Standard No.:	YY 9706.278-2023
English Name:	Medical electrical equipment--Part 2-78 : Particular requirements forbasic safety and essential performance of medical robots for rehabilitation,assessment，compensation or alleviation
Chinese Name:	医用电气设备 第2-78部分：康复、评定、代偿或缓解用医用机器人的基本安全和基本性能专用要求
Chinese Classification:	C30    Medical apparatus and devices in general
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.040.01 11.040.01    Medical equipment in general 11.040.01
Issued by:	National Medical Products Adminstration
Issued on:	2023-03-14
Implemented on:	2026-5-1
Status:	to be valid
Language:	English
File Format:	PDF
Word Count:	30000 words
Price(USD):	900.00
Delivery:	via email in 1~5 business day

本文件规定了预期与患者产生身体接触、实现患者肢体运动功能的康复、评定、代偿或缓解的医用机器人的基本安全和基本性能。
本文件适用于预期与患者产生身体接触、实现患者肢体运动功能的康复、评定、代偿或缓解的医用机器人。
本文件不适用于假肢和矫形器、轮椅车、诊断成像设备和个人助理机器人。