YY/T 0952-2022 Active Industry standards-Medicine

YY/T 0952-2022 Clinical thermoregulatory equipment

Publish Date: 2022-10-17 Implement Date: 2023-10-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0952-2022

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: 2022-10-17

Implement Date: 2023-10-01

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: 9 pages

Scope

本文件规定了医用控温仪（以下简称“控温仪”）的组成、要求，并描述了相应的试验方法。
本文件适用于在医疗机构临床使用环境下，通过毯、垫等部件与人体进行热交换，对人体进行体外物理升温和/或降温，达到辅助调节体温目的的设备。

Development Information

Drafting Units:

天津市医疗器械质量监督检验中心、北京市医疗器械技术审评中心、四川省药品检验研究院(四川省医疗器械检测中心)、巴德医疗科技(上海)有限公司

Drafting Persons:

张赟、杨国涓、乔嘉琪、郑坤、潘东萍、陈然、官辉、代敬

Word Count: 16 Thousand words Pages: 9 pages

Replace the following standards

YY/T 0952-2015 Temperature control blanket for medical use YY 0952-2015 Medical temperature control blanket

Referenced Standards

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 GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 21416-2008 Clinical electronic thermometer YY 0785-2010 Clinical thermometers—Performance of electrical thermometers for continuous measurement 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 9706.235-2021 Medical electrical equipment—Part 2-35:Particular requirements for the basic safety and essential performance of heating devices using blankets,pads or mattresses and intended for heating in medical use

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