................................................................................................................ 2
FOREWORD ........................................................................................................................... 6
INTRODUCTION ..................................................................................................................... 9
1 Scope, object and related standards .............................................................................. 11
1.1 * Scope ............................................................................................................ 11
1.2 Object .............................................................................................................. 11
1.3 Related standards ............................................................................................ 11
1.3.1 IEC 60601-1 ................................................................................... 11
1.3.2 Particular standards ........................................................................ 11
2 Normative references .................................................................................................... 11
3 Terms and definitions .................................................................................................... 13
4 General requirements .................................................................................................... 17
4.1 RISK MANAGEMENT PROCESS for ME EQUIPMENT and ME SYSTEMS ........................ 17
4.2 * Non-ME EQUIPMENT used in an ME SYSTEM ...................................................... 17
4.3 General test conditions .................................................................................... 17
4.3.1 * Configurations .............................................................................. 17
4.3.2 Artificial hand.................................................................................. 18
4.3.3 * Power input voltages and frequencies .......................................... 18
5 ME EQUIPMENT and ME SYSTEMS identification, marking and documents .......................... 20
5.1 Additional requirements for marking on the outside of ME EQUIPMENT and
ME SYSTEMS that are specified for use only in a shielded location SPECIAL
ENVIRONMENT
.................................................................................................... 20
5.2 ACCOMPANYING DOCUMENTS .............................................................................. 20
5.2.1 Instructions for use ......................................................................... 20
5.2.2 Technical description ...................................................................... 21
6 Documentation of the tests ............................................................................................ 23
6.1 General ............................................................................................................ 23
6.2 Test plan .......................................................................................................... 23
6.3 Test report ....................................................................................................... 23
7 ELECTROMAGNETIC EMISSIONS requirements for ME EQUIPMENT and ME SYSTEMS .............. 23
7.1 Protection of radio services and other equipment ............................................. 23
7.1.1 * General ........................................................................................ 23
7.1.2 Operating modes ............................................................................ 23
7.1.3 Multimedia equipment ..................................................................... 24
7.1.4 * Subsystems .................................................................................. 24
7.1.5 ME EQUIPMENT and ME SYSTEMS specified for use only in a
shielded location
SPECIAL ENVIRONMENT ........................................... 24
7.1.6 ME EQUIPMENT and ME SYSTEMS that include radio equipment .......... 24
7.1.7 * ME EQUIPMENT whose main functions are performed by
motors and switching or regulating devices ..................................... 25
7.1.8 ME EQUIPMENT and ME SYSTEMS containing X-ray generators ........... 25
7.1.9 PATIENT physiological simulation ..................................................... 25
7.1.10 Artificial hand.................................................................................. 25
7.1.11 PATIENT-coupled cables .................................................................. 25
7.1.12 PERMANENTLY INSTALLED LARGE ME EQUIPMENT and LARGE
ME SYSTEMS .................................................................................... 25
7.2 Protection of the PUBLIC MAINS NETWORK ........................................................... 26
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7.2.1 * Harmonic distortion ...................................................................... 26
7.2.2 * Voltage fluctuations and flicker ..................................................... 26
7.3 EMISSIONS requirements summary .................................................................... 26
8 Electromagnetic IMMUNITY requirements for ME EQUIPMENT and ME SYSTEMS ................... 27
8.1 * General ......................................................................................................... 27
8.2 PATIENT physiological simulation ...................................................................... 30
8.3 Termination of PATIENT-COUPLED parts .............................................................. 30
8.4 HAND-HELD ME EQUIPMENT and parts intended to be HAND-HELD ......................... 30
8.5 * Subsystems ................................................................................................... 31
8.6 PERMANENTLY INSTALLED LARGE ME EQUIPMENT and LARGE ME SYSTEMS .............. 31
8.7 * Operating modes ........................................................................................... 31
8.8 * Non-ME EQUIPMENT ......................................................................................... 32
8.9 * IMMUNITY TEST LEVELS .................................................................................... 32
8.10 * IMMUNITY to proximity fields from RF wireless communications
equipment ........................................................................................................ 39
9 * Test report .................................................................................................................. 41
Annex A (informative) General guidance and rationale ......................................................... 43
A.1 Safety and performance ................................................................................... 43
A.2 Testing of normally non-observable functions................................................... 43
A.3 Rationale for particular clauses and subclauses ............................................... 43
Annex B (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and
ME SYSTEMS .................................................................................................................... 57
B.1 Marking on the outside of ME EQUIPMENT, ME SYSTEMS or their parts ................. 57
B.2 ACCOMPANYING DOCUMENTS, instructions for use ............................................... 57
B.3 ACCOMPANYING DOCUMENTS, technical description ............................................. 57
Annex C (informative) Guidance in classification according to CISPR 11 ............................. 59
C.1 General ............................................................................................................ 59
C.2 Separation into groups ..................................................................................... 59
C.3 Division into classes ........................................................................................ 60
Annex D (informative) Guidance in the application of IEC 60601-1-2 to particular
standards .............................................................................................................................. 61
D.1 General ............................................................................................................ 61
D.2 Recommended modifications ........................................................................... 61
D.2.1 Testing requirements ...................................................................... 61
D.2.2 ACCOMPANYING DOCUMENTS ............................................................. 61
D.3 Cautions .......................................................................................................... 61
Annex E (informative) Determination of IMMUNITY TEST LEVELS for SPECIAL
ENVIRONMENTS
....................................................................................................................... 63
E.1 General ............................................................................................................ 63
E.2 Summary of method for E.1 a) ......................................................................... 66
E.3 Summary of method for E.1 b), c) and d) .......................................................... 66
E.4 Determination of EM DISTURBANCE level reduction ............................................. 66
E.5 Assessment of EM DISTURBANCE sources .......................................................... 66
E.6 Reasonably foreseeable maximum EM DISTURBANCE levels ............................... 67
E.7 Determination of IMMUNITY TEST LEVELS ............................................................ 67
E.8 RF radiators in SPECIAL ENVIRONMENTS ............................................................. 67
E.9 Examples of mitigations and special conditions ................................................ 68
Annex F (informative) RISK MANAGEMENT for BASIC SAFETY and ESSENTIAL PERFORMANCE
with regard to
ELECTROMAGNETIC DISTURBANCES ..................................................................... 69
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