• 00/560888 DC : APR 2000

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    IEC 60601-1-2 EDITION 2 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD - ELECTROMAGNETIC COMPATIBILITY - REQUIREMENTS AND TESTS

    Available format(s): 

    Superseded date:  22-02-2002

    Language(s): 

    Published date:  23-11-2012

    Publisher:  British Standards Institution

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    Table of Contents - (Show below) - (Hide below)

    FOREWORD
    INTRODUCTION
    1 Scope
              1.201 Scope
              1.202 Object
    2 Terminology and definitions
              2.201 COMPLIANCE LEVEL
              2.202 CRITICAL FUNCTION
              2.203 DEGRADATION
              2.204 EFFECTIVE RADIATED POWER
              2.205 ELECTROMAGNETIC COMPATIBILITY
              2.206 ELECTROMAGNETIC DISTURBANCE
              2.207 ELECTROMAGNETIC EMISSION
              2.208 ELECTROMAGNETIC ENVIRONMENT
              2.209 ELECTROMAGNETIC NOISE
              2.210 EXCLUSION BAND
              2.211 FUNCTION
              2.212 IEC 60601-1-2 TEST LEVEL
              2.213 IMMUNITY
              2.214 IMMUNITY LEVEL
              2.215 IMMUNITY TEST LEVEL
              2.216 INFORMATION TECHNOLOGY EQUIPMENT
              2.217 LARGE EQUIPMENT and/or SYSTEM
              2.218 LIFE-SUPPORTING EQUIPMENT and/or SYSTEM
              2.219 LOW VOLTAGE
              2.220 MEDICAL ELECTRICAL SYSTEM
              2.221 OPERATING FREQUENCY
              2.222 PATIENT-COUPLED EQUIPMENT and/or SYSTEM
              2.223 PHYSIOLOGICAL SIMULATION FREQUENCY
              2.224 PUBLIC MAINS NETWORK
              2.225 RADIO FREQUENCY
    3 General requirements
              3.201 General requirements for ELECTROMAGNETIC
                          COMPATIBILITY of EQUIPMENT and/or
                          SYSTEMS
              3.201.1 ELECTROMAGNETIC COMPATIBILITY
              3.201.2 CRITICAL FUNCTIONS
              3.201.3 MEDICAL ELECTRICAL EQUIPMENT
              3.201.4 Non-medical equipment
    6 IDENTIFICATION, marking and documents
              6.1.201 Markings on the outside of EQUIPMENT or
                          EQUIPMENT parts
              6.8.201 ACCOMPANYING DOCUMENTS
    SECTION TWO TO FOUR - NOT USED
    SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED OR
                   EXCESSIVE RADIATION
    36 ELECTROMAGNETIC COMPATIBILITY
              36.201 EMISSIONS
              36.202 IMMUNITY
    SECTIONS SIX TO TEN - NOT USED
    TABLE 201 - ELECTROMAGNETIC EMISSIONS Guidance and
                manufacturer's declaration - for all EQUIPMENT
                and/or SYSTEMS
    TABLE 202 - Electromagnetic IMMUNITY Guidance and
                manufacturer's declaration - for all EQUIPMENT
                and/or SYSTEMS
    TABLE 203a - Electromagnetic IMMUNITY Guidance and
                 manufacturer's declaration - LIFE SUPPORTING
                 EQUIPMENT and/or SYSTEMS
    TABLE 203b - Electromagnetic IMMUNITY Guidance and
                 manufacturer's declaration - for all EQUIPMENT
                 and/or SYSTEMS that are not LIFE-SUPPORTING
    TABLE 204a - Recommended Separation distances for Portable
                 and Mobile RF Communications Equipment - for
                 LIFE-SUPPORTING EQUIPMENT and/or SYSTEMS
    TABLE 204b - Recommended Separation Distances for Portable
                 and Mobile RF Communications Equipment - for
                 EQUIPMENT and/or SYSTEMS that are not LIFE-
                 SUPPORTING
    TABLE 205a - Electromagnetic IMMUNITY Guidance and
                 manufacturer's declaration - for LIFE-SUPPORTING
                 EQUIPMENT and/or SYSTEMS that are specified for
                 use only in a shielded location
    TABLE 205b - Electromagnetic IMMUNITY Guidance and
                 manufacturer's declaration - for EQUIPMENT
                 and/or SYSTEMS that are not LIFE-SUPPORTING and
                 are specified for use only in a shielded location
    TABLE 206 - Modulation Frequency, PHYSIOLOGICAL SIMULATION
                FREQUENCY, and OPERATING FREQUENCY
    TABLE 207 - IMMUNITY TEST LEVELS for voltage dips
    TABLE 208 - IMMUNITY TEST LEVEL for voltage interruption
    FIGURE 201a - Instructions for completing Table 201 - for
                  CISPR 11 EQUIPMENT and/or SYSTEMS
    FIGURE 201b - Instructions for completing Table 201 - for
                  CISPR 14 and CISPR 15 EQUIPMENT
    FIGURE 202 - Instructions for completing Table 202
    FIGURE 203a - Instructions for completing Tables 203a and 204a
                  - for LIFE-SUPPORTING EQUIPMENT and/or SYSTEMS
    FIGURE 203b - Instructions for completing Tables 203b and 204b
                  - for EQUIPMENT and/or SYSTEMS that are not
                  LIFE-SUPPORTING
    FIGURE AAA201 - Example of cable arrangement for radiated
                    IMMUNITY test
    FIGURE AAA202 - Examples showing maximum dimension for an
                    EQUIPMENT with one and with two cables
    ANNEX AAA - General guidance and rationale
    ANNEX BBB - Example completion of Tables 201, 202, 203a, 203b,
                204a, 204b and 205a
    ANNEX CCC - Guidance in classification to CISPR 11
    ANNEX DDD - Guidance in the application of IEC 60601-1-2 to
                Particular Standards
    ANNEX EEE - ELECTROMAGNETIC ENVIRONMENTS
    ANNEX FFF - Normative references
    ANNEX GGG - Bibliography

