YY/T 1539-2025 Pending Industry standards-Medicine

YY/T 1539-2025 Medical clean bench

Publish Date: 2025-10-30 Implement Date: 2027-11-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1539-2025

Standard Type: Industry standards

Standard Status: Pending

is_force_gb: no

CCS Name: Medical laboratory equipment

ICS Name: Hospital equipment

Publish Date: 2025-10-30

Implement Date: 2027-11-01

Publisher: 国家药品监督管理局

Technical Committee: 全国测量、控制和实验室电器设备安全标准化技术委员会医用设备分技术委员会(SAC/TC 338/SC 1)

Pages: 32 pages

Scope

本文件给出了医用洁净工作台（以下简称洁净台）的类型，规定了要求、标签及随机文件、包装、运输和贮存的内容，描述了相应的试验方法。
本文件适用于医疗机构使用的医用洁净工作台。

Development Information

Drafting Units:

北京市医疗器械检验研究院(北京市医用生物防护装备检验研究中心)、苏州安泰空气技术有限公司、青岛海尔生物医疗股份有限公司、济南鑫贝西生物技术有限公司、益世科(上海)企业发展有限公司、北京东联哈尔仪器制造有限公司、北检润和(北京)技术服务有限公司、上海拜艾斯净化设备有限公司、中科美菱低温科技股份有限公司、山东新华医疗器械股份有限公司

Drafting Persons:

王霖、王会如、战玢、陈旭东、吴峻、孔维益、林良、袁文虎、马玉林、曲耀辉、苏建程、沈丹林、刘思敏、龙国辉

Word Count: 50 Thousand words Pages: 32 pages

Replace the following standards

YY/T 1539-2017 Medical clean bench

Referenced Standards

GB/T 191-2000 Packaging—Pictorial marking for handling of goods GB/T 191-2008 Packaging—Pictorial marking for handling of goods GB/T 191-2025 Graphical symbols marking for handling and storage of packages 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 18268.1-2010 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 1:General requirements GB/T 18268.1-2025 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 1:General requirements GB/T 42125.1-2024 Safety requirements for electrical equipment for measurement,control and laboratory use—Part 1:General requirements 中华人民共和国药典

Related Standards

GB 9706.5-1992 Replaced

GB 9706.5-1992 Medical electrical equipment—Particular requirements for the safety of medical electron accelerators in the range 1 MeV to 50 MeV

Publish Date: 1992-11-24

GB 9706.6-1992 Replaced

GB 9706.6-1992 Particular requirements for the safety of microwave therapy equipment

Publish Date: 1992-12-08

GB/T 14710-1993 Replaced

GB/T 14710-1993 The environmental requirements and test methods for medical electrical equipment

Publish Date: 1993-11-19

GB 9706.7-1994 Replaced

GB 9706.7-1994 Medical electrical equipment—Particular requirements for the safety of ultrasonic therapy equipment

Publish Date: 1994-09-24

GB 12130-1995 Replaced

GB 12130-1995 Medical hyperbaric oxygen chamber

Publish Date: 1995-12-08

GB 9706.1-1995 Replaced

GB 9706.1-1995 Medical electrical equipment—Part 1:General requirements for safety

Publish Date: 1995-12-21