Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
This standard is developed in accordance with the rules given in GB/T 1.1-2009.
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 National Medical Products Administration of the People’s Republic of China.
This standard is under the jurisdiction of the National Technical Committee on Medical Electrical Equipment of Standardization Administration of China (SAC/TC 10).
Drafting organizations of this standard: Shanghai Testing and Inspection Institute for Medical Devices (CMTC), China Institutes for Food and Drug Control, Shenzhen Mindray Bio-medical Electronics Co., Ltd., Siemens Shanghai Medical Equipment Ltd. (SSME), TSGS (Shanghai) Co., Ltd., BMC Medical Co., Ltd. *
Chief drafters of this standard: He Jun, Yu Xinhua, Zheng Jia, Shao Lingyun, Zhu Chao, Wang Weiqing, Xiao Yahui, Yin Yong, Li Yanhua, Chen Xingwen, Zhuang Zhi and Li Chong.
Energy consumption measurement methods for medical electrical equipment
1 Scope
This standard specifies the ENERGY CONSUMPTION test and calculation method of medical electrical equipment/system (hereinafter referred to as “ME EQUIPMENT/SYSTEM”).
This standard is applicable to ME EQUIPMENT/SYSTEMS powered by MAINS SUPPLY.
This standard is not applicable to ME EQUIPMENT/SYSTEMS powered by INTERNAL ELECTRICAL POWER SOURCE only.
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 (including any amendments) applies.
GB 9706.1-2020 Medical electrical equipment — Part 1: General requirements for basic safety and essential performance
3 Terms and definitions
For the purposes of this document, the terms and definitions given in GB 9706.1-2020, as well as the following, apply. For the convenience of application, some terms and definitions specified in GB 9706.1-2020 are listed below.
3.1
medical electrical equipment
electrical equipment having an APPLIED PART or transferring energy to or from the PATIENT or detecting such energy transfer to or from the PATIENT and which is:
a) provided with not more than one connection to a particular SUPPLY MAINS; and
b) intended by its MANUFACTURER to be used:
1) in the diagnosis, treatment, or monitoring of a PATIENT; or
2) for eradication or alleviation of disease, INJURY or disability
[GB 9706.1-2020, Definition 3.63]
3.2
medical electrical system
combination, as specified by its MANUFACTURER, of items of equipment, at least one of which is ME EQUIPMENT to be inter-connected by FUNCTIONAL CONNECTION or by use of a MULTIPLE SOCKET-OUTLET
[GB 9706.1-2020, Definition 3.64]
3.3
supply mains
source of electrical energy not forming part of ME EQUIPMENT or ME SYSTEM
Note: The electric energy in this standard refers to the energy provided by the MAINS SUPPLY, excluding the battery system and energy conversion system in ambulances and similar environments.
[GB 9706.1-2020, Definition 3.120]
3.4
internal electrical power source
electrical power source for operating equipment that is a part of the equipment and which produces electrical current from some other form of energy
Note: An internal electrical power source can be inside the principal part of equipment, attached to the outside, or contained in a separate enclosure.
[GB 9706.1-2020, Definition 3.45]
3.5
energy consumption
electric energy consumption of ME EQUIPMENT/SYSTEM
Note: ENERGY CONSUMPTION is expressed in kW·h in this standard.
3.6
off mode
state in which the ME EQUIPMENT/SYSTEM is turned off while still connected to the MAINS SUPPLY as specified by the MANUFACTURER
3.7
standby mode
state in which the ME EQUIPMENT/SYSTEM is ready for operation, but the OPERATING MODE is not started, as specified by the MANUFACTURER
3.8
operating mode
state in which the ME EQUIPMENT/SYSTEM is connected to the MAINS SUPPLY, and performs the function specified by the MANUFACTURER
3.9
low power consumption mode
state in which the ENERGY CONSUMPTION is lower than that in the STANDBY MODE through manually setting ME EQUIPMENT/SYSTEM or not operating ME EQUIPMENT/SYSTEM for a period of time, as specified by the MANUFACTURER
3.10
charging mode
state, in which, when the electric charge quantity of INTERNAL ELECTRICAL POWER SOURCE of ME EQUIPMENT/SYSTEM decreases to the point where it can't operate normally, charge the INTERNAL ELECTRICAL POWER SOURCE of ME EQUIPMENT/SYSTEM as specified by the MANUFACTURER until the INTERNAL ELECTRICAL POWER SOURCE is fully charged
Note: For INTERNAL ELECTRICAL POWER SOURCES that need to be removed from ME EQUIPMENT/SYSTEM before charging, the ENERGY CONSUMPTION in the CHARGING MODE is negligible.
