YY/T 1738-2020 English PDF (YYT1738-2020)
YY/T 1738-2020 English PDF (YYT1738-2020)
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YY/T 1738-2020: Energy consumption measurement methods for medical electrical equipment
YY/T 1738-2020
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040
C 30
Energy consumption measurement methods for
medical electrical equipment
ISSUED ON: SEPTEMBER 27, 2020
IMPLEMENTED ON: SEPTEMBER 01, 2021
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Terms and definitions ... 4
4 General requirements ... 6
5 Test process ... 8
6 Energy consumption calculation ... 11
Appendix A (Informative) Information required for energy consumption test .. 12
Appendix B (Informative) Energy consumption calculation example ... 13
Energy consumption measurement methods for
medical electrical equipment
1 Scope
This Standard specifies the energy consumption measurement and calculation
methods for medical electrical equipment/system (hereinafter referred to as ME
equipment/system).
This Standard applies to ME equipment/system which is powered by mains.
This Standard does not apply to ME equipment/system which is powered by
internal electrical power source only.
2 Normative references
The following documents are indispensable for the application of this document.
For dated references, only the dated version applies to this document. For
undated references, the latest edition (including all amendments) applies to this
document.
GB 9706.1-2020, Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance
3 Terms and definitions
Terms and definitions determined by GB 9706.1-2020 and the following ones
are applicable to this document. For ease of use, some of the terms and
definitions in GB 9706.1-2020 are repeated below.
3.1
Medical electrical equipment
Electrical equipment that has an applied part or transmits or obtains energy to
the patient or detects the transmitted or obtained energy. Such electrical
equipment:
a) Has no more than one connection to a specified power supply mains; and
b) Its manufacturer intends to use it for:
1) Diagnosis, treatment or monitoring of patients; or
Off mode
The mode where the ME equipment/system is turned off according to the
manufacturer’s regulations, and the ME equipment/system is connected to the
mains.
3.7
Standby mode
The mode where the ME equipment/system is ready for operation according to
the manufacturer's regulations, but the operating mode is not yet started.
3.8
Operating mode
The mode where the ME equipment/system is connected to the mains to
perform the functions that are specified by the manufacturer.
3.9
Low power consumption mode
The mode where the energy consumption of the ME equipment/system is lower
than the standby mode when it is set manually or when it has not been operated
for a period of time according to the manufacturer’s regulations.
3.10
Charging mode
When the power of the internal electrical power source of the ME
equipment/system drops to the point where it cannot operate normally, charge
the internal electrical power source of the ME equipment/system according to
the manufacturer’s regulations until the internal electrical power source is fully
charged.
Note: For the internal electrical power source that needs to be removed from
the ME equipment/system for charging, do not count the energy
consumption of the charging mode.
4 General requirements
4.1 Environmental requirements
c) Connect the test equipment to the mains input end of the ME
equipment/system, to ensure that all energy consumption of the ME
equipment/system is collected.
d) Restore the unspecified setting parameters to the factory default values;
any energy-saving measures that affect the normal operation of the ME
equipment/system shall not be activated.
5 Test process
Test the power or power consumption of the ME equipment/system in each
mode in the following order.
Note: Except for the operating mode, other modes are not necessary.
5.1 Off mode
Perform according to the following tests:
a) Connect necessary accessories and loads as specified by the
manufacturer.
b) Connect to the mains; if the ME equipment/system has an internal
electrical power source, make sure that the internal electrical power
source is fully charged.
c) Turn off the ME equipment/system power supply in off mode according to
the requirements of the manufacturer’s attached documents; keep the ME
equipment/system connected to the mains.
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, test at least one cycle and not less than 15 minutes. Record the
test time (T off mode test time) and the electric energy that is consumed by the
ME equipment/system during the test time (E off mode) or the average power
(P off mode AVG).
e) If there is no cyclic change, test for at least 15 minutes. Record the electric
power that is consumed by the ME equipment/system during the test time
(E off mode) or the maximum power (P off mode MAX).
5.2 Standby mode
Perform according to the following tests:
a) Connect necessary accessories and loads as specified by the
manufacturer.
operating period and record the test time (T operating mode test time) and the
electric power that is consumed by the ME equipment/system during the
test time (E operating mode) or the average power (P operating mode AVG); if the
power does not change cyclically in the current mode, test the power
during the entire operating period and record the electric power that is
consumed by the ME equipment/system during the test time (E operating mode)
or the maximum power (P operating mode MAX).
5.4 Low power consumption mode
Perform according to the following tests:
a) Connect necessary accessories and loads as specified by the
manufacturer.
b) Connect to the mains; if the ME equipment/system has an internal
electrical power source, make sure that the internal electrical power
source is fully charged.
c) Connect the ME equipment/system power supply according to the
manufacturer’s attached documents and set the relevant parameters; then,
choose the low power consumption mode, or wait for the ME
equipment/system to automatically enter the low power consumption
mode; keep the ME equipment/system connected to the mains.
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, test at least one cycle and not less than 15 minutes. Record the
test time (T low power consumption mode test time) and the electric energy that is
consumed by the ME equipment/system during the test time (E low power
consumption mode) or the average power (P low power consumption mode AVG).
e) If there is no cyclic change, test for at least 15 minutes. Record the electric
power that is consumed by the ME equipment/system during the test time
(E low power consumption mode) or the maximum power (P low power consumption mode
MAX).
5.5 Charging mode
Perform according to the following tests:
a) Disconnect the ME equipment/system from the mains; use the internal
electrical power source of the ME equipment/system to run, until the ME
equipment/system cannot operate normally.
