Certification and Registration
Dental and Medical Equipment Testing Standards
Category:
Dental Equipment
GB 9706.260-2020 Medical electrical equipment — Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
GB 9706.260 specifies the basic safety and essential performance requirements for dental equipment, including dental units, dental patient chairs, dental handpieces, and oral lights (hereinafter collectively referred to as dental equipment).
GB 9706.260 does not apply to amalgam mixers, disinfection and sterilization equipment, or dental X-ray equipment.
In addition to the requirements specified in the general standard, including 7.2.13 and 8.4.1, GB 9706.260 does not address hazards inherent to the characteristics and functions of relevant medical electrical equipment or medical electrical systems within its scope.
The purpose of GB 9706.260 is to establish requirements for the basic safety and essential performance of dental equipment.
GB 9706.263-2020 Medical electrical equipment — Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
GB 9706.263 applies to extraoral dental imaging X-ray equipment (hereinafter referred to as ME equipment) and specifies its basic safety and essential performance requirements.
The scope includes equipment containing such ME equipment as well as ME systems incorporating these devices.
GB 9706.263 includes panoramic dental imaging equipment, cephalometric analysis equipment, and dental volumetric reconstruction equipment as defined in 201.3.203 of this standard.
GB 9706.263 applies only to the following X-ray radiation equipment: equipment in which the high-voltage generator assembly, X-ray tube assembly, X-ray source, anatomical region to be imaged, and geometric relationship between the X-ray source and image receptor are preset and cannot be freely modified by the operator during use.
GB 9706.263 does not apply to intraoral dental X-ray equipment.
The purpose of GB 9706.263 is to ensure that dental extraoral imaging X-ray equipment meets the basic safety and essential performance requirements.
GB 9706.265-2021 Medical electrical equipment — Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
GB 9706.265 applies to intraoral dental imaging X-ray equipment and its main components (hereinafter referred to as ME equipment) and specifies the basic safety and essential performance requirements.
GB 9706.265 applies only to X-ray equipment containing an X-ray tube assembly with a high-voltage generator assembly.
GB 9706.265 does not apply to extraoral dental X-ray equipment.
The scope of this standard does not include radiation therapy simulators, bone or tissue absorption density meters, or dental fluoroscopy equipment.
The purpose of GB 9706.265 is to ensure that intraoral dental imaging X-ray equipment meets the basic safety and essential performance requirements.
SATISFY provides one-stop dental medical device testing services, including preliminary assessment, preparation and submission of technical documentation, complete test monitoring, report interpretation, data analysis, and corrective action recommendations.
Previous page
Related Information
SATISFY TECH AND SERVICE LLC
SATISFY TECH AND SERVICE LLC delivers full-lifecycle technical solutions for children’s products, hygiene care, protective equipment, furniture, and building materials. Our framework spans compliance pre-assessment, standard upgrading, and risk control. We empower manufacturers and exporters through expert testing, certification, consulting, and standards interpretation.
Contact Us
Address: Room 7D, Building A, Zhongzhou Holdings Financial Center, No. 88 Haide 1st Road, Haizhu Community, Yuehai Subdistrict, Nanshan District, Shenzhen
Phone: 0755-8273-9683
Mobile: 189-2676-2893
Email: info@sdswcn.com
Sales Window
WeChat Applet