China Medical Device Testing Laboratory

Medical electrical equipment refers to medical devices used for diagnosing, treating, and monitoring patients, as well as for eliminating or alleviating diseases, injuries, or disabilities. With the rapid development of science and technology, along with the continuous improvement in people’s living standards and healthcare awareness, the application scope and fields of medical electrical equipment are expanding. Meanwhile, the control of its usage risks and the improvement of its quality are becoming increasingly important.  

The quality control of medical devices has always been a key focus in the country's public services.

Relevant Standards  

GB 9706.1 / IEC 60601-1: Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance  

GB 9706.4 / IEC 60601-2-2: Medical Electrical Equipment - Part 2-2: Particular Requirements for the Safety of High Frequency Surgical Equipment  

GB 9706.25 / IEC 60601-2-27: Medical Electrical Equipment - Part 2-27: Particular Requirements for the Safety of Electrocardiographic Monitoring Equipment  

YY 0505 / IEC 60601-1-2: Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests  

YY 9706.102 / 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  

GB 4824 / CISPR11: Industrial, Scientific, and Medical Equipment - Radio-Frequency Disturbance Characteristics - Limits and Methods of Measurement  

GB 4793.1 / IEC 61010-1: Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use - Part 1: General Requirements  

GB 4793.2 / IEC 61010-2-032: Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use - Part 2: Particular Requirements for Handheld and Hand-Operated Current Sensors for Electrical Measurement and Test  

GB 4793.5 / IEC 61010-2-031: Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use - Part 5: Safety Requirements for Hand-Held Probe Assemblies for Electrical Measurement and Test

The China JJR Laboratory, located in China, offers related testing for medical devices including IEC 60601, biocompatibility testing such as ISO 10993 and ISO 18562. Feel free to contact us for inquiries!