YY/T 0833-2020 Active Industry standards-Medicine

YY/T 0833-2020 General technical requirements for compression physiotherapy equipment for limbs

Publish Date: 2020-02-21 Implement Date: 2022-01-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0833-2020

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: 2020-02-21

Implement Date: 2022-01-01

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: 12 pages

Scope

本标准规定了肢体加压理疗设备（以下简称设备）的术语和定义、分类和组成、要求和试验方法。
本标准适用于将加压腔体套在肢体外周，按照一定治疗程序对肢体施加正压，通过变化的气压对患者进行物理治疗的电气设备。

Development Information

Drafting Units:

天津市医疗器械质量监督检验中心、重庆医疗器械质量检验中心、四川千里倍益康医疗科技股份有限公司、康蒂思(上海)医疗器械有限公司

Drafting Persons:

高山、张赟、刘博、周平、蒋用羽、王志芳、张文

Word Count: 18 Thousand words Pages: 12 pages

Replace the following standards

YY 0833-2011 Compression physiotherapy equipment for limbs

Referenced Standards

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 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 YY 0505-2005 Medical electrical equipment—Part 1-2:General requirements for safety—Collateral standard:Electromagnetic compatibility—Requirements and tests YY 0505-2012 Medical electrical equipment—Part 1-2:General requirements for safety—Collateral standard:Electromagnetic compatibility—Requirements and tests

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