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All technical contents of this standard are compulsory.
This standard is developed in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY 0649-2008 High electrical potential therapy equipment. In addition to editorial changes, the following main technical changes have been made with respect to YY 0649-2008:
——The following terms and definitions are modified: electrical potential therapy equipment, applied part and over current protective device (see 3.1, 3.2 and 3.9);
——The following terms and definitions are added: pad, blanket and mattress (see 3.3, 3.4 and 3.5);
——The requirements for time stability of output voltage (see 4.5.2), safety range of electric field space (see 4.8), safety range of magnetic field space (see 4.9), durability of pad, blanket and mattress (see 4.10), operating noise (see 4.11), biocompatibility (see 4.12) and timer (see 4.13.5) are added;
——The requirements for output voltage stability (see 4.5.1), output over current protection (see 4.7), functions (see 4.13.3), external marks (4.14.2.2), instructions for use (see 4.14.2.3), technical instructions (see 4.14.2.4), continuous leakage current and patient auxiliary current (see 4.14.2.6), abnormal operation and fault conditions (see 4.14.2.10), components and assemblies (4.14.2.11) and electromagnetic compatibility (see 4.15) are modified;
——Annex B is added.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing body of this document shall not be held responsible for identifying any or all such patent rights.
This standard was proposed by the China Food and Drug Administration.
This standard is under the jurisdiction of SAC/TC 10/SC 4 Subcommittee on Physical Therapy Equipment of the National Technical Committee on Medical Electrical Equipment of Standardization Administration of China.
The previous edition of this standard is as follows:
——YY 0649-2008.
Electrical potential therapy equipment
1 Scope
This standard specifies the terms and definitions, requirements, test methods, inspection rules, marking, labeling and instructions for use, and packaging, transportation and storage of electrical potential therapy equipment.
This standard is applicable to the electrical potential therapy equipment specified in 3.1 (hereinafter referred to as the equipment). It is also applicable to combined equipment with potential therapy function.
This standard is not applicable to the following equipment:
——static sticker;
——wearable equipment.
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/T 191-2008 Packaging - Pictorial marking for handling of goods (ISO 780:1997, MOD)
GB 9706.1-2007 Medical electrical equipment - Part 1: General requirements for safety (IEC 60601-1:1988, IDT)
GB 9706.15-2008 Medical electrical equipment - Part 1: General requirements for safety - 1. Collateral standard: Safety requirements for medical electrical systems (IEC 60601-1-1:2000, IDT)
GB/T 14710-2009 Environmental requirement and test methods for medical electrical equipment
GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009, IDT)
YY/T 0466.1-2009 Medical devices- Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2007, IDT)
YY 0505-2012 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standards: Electromagnetic compatibility - Requirements and tests (IEC 60601-1-2:2004, IDT)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
electrical potential therapy equipment
equipment for therapy by electric field generated by voltage with r.m.s value of not more than 30kV and frequency of not more than 100kHz, including equipment that use AC and DC electric fields
3.2
applied part
component that comes into contact or may come into contact with the patient during therapy, including local probe, pad, blanket for systemic therapy, mattress, chair, pedal, etc., and output cables that may come into contact with patients near the aforementioned parts
3.3
pad
flexible applied component which is connected to the output end of the equipment by cable, has a built-in conductive layer and an external insulating layer, is placed on or under the patient body during therapy, and can be bent but not folded
3.4
blanket
flexible applied component which is connected to the output end or embedded controller of the equipment by cable, has a built-in conductive layer and an external insulating layer, is expected to form a part of bedding and can be bent
3.5
mattress
non-flexible applied component which is connected to the output end or embedded controller of the equipment by cable, has a built-in conductive layer and an external insulating layer, is expected to form a part of bedding, is placed under the patient body during therapy, and cannot be bent
3.6
output voltage
voltage output by the output terminal of the equipment in no-load state in order to generate the therapeutic electric field
3.7
short circuit current
current flowing when the output terminals of the equipment are short-circuited between each other or current flowing to the ground when the terminal is grounded
3.8
protective impedance
impedance network in the output loop, which makes the current not exceed the limit of short circuit current when the output is short-circuited
3.9
over current protective device
device for monitoring the current in the output loop, which cuts off the output when the current in the output loop exceeds the set value (not more than the limit of short circuit current)
4 Requirements
4.1 Operating conditions
They shall meet the requirements of the manufacturer. If not specified, they shall meet the requirements of GB 9706.1-2007, Clause 10.
4.2 Appearance
The enclosure of the equipment shall be free from mechanical damage, with neat surface and clearly visible marks.
4.3 Output voltage
Under the rated power supply voltage, the r.m.s. value error of the output voltage of each gear of the equipment shall not exceed ±10% of the voltage set value of the corresponding gear.
