In the field of medical device testing, Pony Testing Group has many advanced instruments and equipment, and has passed the CMA/CNAS qualification recognition, testing professional and efficient, accurate data, test report has international credibility, and it is also a third-party health service head enterprise. The test report issued by Buni Testing Group meets the requirements of domestic medical device registration, CE registration, FDA registration and other regulations. It can provide medical device enterprises with the whole process technical support from raw material research and development to terminal product listing.
First, general standardsGB9706.1-2020 Diagnostic and therapeutic equipment
GB4793.1-2007 Non-diagnostic treatment equipment
Second, electromagnetic compatibility EMC (10 meters method half anechoic chamber) :Detection items: radiation emission, conducted emission, harmonics, voltage fluctuation and flicker immunity test, electrostatic discharge, electrical fast transient pulse group, surge, radiation immunity, radiation immunity, conducted disturbance immunity, voltage dip/short time interruption and voltage change, power frequency magnetic field
According to standard: YY9706.102-2021; GB 4824-2019; GBT 18268.1-2010; GBT 18268.26-2010
Three, Product standards (including special standards) :Ecg: YY/T 0196, YY 1139, GB9706.225, GB9706.227, YY9706.247
Eeg: GB9706.226
Endoscopic series: GB9706.218,YY 0843,
Respiratory category: YY 0601
High frequency and accessories: GB9706.202
In vitro diagnosis class: YY0648, GB4793.6, GB/T42125.14
Foot switch: YY 1057
Nerve and muscle stimulator: YY9706.210, YY/T0696,
Multi-parameter monitor: GB 9706.227, YY0667, YY9706.230, YY9706.261
Plasma surgical equipment: YY/T1409
Microwave therapy: GB9706.206,
Oxygen generator: YY 9706.269
Biosafety cabinet: YY 0569, GB 41918
Clean work table: YY/T 1539
Medical storage box and sterilizer: YY/T1007, GB 4793.4, GB8599, YY/T 0791, YY/T 0646, YY0504, YY/T 1757, GB/T 20154, YY/T 0086, YY/T 1641
Operating shadowless lamp: YY9706.241
Bed and operating table: YY 9706.252, YY 9706.246, YY/T 1106
Oxygen supply and suction system of medical center: YY/T 0187, YY/T 0186
Hot pad: YY/T 0165, YY 9706.235, YY 9706.110
Electronic blood pressure monitor: YY9706.230, YY 9706.112-2021, YY 9706.111-2021
Four, Environmental testGB/T14710, ASTM D4169 and other standards for the sample packaging test
