12/30159217 DC : 0
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BS EN 60601-1-2 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS
Hardcopy , PDF
31-10-2015
English
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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) - Guidance for 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 contents
ANNEX H (informative) - PATIENT-COUPLED cables EMISSIONS
Annex I (informative) - Identification of IMMUNITY
pass/fail criteria
Annex J (informative) - ELECTROMAGNETIC COMPATIBILITY
(EMC performance)
Bibliography
Index of defined terms used in this collateral standard
BS EN 60601-1-2.
| Committee |
CH/62/1
|
| DocumentType |
Draft
|
| Pages |
98
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| 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 TR 61000-1-1:1992 | Electromagnetic compatibility (EMC) - Part 1: General - Section 1: Application and interpretation of fundamental definitions and terms |
| 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 |
| 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 |
| 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 61000-3-12:2011 | 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 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 TR 61000-2-5:2017 | Electromagnetic compatibility (EMC) - Part 2-5: Environment - Description and classification of electromagnetic environments |
| CISPR 22:2008 | Information technology equipment - Radio disturbance characteristics - Limits and methods of measurement |
| 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 |
| 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 |
| AAMI TIR18:2010 | GUIDANCE ON ELECTROMAGNETIC COMPATIBILITY OF MEDICAL DEVICES IN HEALTHCARE FACILITIES |
| 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 |
| 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 |
| IEC 61496-1:2012 | Safety of machinery - Electro-sensitive protective equipment - Part 1: General requirements and tests |
| 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 |
| 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 |
| 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 |
| 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 |
| 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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