    Abstract - (Show below) - (Hide below)

    (62A/308/CDV) (WILL SUPERSEDE BS EN 60601-1-2:1993) The guidance given is intended to ensure that all conmments receive appropriate and efficient attention by the responsible BSI committee. Annotated drafts will be rejected as unacceptable. Each comment shall be clearly separated from others, make one point only, and be structured in clause order as follows: clause/sub-clause; paragraph/table/figure number; type of comment (general; technical or editorial); comment (with rationale); proposed change.

    General Product Information - (Show below) - (Hide below)

    Comment Closes On
    Committee CH/64
    Document Type Draft
    Publisher British Standards Institution
    Status Superseded
    Superseded By

    Standards Referencing This Book - (Show below) - (Hide below)

    IEC 61000-4-8 : 2.0 ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-8: TESTING AND MEASUREMENT TECHNIQUES - POWER FREQUENCY MAGNETIC FIELD IMMUNITY TEST
    CISPR 14-1:2016 Electromagnetic compatibility - Requirements for household appliances, electric tools and similar apparatus - Part 1: Emission
    IEC 61000-1-2:2016 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 3744:2010 Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Engineering methods for an essentially free field over a reflecting plane
    IEC 61000-4-4 : 3.0EN+(REDLINE+VERSION) ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-4: TESTING AND MEASUREMENT TECHNIQUES - ELECTRICAL FAST TRANSIENT/BURST IMMUNITY TEST
    IEC 61000-4-1:2006 Electromagnetic compatibility (EMC) - Part 4-1: Testing and measurement techniques - Overview of IEC 61000-4 series
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    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
    CISPR 15:2013+AMD1:2015 CSV Limits and methods of measurement of radio disturbance characteristics of electrical lighting and similar equipment
    IEC TR 60513:1994 Fundamental aspects of safety standards for medical electrical equipment
    IEC TR 61000-5-2:1997 Electromagnetic compatibility (EMC) - Part 5: Installation and mitigation guidelines - Section 2: Earthing and cabling
    IEC 61000-4-6 : 4.0 ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-6: TESTING AND MEASUREMENT TECHNIQUES - IMMUNITY TO CONDUCTED DISTURBANCES, INDUCED BY RADIO-FREQUENCY FIELDS
    CISPR 22:2008 Information technology equipment - Radio disturbance characteristics - Limits and methods of measurement
    IEC 61000-4-28:1999+AMD1:2001+AMD2:2009 CSV Electromagnetic compatibility (EMC) - Part 4-28: Testing and measurement techniques - Variation of power frequency, immunity test for equipment with input current not exceeding 16 A per phase
    IEC TR 60878:2015 Graphical symbols for electrical equipment in medical practice
    CISPR 16-2:2003 Specification for radio disturbance and immunity measuring apparatus and methods - Part 2: Methods of measurement of disturbances and immunity
    IEC 60417-2:1998 Graphical symbols for use on equipment - Part 2: Symbol originals
    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 TS 61000-3-4:1998 Electromagnetic compatibility (EMC) - Part 3-4: Limits - Limitation of emission of harmonic currents in low-voltage power supply systems for equipment with rated current greater than 16 A
    ISO 14971-1:1998 Medical devices Risk management Part 1: Application of risk analysis
    IEC 61000-3-3 : 3.0EN+(REDLINE+VERSION) 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
    CISPR 11:2015 RLV Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement
    IEC 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
    IEC 60601-1-4:1996+AMD1:1999 CSV Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems
    CISPR 16-1:1999+AMD1:2002 CSV Specification for radio disturbance and immunity measuring apparatus and methods - Part 1: Radio disturbance and immunity measuring apparatus
    I-ETS 300 220 : OCT 93
    IEC TR 61000-5-1:1996 Electromagnetic compatibility (EMC) - Part 5: Installation and mitigation guidelines - Section 1: General considerations - Basic EMC publication
    IEC 61000-3-2 : 4.0 ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 3-2: LIMITS - LIMITS FOR HARMONIC CURRENT EMISSIONS (EQUIPMENT INPUT CURRENT <= 16 A PER PHASE)
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