Recommended Course:[Shanghai Inspection Institute] “Medical Electrical Equipment 9706 Series Related Standards Promotion”
On the 17th, the National Medical Products Administration’s Standardization Center released the GB 9706.1-2020 Test Equipment List, as follows:
GB 9706.1-2020 “Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance” will be implemented on May 1, 2023.
To further promote the smooth implementation of the standard and implement the relevant spirit of the “National Medical Products Administration and the National Standardization Management Committee’s Opinions on Further Promoting the High-Quality Development of Medical Device Standardization Work” (National Medical Products Administration Document [2021] No. 21), the Secretariat of the National Medical Electrical Standardization Technical Committee (SAC/TC10) jointly with the National Medical Products Administration’s Key Laboratory for Medical Electrical Equipment, referenced relevant international documents to compile the “GB 9706.1-2020 Test and Test Equipment Reference List” (see attachment) for reference by relevant units (the test equipment in the list is not a mandatory configuration requirement; relevant units need to determine based on their own testing needs).
GB 9706.1-2020 Test and Test Equipment Reference List
|
Standard Clause Number |
Measurement/Test |
Required Testing/Measurement Equipment/Materials |
|---|---|---|
|
4.11 |
Input Power |
Appropriate measuring devices for voltage, current/power, and frequency. Power Supply: Single-phase and three-phase adjustable transformers |
|
5.3 |
Ambient Temperature, Humidity, and Atmospheric Pressure |
Appropriate devices for recording ambient temperature, humidity, and atmospheric pressure |
|
5.7 |
Humidity Preconditioning |
Environmental conditions: environmental test chamber with controlled temperature and humidity |
|
5.9.2 |
Accessible Parts |
Force gauge (30N), standard test probe (Figure 6), rigid test probe, test hook (Figure 7) |
|
7.1.2 |
Marking Recognizability |
Illuminance meter |
|
7.1.3 |
Marking Durability |
Distilled water, ethanol (96% purity), isopropanol, timer/stopwatch |
|
8.4.2 |
Accessible Parts and Application Parts |
Oscilloscope, oscilloscope leads, appropriate devices for measuring voltage, current, capacitance, test probes (Figure 8), metal test rods (diameter=4mm, length=100mm), force gauge (10N). |
|
8.4.3, 8.4.4 |
Voltage and Power Limits |
Appropriate recording oscilloscope/settings and RCL meter |
|
8.5.5.1 |
Defibrillation Protection |
5kV test circuit and oscilloscope interface circuit conforming to Figures 9 and 10, oscilloscope |
|
8.5.5.2 |
Energy Reduction Test |
Test circuit conforming to Figure 11, oscilloscope, oscilloscope leads |
|
8.6.4 |
Impedance and Current Carrying Capacity |
Current source (minimum 25A, 50 or 60Hz, maximum 6V) |
|
8.7 |
Leakage Current and Patient Auxiliary Current |
Measurement device conforming to Figure 12, network power isolation transformer, adjustable transformer, voltmeter, millivoltmeter, aluminum foil, different circuits (Figures 13 to 20) |
|
8.8.3 |
Dielectric Strength |
High voltage tester, isolation transformer for high voltage testing, stopwatch/timer |
|
8.8.4.1 a) |
Ball Pressure Test |
Testing equipment conforming to IEC 60695-10-2 (GB/T 5169.21) |
|
8.8.4.2 |
Environmental Stress Endurance |
Oxygen aging test device for rubber |
|
8.9 |
Creepage Distance and Electrical Clearance |
Oscilloscope, oscilloscope leads, calipers, micrometers, plug gauges, force gauge (2N and 30N), standard test probe (Figure 6) |
|
8.9.1.7 |
Material Group Classification |
Testing equipment conforming to IEC 60112 (GB/T 4207) |
|
8.9.3.4 |
Thermal Cycling Test |
Heating chamber |
|
8.11.3.5 |
Parts for Fixing Wires |
Force gauge (at least 100N), torque meter (at least 0.35Nm) |
|
8.11.3.6 |
Soft Wire Protective Sleeve |
Scale, angle gauge, radius gauge |
|
9.4 |
Instability Hazards (Sources) |
5° and 10° slopes or inclinometer or angle measurement calculations, force gauge (at least 220N), 20cm×20cm testing plane, scale, testing threshold (height 10mm and width 80mm), 7cm handle strap, stopwatch/timer |
|
9.5.2 |
Cathode Ray Tube |
Relevant tests in Chapter 18 of IEC 60065 (GB 8898) |
