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1 Translated English of Chinese Standard: YY NATIONAL STANDARD OF THE GB PEOPLE S REPUBLIC OF CHINA ICS C 39 Medical electrical equipment - Part 2: Particular requirements for the safety of electromyographs and evoked response equipment 医用电气设备第 2 部分 : 肌电及诱发反应设备安全专用要求 (IEC :1998, Medical electrical equipment - Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment, MOD) Issued on: October 21, 2013 Implemented on: October 1, 2014 Issued by: China Food and Drug Administration Page 1 of 20

2 Table of Contents Foreword... 4 Section 1. General Scope and object Terminology and definitions Classification Identification, marking and documents Power input Section 2. Environmental conditions Section 3. Protection against electric shock hazards Requirements related to classification Dielectric strength Section 4. Protection against mechanical hazards Section 5. Protection against hazards from unwanted or excessive radiation Electromagnetic compatibility Section 6. Protection against hazards of ignition of flammable anaesthetic mixtures. 14 Section 7. Protection against excessive temperatures and other safety hazards Excessive temperatures * Human errors Section 8. Accuracy of operating data and protection against hazardous output Accuracy of operating data Protection against hazardous output Section 9. Abnormal operation and fault conditions; environmental tests Page 2 of 20

3 Section 10. Constructional requirements Annex L (normative) Normative references Annex AA (informative) General guidance and rationale Page 3 of 20

4 Foreword Medical electrical equipment standards are a series of standards, consisting of two major parts: - Part 1: General requirements for safety of medical electrical equipment; - Part 2: Particular requirements for safety of medical electrical equipment. This Particular Standard is Part 2-40 of Medical electrical equipment. This Particular Standard is the amendment and addition of GB Medical electrical equipment - Part 1: General requirements for safety. This Particular Standard is drafted according to the rules given in GB/T This Particular Standard uses redrafting method to amend and adopt the International Electrotechnical Commission Standard IEC :1998 Medical electrical equipment - Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment (English version). Main technical differences between this Standard and IEC :1998 are as follows: - Clause 36 in IEC :1998 is the addition to the collateral standard IEC :1993, and China's current electromagnetic compatibility standards YY Medical electrical equipment - Part 1: General requirements for safety - 2. Collateral standard: Electromagnetic compatibility - Requirements and tests is equivalent to IEC :2004. Therefore, in the development of this Particular Standard, the Standardization Administration of China believes that it is necessary to update the specifications on electromagnetic compatibility with reference to the requirements of the latest collateral standards. - For the other International standards referenced in the standard, if the standard has been transformed into China s national standard, the referenced China s national standards shall prevail; - DELETE the cover and foreword of IEC :1998. This Particular Standard is the amendment and addition of GB Medical electrical equipment - Part 1: General requirements for safety, so this Particular Standard takes priority over the General Standard. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. Issuing organizations of this document shall not be held responsible for identifying any or all such patent rights. Page 4 of 20

5 This Particular Standard is proposed and under the jurisdiction of Technical Sub- Committee on Medical Electrical Equipment of National Technical Committee on Medical Electrical Equipment of Standardization Administration of China (SAC/TC 10/SC 5). Drafting organization of this Particular Standard: Shanghai Medical Devices Testing Institute. Main drafters of this Particular Standard: Shi Daifeng, Tao Kan. Page 5 of 20

6 Medical electrical equipment - Part 2: Particular requirements for the safety of electromyographs and evoked response equipment Section 1. General The clauses and subclauses of this section of the General Standard apply except as follows: 1 Scope and object This clause of the General Standard applies except as follows: 1.1 Scope Addition: This Particular Standard applies to ELECTROMYOGRAPHS as defined in and EVOKED RESPONSE EQUIPMENT as defined in , hereinafter referred to as EQUIPMENT. 1.2 Object Replacement: The object of this Particular Standard is to establish particular requirements for the safety of ELECTROMYOGRAPHS and EVOKED RESPONSE EQUIPMENT as defined in and , respectively. 1.3 Particular Standards Addition: This Particular Standard refers to GB Part 1 is referred to in this Particular Standard either as the General Standard or as the General Requirement(s). Page 6 of 20

7 The use of the phantom is intended to standardize the testing for EMC, particularly for susceptibility. Contamination of the display resulting from the radiated radiofrequency electromagnetic field tests is not considered to be hazardous and, therefore, not a noncompliance. Instructions for use should specify maximum electromagnetic fields within which all performance specifications will be met, if these are necessarily lower than the levels specified for the tests of Switching on the ELECTRICAL STIMULATOR inadvertently is considered to be a normal occurrence since the ELECTRICAL STIMULATOR is likely to be short-circuited or open-circuited accidentally during use due to movements of the electrodes and/or the PATIENT A small increase in output amplitude may produce a disproportionate stimulus to the PATIENT. A control which enables the USER to adjust the output amplitude smoothly or in small increments is considered to be an important safety feature. Limitation of the output available at the minimum setting of the output control enables the USER to commence stimulation from a low output level An accuracy of ± 30 % is considered to provide adequate safety, since the values selected are mainly determined by the electrophysiological responses and the subjective reaction of the PATIENT Supply voltage fluctuations not exceeding the limit of the General Standard should not influence the output parameters excessively The indication should advise the USER that the ELECTRICAL STIMULATOR is delivering stimuli, or that the ELECTRICAL STIMULATOR is armed to deliver stimuli as a result of further action by the USER, for example manual triggering Experience shows that the limits specified allow all known diagnostic applications to be carried out without exceeding the allowable value The value of 125 db HTL is taken from GB/T END Page 20 of 20