Detail of YY 9706.102-2021

Introduction of YY 9706.102-2021

Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance— Collateral standard: Electromagnetic compatibility—Requirements and tests 1 Scope, object and related standards 1.1 *Scope This part applies to the basic safety and essential performance of Medical Electrical Equipment and Medical Electrical Systems, hereafter referred to as ME Equipment and ME Systems. This part applies to electromagnetic compatibility of ME Equipment and ME Systems. Note: The clauses and subclauses with asterisk (*) in this part are described in Annex A. 1.2 Object The object of this part is to specify general requirements and tests for electromagnetic compatibility of ME Equipment and ME Systems. They are in addition to the requirements of the general standard and serve as the basis for particular standards. 1.3 Related standards 1.3.1 GB 9706.1 For ME Equipment and ME Systems, this part complements GB 9706.1. When referring to GB 9706.1 or to this part, either individually or in combination, the following conventions are used: ——“the general standard” designates GB 9706.1 alone; ——"this part” designates YY 9706.102 alone; ——“this standard" designates the combination of the general standard and this part. 1.3.2 Particular standards A requirement in a particular standard takes priority over the corresponding requirement in this part. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. GB 4343.1 Electromagnetic compatibility requirements for household appliances, electric tools and similar apparatus—Part 1: Emission (GB 4343.1-2018, CISPR 14-1: 2011, IDT) GB 4824 Industrial, scientific and medical (ISM) radio-frequency equipment—Disturbance characteristics—Limits and methods of measurement (GB 4824-2013, CISPR 11: 2010, IDT) GB/T 5465.2-2008 Graphical symbols for use on electrical equipment—Part 2: Graphical symbols (IEC 60417 DB: 2007, IDT) GB/T 6113.102 Specification for radio disturbance and immunity measuring apparatus and methods—Part 1-2: Radio disturbance and immunity measuring apparatus—Coupling devices for conducted disturbance measurements (GB/T 6113.102-2018, CISPR 16-1-2: 2014, IDT) GB/9254 Information technology equipment—Radio disturbance characteristics—Limits and methods of measurement (GB/T 9254-2008, CISPR 22: 2006, IDT) GB 9706.1-2020 Medical electrical equipment—Part 1: General requirements for basic safety and essential performance (IEC 60601-1: 2012, MOD) GB 17625.1 Electromagnetic compatibility—Limits—Limits for harmonic current emissions (equipment input current ≤16A per phase) (GB 17625.1-2012, IEC 61000-3-2: 2009, ID) GB/T 17625.2 Electromagnetic compatibility (EMC)—Limits—Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems, for equipment with rated current ≤16A per phase and not subject to conditional connection (GB/T 17625.2-2007, IEC 61000-3-3: 2005, IDT) GB/T 17626.2 Electromagnetic compatibility (EMC)—Testing and measurement techniques—Electrostatic discharge immunity test (GB/T 17626.2-2018, IEC 61000-4-2: 2008, IDT) GB/T 17626.3 Electromagnetic compatibility—Testing and measurement techniques—Radiated radio-frequency electromagnetic field immunity test (GB/T 17626.3—2016, IEC 61000-4-3: 2010, IDT) GB/T 17626.4-2018 Electromagnetic compatibility—Testing and measurement techniques—Electrical fast transient/burst immunity test (IEC 61000-4-4: 2012, IDT) GB/T 17626.5 Electromagnetic compatibility—Testing and measurement techniques—Surge immunity test (GB/T 17626.5-2008, IEC 61000-4-5: 2014, IDT) GB/T 17626.6-2017 Electromagnetic compatibility—Testing and measurement techniques—Immunity to conducted disturbances, induced by radio-frequency fields (IEC 61000-4-6: 2013, IDT) GB/T 17626.8 Electromagnetic compatibility—Testing and measurement techniques—Power frequency magnetic field immunity test (GB/T 17626.8-2006, IEC 61000-4-8: 2001, IDT) GB/T 17626.11 Electromagnetic compatibility—Testing and measurement techniques—Voltage dips, short interruptions and voltage variations immunity tests (GB/T 17626.11-2008, IEC 61000-4-11: 2004, IDT) GB/T 17743 Limits and methods of measurement of radio disturbance characteristics of electrical lighting and similar equipment (GB/T 17743-2017, CISPR 15: 2015, IDT) YY 9706.108-2021 Medical electrical equipment—Part 