|
9.6.2.1 |
Audible Sound Energy |
A-weighted sound pressure level that meets the requirements of ISO 3746 (GB/T 3768), ISO 9614-1 or IEC 61672-1 (GB/T 3785.1). |
|
9.6.3 |
Hand-Transmitted Vibration |
Measurements conducted according to ISO 5349-1 (GB/T 14790.1) |
|
9.7.5 |
Pressure Vessel |
Water pressure testing device |
|
9.8 |
Mechanical Hazards Related to Support Systems |
Weights or force sensors, 0.1 m2 testing plane, stopwatch/timer, human test mass (Figure 33) |
|
10.1 |
X-Ray Radiation |
Radiation meter |
|
10.3 |
Microwave Radiation |
Radiation meter |
|
10.4 |
Laser |
Testing equipment conforming to IEC 60825-1 (GB 7247.1) |
|
11.1 |
Overtemperature |
Temperature indicator/recorder suitable for this function and thermocouple, 4-wire impedance component, test angle, adjustable transformer |
|
11.2 |
Fire Protection |
Sparking ignition test device (Figure 34), oxygen concentration analyzer |
|
11.3 |
Structural Requirements for Fireproof Enclosures |
FV tests specified in IEC 60695-11-10 (GB/T 5169.16) |
|
11.6.2 |
Overflow |
15° slope or inclinometer or angle measurement calculations, stopwatch/timer, high voltage testing device |
|
11.6.3 |
Liquid Splash |
Beaker or graduated cylinder, stopwatch/timer |
|
11.6.5 |
Water or Particulate Ingress |
Classification tests according to IEC 60529 (GB/T 4208) |
|
11.6.6 |
Cleaning and Disinfection |
Dielectric strength and leakage current tests (if applicable) |
|
11.6.7 |
Sterilization |
Sterilization as specified by the customer |
|
13 |
Hazardous Situations and Fault Conditions |
Stopwatch/timer, voltmeter, ammeter, temperature indicator/recorder suitable for this function and thermocouple, 4-wire impedance component, coarse cotton cloth |
|
15.3 |
Mechanical Strength |
Force gauge (minimum 250N), circular plane with a diameter of 30mm, 500g steel ball, 50mm thick hard wood board (hardwood >600 kg/m3), 40mm crossbar, hardwood door frame (40 mm2), air-circulating oven |
|
15.4.2 |
Temperature and Overload Control Devices |
Positive temperature coefficient devices (PTC) as specified in Chapters 15, 14, J.15 and J.17 of IEC 60730-1 |
|
15.4.3.4 |
Lithium Primary Battery |
Performance tests as defined in IEC 60086-4 (GB 8897.4) |
|
15.4.3.4 |
Lithium Rechargeable Battery |
Performance tests as defined in IEC 62133 (GB/T 28164) |
|
15.4.6 |
Controller Operating Parts |
Force gauge (at least 100N), torque meter (at least 6Nm), stopwatch/timer |
|
15.4.7 |
Hand-held and Foot-operated Control Devices with Wired Connections |
Force gauge (minimum 1350N), testing tool with a diameter of 30mm, stopwatch/timer |
|
15.4.7.3 |
Liquid Ingress |
Classification tests according to IEC 60529 (GB/T 4208) |
|
15.5.1.1 |
Transformer |
Transformer winding tester, temperature indicator/recorder suitable for this function and thermocouple, adjustable transformer, load |
|
15.5.2 |
Dielectric Strength |
Dielectric strength test fixture for five times voltage/frequency, stopwatch/timer |
|
16.6 |
Leakage Current |
According to clause 8.7 |
|
A 10.4 |
Light Emitting Diode |
As specified in IEC 62471 |
|
G |
Protection against Ignition Hazards of Flammable Anesthetic Mixtures (Sources) |
4mm and 12mm diameter test rods, timer/stopwatch, sealing pad tests in IEC 60068-2-2 (GB/T 2423.2) B-b, force gauge (minimum 100N), gas pressure gauge (range 0 to 400Pa), voltmeter, ammeter, ohmmeter, capacitance and inductance meter, ether-oxygen mixture (ether volume percentage 12.2% ± 0.4%), test device for flammable mixtures (Figure G.7) |
|
G.4.3 |
Electrostatic Prevention |
Antistatic material testing according to ISO 2882 |
|
L |
Insulated Winding Wire without Padding |
Samples prepared according to IEC 60851-5 (GB/T 4074.5) and dielectric strength tests conducted according to GB 9706.1; flexibility and adhesion tests conducted according to test method 8 in IEC 60851-3 (GB/T 4074.3); spool diameter according to Table L.1; thermal shock tests conducted according to test method 9 in IEC 60851-6 (GB/T 4074.6); stainless steel particles with a diameter of 2mm, nickel particles or nickel-plated iron particles |
Note: The figure numbers in the table correspond to the figure numbers in the GB9706.1-2020 standard.
