Medical Electrical Equipment YY0505 Testing Laboratory

Since the implementation of the new standard YY0505-2012 for medical electrical equipment, many medical companies have applied for electromagnetic compatibility (EMC) project pREDictions and rectifications. From discussions with companies, we learned that previously, medical registration only required safety regULations projects, but since last year, EMC requirements were added. As a result, many companies did not give much consideration to EMC design during product development. A significant number of engineers in these companies lack a thorough understanding of EMC, leading to difficulties in passing emc testing in one go when applying for medical registration certificates.

JJR Laboratory was once commissioned by a medical company to retrieve failed test samples from the Guangdong Medical Institute. On-site, we observed piles of failed samples due to EMC test failures, re-submitted samples after rectification, and engineers struggling to make improvements. After communicating with staff, we learned that due to the increased number of cases, the medical institute only provides one opportunity for EMC retesting. This retest must be scheduled and conducted after hours. If the retest fails, the case is returned, and the entire process, including all fees, must start over.

First, it's essential to understand the EMC items in YY0505-2012. Please refer to the following details:

- Conducted Emission

- Radiated Emission

- Harmonics

- Voltage Flicker

- Electrostatic Discharge (ESD)

- Radiated Susceptibility (R/S)

- Electrical Fast Transient/Burst (EFT/B)

- Surge

- Conducted Susceptibility (C/S)

- Power Frequency Magnetic Field (M/S)

- Voltage Dips, Short Interruptions, and Voltage Variations

Among the YY0505 testing items, radiated emission has the highest difficulty in passing. The most common issues raised by companies are:

1. Why is the pass rate for radiated emissions low?

   - The increasing number of high-performance electronic products, large-scale data processing, high-definition video, etc., coupled with the shortage of EMC talent, are the main reasons.

2. How to achieve rectification, and what is the process?

   - Step 1: Rectification must be based on an understanding of the product and test data. Start with a pre-test of the complete unit. If there is already non-compliant data, please provide it.

   - Step 2: Analyze the complete unit test data and disassembled circuit test data.

   - Step 3: Rectify the issue.

   - Step 4: Redesign the PCB.

   - Step 5: Perform validation testing.

3. Can mass production be achieved after rectification?

   - After completing the rectification, to ensure consistency in mass-produced products, PCB redesign is essential. When redesigning, it is crucial to refer to the rectified prototype to ensure comparability in test results for the newly redesigned product.

Our laboratory has extensive experience in EMC testing and rectification for medical electrical equipment under YY0505-2012. Our clients include Shenzhen Guokong Medical, Shenzhen Mindray, Guangzhou Sunmed Medical, Changsha Xieda Biotechnology Co., Ltd., and Shenzhen Henergy Technology Co., Ltd. With our assistance, their medical electrical equipment has successfully passed the testing of provincial medical laboratories. For inquiries regarding EMC rectification for medical electrical equipment under YY0505-2012, feel free to contact us.