GB 9706.260-2020 (English Version)

Scope: This section applies to the basic safety and basic performance requirements for dental units, dental patient chairs, dental handheld devices, and dental lights (hereinafter collectively referred to as dental equipment). Excludes amalgam blenders, sterilization equipment and dental X-ray equipment. If a clause or sub-clause expressly applies only to medical electrical equipment or only to medical electrical systems, this will be stated in its title and content. If no explanation is given, this clause or sub-clause shall apply to both relevant medical electrical equipment and medical electrical systems. In addition to the content specified in 7.2.13 and 8.4.1 of the general standard, the hazards inherent in the characteristic functions of the relevant medical electrical equipment or medical electrical systems within the scope of this section are not described in the specific requirements of this section. Note: Please refer to 4.2 in the general standard.

GB 9706.260-2020 Referenced Document

GB 7247.1 Safety of laser products.Part 1:Equipment classification and requirements
GB/T 16935.1-2008 Insulation coordination for equipment within low-voltage systems.Part 1:Principles,requirements and tests
GB/T 16935.4-2011 Insulation coordination for equipment within low-voltage systems.Part 4: Consideration of high-frequency voltage stress
IEC 60601-2-22:2007 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
IEC 61180:2016 High-voltage test techniques for low-voltage equipment - Definitions, test and procedure requirements, test equipment
IEC 61810-1:2008 Electromechanical elementary relays - Part 1: General requirements
ISO 14457:2017 Dentistry - Handpieces and motors

2020 GB 9706.260-2020 Medical electrical equipment—Part 2-60: Paticular requirments for the basic safety and essential performance of dental equipment