1-8: General requirements for basic safety and essential performance—Collateral standard: General requirements, test and guidance for alarm systems in medical electrical equipment and medical electrical systems (IEC 60601-1-8: 2012, MOD) 3 Terms and definitions For the purposes of this document, the terms and definitions given in GB 9706.1-2020 and YY 9706.108-2021 and the following apply. Note 1: Where the terms “voltage” and “current” are used in this part, they mean the r.m.s. values of an alternating, direct or composite voltage or current unless stated otherwise. Note 2: The term “electrical equipment” is used to mean ME Equipment or other electrical equipment. This part also uses the term “equipment” to mean ME Equipment or other electrical or non-electrical equipment in the context of an ME System. 3.1 (immunity) compliance level level less than or equal to the immunity level for which the ME Equipment or ME System meets the requirements of the applicable subclause of 6.2 Note: Additional requirements for compliance levels are specified in 5.2.2. 3.2 *degradation (of performance) undesired departure in the operational performance of ME Equipment or an ME System from its intended performance Note 1: The term "degradation" can apply to temporary or permanent failure. Note 2: It is modified from GB/T 4365-2003, Definition 161-01-19. 3.3 *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 1: 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 2: It is modified from GB/T 4365-2003, Definition 161-04-16. 3.4 *electromagnetic compatibility; EMC ability of ME Equipment or an ME System to function satisfactorily in its electromagnetic environment without introducing intolerable electromagnetic disturbances to anything in that environment Note: It is modified from GB/T 4365-2003, Definition 161-01-07. 3.5 *electromagnetic disturbance any electromagnetic phenomenon that may degrade the performance of a device, equipment or system Note 1: An electromagnetic disturbance may be electromagnetic noise, an unwanted signal or a change in the propagation medium itself. Note 2: It is modified from GB/T 4365-2003, Definition 161-01-05. 3.6 (electromagnetic) emission phenomenon by which electromagnetic energy emanates from a source [GB/T 4365-2003, Definition 161-01-08]   3.7 electromagnetic environment totality of electromagnetic phenomena existing at a given location Note: In general, the electromagnetic environment is time dependent and its description may need a statistical approach. [GB/T 4365-2003, Definition 161-01-01] 3.8 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, Definition 161-01-02] 3.9 electrostatic discharge transfer of electric charge between objects of different electrostatic potentials in proximity or through direct contact [GB/T 4365-2003, Definition 161-01-22] 3.10 *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 80 MHz 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. 3.11 *function clinically significant operation that the ME Equipment or ME System is intended to perform in the diagnosis, treatment or monitoring of a patient or for compensation or alleviation of disease, injury or disability 3.12 IEC 60601 test level immunity test level specified in 6.2 by this part or a particular standard   3.13 *immunity (to a disturbance) ability of ME Equipment or an ME System to perform without degradation in the presence of an electromagnetic disturbance Note: It is modified from GB/T 4365-2003, Definition 161-01-20. 3.14 immunity level maximum disturbance level at which a given electromagnetic disturbance is applied to a device, equipment, or system while it still works properly and maintains the required performance level [GB/T 4365-2003, Definition 161-03-14] 3.15 immunity test level level of a test signal used to simulate an electromagnetic disturbance when performing an immunity test [GB/T 4365-2003, Definition 161-04-41] 3.16 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) Note: This definition includes electrical or electronic units or systems that predominantly generate a multiplicity of periodic binary pulsed electrical or electronic waveforms and are designed to perform data processing functions such as word processing, electronic computation, data