Section One General
1 Scope and Object
1.201* Scope
This standard applies to ELECTROMAGNETIC COMPATIBILITY of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereinafter referred to as EQUIPMENT and SYSTEMS, respectively.
1202 Object
This standard specifies requirements and tests for ELECTROMAGNETIC COMPATIBILITY of EQUIPMENT and SYSTEMS and serves as the basis of ELECTROMAGNETIC COMPATIBILITY requirements and tests in Particular Standards.
2 Terminology and Definitions
For the purposes of this standard, the terms and definitions given in GB 9706-1-2007, GB 9706.15-2008, YY 0709-2009 and YY/T 0316-2008 and the following apply:
2.201
(immunity) compliance level
level less than or equal to the IMMUNITY LEVEL for which the EQUIPMENT or SYSTEM meets the requirements of the applicable subclause of 36.202
Note: additional requirements for COMPLIANCE LEVELS are specified in 6.8.3.201.
2.202*
degradation (of performance)
undesired departure in the operational performance of an EQUIPMENT or SYSTEM from its intended performance
Note: the term "DEGRADATION" can apply to temporary or permanent failure.
Note: modified from GB/T 4365-2003, 161-01-19.
2.203*
effective radiated power; ERP
power required at the input of a lossless reference antenna to produce, in a given direction at any specified distance, the same power flux density as that radiated by a given device Note: as used by the ITU and as used in Chapter 712 of the IEV, the term “effective radiated power” appears without qualification only when the reference antenna is a half-wave dipole.
Note: modified from GB/T 4365-2003, 161-04-16.
2.204*
electromagnetic compatibility; EMC
ability of an EQUIPMENT or SYSTEM to function satisfactorily in its ELECTROMAGNETIC ENVIRONMENT without introducing intolerable ELECTROMAGNETIC DISTURBANCES to anything in that environment
Note: modified from GB/T 4365-2003, 161-01-07.
2.205*
electromagnetic disturbance
any electromagnetic phenomenon that may degrade the performance of a device, equipment or system
Notes:
1 An ELECTROMAGNETIC DISTURBANCE may be an ELECTROMAGNETIC NOISE, an unwanted signal or a change in the propagation medium itself.
2 Modified from GB/T 4365-2003, 161-01-05.
2.206
(electromagnetic) emission
phenomenon by which electromagnetic energy emanates from a source
[GB/T 4365-2003,161-01-08]
2.207*
electromagnetic environment
totality of electromagnetic phenomena existing at a given location
Notes:
1 In general, the ELECTROMAGNETIC ENVIRONMENT is time dependent and its description may need a statistical approach.
2 Modified from GB/T 4365-2003, 161-01-01.
2.208
electromagnetic noise
time-varying electromagnetic phenomenon apparently not conveying information and which may be superimposed on or combined with a wanted signal
[GB/T 4365-2003, 161-01-02]
2.209
electrostatic discharge; ESD
a transfer of electric charge between bodies of different electrostatic potential in proximity or through direct contact
[GB/T 4365-2003, 161-01-22]
2.211*
exclusion band
frequency band for intentional receivers of RF electromagnetic energy that extends from -5% to +5% of the frequency, or frequency band, of reception for frequencies of reception greater than or equal to 80MHz and from -10% to +10% of the frequency, or frequency band, of reception for frequencies of reception less than 80 MHz
Note: other definitions of this term are sometimes used for other purposes in national radio regulations.
2.212*
function (of an equipment or system)
clinically significant operation that the EQUIPMENT or SYSTEM is intended to perform in the diagnosis, treatment or monitoring of a PATIENT
2.213
IEC 60601 test level
IMMUNITY TEST LEVEL specified in 36.202 by this standard or a Particular Standard
2.214*
immunity(to a disturbance)
ability of an EQUIPMENT or SYSTEM to perform without DEGRADATION in the presence of an ELECTROMAGNETIC DISTURBANCE
Note: modified from GB/T 4365-2003, 161-01-20.