4 General requirements
4.1 Environmental requirements
Unless otherwise specified by the MANUFACTURER, the test shall be conducted under the following specified environmental conditions:
——ambient temperature: 23°C±2°C;
——relative humidity: 45%~75%;
——atmospheric pressure: 86kPa~106kPa;
——test voltage: single phase: 220V; three phase: 380V; with a relative error of not more than ±2%;
——test frequency: 50Hz, with a relative error of not more than ±2%;
4.2 Test equipment requirements
For (active) power meters or equipment capable of measuring three-phase voltage and current and calculating the power integral relative to time (energy), the power shall be less than or equal to 3,000W with an error of not more than 3%, or more than 3,000W with an error of not more than 5%; their resolution should meet the following requirements:
——The measured resolution reaches 0.01W, when measuring at an active power of not more than 10W;
——The measured resolution reaches 0.1W, when measuring at an active power of more than 10W and less than or equal to 100W;
——The measured resolution reaches 1W, when measuring at an active power of more than 100W and less than 1,500W;
——The measured resolution reaches 1% of the full range, when measuring at an active power of more than 1,500W;
4.3 Preparation before test
The requirements for preparation before test are as follows:
a) Place the tested ME EQUIPMENT/SYSTEM in the environment specified in 4.1 for at least 1h. In this process, except for permanently installed equipment, the ME EQUIPMENT/SYSTEM shall not be connected to MAINS SUPPLY.
b) Confirm the necessary conditions for the test (including the configuration of the tested ME EQUIPMENT/SYSTEM, ACCESSORIES used, parameters set, load, operating time in each mode, etc.), and record relevant information (see Annex A).
c) Connect the test equipment to the MAINS SUPPLY input terminal of the ME EQUIPMENT/SYSTEM to ensure that all ENERGY CONSUMPTION of the ME EQUIPMENT/SYSTEM is collected.
d) For unspecified set parameters, restore to factory default values, and do not activate any energy-saving measures that may affect the normal operation of ME EQUIPMENT/SYSTEM.
5 Test process
Test the power or energy consumption of ME EQUIPMENT/SYSTEM in each mode in the following sequence.
Note: Except the OPERATING MODE, other modes are not required.
5.1 OFF MODE
The test shall be conducted as follows:
a) Connect to necessary ACCESSORIES and loads as specified by the MANUFACTURER.
b) Connect to the MAINS SUPPLY. If the ME EQUIPMENT/SYSTEM contains INTERNAL ELECTRICAL POWER SOURCE, ensure that the INTERNAL ELECTRICAL POWER SOURCE is fully charged.
c) Disconnect the ME EQUIPMENT/SYSTEM to the power supply to OFF MODE as specified in the ACCOMPANYING DOCUMENT of the MANUFACTURER, and keep the ME EQUIPMENT/SYSTEM connected with the MAINS SUPPLY.
d) Start measuring the ENERGY CONSUMPTION of the ME EQUIPMENT/SYSTEM. If the power of the ME EQUIPMENT/SYSTEM changes cyclically in the current mode, it shall be tested for at least one cycle and not less than 15min. Record the test time (TOFF MODE) and the ENERGY CONSUMPTION (EOFF MODE) or average power (POFF MODE AVG) of the ME EQUIPMENT/SYSTEM during the test time.
e) If there is no cyclic change, it shall be tested for at least 15min. Record the energy consumption (EOFF MODE) or the maximum power (POFF MODE MAX) of the ME EQUIPMENT/SYSTEM during the test time.
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Test process
6 Calculation of ENERGY CONSUMPTION
Annex A (Informative) Information required for ENERGY CONSUMPTION test
Annex B (Informative) Examples of ENERGY CONSUMPTION calculation
