After determining product specifications and breaking through key technologies, we design, test, verification and validation the instruments comply with highest international standards. There are no mandatory performance standards or special controls in existence for this the 5RMED Laparoscopic Hand Instruments which were designed to meet the following voluntary standards:
　　EN 60601-1, EN 60601-1-2, EN 60601-2-2, EN 60601-2-18, Medical electrical equipment, General requirements for basic safety and essential performance;
ISO 10993-1, ISO 10993-5, ISO 10993-10, Biological evaluation of medical devices;
ISO 11607-1, EN 868-5, ASTM F 1980-02, ASTM F1929, ASTM F88, relevant test standards for sterile barrier systems;
　　ISO 14644, ISO 14698, ISO 11737-1, Cleanrooms, Bio-contamination control;
ISO 11137-1, ISO 11137-2, EN 556-1, Irradiation sterilization;
EN 1041, EN 980, ISO 15223-1, ISO 16061, relevant standards for labeling, instruction for use; 
EN 62366-1, Medical devices — part 1: application of usability engineering to medical devices；
EN ISO 7153-1:2016, EN ISO13402, EN10088, relevant standards for metals, surgical instruments； 
ISO 7741-1986, ASTM F1079-87(2014) Standard Specification for Surgical Scissors;
　　In addition to testing according to the above international standards, we also carry out the　necessary performance tests, including:
　　dimensional accuracy testing, 
　　material performance testing, 
　　ultimate strength testing of working-jaw, 
　　heat resistance testing of instrument insulation tubes, 
　　consistency of driving force, 
　　ergonomics test, 
　　simulation test under the simulator, etc.
　　Under the condition of signing a confidentiality agreement, we could provide you with relevant test reports.