Standards

YY/T 1535-2024 Active

YY/T 1535-2024 Medical devices for human assisted reproductive technology—Human sperm viability assay(HSVA)

本文件描述了人类辅助生殖技术用医疗器械产品进行人精子存活的试验方法，包含人精子活力试验、人精子活力恢复试验和人精子冷冻复苏试验。人精子活力试验适用于评价人类辅助生殖技术用医疗器械中与精子直接接触的培养液类及器具/耗材类产品可能产生的毒性风险。通过观察精子与液体类产品或浸提液直接接触后的活力变化情况，评价培养液类及器具/耗材类产品可能产生的精子毒性风险。人精子活力恢复试验适用于评价精子制动液和类似产品可能产生的毒性风险。通过观察精子与精子制动液或类似产品直接接触后的活力恢复情况，评价精子制动液或类似产品可能产生的毒性风险。人精子冷冻复苏试验适用于评价人类精子冷冻液产品可能产生的精子毒性和冷冻复苏伤害风险。通过观察精子与精子冷冻液的直接接触以及冷冻复苏后的活力恢复情况，判断精子冷冻液产品可能产生的毒性和冷冻复苏伤害风险。

Publish Date: 2024-07-08

YY/T 1754.4-2024 Active

YY/T 1754.4-2024 Preclinical animal study of medical devices—Part 4:Acute trauma model for evaluating the healing promoting performance of dressing

本文件描述了试验用猪背部全皮层急性创伤模型的制备方法。
本文件适用于创面敷料促愈合性能的测试与评价。

Publish Date: 2024-07-08

YY/T 1786-2024 Active

YY/T 1786-2024 Hepatitis B e antigen (HBeAg) detection kit(chemiluminescent immunoassay)

本文件规定了乙型肝炎病毒e抗原检测试剂盒（化学发光免疫分析法）的技术要求、标识、标签、使用说明书、包装、运输和贮存等，描述了相应的试验方法。本文件适用于利用化学发光免疫分析技术，测定人血清、血浆中乙型肝炎病毒e抗原的试剂盒（以下简称“试剂盒”）。包括化学发光、微粒子化学发光、电化学发光、光激化学发光和时间分辨荧光等方法。本文件不适用于：a) 拟用于单独销售的乙型肝炎病毒e抗原校准品和乙型肝炎病毒e抗原质控品；b) 以化学发光免疫分析为原理的生物芯片。

Publish Date: 2024-07-08

YY/T 1922-2024 Active

YY/T 1922-2024 Implants for sports medicine—Interference screw

本文件规定了运动医学植入器械肌腱韧带固定螺钉的性能要求，描述了相应的试验方法，规定了制造、灭菌、生物学安全性评价、包装和制造商提供的信息的内容。本文件适用于运动医学植入器械肌腱韧带固定螺钉(以下简称“肌腱韧带固定螺钉”)，该产品可供运动医学手术中肌腱韧带移植物固定于骨隧道内使用。

Publish Date: 2024-07-08

YY/T 1933-2024 Active

YY/T 1933-2024 Particular specification for MR injector

本文件规定了磁共振（MR）造影注射装置（以下简称注射装置）的要求，描述了相应的试验方法。本文件适用于注射装置。本文件不适用于注射装置专用的一次性使用高压造影注射器及其附件。

Publish Date: 2024-07-08

YY/T 1936-2024 Active

YY/T 1936-2024 Customized fixed prosthesis

本文件规定了定制式固定义齿的要求，描述了相应的试验方法。
本文件适用于定制式固定义齿以及作为产品出厂的冠桥基底（包括金属基底及氧化锆基底)。

Publish Date: 2024-07-08

YY/T 1939-2024 Active

YY/T 1939-2024 Test for bacterial endotoxins of medical devices—Recombinant factor C method

本文件描述了利用重组C因子法检测医疗器械中细菌内毒素含量的试验方法。
本文件适用于对医疗器械进行细菌内毒素的检测。

Publish Date: 2024-07-08

YY/T 0865.1-2024 Pending

YY/T 0865.1-2024 Ultrasonics—Hydrophones—Part 1:Measurement and characterization of medical ultrasonic fields

This document describes the method of measuring the acoustic field generated by medical ultrasound equipment in liquids using a calibrated hydrophone, including the requirements for the bandwidth standard and calibration frequency range depending on the spectral components of the acoustic field to be characterized.
This document:
——Provides a set of measurable acoustic parameters based on acoustic fundamentals;
——Provides a set of derived auxiliary acoustic parameters, called derived acoustic parameters, under certain assumptions of these measurements;
——Provides measurement steps that can be used to determine acoustic pressure parameters;
——Provides conditions for measuring acoustic parameters using a calibrated hydrophone;
——Provides steps to correct the limitations caused by using hydrophones with limited bandwidth and limited sensitive element sizes, and is used to estimate the corresponding uncertainties.
This document is applicable to the measurement and characterization of medical ultrasound fields using ultrasonic hydrophones.

