Detail of YY 0505-2012

Introduction of YY 0505-2012

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)

Contents of YY 0505-2012

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