Whether GB 9706.1 and YY 0505 standards are required when applying for medical device registration

2022-05-26 0 By

Dental mobile phone products are composed of mobile phone head, rotor group, drive shaft group and rear segment group, which can be used by stomatology department to hold slow speed dental needle for drilling and grinding operations.As a common dental medical device, whether the dental mobile phone needs to refer to GB 9706.1 and YY 0505 standards when applying for medical device registration?When applying for registration of medical devices, different structures should be considered. Whether GB 9706.1 and YY 0505 standards need to be referenced depends on the specific situation: Lighting power supply mode of dental mobile phone and joint (if any) should be considered, which can be divided into three modes: lighting device type, light guide type and no lighting type.A structure with a lighting device includes a lighting source;Light guide structure does not contain lighting source, only contains light guide fiber bundle;No lighting structure does not contain either lighting source or light guiding device.GB9706.1 and YY 0505 standards shall be used for lighting devices, and GB9706.1 and YY 0505 standards shall not be used for light-guiding and non-lighting types.