Standards

YY/T 0688.2-2024 Active

YY/T 0688.2-2024 Clinical laboratory testing and in vitro diagnostic test systems—Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices—Part 2:Evaluation of performance of antimicrobial susceptibility test devices against reference broth micro-dilution

This document establishes acceptable performance standards for antimicrobial susceptibility testing (AST) equipment. These devices are used in medical laboratories to determine the minimum inhibitory concentration (MIC) of bacteria to antimicrobial drugs.
This document specifies the requirements for AST equipment and the procedures for evaluating the performance of these devices. It provides guidance on how to conduct performance evaluations of AST equipment.
This document is applicable to guiding manufacturers in conducting performance evaluation studies.

Publish Date: 2024-09-29

YY/T 0581.2-2024 Active

YY/T 0581.2-2024 Infusion access adapter—Part 2:Needleless access adapters

This document specifies the requirements for single-use needle-free connectors (hereinafter referred to as connectors) and describes the corresponding test methods.
This document is applicable to self-sealing, single-use needle-free connectors used in non-puncture applications. Products supplied with connectors integrated into intravascular indwelling devices (such as intravenous indwelling needles) shall refer to and implement this document.
The anti-reflux valves specified in YY 0585.4 are not included in the scope of this document.
The switches specified in YY 0585.2 are not included in the scope of this document.

Publish Date: 2024-09-29

YY/T 0576-2024 Active

YY/T 0576-2024 Columbia blood agar medium

This document specifies the main components and preparation methods, requirements, marking, labeling, and usage instructions, packaging, transportation, and storage of Columbia blood agar media, and describes the corresponding testing methods.
This document is applicable to Columbia blood agar media, including dry powder media and plate media.

Publish Date: 2024-09-29

YY/T 0339-2024 Active

YY/T 0339-2024 Suction catheters for use in the respiratory tract

This document specifies the dimensions and requirements for respiratory suction catheters.
This document applies to open and closed suction catheters made of flexible materials intended for respiratory suction.
This document does not apply to suction catheters intended for use with flammable anesthetic gases or reagents, laser or electrosurgical equipment.

Publish Date: 2024-09-29

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