- Standard No.
- GB 9706.205-2020
- Language
- Chinese, Available in English version
- Release Date
- 2020
- Published By
- 国家市场监督管理总局、中国国家标准化管理委员会
- Latest
-
GB 9706.205-2020
- Replace
-
GB 9706.7-2008
- Scope
- This section applies to the basic safety and basic performance of ultrasonic physiotherapy equipment as defined in 201.3.216. Hereinafter referred to as ME equipment. This section only involves ultrasonic physiotherapy equipment that uses a single plane non-focused circular transducer as the treatment head, which generates a static sound beam perpendicular to the end surface of the treatment head. This section also applies to ultrasonic physiotherapy devices for compensation or relief of disease, injury or disability. In the case of combined equipment (for example, the equipment has an additional electrical stimulation function or application part), such equipment should also comply with the provisions of the special standards involved in the increased functional safety requirements. If a chapter or clause is specifically intended to apply only to ME EQUIPMENT, or only to ME SYSTEMS, this shall be stated in the title and content of the chapter or clause. If not stated otherwise, chapters or clauses apply to ME EQUIPMENT and ME SYSTEMS. Hazards inherent in the intended physiological functions of ME EQUIPMENT or ME SYSTEM within the scope of this Part, except for general standards 7.2.13 and 8.4.1, are not included in the special requirements of this Part. Note: See 4.2 of the general standard. This particular standard does not apply to:
——equipment that utilizes ultrasonic driven tools (for example, equipment used in surgery and dentistry);
——equipment that uses focused ultrasonic pulse waves to break up aggregates such as kidney or bladder stones (lithotripters) ( See GB 9706.22);
——Ultrasonic physiotherapy equipment using focused ultrasound.
GB 9706.205-2020 history
- 2020 GB 9706.205-2020 Medical electrical equipment—Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
- 2008 GB 9706.7-2008 Medical electrical equipment.Part2-5:Particular requirements for the safety of ultrasonic physiotherapy equipment
- 1994 GB 9706.7-1994 Medical electrical equipment-Particular requirements for the safety of ultrasonic therapy equipment
GB 9706.205-2020 Medical electrical equipment—Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment has been changed from GB 9706.7-2008 Medical electrical equipment.Part2-5:Particular requirements for the safety of ultrasonic physiotherapy equipment.