2.215
immunity level
maximum level of a given ELECTROMAGNETIC DISTURBANCE incident on a particular device, equipment or system for which it remains capable of operating at a required degree of performance
[GB/T 4365-2003.161-03-14]
2.216*
immunity test level
level of a test signal used to simulate an ELECTROMAGNETIC DISTURBANCE when performing an IMMUNITY test
Note: modified from GB/T 4365-2003, 161-04-41.
2.217
information technology equipment; ITE
equipment designed for the purpose of:
a) receiving data from an external source (such as a data input line or via a keyboard);
b) performing some processing functions on the received data (such as computation, data transformation or recording, filing, sorting, storage, transfer of data);
c) providing a data output (either to other equipment or by the reproduction of data or images)
Foreword i
Introduction iii
Section One General
1 Scope and Object
2 Terminology and Definitions
3 General Requirements
6 Identification, Marking and Documents
Sections Two To Four
Section Five Protection against Hazards from Unwanted or Excessive Radiation
36 Electromagnetic Compatibility
Sections Six to Ten
Annex A (Informative) General Guidance and Rationale
Annex B (Informative) Example Completion of Tables 201 through 208
Annex C (Informative) Guidance in Classification according to GB 4824
Annex D (Informative) Guidance in the Application of YY 0505 to Particular Standards
Annex E (Informative) Electromagnetic Environments
Annex F (Normative) Normative References
Annex G (Informative) Guidance in the Identification of Essential Performance
Annex H (Informative) Guidance for Determining if Non-medical Electrical Equipment Used in a SYSTEM is Exempt from the EMC Testing Requirements of This Standard
Figure 201 Instructions for Completing Table 201 for GB 4824 EQUIPMENT and SYSTEMS
Figure 202 Instructions for Completing Table 201 for GB 4343 and GB 17743 EQUIPMENT
Figure 203 Instructions for Completing Table 202
Figure 204 Instructions for Completing Tables 203 and 205 for Life-supporting Equipment and Systems
Figure 205 Instructions for Completing Tables 204 and 206 for Life-supporting Equipment and Systems
Figure A.1 Example of Cable Arrangement for Radiated Immunity Test
Figure A.2 Examples Showing Maximum Dimension for An Equipment with One and with Two Cables
Figure H.1 Procedure for Determining if Non-medical electrical Equipment Used in a SYSTEM is Exempt from the EMC Testing Requirements of This Standard
Table 201 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions – for all EQUIPMENT and SYSTEMS
Table 202 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity - for All Equipment and Systems
Table 203 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity - for Life-supporting Equipment and Systems
Table 204 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity - for Equipment and Systems That are Not Life-supporting
Table 205 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the Equipment or System - for Life-supporting Equipment and Systems
Table 206 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the Equipment or System - for Equipment and Systems That are Not Life-supporting
Table 207 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity - for Life-supporting Equipment and Systems That are Specified for Use Only in a Shielded Location
Table 208 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity - for Equipment and Systems That are Not Life-supporting and are Specified for Use Only in a Shielded Location
Table 209 Modulation Frequency, Physiological Simulation Frequency, and Operating Frequency
Table 210 Immunity Test Levels for Voltage Dips
Table 211 Immunity Test Level for Voltage Interruption
Table B.1 Example (1) of Completed Table 201
Table B.2 Example (2) of Completed Table 201
Table B.3 Example (3) of Completed Table 201
Table B.4 Example of Completed Table 202
Table B.5 Example (1) Test, Immunity and Compliance Levels
Table B.6 Example of Completed Table 203
Table B.7 Example of Completed Table 205
Table B.8 Example of Completed Table 204
Table B.9 Example of Completed Table 206
Table B.10 Example (2) Test, Immunity and Compliance Levels
Table B.11 Example of Completed Table 207
Table B.12 Example (3) Test, Immunity and Compliance Levels
Table B.13 Example of Completed Table 208
Table E.1 Electromagnetic Environments
