YY/T 0323-2024 Active Industry standards-Medicine

YY/T 0323-2024 Infrared ray cauterization therapy equipment

Publish Date: 2024-02-07 Implement Date: 2025-03-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0323-2024

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Physiotherapy and traditional Chinese medicine instruments and equipment

ICS Name: Treatment equipment

Publish Date: 2024-02-07

Implement Date: 2025-03-01

Publisher: 国家药品监督管理局

Technical Committee: 全国医用电器标准化技术委员会物理治疗设备分技术委员会(SAC/TC 10/SC 4)

Pages: 8 pages

Scope

本文件规定了红外热灼治疗设备(以下简称“设备”)的要求，描述了相应的试验方法。本文件适用于红外热灼治疗设备。本文件不适用于红外激光类治疗设备。

Development Information

Drafting Units:

天津市医疗器械质量监督检验中心、河南翔宇医疗设备股份有限公司、辽宁省医疗器械检验检测院

Drafting Persons:

杨国涓、钱学波、潘东萍、王博、何永正、李飞

Word Count: 8 Thousand words Pages: 8 pages

Replace the following standards

YY 0323-2018 Particular requirements for the safety of infrared therapy equipment

Referenced Standards

GB/T 5465.2-2008 Graphical symbols for use on electrical equipment—Part 2:Graphical symbols GB 9706.1-1995 Medical electrical equipment—Part 1:General requirements for safety GB 9706.1-2007 Medical electrical equipment—Part 1:General requirements for safety GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance GB/T 14710-1993 The environmental requirements and test methods for medical electrical equipment GB/T 14710-2009 Environmental requirement and test methods for medical electrical equipment YY 9706.102-2021 Medical electrical equipment—Part 1-2:General requirements for basic safety and essential performance—Collateral standard:Electromagnetic compatibility—Requirements and tests YY 9706.257-2021 Medical electrical equipment—Part 2-57:Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic,diagnostic,monitoring and cosmetic/aesthetic use

Related Standards

GB 12259-1990 Abolished

GB 12259-1990 Artificial heart-lung machine

Publish Date: 1990-01-08

GB 12261-1990 Abolished

GB 12261-1990 Artificial heart-lung machine—Bubble oxygenator

Publish Date: 1990-01-08

GB 12262-1990 Abolished

GB 12262-1990 Artificial heart-lung machine—Heat exchanger

Publish Date: 1990-01-08

GB 2024-1994 Replaced

GB 2024-1994 Acupuncture needles

Publish Date: 1994-04-12

GB 10035-1994 Replaced

GB 10035-1994 The air-bag type sequential external counter-pulsation device

Publish Date: 1994-07-06

GB 16174.1-1996 Replaced

GB 16174.1-1996 Cardiac pacemakers—Part 1:Implantable pacemakers

Publish Date: 1996-03-07