YY/T 0573.4-2025 Pending

YY/T 0573.4-2025 Sterile hypodermic syringes for single use—Part 4:Syringes with re-use prevention feature

本文件规定了一次性防止重复使用注射器(以下简称“注射器”)的特性和性能。
本文件适用于由塑料和橡胶材料制成,带针或不带针的,用于抽吸药液或抽吸液体后立即注射用的,且设计上能够防止再次使用的一次性使用无菌注射器。
本文件不适用于玻璃制注射器、固定剂量疫苗用自毁注射器和预充型注射器。
本文件不涉及注射器与注射液的兼容性。当注射器用于本文件规定以外的任何其他预期用途时,能适用其他标准。
注:旨在降低针刺伤风险的注射器也能遵守本文件关于其防止重复使用的特性,但需要强调的是,本文件中并没有涉及注射器的防针刺伤特性。

Publish Date: 2025-09-15

YY/T 0573.3-2025 Pending

YY/T 0573.3-2025 Sterile hypodermic syringes for single use—Part 3:Auto-disable syringes for fixed dose immunization

本文件规定了在输送至预设的疫苗剂量时,会自动失效的一次性使用无菌注射器(以下简称注射器)的特性和性能。
本文件适用于由塑料、橡胶或其他材料制成的供抽吸疫苗或注入疫苗后立即注射用的带针或不带针的一次性使用无菌注射器。
本文件不适用于胰岛素注射器、动力驱动注射泵用注射器、防止重复使用注射器、不固定剂量自毁型注射器以及预装药液注射器。

Publish Date: 2025-09-15

YY/T 0573.2-2025 Pending

YY/T 0573.2-2025 Sterile hypodermic syringes for single use—Part 2:Syringes for use with power-driven syringe pumps

本文件规定了由高分子材料制成的公称容量为1 mL及以上的动力驱动注射泵用注射器的要求,动力驱动注射泵用注射器与经制造商确认的注射泵配套使用。
本文件不适用于具有自毁功能的注射器、胰岛素注射器、玻璃注射器、由制造厂预装药液的注射器以及与药液配套的注射器等。本文件不涉及泵用注射器与注射药液的相容性。

Publish Date: 2025-09-15

YY/T 0497-2025 Pending

YY/T 0497-2025 Sterile insulin syringe for single use

本文件规定了一次性使用无菌胰岛素注射器(以下简称注射器)的要求,描述了相应的试验方法。该注射器仅一次性使用,用于抽吸胰岛素后立即进行人体注射。
本文件适用于注射40单位每毫升(U-40)和100单位每毫升 (U-100)胰岛素的注射器。
本文件不适用于长期储存胰岛素的注射器。

Publish Date: 2025-09-15

YY/T 0474-2025 Pending

YY/T 0474-2025 Implants for surgery—Homopolymers,copolymers and blends on poly(lactide)—In vitro degradation testing

本文件描述了聚丙交酯(以L-丙交酯、D-丙交酯和/或D,L-丙交酯为结构单元的均聚物、共聚物和/或共混物)在体外降解条件下化学和/或机械性能变化的测定方法。本文件还描述了可吸收聚丙交酯或其他可水解材料及器械进行体外降解表征所需的基本物理和机械性能评价。
本文件适用于生产外科植入物的聚丙交酯均聚物、共聚物和/或共混物,包括原材料、加工材及最终产品(经包装和灭菌的植入物)。
本文件中规定的试验方法,也用于测定含有其他共聚单体(如乙交酯、三亚甲基碳酸酯和/或ε-己内酯)的聚丙交酯基的共聚物和/或共混物的体外降解速率和相关材料特性的变化。本文件中的体外试验方法不能用来准确预测材料在体内的行为,除非对具体器械进行了验证。

Publish Date: 2025-09-15

YY/T 0337-2025 Pending

YY/T 0337-2025 Anaesthetic and respiratory equipment—Tracheal tubes and connectors