The following is the main text:
On the 17th, the National Medical Products Administration’s Standardization Center released the GB 9706.1-2020 Test Equipment List, as follows:
GB 9706.1-2020 “Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance” will be implemented on May 1, 2023.
To further promote the smooth implementation of the standard and implement the relevant spirit of the “National Medical Products Administration and the National Standardization Management Committee’s Opinions on Further Promoting the High-Quality Development of Medical Device Standardization Work” (National Medical Products Administration Document [2021] No. 21), the Secretariat of the National Medical Electrical Standardization Technical Committee (SAC/TC10) jointly with the National Medical Products Administration’s Key Laboratory for Medical Electrical Equipment, referenced relevant international documents to compile the “GB 9706.1-2020 Test and Test Equipment Reference List” (see attachment) for reference by relevant units (the test equipment in the list is not a mandatory configuration requirement; relevant units need to determine based on their own testing needs).
GB 9706.1-2020 Test and Test Equipment Reference List
|
Standard Clause Number |
Measurement/Test |
Required Testing/Measurement Equipment/Materials |
|---|---|---|
|
4.11 |
Input Power |
Appropriate measuring devices for voltage, current/power, and frequency. Power Supply: Single-phase and three-phase adjustable transformers |
|
5.3 |
Ambient Temperature, Humidity, and Atmospheric Pressure |
Appropriate devices for recording ambient temperature, humidity, and atmospheric pressure |
|
5.7 |
Humidity Preconditioning |
Environmental conditions: environmental test chamber with controlled temperature and humidity |
|
5.9.2 |
Accessible Parts |
Force gauge (30N), standard test probe (Figure 6), rigid test probe, test hook (Figure 7) |
|
7.1.2 |
Marking Recognizability |
Illuminance meter |
|
7.1.3 |
Marking Durability |
Distilled water, ethanol (96% purity), isopropanol, timer/stopwatch |
|
8.4.2 |
Accessible Parts and Application Parts |
Oscilloscope, oscilloscope leads, appropriate devices for measuring voltage, current, capacitance, test probes (Figure 8), metal test rods (diameter=4mm, length=100mm), force gauge (10N). |
|
8.4.3, 8.4.4 |
Voltage and Power Limits |
Appropriate recording oscilloscope/settings and RCL meter |
|
8.5.5.1 |
Defibrillation Protection |
5kV test circuit and oscilloscope interface circuit conforming to Figures 9 and 10, oscilloscope |
|
8.5.5.2 |
Energy Reduction Test |
Test circuit conforming to Figure 11, oscilloscope, oscilloscope leads |
|
8.6.4 |
Impedance and Current Carrying Capacity |
Current source (minimum 25A, 50 or 60Hz, maximum 6V) |
|
8.7 |
Leakage Current and Patient Auxiliary Current |
Measurement device conforming to Figure 12, network power isolation transformer, adjustable transformer, voltmeter, millivoltmeter, aluminum foil, different circuits (Figures 13 to 20) |
|
8.8.3 |
Dielectric Strength |
High voltage tester, isolation transformer for high voltage testing, stopwatch/timer |
|
8.8.4.1 a) |
Ball Pressure Test |
Testing equipment conforming to IEC 60695-10-2 (GB/T 5169.21) |
|
8.8.4.2 |
Environmental Stress Endurance |
Oxygen aging test device for rubber |
|
8.9 |
Creepage Distance and Electrical Clearance |
Oscilloscope, oscilloscope leads, calipers, micrometers, plug gauges, force gauge (2N and 30N), standard test probe (Figure 6) |
|
8.9.1.7 |
Material Group Classification |
Testing equipment conforming to IEC 60112 (GB/T 4207) |
|
8.9.3.4 |
Thermal Cycling Test |
Heating chamber |
|
8.11.3.5 |
Parts for Fixing Wires |
Force gauge (at least 100N), torque meter (at least 0.35Nm) |
|
8.11.3.6 |
Soft Wire Protective Sleeve |
Scale, angle gauge, radius gauge |
|
9.4 |
Instability Hazards (Sources) |
5° and 10° slopes or inclinometer or angle measurement calculations, force gauge (at least 220N), 20cm×20cm testing plane, scale, testing threshold (height 10mm and width 80mm), 7cm handle strap, stopwatch/timer |
|
9.5.2 |
Cathode Ray Tube |
Relevant tests in Chapter 18 of IEC 60065 (GB 8898) |
|
9.6.2.1 |
Audible Sound Energy |
