GB 9706.237-2020
Medical electrical equipment—Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment (English Version)

Standard No.

GB 9706.237-2020

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 9706.237-2020

Replace

GB 9706.9-2008

Scope

The content of this specific standard is largely determined to cover ultrasonic medical diagnostic and monitoring equipment, including ultrasonic echo ranging devices (manual and automatic scanning), Doppler echo ultrasonic diagnostic equipment and their combinations. The scope is kept as applicable as possible to most (non-therapeutic) medical ultrasound diagnostic equipment. For example, in order to cover a wide range of applications, some ultrasonic diagnostic equipment has the ability to connect many different types, rated power and frequency transducer components. These factors were also taken into account when drafting this specific standard. It is expected that the subsequent editions of this specific standard can better specify different or additional parameters for safety-related technical specifications to reflect the future understanding of biophysics and the development level of measurement technology. About 201.7.2.

GB 9706.237-2020 Referenced Document

• GB 4824-2019 Industrial,scientific and medical equipment—Radio-frequency disturbance characteristics—Limits and methods of measurement
• GB 9706.1-2020 Medical electrical equipment—Part 1: General requirements for basic safety and essential performance
• GB/T 6113.102-2018 Specification for radio disturbance and immunity measuring apparatus and methods—Part 1-2:Radio disturbance and immunity measuring apparatus—Coupling devices for conducted disturbance measurements
• IEC 62127-1:2007 Ultrasonics - Hydrophones - Part 1: Measurement and characterization of medical ultrasonic fields up to 40 MHz
• YY/T 0642-2014 Ultrasonics.Field characterization.Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields

GB 9706.237-2020 history

• 2020 GB 9706.237-2020 Medical electrical equipment—Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
• 2008 GB 9706.9-2008 Medical electrical equipment.Part2-37:Particular requirements for the safety of ultrasonic medical diagnosetic and monitoring equipment
• 1997 GB 9706.9-1997 Medical electrical equipment--Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment

GB 9706.237-2020 Medical electrical equipment—Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment has been changed from GB 9706.9-2008 Medical electrical equipment.Part2-37:Particular requirements for the safety of ultrasonic medical diagnosetic and monitoring equipment.

GB 9706.237-2020 -All Parts