Publish Date: 2024-07-08

YY/T 0916.7-2024 Pending

YY/T 0916.7-2024 Small-bore connectors for liquids and gases in healthcare applications—Part 7:Connectors for intravascular or hypodermic applications

This document specifies the dimensions of small-bore connectors, as well as the requirements for their design and functional characteristics, which are intended for use in medical devices and accessories for intravascular applications or subcutaneous injection connections in medical devices and accessories.
Example: Subcutaneous syringes and injection needles or intravascular (IV) catheters with male and female luer non-locking (sliding) connectors and luer locking connectors.
Note 1: See Appendix A.
Note 2: Luer connectors were originally designed for pressures not exceeding 300 kPa.
This document does not specify the requirements for medical devices or accessories that use these connectors. These requirements are given in the dedicated documents for specific medical devices or accessories.
This document does not specify the requirements for small-bore connectors specified in the following other documents:
—— Blood dialyzers, blood dialysis filters, and blood filter blood chamber interfaces (applicable parts of ISO 8637 and ISO 8638 related to blood chamber interfaces);
—— Connectors for blood dialysis, blood dialysis filtration, and blood filtration equipment (ISO 8637);
—— Bottle cap penetration connectors for infusion systems (ISO 85364).
Note 3: Even if the current dedicated documents related to medical devices do not make requirements, manufacturers are encouraged to apply small-bore connectors that comply with this document to medical devices or accessories. It is expected that when the relevant dedicated medical device documents are revised, the requirements for small-bore connectors specified in YY/T 0916 will be included therein.
Note 4: Chapter 7 of YY/T 0916.1—2021 specifies alternative methods for small-bore connectors that comply with YY/T 0916.1—2021 but do not comply with this document, which are intended for use in medical devices or accessories for intravascular applications or subcutaneou

Publish Date: 2024-07-08

YY/T 1935-2024 Active

YY/T 1935-2024 Requirements and test methods for safety of implantable pacemakers and cardioverter defibrillators exposed to magnetic resonance imaging

This document specifies the safety requirements for implantable pacemakers and cardioverter-defibrillators operating under the stimulation of whole-body coils in 1.5 T and 3.0 T cylindrical (round or elliptical cross-section) scanning bore whole-body magnetic resonance imaging (MRI) equipment, and describes the corresponding testing methods.
This document applies to implantable pacemakers and cardioverter-defibrillators that meet the following conditions:
—— Systems that do not use sensing functions or are programmed to not use sensing functions during MRI scanning;
—— Systems that disable high-voltage therapy during MRI scanning;
—— Devices implanted in the patient's chest area.
This document does not apply to the non-implanted parts of active implantable medical devices.
Note 1: Subcutaneous ICD systems, leadless pacemakers, and implantable electrocardiograph recorders are not within the scope of this document, but the requirements and testing methods of this document can be used as a reference.
Note 2: The safety requirements for MRI equipment are specified in IEC 60601-2-33.
Note 3: The principle explanations of the provisions of this document are provided in Appendix A.

Publish Date: 2024-07-08

YY 1001-2024 Active

YY 1001-2024 Glass syringes

本文件规定了全玻璃注射器和蓝芯全玻璃注射器（以下简称“注射器”）的结构型式、材料、要求、标志、包装、运输和贮存等，描述了相应的试验方法。本文件适用于全玻璃注射器和蓝芯全玻璃注射器，该产品装上注射针后，供人体皮下、肌肉、静脉注射药液及抽取液体用。

Publish Date: 2024-02-07

YY/T 0062.1-2024 Active

YY/T 0062.1-2024 Medical electrical equipment—Diagnostic X-rays—Part 1:Determination of quality equivalent filtration and permanent filtration

本文件描述了X射线管组件的固有滤过和滤过材料质量等效滤过的测定方法，规定了X射线管组件在随附文件中的符合性声明和 X 射线管组件标记的要求，以及对滤过材料的指示和符合性声明要求。本文件适用于医疗诊断应用中高压150 kV以下的 X 射线管组件和滤过材料。对于高压大于50 kV，本文件仅适用于带有钨或钨合金靶的 X 射线管组件。

Publish Date: 2024-02-07