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Chinese Standard: GB 9706.283-2022

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Medical electrical equipment—Part 2-83:Particular requirements for the basic safety and essential performance of home light therapy equipment


Standard in brief
Scope of Application:  
GB9706的本部分规定了ME设备和ME系统的基本安全和基本性能的通用要求。本部分适用于医用电气设备和医用电气系统(以下简称ME设备和ME系统)。本文件适用于家庭护理环境中使用的家用光治疗设备的基本安全和基本性能。家用光治疗设备通常由无经验的操作者使用。本文件的范围包括除激光以外的所有光源。如果某一章或条仅适用于ME设备或ME系统,该章或条的标题和内容将明确说明这一点。否则,本章或条同时适用于ME设备和ME系统。

Basic information
Standard No:GB 9706.283-2022
Standard Name:医用电气设备 第2-83部分:家用光治疗设备的基本安全和基本性能专用要求
English Name:Medical electrical equipment—Part 2-83:Particular requirements for the basic safety and essential performance of home light therapy equipment
Standard Status:现行
Release Date:2022-12-29
Effective Date:2026-01-01
Language of Publication:中文简体

Standard Classification
ICS Number:11.040.60
CCS Number:C40

Related Standards
Referenced Standards:GB/T 191,GB/T 1002,GB/T 1003,GB/T 2099.1,GB/T 2423.2-2008,GB/T 2439,GB/T 2941,GB/T 3667.1,GB/T 3768,GB/T 3785.1,GB/T 3785.2,GB 3836.1,GB/T 3836.5,GB/T 3836.6,GB/T 3836.7,GB/T 4026,GB/T 4074.6-2008,GB/T 4205,GB/T 4207,GB/T 4208,GB 4706.1-2005,GB 4943.1-2011,GB/T 5013.1-2008,GB/T 5023.1-2008,GB/T 5169.16,GB/T 5465.2,GB/T 6346.14-2015,GB 7247.1-2012,GB 8897.4,GB 8898-2011,GB/T 9364.1,GB 9706.12,GB/T 11021,GB/T 11210,GB/T 11918.1,GB/T 11918.2,GB/T 14790.1,GB/T 15092.1,GB/T 16886(所有部分),GB/T 16895.21,GB/T 16935.1-2008,GB/T 17465.1,GB 18278.1,GB 18279.1-2015,GB 18280.1-2015,GB/T 19212.2,GB/T 23821-2009,GB 27701,GB/T 28164,YY/T 0316-2016,YY/T 0466.1,YY 0505,YY/T 0664-2008,YY 0709,ISO 2882,ISO 3864-1:2002,ISO 7000:2004,ISO 7010:2011,ISO 9614-1,ISO 80000-1:2009,IEC 60601-1-6,IEC 60730-1:2010,IEC 60851-3:2009,IEC 60851-5:2008,YY/T 0466.1-2016,YY 9706.102-2021,YY/T 9706.106-2021,GB/T 2893.1-2013,GB 9706.1-2020,GB/T 20145-2006,YY 9706.111-2021
Adopted Standards:IEC 60601-2-83:2019
Adopted Standard Name:《医用电气设备 第2-83部分:家用光治疗设备的基本安全和基本性能专用要求》
Adoption Level:MOD

Publication Information
Number of pages:32
Number of words:54 K
Format:大16
Edition:1
Color Pages:0
Electronic Version:Yes
Color Images:Yes
Print Publication Date:2022-12-01

Standard Revision Information
Has Amendment:No

Other Information
Application Dept:国家市场监督管理总局、国家标准化管理委员会
Standard Type:CN
Standard Attribute:GB
Other Standard Number:9706.283
Management Organization:国家药品监督管理局
Proposing Department:国家药品监督管理局

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