transformation, recording, filing, sorting, storage, retrieval and transfer, and reproduction of data as images. [GB/T 4365-2003, Definition 161-05-04]   3.17 *large ME Equipment or ME System ME Equipment or ME System that cannot fit within a 2m × 2m × 2.5m volume, excluding cables, but including distributed ME Systems 3.18 *life-supporting ME Equipment or ME System ME Equipment or ME System that includes at least one function that is intended to actively keep alive or resuscitate patients and the failure of which to comply with the requirements of 6.2.1.10 is likely to lead to serious injury or death of a patient 3.19 *low voltage line-to-line or line-to-neutral voltage that is less than or equal to 1,000 V a.c. or 1,500 V d.c. 3.20 *operating frequency fundamental frequency of a signal, electrical or non-electrical, that is set in ME Equipment or an ME System intended to control a physiological parameter 3.21 *patient-coupled ME Equipment or ME System ME Equipment or ME System that contains at least one applied part whereby contact with the patient provides a sensing or treatment point necessary for the normal operation of the ME Equipment or ME System and provides a path for electromagnetic energy, whether coupled conductively, capacitively or inductively and whether intended or unintended 3.22 *physiological simulation frequency fundamental frequency of a signal, electrical or non-electrical, used to simulate a physiological parameter such that the ME Equipment or ME System will operate in a manner consistent with use on a patient 3.23 *professional ME Equipment or ME System ME Equipment or ME System for use by healthcare professionals and that is not intended for sale to the general public Note: It is modified from GB/T 4365-2003, Definition 161-05-05. 3.24 *public mains network low voltage electricity power lines to which all categories of consumers have access 3.25 *radio frequency; RF frequency in the portion of the electromagnetic spectrum that is between the audio-frequency portion and the infrared portion; frequency useful for radio transmission Note: The limits are generally accepted to be 9 kHz to 3,000 GHz. 3.26 type A professional ME Equipment or ME System professional ME Equipment or ME System that complies with GB 4824 group 2 Class B except for the third harmonic of the fundamental frequency of the ME Equipment or ME System, in which case the third harmonic complies with the group 2 Class A electromagnetic radiation disturbance limit Note: See subclause 6.1.1.1 f). 4 General requirements 4.1 General requirements for electromagnetic compatibility of ME Equipment and ME Systems 4.1.1 *Electromagnetic compatibility ME Equipment and ME Systems shall not emit electromagnetic disturbances that could affect radio services, other equipment or the essential performance of other ME Equipment and ME Systems. ME Equipment and ME Systems shall have adequate immunity to be able to provide its basic safety and essential performance in the presence of electromagnetic disturbances. Consider compliance to exist if the requirements of this part are met. 4.1.2 Non-medical electrical equipment Electrical equipment that is not ME Equipment and that is supplied as part of an ME System is exempt from the EMC testing requirements of this part provided all of the following conditions are met (see also Annex G): a) the electrical equipment that is not ME Equipment complies with applicable international EMC standards; b) both the emissions and immunity of the electrical equipment that is not ME Equipment have been determined not to adversely affect the basic safety or essential performance of the ME system; c) the emissions of the electrical equipment that is not ME Equipment have been determined not to cause the emissions of the ME System to exceed applicable limits. Check compliance by inspection of the documents for this determination and other appropriate documents or certificates or, if this determination is not performed, by inspection of the documents to verify that the electrical equipment that is not ME Equipment has been tested in accordance with this part. 4.2 *Single fault condition for ME Equipment For EMC testing, the single fault condition requirements of the general standard do not apply. 5 Identification, marking and documents 5.1 Marking on the outside of ME Equipment or ME Equipment parts