A-weighted sound pressure level that meets the requirements of ISO 3746 (GB/T 3768), ISO 9614-1 or IEC 61672-1 (GB/T 3785.1). |
|
9.6.3 |
Hand-Transmitted Vibration |
Measurements conducted according to ISO 5349-1 (GB/T 14790.1) |
|
9.7.5 |
Pressure Vessel |
Water pressure testing device |
|
9.8 |
Mechanical Hazards Related to Support Systems |
Weights or force sensors, 0.1 m2 testing plane, stopwatch/timer, human test mass (Figure 33) |
|
10.1 |
X-Ray Radiation |
Radiation meter |
|
10.3 |
Microwave Radiation |
Radiation meter |
|
10.4 |
Laser |
Testing equipment conforming to IEC 60825-1 (GB 7247.1) |
|
11.1 |
Overtemperature |
Temperature indicator/recorder suitable for this function and thermocouple, 4-wire impedance component, test angle, adjustable transformer |
|
11.2 |
Fire Protection |
Sparking ignition test device (Figure 34), oxygen concentration analyzer |
|
11.3 |
Structural Requirements for Fireproof Enclosures |
FV tests specified in IEC 60695-11-10 (GB/T 5169.16) |
|
11.6.2 |
Overflow |
15° slope or inclinometer or angle measurement calculations, stopwatch/timer, high voltage testing device |
|
11.6.3 |
Liquid Splash |
Beaker or graduated cylinder, stopwatch/timer |
|
11.6.5 |
Water or Particulate Ingress |
Classification tests according to IEC 60529 (GB/T 4208) |
|
11.6.6 |
Cleaning and Disinfection |
Dielectric strength and leakage current tests (if applicable) |
|
11.6.7 |
Sterilization |
Sterilization as specified by the customer |
|
13 |
Hazardous Situations and Fault Conditions |
Stopwatch/timer, voltmeter, ammeter, temperature indicator/recorder suitable for this function and thermocouple, 4-wire impedance component, coarse cotton cloth |
|
15.3 |
Mechanical Strength |
Force gauge (minimum 250N), circular plane with a diameter of 30mm, 500g steel ball, 50mm thick hard wood board (hardwood >600 kg/m3), 40mm crossbar, hardwood door frame (40 mm2), air-circulating oven |
|
15.4.2 |
Temperature and Overload Control Devices |
Positive temperature coefficient devices (PTC) as specified in Chapters 15, 14, J.15 and J.17 of IEC 60730-1 |
|
15.4.3.4 |
Lithium Primary Battery |
Performance tests as defined in IEC 60086-4 (GB 8897.4) |
|
15.4.3.4 |
Lithium Rechargeable Battery |
Performance tests as defined in IEC 62133 (GB/T 28164) |
|
15.4.6 |
Controller Operating Parts |
Force gauge (at least 100N), torque meter (at least 6Nm), stopwatch/timer |
|
15.4.7 |
Hand-held and Foot-operated Control Devices with Wired Connections |
Force gauge (minimum 1350N), testing tool with a diameter of 30mm, stopwatch/timer |
|
15.4.7.3 |
Liquid Ingress |
Classification tests according to IEC 60529 (GB/T 4208) |
|
15.5.1.1 |
Transformer |
Transformer winding tester, temperature indicator/recorder suitable for this function and thermocouple, adjustable transformer, load |
|
15.5.2 |
Dielectric Strength |
Dielectric strength test fixture for five times voltage/frequency, stopwatch/timer |
|
16.6 |
Leakage Current |
According to clause 8.7 |
|
A 10.4 |
Light Emitting Diode |
As specified in IEC 62471 |
|
G |
Protection against Ignition Hazards of Flammable Anesthetic Mixtures (Sources) |
4mm and 12mm diameter test rods, timer/stopwatch, sealing pad tests in IEC 60068-2-2 (GB/T 2423.2) B-b, force gauge (minimum 100N), gas pressure gauge (range 0 to 400Pa), voltmeter, ammeter, ohmmeter, capacitance and inductance meter, ether-oxygen mixture (ether volume percentage 12.2% ± 0.4%), test device for flammable mixtures (Figure G.7) |
|
G.4.3 |
Electrostatic Prevention |
Antistatic material testing according to ISO 2882 |
|
L |
Insulated Winding Wire without Padding |
Samples prepared according to IEC 60851-5 (GB/T 4074.5) and dielectric strength tests conducted according to GB 9706.1; flexibility and adhesion tests conducted according to test method 8 in IEC 60851-3 (GB/T 4074.3); spool diameter according to Table L.1; thermal shock tests conducted according to test method 9 in IEC 60851-6 (GB/T 4074.6); stainless steel particles with a diameter of 2mm, nickel particles or nickel-plated iron particles |
Note: The figure numbers in the table correspond to the figure numbers in the GB9706.1-2020 standard.
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