4.4 Output frequency
Under the rated power supply voltage, the output frequency error of each gear of the equipment shall not exceed ±10% of the frequency set value of the corresponding gear.
4.5 Output voltage stability
4.5.1 When the power supply voltage changes within ±10% of the rated power supply voltage, the output voltage error shall not exceed ±15% of the voltage set value of the corresponding gear.
4.5.2 After the equipment has been operating continuously for 30min under the rated power supply voltage, the error of the maximum output voltage gear shall not exceed ±10%.
4.6 Short circuit current
The protective impedance in the output circuit of the equipment must be large enough so that the short circuit current does not exceed the limit specified in Table 1.
Table 1 Limits of short circuit current
Frequency f DC current 1kHz~1kHz (excluding 1kHz) 1kHz~100kHz
Limit/mA 10 3.5 10
For the DC current with a peak-to-peak ripple of no more than 10%, the DC current limit shall apply. If the ripple exceeds the above-mentioned value, the limit of 1kHz~1kHz shall apply.
4.7 Output over current protection
The output over current protection shall meet the following requirements:
a) the equipment shall be provided with at least two over current protection measures to ensure that the equipment can still meet the requirements of 4.6 when one of the protection measures fails. Over current protection measures include but are not limited to protective impedance and over current protective device.
b) if the short circuit current is greater than 1mA, the equipment must be provided with over current protection device.
4.8 Safety range of electric field space
When the nominal output voltage is lower than 1,000V, there is no need to test the electric field intensity in this mode.
When the nominal output voltage is not lower than 1,000V, the manufacturer shall indicate in the instructions whether the electric field intensity exceeds the limit specified in Table 2. If the limit is exceeded, a description of the safety range of electric field space shall be given.
Table 2 Limits of electric field intensity
Frequency range f Electric field intensity E/(kV/m)
≤25Hz 20
25Hz~820Hz 500/f
820Hz~100kHz 0.61
4.9 Safety range of magnetic field space
The manufacturer shall indicate in the instructions whether the magnetic induction intensity exceeds the limit specified in Table 3. If the limit is exceeded, a description of the safety range of magnetic field space shall be given.
Table 3 Limits of magnetic induction intensity
Frequency range f Magnetic induction intensity B/μT
Static magnetic field 2×105
1Hz~8Hz 2×105/f2
8Hz~820Hz 2×104/f
820Hz~65kHz 30.7
65kHz~100kHz 2×106/f
4.10 Durability of pad, blanket and mattress
The durability of pad, blanket and mattress shall be determined by the following tests:
——the pad shall be subjected to the test given in 5.9.1;
——the blanket shall be subjected to the test given in 5.9.2;
——the mattress shall be subjected to the test given in 5.9.3.
After the test, the electrical insulation of the applied part shall meet the requirements of 4.14.2.7. At the same time, the internal conductor of the applied part shall not be completely broken.
4.11 Operating noise
The operating noise of the equipment during normal operation shall not be more than 60dB(A).
4.12 Biocompatibility
The equipment components expected to come into contact with patients' skin shall be evaluated and documented according to the guidelines and principles given in GB/T 16886.1-2011.
4.13 Functions
4.13.1 All control keys must be sensitive and accurately controlled.
4.13.2 If the equipment has different voltage outputs, it must have an output voltage setting function.
4.13.3 If the equipment has different voltage outputs, it must have the function of indicating the output voltage set value. When absolute indication is adopted, the r.m.s. value of output voltage shall be indicated and meet the requirements of 4.3. If it is not a r.m.s. value, the meaning of the indicated value shall be clearly marked. The relative indication cannot be displayed with numbers that may be confused with the actual output voltage value.
4.13.4 When the equipment has output, there must be an obvious indication.
4.13.5 The equipment shall be equipped with a timer to stop the output immediately after reaching the scheduled operating time. The tolerance of timer is ±1min.
4.14 Safety requirements
4.14.1 General
The equipment shall meet the requirements of GB 9706.1-2007. The equipment constituting a medical electrical system shall meet the requirements of GB 9706.15-2008.
4.14.2 Amendments and supplements to the corresponding contents of GB 9706.1-2007
4.14.2.1 Classification
GB 9706.1-2007, 5.2:
Type CF applied part is deleted.
4.14.2.2 External marks
GB 9706.1-2007, 6.1q) is revised as:
Symbol 14 and warning instructions given in Table D.1 in Annex D must be marked in obvious position.
GB 9706.1-2007, 6.1s) is revised as:
In the vicinity of the high-voltage output terminal of the equipment, the "dangerous voltage" mark must be provided (see Symbol 6 given in Table D.2 in Annex D).
GB 9706.1-2007, 6.1p) is revised as:
The maximum nominal output voltage and the corresponding output frequency must be permanently marked on the obvious position of the equipment.
