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00/560888 DC : APR 2000

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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

Superseded date

02-22-2002

Published date

11-23-2012

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

(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.

Committee
CH/64
DocumentType
Draft
PublisherName
British Standards Institution
Status
Superseded
SupersededBy

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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