本文件规定了经口、经鼻气管插管和气管插管接头,管壁用金属或塑料作为加强筋的气管插管,有肩部的气管插管、锥形气管插管,提供具有抽吸、监测或输送药物或其他气体的气管插管,以及为特殊用途而设计的多种其他类型的专用气管插管的基本安全和基本性能。
本文件适用于上述气管插管。
本文件不适用于气管支气管导管(包括支气管内管)(见YY/T 0490)、气管切开插管和接头(见YY/T 0338)和上喉部通气道(见YY/T 0985)。
本文件不适用于与易燃麻醉气体或药剂、激光或外科电气设备一起使用的气管插管。
注1:附录A中A.2给出了有本章相关的指南或基本原理。
注2: 涉及气道激光手术的ISO 11990-1、ISO 11990-2和ISO 14408。

Publish Date: 2025-09-15

YY 0780-2025 Pending

YY 0780-2025 Traditional Chinese medical device—Electroacupuncture therapy device

本文件规定了电针治疗仪(以下简称“治疗仪”)的要求,描述了相应的试验方法。
本文件适用于通过电针给患者进行治疗和辅助治疗的仪器。

Publish Date: 2025-06-18

YY/T 1982-2025 Pending

YY/T 1982-2025 Implants for surgery—Test method for morphological characteristics of porous structures

This document describes the experimental methods for characterizing the morphological features of porous structures in surgical implants, including parameters such as porosity, pore size, wire diameter, internal connectivity, pore gradient, porous structure thickness, and internal structural defects. This document is applicable to porous structures in surgical implants. The materials covered by this document may include: - Metals, such as titanium, tantalum, magnesium, and their alloys; - Ceramics, such as hydroxyapatite and β-tricalcium phosphate; - Polymer materials (degradable or non-degradable), such as polyethylene, polyetheretherketone, polylactic acid, or polycaprolactone; - Composite materials. The manufacturing techniques covered by this document may include, but are not limited to: - Additive manufacturing; - Adding foaming agents; - Template method; - Gas pore formation method; - Vapor deposition method, etc. This document is not applicable to various porous coatings attached to non-porous substrates specified in YY/T 0988.14, such as plasma sprayed pure titanium coatings, plasma sprayed hydroxyapatite coatings, and sintered coatings formed by thermally polymerizing individual entities (powder particles, metal wires, meshes, beads, etc.). Note: Users of this document can select appropriate experimental items based on the test samples and manufacturing techniques.

Publish Date: 2025-06-18

YY/T 1981-2025 Pending

YY/T 1981-2025 Radiotherapy treatment planning software—Requirement and test method for electron beam dose calculation accuracy

This document specifies the requirements for the accuracy of electron beam dose calculation in radiation therapy planning software (RTPS) and describes the corresponding testing methods.
This document is applicable to radiation therapy planning software with remote electron beam dose calculation functions used in conjunction with medical electron accelerators.
This document is not applicable to radiation therapy planning software for special applications involving electron beam therapy.

Publish Date: 2025-06-18

YY/T 1980-2025 Pending

YY/T 1980-2025 Sterile wound protector for single use

This document specifies the classification and marking, materials, requirements, labels and instructions, packaging, transportation, and storage of single-use sterile incision protection sleeves (hereinafter referred to as "incision protection sleeves"), and describes the corresponding test methods.
This document is applicable to incision protection sleeves that play a role in fixing, retracting, dilating, and isolating contamination at endoscopic or open surgical incision sites.
This document is not applicable to single-use endoscopic protection sleeves.

Publish Date: 2025-06-18

YY/T 1979-2025 Pending

YY/T 1979-2025 Traditional Chinese medical device—Gua Sha instruments

This document specifies the requirements for scraping tools and describes the corresponding test methods.
This document is applicable to scraping tools.
This document is not applicable to electronic scraping tools.

Publish Date: 2025-06-18

YY/T 1978-2025 Pending

YY/T 1978-2025 Dentistry—Trephine burs

This document specifies the requirements for dental burrs used in oral implant surgery (such as bone tissue extraction or implant removal), provides a classification, describes the corresponding test methods, and also stipulates the requirements for marking, labeling, and user manuals.
This document is applicable to dental burrs used in oral implant surgery.

Publish Date: 2025-06-18