YY/T 1411-2023 Active Industry standards-Medicine

YY/T 1411-2023 Dentistry—Test methods for dental unit waterline biofilm treatment

YY/T 1411-2023 Dentistry—Test methods for dental unit waterline biofilm treatment

Publish Date: 2023-03-14 Implement Date: 2024-05-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1411-2023

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Dental instruments, equipment, and materials

ICS Name: Dental equipment

Publish Date: 2023-03-14

Implement Date: 2024-05-01

Publisher: 国家药品监督管理局

Technical Committee: 全国口腔材料和器械设备标准化技术委员会齿科设备与器械分技术委员会(SAC/TC 99/SC 1)

Pages: 20 pages

Scope

本文件提供了型式检验的方法，主要用于评估在实验室条件下对牙科治疗机水路系统中的生物膜防止、抑制其形成或去除的处理方法的有效性。
本文件不适用于输送无菌处理水或无菌溶液的设备，也不适用于在牙科治疗机内输送压缩空气的管线、管道或软管。
本文件对相应的微生物学指标不做限度规定。所述方法不适用于临床条件。本文件也未建立用于评估可能由处理方法引起的任何有害副作用的试验方法。
本文件提供的试验方法可用于测试其他向口腔输送非无菌水的牙科设备。

Development Information

Drafting Units:

广东省医疗器械质量监督检验所、西诺医疗器械集团有限公司、四川大学华西口腔医学院、浙江新亚医疗科技有限公司、广东福肯科技工业有限公司、北京大学口腔医院

Drafting Persons:

杨立峰、李梦洁、何灼华、赵丽君、舒睿、陈贤明、雷康宁、陈霄迟、钟静

Word Count: 32 Thousand words Pages: 20 pages

Replace the following standards

YY/T 1411-2016 Dentistry—Essential characteristics of test methods for the evaluation of treatment methods intended to improve or maintain the microbiological quality of dental unit procedural water

Referenced Standards

GB/T 6682-2008 Water for analytical laboratory use—Specification and test methods ISO 19458 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 9937-1988 Terms associated with the testing and the operating of dental material, instruments and equipment GB/T 9937-2020 Dentistry—Vocabulary GB/T 9937.1-2008 Dental vocabulary—Part 1:General and clinical terms GB/T 9937.2-2008 Dental vocabulary—Part 2:Dental materials GB/T 9937.3-2008 Dental vocabulary—Part 3:Dental instruments GB/T 9937.4-2005 Dental vocabulary—Part 4:Dental equipment GB/T 9937.5-2008 Dental vocabulary—Part 5:Terms associated with testing GB/T 22592-2008 Water treatment reagent—General rules for the determination of pH YY/T 1043.1-2016 Dentistry—Dental units—Part 1:General requirements and test methods YY/T 1043.1-2022 Dentistry—Stationary dental units and dental patient chairs—Part 1:General requirements YY/T 1043.2-2018 Dentistry—Dental units—Part 2:Air,water,suction and wastewater systems

Adopt standards

ISO 16954:2015

Related Standards

GB 8666.1-1988 Abolished

GB 8666.1-1988 General specifications for tooth forceps

Publish Date: 1988-02-13

YY 0460-2003 Replaced

YY 0460-2003 Ultrasonics dental descaler equipment

Publish Date: 2003-06-20

GB 19342-2003 Replaced

GB 19342-2003 Tooth Brush

Publish Date: 2003-10-09

YY/T 0058-2004 Replaced

YY/T 0058-2004 Dental patient chair

Publish Date: 2004-10-10

YY/T 1012-2004 Replaced

YY/T 1012-2004 Dental handpieces—Coupling dimensions

Publish Date: 2004-10-10

YY/T 1043-2004 Replaced

YY/T 1043-2004 Dental units

Publish Date: 2004-10-10