Appendix B
(Informative)
Energy consumption calculation example
B.1 Examples of calculation formula for energy c...
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YY/T 1738-2020: Energy consumption measurement methods for medical electrical equipment
YY/T 1738-2020
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040
C 30
Energy consumption measurement methods for
medical electrical equipment
ISSUED ON: SEPTEMBER 27, 2020
IMPLEMENTED ON: SEPTEMBER 01, 2021
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Terms and definitions ... 4
4 General requirements ... 6
5 Test process ... 8
6 Energy consumption calculation ... 11
Appendix A (Informative) Information required for energy consumption test .. 12
Appendix B (Informative) Energy consumption calculation example ... 13
Energy consumption measurement methods for
medical electrical equipment
1 Scope
This Standard specifies the energy consumption measurement and calculation
methods for medical electrical equipment/system (hereinafter referred to as ME
equipment/system).
This Standard applies to ME equipment/system which is powered by mains.
This Standard does not apply to ME equipment/system which is powered by
internal electrical power source only.
2 Normative references
The following documents are indispensable for the application of this document.
For dated references, only the dated version applies to this document. For
undated references, the latest edition (including all amendments) applies to this
document.
GB 9706.1-2020, Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance
3 Terms and definitions
Terms and definitions determined by GB 9706.1-2020 and the following ones
are applicable to this document. For ease of use, some of the terms and
definitions in GB 9706.1-2020 are repeated below.
3.1
Medical electrical equipment
Electrical equipment that has an applied part or transmits or obtains energy to
the patient or detects the transmitted or obtained energy. Such electrical
equipment:
a) Has no more than one connection to a specified power supply mains; and
b) Its manufacturer intends to use it for:
1) Diagnosis, treatment or monitoring of patients; or
Off mode
The mode where the ME equipment/system is turned off according to the
manufacturer’s regulations, and the ME equipment/system is connected to the
mains.
3.7
Standby mode
The mode where the ME equipment/system is ready for operation according to
the manufacturer's regulations, but the operating mode is not yet started.
3.8
Operating mode
The mode where the ME equipment/system is connected to the mains to
perform the functions that are specified by the manufacturer.
3.9
Low power consumption mode
The mode where the energy consumption of the ME equipment/system is lower
than the standby mode when it is set manually or when it has not been operated
for a period of time according to the manufacturer’s regulations.
3.10
Charging mode
When the power of the internal electrical power source of the ME
equipment/system drops to the point where it cannot operate normally, charge
the internal electrical power source of the ME equipment/system according to
the manufacturer’s regulations until the internal electrical power source is fully
charged.
Note: For the internal electrical power source that needs to be removed from
the ME equipment/system for charging, do not count the energy
consumption of the charging mode.
4 General requirements
4.1 Environmental requirements
c) Connect the test equipment to the mains input end of the ME
equipment/system, to ensure that all energy consumption of the ME
equipment/system is collected.
d) Restore the unspecified setting parameters to the factory default values;
any energy-saving measures that affect the normal operation of the ME
equipment/system shall not be activated.
5 Test process
Test the power or power consumption of the ME equipment/system in each
mode in the following order.
Note: Except for the operating mode, other modes are not necessary.
5.1 Off mode
Perform according to the following tests:
a) Connect necessary accessories and loads as specified by the
manufacturer.
b) Connect to the mains; if the ME equipment/system has an internal
electrical power source, make sure that the internal electrical power
source is fully charged.
c) Turn off the ME equipment/system power supply in off mode according to
the requirements of the manufacturer’s attached documents; keep the ME
equipment/system connected to the mains.
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, test at least one cycle and not less than 15 minutes. Record the
test time (T off mode test time) and the electric energy that is consumed by the
ME equipment/system during the test time (E off mode) or the average power
(P off mode AVG).
e) If there is no cyclic change, test for at least 15 minutes. Record the electric
power that is consumed by the ME equipment/system during the test time
(E off mode) or the maximum power (P off mode MAX).
5.2 Standby mode
Perform according to the following tests:
a) Connect necessary accessories and loads as specified by the
manufacturer.
operating period and record the test time (T operating mode test time) and the
electric power that is consumed by the ME equipment/system during the
test time (E operating mode) or the average power (P operating mode AVG); if the
power does not change cyclically in the current mode, test the power
during the entire operating period and record the electric power that is
consumed by the ME equipment/system during the test time (E operating mode)
or the maximum power (P operating mode MAX).
5.4 Low power consumption mode
Perform according to the following tests:
a) Connect necessary accessories and loads as specified by the
manufacturer.
b) Connect to the mains; if the ME equipment/system has an internal
electrical power source, make sure that the internal electrical power
source is fully charged.
c) Connect the ME equipment/system power supply according to the
manufacturer’s attached documents and set the relevant parameters; then,
choose the low power consumption mode, or wait for the ME
equipment/system to automatically enter the low power consumption
mode; keep the ME equipment/system connected to the mains.
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, test at least one cycle and not less than 15 minutes. Record the
test time (T low power consumption mode test time) and the electric energy that is
consumed by the ME equipment/system during the test time (E low power
consumption mode) or the average power (P low power consumption mode AVG).
e) If there is no cyclic change, test for at least 15 minutes. Record the electric
power that is consumed by the ME equipment/system during the test time
(E low power consumption mode) or the maximum power (P low power consumption mode
MAX).
5.5 Charging mode
Perform according to the following tests:
a) Disconnect the ME equipment/system from the mains; use the internal
electrical power source of the ME equipment/system to run, until the ME
equipment/system cannot operate normally.
Appendix B
(Informative)
Energy consumption calculation example
B.1 Examples of calculation formula for energy c...