YY/T 0294.1-2024 Active

YY/T 0294.1-2024 Surgical instruments—Materials—Part 1:Metals

This document provides examples of common stainless steel materials, hard alloys, titanium, and titanium alloys used in the manufacture of various standard surgical instruments and components, as well as information on the grades and hardness ranges of commonly used materials.
This document is applicable to the selection of metal materials used in the manufacture of surgical instruments. Surgical instruments include, but are not limited to, general surgery, orthopedic surgery, and dental instruments.
Note 1: Although this document is not applicable to surgical instruments for special applications, such as implantation and minimally invasive surgery, some parts of it may be applicable to these instruments.
Note 2: When selecting metal materials, manufacturers need to consider factors such as the instrument design and factory manufacturing, in addition to the metal grade, shape, size, and delivery state. Therefore, manufacturers are responsible for the selection of materials, and the possibility of referring to other existing standards is not ruled out. When appropriate standards are issued, the applicability of the new standards should be considered.

Publish Date: 2024-09-29

YY/T 0109-2024 Active

YY/T 0109-2024 Medical ultrasonic nebulizer

This document specifies the requirements for medical ultrasonic nebulizers (hereinafter referred to as "nebulizers") and describes the corresponding test methods.
This document is applicable to medical ultrasonic nebulizers that use ultrasound to atomize liquid medications.

Publish Date: 2024-09-29

YY/T 0107-2024 Active

YY/T 0107-2024 A mode ultasonic biometer for ophthalmology scanner

This document specifies the product classification and requirements for ophthalmic Type A ultrasonic measuring devices (hereinafter referred to as "measuring devices"), and describes the corresponding test methods.
This document is applicable to ophthalmic ultrasonic measuring devices with Type A displays, which are mainly used for measuring corneal thickness and eye axis length in ophthalmology.

Publish Date: 2024-09-29

YY/T 0063-2024 Active

YY/T 0063-2024 Medical electrical equipment—X-ray tube assemblies for medical diagnosis—Focal spot dimensions and related characteristics

本文件适用于在150 kV及以下的X射线管电压下工作的医用诊断X射线管组件的焦点。
本文件描述了使用数字探测器测定以下各项的试验方法:
a) 按焦点标称值表示的焦点尺寸,范围为0.1~3.0;
b) 线扩散函数;
c) 一维调制传递函数;
d) 焦点针孔射线照片。
本文件还描述表明符合性的方式。
在资料性附录中,描述了星卡成像(见附录A)和散焦值(见附录B)。

Publish Date: 2024-07-08

YY/T 1306-2024 Active

YY/T 1306-2024 Steam therapy apparatus

本文件规定了熏蒸治疗仪(以下简称“治疗仪”)的分类、要求,描述了相应的试验方法。
本文件适用于熏蒸治疗仪(不含药)。

Publish Date: 2024-07-08

YY/T 1307-2024 Active

YY/T 1307-2024 Medical digital X-ray image detector used in mammography

本文件规定了医用乳腺X射线摄影用探测器(以下简称探测器)的分类和组成、要求,描述了相应的试验方法。
本文件适用于具有单次或多次曝光成像功能的用于乳腺X射线设备的探测器,包括但不限于非晶硅探测器、非晶硒探测器、CCD(电荷耦合器件)探测器、CMOS(互补金属氧化物半导体)探测器、IGZO(铟镓锌氧化物)探测器、光子计数探测器等。
本文件不适用于:
——普通摄影用探测器和牙科摄影用探测器;
——计算机体层摄影用探测器;
——动态成像用探测器。

Publish Date: 2024-07-08

YY/T 1932-2024 Active

YY/T 1932-2024 Dentistry—Dental splint bracketless orthodontic aligner

本文件规定了膜片式无托槽正畸矫治器和制作该矫治器所用的3D打印牙模的性能要求、试验及评价方法、标签和产品使用说明书信息。
本文件适用于膜片式无托槽正畸矫治器。
注: 在不引起混淆的情况下,本文件中的“膜片式无托槽正畸矫治器”简称为“矫治器”。

Publish Date: 2024-07-08

YY/T 1937-2024 Active

YY/T 1937-2024 Customized removable denture

本文件规定了定制式活动义齿的要求,描述了相应的试验方法。
本文件适用于定制式活动义齿。

Publish Date: 2024-07-08

YY/T 1550.3-2024 Active

YY/T 1550.3-2024 Guidance of study on the compatibility of infusion equipments and pharmaceutical products—Part 3:Leachable study—Unknown substance

本文件描述了在模拟临床输液条件下或临床输液条件下,一次性使用输液器具与药物接触过程中可沥滤物中未知物的研究方法。
本文件适用于需要开展未知可沥滤物研究的特定输液器具,需要时,与经论证的药物替代溶剂或拟输液的药物,开展未知可沥滤物研究。其他输注器具如需评价时,参考使用。

Publish Date: 2024-07-08

YY/T 1942-2024 Active

YY/T 1942-2024 Form and content of the unique device identifier

本文件规定了医疗器械唯一标识的形式和内容、数据分隔符和唯一标识的解析。
本文件适用于各相关方实施和应用医疗器械唯一标识。

Publish Date: 2024-07-08

YY/T 1943-2024 Active

YY/T 1943-2024 UDI implementation and application in medical device package levels

本文件规定了医疗器械的各产品包装级别包装的唯一标识实施和在供应链中的解析。
本文件适用于多级包装医疗器械产品唯一标识的实施和应用。

Publish Date: 2024-07-08

YY/T 0870.8-2024 Active

YY/T 0870.8-2024 Test for genotoxicity of medical devices—Part 8:Unscheduled DNA synthesis test with mammalian liver cells in vivo

本文件描述了医疗器械体内哺乳动物肝细胞程序外DNA合成试验方法。
本文件适用于通过测定医疗器械引起的哺乳动物肝细胞程序外DNA损伤,评价医疗器械是否具有潜在遗传毒性作用。
注: 纳米材料的体内哺乳动物肝细胞程序外DNA合成试验可能需要对本文件中的方法进行特定的修订,但本文件未给予描述。

Publish Date: 2024-07-08