I.S. EN 60601-1-2:2015
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS
Hardcopy , PDF
12-04-2021
English
01-01-2015
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National Foreword
FOREWORD
INTRODUCTION
1 Scope, object and related standards
2 Normative references
3 Terms and definitions
4 General requirements
5 ME EQUIPMENT and ME SYSTEMS identification,
marking and documents
6 Documentation of the tests
7 ELECTROMAGNETIC EMISSIONS requirements for
ME EQUIPMENT and ME SYSTEMS
8 Electromagnetic IMMUNITY requirements for ME
EQUIPMENT and ME SYSTEMS
9 Test report
Annex A (informative) - General guidance and rationale
Annex B (informative) - Guide to marking and labelling
requirements for ME EQUIPMENT and ME SYSTEMS
Annex C (informative) - Guidance in classification according
to CISPR 11
Annex D (informative) - Guidance in the application of
IEC 60601-1-2 to particular standards
Annex E (informative) - Determination of IMMUNITY TEST
LEVELS for SPECIAL ENVIRONMENTS
Annex F (informative) - RISK MANAGEMENT for BASIC
SAFETY and ESSENTIAL PERFORMANCE
with regard to ELECTROMAGNETIC DISTURBANCES
Annex G (informative) - Guidance: Test plan
Annex H (informative) - PATIENT-coupled cables
EMISSIONS
Annex I (informative) - Identification of IMMUNITY pass/fail
criteria
Bibliography
Index of defined terms used in this collateral standard
Annex ZA (normative) - Normative references to
international publications with their
corresponding European publications
Annex ZZ (informative) - Coverage of Essential
Requirements of EU Directives
Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS.
| DevelopmentNote |
For CENELEC adoptions of IEC publications, please check www.iec.ch to be sure that you have any corrigenda that may apply. (01/2017)
|
| DocumentType |
Standard
|
| Pages |
208
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| SN EN 60601-1-2 : 2015 | Identical |
| NF EN 60601-1-2 : 2016 | Identical |
| EN 60601-1-2:2015 | Identical |
| BS EN 60601-1-2:2015 | Identical |
| UNE-EN 60601-1-2:2008 | Identical |
| DIN EN 60601-1-2 : 2006-10 | Identical |
| CISPR 14-1:2016 | Electromagnetic compatibility - Requirements for household appliances, electric tools and similar apparatus - Part 1: Emission |
| ISO/IEC 17025:2005 | General requirements for the competence of testing and calibration laboratories |
| IEC 60601-2-3:2012+AMD1:2016 CSV | Medical electrical equipment - Part 2-3: Particular requirements for the basic safety and essential performance of short-wave therapy equipment |
| IEC TR 61000-1-1:1992 | Electromagnetic compatibility (EMC) - Part 1: General - Section 1: Application and interpretation of fundamental definitions and terms |
| EN 61000-4-11:2004/A1:2017 | ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-11: TESTING AND MEASUREMENT TECHNIQUES - VOLTAGE DIPS, SHORT INTERRUPTIONS AND VOLTAGE VARIATIONS IMMUNITY TESTS (IEC 61000-4-11:2004/A1:2017) |
| IEC 61000-6-2:2016 | Electromagnetic compatibility (EMC) - Part 6-2: Generic standards - Immunity standard for industrial environments |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| CISPR 16-1-1:2015 | Specification for radio disturbance and immunity measuring apparatus and methods - Part 1-1: Radio disturbance and immunity measuring apparatus - Measuring apparatus |
| IEC 61000-4-11:2004+AMD1:2017 CSV | Electromagnetic compatibility (EMC) - Part 4-11: Testing and measurement techniques - Voltage dips, short interruptions and voltage variations immunity tests |
| EN 61000-3-3:2013 | 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 (IEC 61000-3-3:2013) |
| IEC TS 61000-1-2:2008 | Electromagnetic compatibility (EMC) - Part 1-2: General - Methodology for the achievement of functional safety of electrical and electronic systems including equipment with regard to electromagnetic phenomena |
| IEC TR 60788:2004 | Medical electrical equipment - Glossary of defined terms |
| ISO 11451-3:2015 | Road vehicles — Vehicle test methods for electrical disturbances from narrowband radiated electromagnetic energy — Part 3: On-board transmitter simulation |
| ISO 7637-2:2011 | Road vehicles Electrical disturbances from conduction and coupling Part 2: Electrical transient conduction along supply lines only |
| IEC 61000-4-8:2009 | Electromagnetic compatibility (EMC) - Part 4-8: Testing and measurement techniques - Power frequency magnetic field immunity test |
| IEC 61000-3-12:2011 | Electromagnetic compatibility (EMC) - Part 3-12: Limits - Limits for harmonic currents produced by equipment connected to public low-voltage systems with input current >16 A and ≤ 75 A per phase |
