The complete electromagnetic compatibility test platform can provide EMC testing services that meet the standards of YY 0505, IEC 60601-1-2 and EN 60601-1-2, etc. for medical electrical equipment such as computer tomography, nuclear magnetic resonance imaging, diasonograph, biochemical and immunoassay analyzers. The environment and reliability comprehensive test system can provide performance test of weathering, mechanics and comprehensive environment for medical appliances that meet GB/T 14710-2009 and other standards. NMEI Center can provide comprehensive material performance tests including component analysis, mechanical property test, density test and linear expansion coefficient analysis for implants and interventional medical products and materials.
I. EMC Test
NMEI Center offers EMC testing services and boasts many types of high-end electromagnetic compatibility testing equipments, such as anechoic chamber, shielded room and TEM cell. NMEI Center services include the whole life cycle ranging from product design to finished product inspection, EMC simulation, EMC testing EMC design and mend of medical device and products, effectively evaluate the EMC performance and status of products, guide the EMC design of products.
We provide services meeting the following standards:
YY 0505 Medical electrical equipment-Part 1-2:General requirements for safety-Collateral standard:Electromagnetic compatibility-Requirements and tests
YY 0607 Medical electrical equipment-Part 2: Particular requirements for the safety of nerve and muscle stimulators
GB/T 18268.1 Electrical equipment for measurement, control and laboratory use-EMC requirements-Part 1: General requirements
GB/T 18268.26 Electrical equipment for measurement, control and laboratory use-EMC requirements-Part 26: Particular requirements-In vitro diagnostic (IVD) medical equipment
GB 4824 Industrial, scientific and medical (ISM) radio-frequency equipment-Disturbance characteristics - Limits and methods of measurement
EN 55011 Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement
IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
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
EN 60601-1-6 Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability
II. Physical Property Test
Our MAT Lab performs physical performance tests in accordance with the latest version of relevant standards which regulate the water absorption rate, hardness, tensile strength, breaking elongation and thermal stability time of the materials used to manufacture medical devices.