11.060.20 牙科设备 标准查询与下载

T/QGCML 3008-2024 多功能折叠升降椅技术规范

本文件规定了多功能折叠升降椅（以下简称“升降椅”）的结构、技术要求、试验方法、检验规则、标志、包装、使用说明、运输和贮存。 本文件适用于多功能折叠升降椅的生产、检验。

Technical Specifications for Multifunctional Folding Lift Chair

ISO/TR 3630-6:2023 牙科学.内牙器械.第6部分:数字编码系统

Dentistry — Endodontic instruments — Part 6: Numeric coding system

ISO 4865-1:2023 牙科 手持器械通用要求 第 1 部分：非铰接手持器械

Dentistry — General requirements of hand instruments — Part 1: Non-hinged hand instruments

DB22/T 3571-2023 导弓式活动矫治技术操作规程

Technical operating procedures for guided arch activity correction

YY/T 0905-2023 牙科学 中央压缩空气源设备

本文件规定了为牙科诊所内牙科治疗机和各种牙科用气设备提供牙科用空气的中央压缩空气源设备的要求，描述了相应的试验方法。本文件还规定了中央压缩空气源设备产生的供牙科用空气的质量要求和测试方法，例如供牙科用空气净化水平的要求。本文件还规定了由制造商提供的关于中央压缩空气源设备的性能、安装、操作和维护的信息要求。本文件仅适用于位于牙科治疗室外的中央压缩空气源设备。本文件不适用于位于牙科治疗室内的中央压缩空气源设备和设施管道。本文件不包括对牙科技工室应用（如CAD/CAM系统）的中央压缩空气源设备的要求。

Dental central compressed air source equipment

YY/T 1021.2-2023 牙科学 拔牙钳 第2部分：标示

本文件规定了牙科用拔牙钳的标示。本文件适用于所有牙科拔牙钳。

Dental extraction forceps Part 2: Labeling

YY/T 1021.3-2023 牙科学 拔牙钳 第3部分：设计

本文件规定了牙科用拔牙钳的设计。本文件适用于所有牙科用拔牙钳。

Dental Extraction Forceps Part 3: Design

YY 0875-2023 外科器械 直线型吻合器及组件

本文件规定了直线型吻合器的结构型式和材料、要求、试验方法、标签、说明书及包装。本文件适用于直线型吻合器及组件。本文件不适用于血管专用吻合器、弧形吻合器及腔镜下使用的吻合器。

Surgical instruments linear staplers and components

ISO/DTR 3630-6:2023 牙科 牙髓器械 第 6 部分：数字编码系统

Dentistry — Endodontic instruments — Part 6: Numeric coding system

ISO 3630-4:2023 牙科 牙髓器械 第 4 部分：辅助器械

Dentistry — Endodontic instruments — Part 4: Auxiliary instruments

23/30468735 DC BS EN ISO 15098 牙科 牙科镊子

BS EN ISO 15098. Dentistry. Dental tweezers

GSO ISO 23450:2023 牙科 口腔内窥镜

This document specifies requirements and test methods for intraoral cameras used in dentistry on patients for pictorial representation of oral cavities in order to support diagnosis and facilitate patient information. It specifies requirements, test methods, instructions for use and marking. This document is not applicable to: a) powered polymerization activators for polymerization of dental materials; b) exclusively extraoral camera equipment to prepare overviews or to record treatments; c) dental microscopes for minimally invasive treatments; d) medical endoscopes; e) camera handpieces for tooth illumination (transillumination); f) CAD or CAM scanner handpieces; g) combinations of dental instruments with camera functions; h) cameras for endodontic purposes; i) devices for root canal inspection (endoscopic microcameras); j) cameras for tool navigation; k) cameras for determination of tooth colour.

Dentistry — Intraoral camera

EN ISO 8325:2023 牙科.旋转器械试验方法

This document specifies general test methods for rotary instruments used in dentistry. These test methods are used for measuring the dimensional characteristics, neck strength and surface roughness of rotary instruments, such as burs, cutters, polishers, grinding instruments and rotary instruments used for oral surgery such as drills and countersinks. Specific tests are specified in the respective instrument standards, if available. This document does not specify test methods for materials used for rotary instruments. NOTE For materials used for rotary instruments, see ISO 21850-1 and respective instrument standards. This document is not applicable to endodontic instruments. For endodontic instruments, see ISO 3630-1.

Dentistry - Test methods for rotary instruments (ISO 8325:2023)

23/30424558 DC BS EN ISO 23402-3 牙科 用于非永久性医疗环境的便携式牙科设备 第 3 部分：便携式抽吸设备

BS EN ISO 23402-3. Dentistry. Portable dental equipment for use in non-permanent healthcare environment - Part 3. Portable suction equipment

YY/T 1411-2023 牙科学 牙科治疗机水路生物膜处理的试验方法

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。

Test method for biofilm treatment in waterways of dental treatment machines in dentistry

ISO 8325:2023 牙科.旋转器械试验方法

This document specifies general test methods for rotary instruments used in dentistry. These test methods are used for measuring the dimensional characteristics, neck strength and surface roughness of rotary instruments, such as burs, cutters, polishers, grinding instruments and rotary instruments used for oral surgery such as drills and countersinks. Specific tests are specified in the respective instrument standards, if available. This document does not specify test methods for materials used for rotary instruments. NOTE For materials used for rotary instruments, see ISO 21850-1 and respective instrument standards. This document is not applicable to endodontic instruments. For endodontic instruments, see ISO 3630-1.

Dentistry — Test methods for rotary instruments

BS EN ISO 3630-2:2023 牙科 牙髓器械 放大机

1   Scope This document specifies the requirements for enlargers not cited in ISO 3630‑1, ISO 3630‑3, ISO 3630‑4, ISO 3630‑5, ISO TR 3630‑6 1 or ISO 3630‑7 2 . This document specifies the requirements for size, marking, product designation, safety considerations, and labelling and packaging, including the instructions for use.

Dentistry. Endodontic instruments. Enlargers

EN ISO 3630-2:2023 牙科.牙根管器械.第2部分:扩大器

This document specifies the requirements for enlargers not cited in ISO 3630-1, ISO 3630-3, ISO 3630-4, ISO 3630-5, ISO TR 3630-6 or ISO 3630-7. This document specifies the requirements for size, marking, product designation, safety considerations, and labelling and packaging, including the instructions for use.

Dentistry - Endodontic instruments - Part 2: Enlargers (ISO 3630-2:2023)

ISO 3630-2:2023 牙根管器械 第2部分:扩大器

This document specifies the requirements for enlargers not cited in ISO 3630-1, ISO 3630-3, ISO 3630-4, This document specifies the requirements for size, marking, product designation, safety considerations, and labelling and packaging, including the instructions for use.

Dentistry — Endodontic instruments — Part 2: Enlargers

KS P ISO 16635-2-2022 牙科学.牙科橡胶坝器械.第2部分:夹钳

Dentistry — Dental rubber dam instruments — Part 2: Clamp forceps