| IEC 61000-4-4:2012 RLV | Electromagnetic compatibility (EMC) - Part 4-4: Testing and measurement techniques - Electrical fast transient/burst immunity test |
| EN 61000-4-2:2009 | Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test |
| CISPR 32:2015 RLV | Electromagnetic compatibility of multimedia equipment - Emission requirements |
| IEC 60601-1-8:2006+AMD1:2012 CSV | Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems |
| IEC 61000-4-6:2013 | Electromagnetic compatibility (EMC) - Part 4-6: Testing and measurement techniques - Immunity to conducted disturbances, induced by radio-frequency fields |
| EN 61000-4-3 : 2006 AMD 2 2010 | ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-3: TESTING AND MEASUREMENT TECHNIQUES - RADIATED, RADIO-FREQUENCY, ELECTROMAGNETIC FIELD IMMUNITY TEST |
| IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| CISPR 25:2016 | Vehicles, boats and internal combustion engines - Radio disturbance characteristics - Limits and methods of measurement for the protection of on-board receivers |
| IEC 60601-2-2:2017 | Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories |
| ISO/TR 16142:2006 | Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices |
| IEEE/ANSI C63.14-2014 REDLINE | American National Standard Dictionary of Electromagnetic Compatibility (EMC) including Electromagnetic Environmental Effects (E3) |
| ISO 14708-3:2017 | Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators |
| MIL-STD-461 Revision G:2015 | REQUIREMENTS FOR THE CONTROL OF ELECTROMAGNETIC INTERFERENCE CHARACTERISTICS OF SUBSYSTEMS AND EQUIPMENT |
| EN 61000-4-8:2010 | Electromagnetic compatibility (EMC) - Part 4-8: Testing and measurement techniques - Power frequency magnetic field immunity test |
| IEC 61000-4-2:2008 | Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test |
| IEC 61000-4-3:2006+AMD1:2007+AMD2:2010 CSV | Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test |
| IEC 60601-2-27:2011 | Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment |
| CISPR 16-2-3:2016 | Specification for radio disturbance and immunity measuring apparatus and methods - Part 2-3: Methods of measurement of disturbances and immunity - Radiated disturbance measurements |
| IEC 61000-3-3:2013 RLV | 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 61000-3-2:2014 | Electromagnetic compatibility (EMC) - Part 3-2: Limits - Limits for harmonic current emissions (equipment input current ≤ 16 A per phase) |
| IEC 61000-6-1:2016 | Electromagnetic compatibility (EMC) - Part 6-1: Generic standards - Immunity standard for residential, commercial and light-industrial environments |
| IEC 61496-1:2012 | Safety of machinery - Electro-sensitive protective equipment - Part 1: General requirements and tests |
| ISO 11452-9:2012 | Road vehicles Component test methods for electrical disturbances from narrowband radiated electromagnetic energy Part 9: Portable transmitters |
| EN 55103-2:2009 | Electromagnetic compatibility - Product family standard for audio, video, audio-visual and entertainment lighting control apparatus for professional use - Part 2: Immunity |
| EN ISO 14971:2012 | Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
| ISO 11452-8:2015 | Road vehicles — Component test methods for electrical disturbances from narrowband radiated electromagnetic energy — Part 8: Immunity to magnetic fields |
| ISO 7137:1995 | Aircraft — Environmental conditions and test procedures for airborne equipment |
| EN 61000-4-4:2012 | ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-4: TESTING AND MEASUREMENT TECHNIQUES - ELECTRICAL FAST TRANSIENT/BURST IMMUNITY TEST (IEC 61000-4-4:2012) |
| CISPR 11:2015 RLV | Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| EN 60601-1-11:2015 | Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment |
| CISPR 24:2010+AMD1:2015 CSV | Information technology equipment - Immunity characteristics - Limitsand methods of measurement |
| IEC 61000-4-13:2002+AMD1:2009+AMD2:2015 CSV | Electromagnetic compatibility (EMC) - Part 4-13: Testing and measurement techniques - Harmonics and interharmonics includingmains signalling at a.c. power port, low frequency immunity tests |
| EN 55014-1:2017 | Electromagnetic compatibility - Requirements for household appliances, electric tools and similar apparatus - Part 1: Emission |
| EN 60601-1-8:2007/A11:2017 | 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 (IEC 60601-1-8:2006/A1:2012) |
| IEC 60601-2-44:2009+AMD1:2012+AMD2:2016 CSV | Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography |
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