Interpretation of GB 9706.1-2020

Standard Overview

This standard specifies the general requirements for basic safety and essential performance of Medical Electrical Equipment (ME Equipment) and Medical Electrical Systems (ME Systems), applicable to the design, production, inspection, and use of various medical electrical equipment. Compared with the previous version, the new edition introduces risk management concepts, making safety testing requirements more systematic and rigorous.

Basic Standard Information

Standard Status: Current

Release Date: 2020-04-09

Effective Date: 2023-05-01

Governing Authority: National Medical Products Administration (NMPA)

Responsible Department: National Medical Products Administration (NMPA)

Issuing Bodies: State Administration for Market Regulation, Standardization Administration of China

Test Items

No.	Test Item	Description	Remarks
4.11	Input Power	Measure steady-state input, not exceeding 110% of the marked rated value	+ Power Measurement Module
8.4.2	Accessible Parts and Applied Parts	Earth leakage current, touch current, patient leakage current, patient auxiliary current	+ LCR Module + Power Measurement Module
8.4.3	ME Equipment Intended to be Connected to Supply via a Plug	Voltage between each pin and between power pins and enclosure ≤60V at 1s after disconnection; if voltage exceeds 60V, stored charge ≤45μC	+ LCR Module
8.4.4	Internal Capacitance Circuits	Residual voltage ≤60V; if voltage exceeds 60V, stored charge ≤45μC	+ LCR Module
8.5.5.1	Defibrillation Protection	Common-mode test + Differential-mode test	+ 5kV Test Circuit
8.5.5.2	Energy Reduction Test	100Ω load absorbs defibrillator energy	+ 5kV Test Circuit
8.6.4	Impedance and Current-Carrying Capacity	Impedance between protective earth and any earthed part ≤100mΩ or 200mΩ	+ Ground Resistance Measurement Module
8.7	Leakage Current and Patient Auxiliary Current	Earth leakage current, touch current, patient leakage current, patient auxiliary current	+ Test Circuit + Isolation Transformer Module + Leakage Current Measurement Module
8.8.3	Dielectric Strength	Initial test voltage ≤0.5*specified test voltage, increase gradually to specified value within 10s, maintain for 1min, decrease to less than half the specified value within 10s	+ Withstand Voltage Module + Isolation Transformer Module
11.6.6	Cleaning and Disinfection	Dielectric strength and leakage current test	+ Withstand Voltage Module + Leakage Current Measurement Module
15.5.1.1	Transformers	Short-circuit test + Overload test	+ Winding Measurement Module + Temperature Acquisition Module
15.5.2	Dielectric Strength	Apply 5 times rated voltage or 5 times the upper limit of rated voltage range, frequency ≥5 times rated frequency between winding terminals	+ Withstand Voltage Measurement Module
16.6	Leakage Current	Touch current, earth leakage current of multi-socket outlets, patient leakage current	+ Test Circuit + Isolation Transformer Module + Leakage Current Measurement Module

Test Key Points

Leakage Current Test

Normal condition: Touch current 0.1mA, Earth leakage current 5mA, Patient auxiliary current (DC, Type B) 0.01mA, Patient leakage current (DC, Type B) 0.01mA
Single-fault condition: Touch current 0.5mA, Earth leakage current 10mA, Patient auxiliary current (DC, Type B) 0.05mA, Patient leakage current (DC, Type B) 0.05mA

Dielectric Strength Test

Apply 50Hz AC voltage or DC test voltage equivalent to the peak value of AC test voltage for 1 minute
For operators: basic insulation 1kV; for patients: basic insulation 1.5kV
No breakdown shall occur

Impedance and Current-Carrying Capacity Test

50Hz/6V/25A test current, measure protective earth circuit impedance
Protective earth impedance ≤100mΩ or 200mΩ

Voltage and Energy Test

Residual voltage shall not exceed 60V; if voltage exceeds 60V, stored charge shall not exceed 45μC

Transformer Test

Short-circuit test: 5x frequency, 5x voltage or 2x frequency, 2x voltage, directly short-circuit all output windings
Overload test: Adjust load to approach minimum current for protective device activation

Defibrillation Protection Test

During defibrillation discharge, peak voltage at certain points ≤1V; after applying defibrillation voltage, following a recovery period, essential safety and performance shall be provided
Common-mode test and differential-mode test

Test Configuration

No.	Model	Name	Remarks
1	PTS Series	PTS Series Power Supply
2	VectWorks	Electrical Performance Testing Software	Host Computer Software
3	PTS Series	Power Measurement Module	Optional
4	PTS Series	LCR Module	Optional
5	PTS Series	Ground Resistance Measurement Module	Optional
6	PTS Series	Isolation Transformer Module	Optional
7	PTS Series	Leakage Current Measurement Module	Optional
8	PTS Series	Winding Measurement Module	Optional
9	PTS Series	Withstand Voltage Measurement Module	Optional

For details, please contact our company

Testing Software

VectWorks Electrical Performance Testing Software is a software developed by GreenTest Technology based on the GtestWorks automated testing platform. Its engine is based on dynamic test script execution, facilitating easy and direct configuration of test sequences without requiring specific knowledge of remote instrument control. Users only need to configure the test items and test levels, providing high flexibility.

The software provides users with standard-compliant test templates, enabling remote parameter setting, data acquisition, waveform editing, configuration import/export, report viewing, etc., achieving automation of complex tests.

Core Features

Closed-Loop Dynamic Testing

Integrates real-time monitoring and dynamic feedback mechanisms
High/Low Voltage Superimposed Ripple Testing

Complies with standard calibration requirements (including Upp, Ipp ripple monitoring)
Power Supply & Amplifier Architecture

Compatible with bipolar power supply and amplifier architecture solutions

Test Systems

Switch system

High-speed data logger

Current probe

Voltage probe

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中文版

GB 9706.1-2020