Contents of YY 9706.102-2021

Foreword i Introduction iv 1 Scope, object and related standards 2 Normative references 3 Terms and definitions 4 General requirements 5 Identification, marking and documents 6 Electromagnetic compatibility Annex A (Informative) General guidance and rationale Annex B (Informative) Guide to marking and labeling requirements for ME Equipment and ME Systems Annex C (Informative) Example completion of Table 1 through Table Annex D (Informative) Guidance in classification according to GB Annex E (Informative) Guidance applied to particular standards Annex F (Informative) Electromagnetic environment Annex G (Informative) Guidance for determining if electrical equipment that is not ME Equipment and that is used in an ME System is exempt from the EMC test requirements of this part Annex H (Informative) Mapping between the elements of YY 0505-2012 and this part Figure 1 Instructions for completing Table 1 for GB 4824 ME Equipment and ME Systems [see 5.2.2.1 c)] Figure 2 Instructions for completing Table 1 for GB 4343 and GB/T 17743 ME Equipment [see 5.2.2.1 c)] Figure 3 Instructions for completing Table 2 [see 5.2.2.1 f)] Figure 4 Instructions for completing Table 3 and Table 5 for life-supporting ME Equipment and ME Systems (see 5.2.2.2) Figure 5 Instructions for completing Table 4 and Table 6 for ME Equipment and ME Systems that are not life-supporting (see 5.2.2.2) Figure A.1 Example of cable arrangement for radiated immunity test [see 6.2.3.2 h)] Figure A.2 Examples showing maximum dimension for ME Equipment with one and with two cables [See 6.2.6.1 e) and f)] Figure G.1 Procedure for determining if electrical equipment that is not ME Equipment and that is used in an ME System is exempt from the EMC test requirements of this collateral standard (see 4.1.2 and 6.2.1.4) Table 1 Guidance and manufacturer’s declaration – electromagnetic emissions – for ME Equipment and ME Systems [see 5.2.2.1 c)] Table 2 Guidance and manufacturer’s declaration – electromagnetic immunity –for all ME Equipment and ME Systems [see 5.2.2.1 f)] Table 3 Guidance and manufacturer’s declaration – electromagnetic immunity – for life-supporting ME equipment and ME Systems (see 5.2.2.2) Table 4 Guidance and manufacturer’s declaration – electromagnetic immunity – for ME Equipment and ME Systems that are not life-supporting (see 5.2.2.2) Table 5 Recommended separation distances between portable and mobile RF communications equipment and the ME Equipment or ME System – for life-supporting ME Equipment and ME Systems (see 5.2.2.2) Table 6 Recommended separation distances between portable and mobile RF communications equipment and the ME Equipment or ME System – for ME Equipment and ME Systems that are not life-supporting (see 5.2.2.2) Table 7 Guidance and manufacturer’s declaration – electromagnetic immunity for life-supporting ME Equipment and ME Systems that are specified for use only in a shielded location [See 5.2.2.3 d)] Table 8 Guidance and manufacturer’s declaration – electromagnetic immunity for ME Equipment and ME Systems that are not life-supporting and are specified for use only in a shielded location [See 5.2.2.3 d)] Table 9 Modulation frequency, physiological simulation frequency and operating frequency Table 10 Immunity test levels for voltage dips Table 11 Immunity test levels for voltage interruption Table B.1 Marking on the outside of ME Equipment, ME Systems or their parts Table B.2 Accompanying documents, instructions for use Table B.3 Accompanying documents, technical description Table C.1 Example (1) completion of Table Table C.2 Example (2) completion of Table Table C.3 Example (3) completion of Table Table C.4 Example completion of Table Table C.5 Example (1) test, immunity and compliance level Table C.6 Example completion of Table Table C.7 Example completion of Table Table C.8 Example completion of Table Table C.9 Example completion of Table Table C.10 Example (2) test, immunity and compliance level Table C.11 Example completion of Table Table C.12 Example (3) test, immunity and compliance level Table C.13 Example completion of Table Table F.1 Electromagnetic environment Table H.1 Mapping between the elements of the YY0505-2012 and this part