YY/T 0992-2023 Active Industry standards-Medicine

YY/T 0992-2023 Endoscopic washing station

YY/T 0992-2023 Endoscopic washing station

Publish Date: 2023-06-20 Implement Date: 2024-07-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0992-2023

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Public medical equipment

ICS Name: Disinfection equipment

Publish Date: 2023-06-20

Implement Date: 2024-07-01

Publisher: 国家药品监督管理局

Technical Committee: 全国消毒技术与设备标准化技术委员会(SAC/TC 200)

Pages: 16 pages

Scope

本文件规定了内镜清洗工作站（以下简称内镜工作站）的分类与型式、要求、标志、使用说明书、包装、运输和储存,描述了相应的试验方法。
本文件适用于主要用在医疗机构对软式或硬式内镜进行手动清洗，并可使用化学消毒剂进行消毒的内镜工作站。
本文件不适用于对除软式内镜和硬式内镜外的其他医疗器械进行清洗消毒的产品。

Development Information

Drafting Units:

山东新华医疗器械股份有限公司、广东省医疗器械质量监督检验所、广东省药品监督管理局评审认证中心、广州吉好医疗科技有限公司、中山大学附属第一医院、淄博金箭医疗器械有限公司

Drafting Persons:

冯洪营、廖惠儿、陈卓、程君、汤晓炜、翟淑远、余华通、刘春岩、徐伟、栾凯、杜合英

Word Count: 25 Thousand words Pages: 16 pages

Replace the following standards

YY/T 0992-2016 Endoscopic washing station

Referenced Standards

GB/T 35267-2017 Endoscopes washer-disinfectors YY/T 0734.1-2018 Washer-disinfectors—Part 1:General requirements and tests 中华人民共和国药典(二部)(2020年版) GB/T 191-2000 Packaging—Pictorial marking for handling of goods GB/T 191-2008 Packaging—Pictorial marking for handling of goods GB 4793.1-1995 Safety requirements for electrical equipment for measurement, control, and laboratory use Part 1:General requirements GB 4793.1-2007 Safety requirements for electrical equipment for measurement, control, and laboratory use—Part 1:General requirements GB 4793.4-2001 Safety requirements for electrical equipment for measurement, control and laboratory use—Particular requirements for autoclaves using steam for the treatment of medical materials and for laboratory process GB 4793.4-2019 Safety requirements for electrical equipment for measurement,control and laboratory use—Part 4:Particular requirements for sterilizers and washer-disinfectors used to treat medical materials GB/T 18268.1-2010 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 1:General requirements YY/T 0466.1-2009 Medical devices—Symbols to be used with medical device labels, labelling and information to be supplied—Part 1:General requirements YY/T 0466.1-2016 Medical devices—Symbols to be used with medical device labels,labelling and information to be supplied—Part 1:General requirements YY/T 0466.1-2023 Medical devices—Symbols to be used with information to be supplied by the manufacturer—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 191-2025 Graphical symbols marking for handling and storage of packages

Related Standards

GB 15979-2002 Replaced

GB 15979-2002 Hygienic standard for disposable sanitary products

Publish Date: 2002-03-05

YY 0504-2005 Replaced

YY 0504-2005 Portable mode steam sterilizers

Publish Date: 2005-04-05

YY 1007-2005 Replaced

YY 1007-2005 Vertical mode steam sterilizers

Publish Date: 2005-12-07

GB 4793.8-2008 Replaced

GB 4793.8-2008 Safety requirements for electrical equipment for measurement, control, and laboratory use—Part 2-042:Particular requirements for autoclaves and sterilizers using toxic gas for the treatment of medical materials, and for laboratory processes

Publish Date: 2008-03-24

YY 0646-2008 Replaced

YY 0646-2008 Small steam sterilizers—Automatic type

Publish Date: 2008-04-25

YY 0215-2008 Replaced

YY 0215-2008 Medical ozone disinfecting cabinets

Publish Date: 2008-10-17