Certification and Registration
Introduction to EMC Testing for Medical Devices
Category:
EU CE-EMC
The continuous development and innovation of medical devices are essential for ensuring quality of life worldwide. The importance of the medical device industry in protecting the well-being of an increasingly health-conscious population is undeniable. With medical equipment, diseases can be detected earlier, and diagnostic, therapeutic, and patient-monitoring capabilities continue to improve.The design of electronic devices also determines whether they are suitable for medical applications. Specifically, to meet the electromagnetic compatibility (EMC) requirements of medical devices, electromagnetic interference (EMI) standards must be tested. It is essential that medical devices are not affected by interference from mobile phones or other electronic devices, and these standards ensure this.
Electromagnetic Compatibility of Medical Devices (EMC) includes electromagnetic interference (EMI) and electromagnetic immunity (EMS).To address electromagnetic interference (EMI) and electromagnetic immunity (EMS) issues in medical devices, the European Union has established specific requirements for the electromagnetic compatibility of these products. Medical devices must comply with applicable EMC standards and bear the CE marking before being sold in the European market.
Note: Countries where the CE marking is valid: European Economic Area (EEA), including the 27 European Union (EU) member states, Germany, Liechtenstein, Iceland, and Norway.
EMC Medical devices subject to certification include:
Radiation therapy devices, electrocardiographs, analytical instruments, ozone therapy devices, fumigation therapy devices, ultraviolet phototherapy devices, spectral therapy devices, radiofrequency therapy devices, ultrasonic nebulizers, etc.
Lighting fixtures / European medical device EMC standards mainly include the following:
|
EMC Standard |
Test Content |
Test Method |
Requirements |
|
EN 60601-1-2 |
RE Radiation interference |
CISPR 11 |
Group1-ClassB Class of equipment: 30-230MHz:30dB( Quasi-peak) 230-1000MHz:37dB( Quasi-peak) |
|
CE Conducted interference |
CISPR 11 |
Group1-ClassB Class of equipment: 0.15-0.5 MHz: 66~56 dB ( Quasi-peak), 56–46 dB (average) 0.5-5MHz:56dB( Quasi-peak), 46 dB (average) 5-30MHz:60dB( Quasi-peak, 50 dB (average) |
|
|
Harmonic Harmonic current interference |
EN/IEC 61000-3-2:2019 |
A For the standards of this type of product, please refer to Appendix 1. |
|
|
Flicker Voltage Fluctuations and Flicker |
EN 61000-3-3:2013 |
EN61000-3-3:2013 |
|
|
RS Radiation immunity |
EN 61000-4-3:2006+A1:2008+A2:2010 |
3 V/m, 80~2.7 GHz |
|
|
CS Conducted immunity |
EN 61000-4-6:2014 |
3V, 0.15~80MHz |
|
|
ESD Electrostatic immunity |
EN 61000-4-2:2009 |
Contact discharge: ±8 kV; Air discharge: ±15 kV |
|
|
EFT Electrical transient pulse group immunity |
EN 61000-4-4:2012 |
Signal port: 1 kV; Power port: 2 kV |
|
|
Surge Surge (Impact) Immunity |
EN 61000-4-5:2014 |
Line-to-line: 1 kV; Line-to-ground: 2 kV |
|
|
Dips Immunity to voltage sags, short-duration interruptions, and voltage variations |
EN 61000-4-11:2004 |
0%,70%ofUT |
|
|
PMS Power-frequency magnetic field immunity |
EN 61000-4-8:2010 |
30A/m |
Appendix 1:A Harmonic standards for product categories
Radiation Interference Test Procedure
Conducted interference test equipment
In addition to Europe, other countries and regions also have corresponding EMC requirements for electronic products. SATISFY provides EMC testing services in various countries and regions worldwide:
|
Country / Region |
Certification |
Test Requirements |
|
International CISPR/IEC |
CISPR 11/EN55011 ， IEC 60601-1-2:2014 |
|
|
Europe CE |
 |
EN 60601-1-2:2014 |
|
United States FCC |
 |
CFR title 47 part 18 |
|
Canada IC |
 |
ICES-001 |
|
Australia / New Zealand RCM/C-Tick |
 |
AS/NZS CISPR 11 |
|
China CCC |
 |
YY0505-2012 |
|
South Korea KCC/MSIP |
 |
KS C IEC 60601-1-2 |
Appendix: Medical Devices EMC Standard / Test Method Summary
EN/IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
CISPR 11 / EN 55011: Industrial, scientific and medical (ISM) radio-frequency equipment – Electromagnetic disturbance characteristics – Limits and methods of measurement
EN/IEC 61000-3-2: Electromagnetic compatibility (EMC) - Part 3-2: Limits - Limits for harmonic current emissions (equipment input current ≤ 16 A per phase)
EN/IEC 61000-3-3: Electromagnetic compatibility (EMC) - Part 3-3: Limits - Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems, for equipment with rated current ≤ 16 A per phase and not subject to conditional connection
EN/IEC 61000-4-2: Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test
EN/IEC 61000-4-3: Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test
EN/IEC 61000-4-4: Electromagnetic compatibility (EMC) - Part 4-4: Testing and measurement techniques - Electrical fast transient/burst immunity test
EN/IEC 61000-4-5: Electromagnetic compatibility (EMC) - Part 4-5: Testing and measurement techniques - Surge immunity test
EN/IEC 61000-4-6: Electromagnetic compatibility (EMC) - Part 4-6: Testing and measurement techniques - Immunity to conducted disturbances, induced by radio-frequency fields
EN/IEC 61000-4-8: Electromagnetic compatibility (EMC) - Part 4-8: Testing and measurement techniques - Power frequency magnetic field immunity test
EN/IEC 61000-4-11: Electromagnetic compatibility (EMC) - Part 4-11: Testing and measurement techniques - Voltage dips, short interruptions and voltage variations immunity tests for equipment with input current up to 16 A per phase
CFR Title 47 Part 18: Industrial, Scientific and Medical Equipment (ISM)
ICES-001: Industrial, Scientific and Medical (ISM) Equipment
AS/NZS CISPR 11: Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement
YY0505-2012: Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
KS C IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
EMI Prevention in PCB Design
Various design techniques can be used to control electromagnetic interference (EMI) in PCB design and ensure compliance with medical device standards. These include:
1. Multilayer Stacking:To achieve optimal shielding for high-speed transmission lines, a stripline layer configuration is preferred in multilayer boards. Routing sensitive traces between ground planes can minimize wide-edge crosstalk with signals on other layers and reduce radiation from traces.
2. Bypass Capacitors:Place these capacitors close to each power supply pin of active components on the circuit board. They act as current buffers for ICs, reducing the need for rapid current draw from the circuit board.
3. Circuit Isolation:Keeping analog and digital circuits separate is essential to prevent interference between them. Each circuit section should also have its own dedicated ground plane. These grounds can be connected at a single point, but digital return paths should be prevented from crossing the analog ground plane whenever possible.
SATISFY provides professional EMC certification services for medical devices, leveraging our expertise and experience to support your product compliance and successful market access worldwide. Please contact SATISFY customer service for more information.
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