YY/T 0868-2021 Active Industry standards-Medicine

YY/T 0868-2021 Electrodes for nerve and muscle stimulators

Publish Date: 2021-03-09 Implement Date: 2023-05-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0868-2021

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: 2021-03-09

Implement Date: 2023-05-01

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: 7 pages

Scope

本标准规定了神经和肌肉刺激器用电极（以下简称电极）的术语和定义、要求、试验方法。
本标准适用于神经和肌肉刺激器用电极。
本标准不适用于电针、毫针、仅包含中医探穴功能的电极等。

Development Information

Drafting Units:

天津市医疗器械质量监督检验中心、湖南省医疗器械检验检测所、欧姆龙(大连)有限公司、南京鼎世医疗器械有限公司

Drafting Persons:

李雅楠、刘博、张赟、邓振进、张玮奇、邓飞

Word Count: 14 Thousand words Pages: 7 pages

Replace the following standards

YY/T 0868-2011 Electrodes for nerve and muscle stimulators

Referenced Standards

GB/T 3280-2015 Cold rolled stainless steel plate, sheet and strip GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance GB/T 14233.1-2008 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods GB 15979-2002 Hygienic standard for disposable sanitary products YY 9706.210-2021 Medical electrical equipment—Part 2-10:Particular requirements for the basic safety and essential performance of nerve and muscle stimulators 《中华人民共和国药典》2015版四部 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

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