GB 9706.225-2021
Medical electrical equipment—Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs (English Version)

Standard No.

GB 9706.225-2021

Language

Chinese, Available in English version

Release Date

2021

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 9706.225-2021

Replace

GB 10793-2000

Scope

This document specifies the basic safety and basic performance of electrocardiographs defined in 201.3.63 that provide electrocardiographic reports for diagnostic purposes, either by themselves or as part of an ME system, hereafter referred to as ME equipment. The scope of application of this special standard includes commonly used electrocardiographs that can obtain patients' electrocardiograms. The electrocardiograms output by these devices are acquired for diagnostic conclusions, for example, by evaluating the rhythmic and morphological properties of the electrocardiogram signal, to give conclusions about the patient's cardiac status. This scope does not include some special types of electrocardiographs, for which the establishment of minimum safety requirements requires further study. However, in the absence of specific standards for such MEMA equipment, this document serves as a guide to basic safety and essential performance requirements.

GB 9706.225-2021 history

• 2021 GB 9706.225-2021 Medical electrical equipment—Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
• 2000 GB 10793-2000 Medical electrical equipment Part 2: Particular requirements for the safety of electrocardiographs
• 0000 GB 10793-1989

GB 9706.225-2021 Medical electrical equipment—Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs has been changed from GB 10793-2000 Medical electrical equipment Part 2: Particular requirements for the safety of electrocardiographs.

GB 9706.225-2021 -All Parts