11.040.30 外科器械和材料 标准查询与下载

T/ZAMEI 0003-2023 紫杉醇药物涂层球囊扩张导管

对紫杉醇药物涂层球囊扩张导管的外观、物理指标、涂层特性和化学性能及微生物指标进行阐述。

Paclitaxel drug-coated balloon dilatation catheter

T/QGCML 2444-2023 内窥镜弯曲组件

本文件规定了内窥镜弯曲组件（以下简称“产品”）的型号/规格命名、产品结构、材料、技术要求、试验方法、检验规则、标志、包装、运输和贮存、质量承诺。 本文件适用于内窥镜用弯曲组件的生产和检验。

Endoscope bending components

IEC 80601-2-77:2019+AMD1:2023 CSV 医用电气设备.第2-77部分:机器人辅助手术设备的基本安全和基本性能的特殊要求

Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment

T/ZGKSL 012-2023 胶原蛋白产品质量要求

界定了胶原蛋白产品的定义及特征含义；规定了胶原蛋白海绵、胶原蛋白植入剂和胶原蛋白敷料的技术要求，并给出了技术要求对应的试验检验方法和检验规则，以及标志、包装、运输、贮存等内容。

Quality requirements for collagen products

ASTM F899-23 外科器械用锻造不锈钢标准规范

Standard Specification for Wrought Stainless Steels for Surgical Instruments

T/GDSBME 007-2023 医用近红外光学定位系统

1）范围：本标准的规定范围和适用范围。 2）规范性引用文件：引用的相关标准。 3）术语和定义：定义了近红外光学定位系统、空间几何尺寸测量误差等术语。 4）产品的外观与结构：对产品的外观与结构提出了具体要求，包括两部分，主机部分的要求，产品的活动部件的要求。 5）外壳防护等级：对产品的外壳防护等级进行了规定。 6）定位系统的软件功能：对产品的软件系统进行了限定，依据产品的功能说明提出了相关要求。 7）定位系统系统的硬件功能：对产品的系统硬件功能进行了限定，依据产品的功能说明提出了相关要求。 8）电气安全性能：对产品的电气安全性能提出了相关要求，指出其参照标准及检测方法。 9）环境试验要求：对产品的环境试验要求进行了规定。 10）电磁兼容要求：对产品的电磁兼容要求进行了规定。 11）定位系统的空间位置精度：对产品的定位系统的空间位置精度提出了相关的技术指标，包括：空间几何尺寸测量误差，空间移动位置定位误差，测量稳定性，外界温度敏感度，视场范围，并给出检测方法。

Medical near-infrared optical positioning system

T/GDSBME 006-2023 近红外光学定位系统空间位置测试方法

1）范围：本标准的规定范围和适用范围。 2）规范性引用文件：引用的相关标准。 3）术语和定义：定义了近红外光学定位系统、空间几何尺寸测量误差、测量结果一致性、空间移动位置定位误差、测量稳定性、外界温度敏感度、球形反射精度测试靶、视场范围等术语。 4）测试条件：对测试方法的测试条件提出了具体要求，包括三部分，测试环境条件的要求，稳定时间的要求、测试场地的要求、检测项目和主要检测设备的要求。 5）测试方法：对近红外光学定位系统空间位置测试方法进行了规定以及给出测试方法的过程，包括五个方面。空间几何尺寸测量误差，空间移动位置定位误差，长时间测量稳定性，外界温度敏感度，视场范围。

Near-infrared optical positioning system spatial position test method

T/CSBME 069-2023 体外膜肺氧合用聚-4-甲基-1-戊烯中空纤维膜

本文件规定对体外膜肺氧合用聚-4-甲基-1-戊烯中空纤维膜的物理、化学、生物学、使用性能要求

The Poly ( 4-Methyl-1-Pentene) hollow fiber membrane for extracorporeal membrane oxygenation

T/QGCML 1839-2023 丝素蛋白膜 碳酸钠残留测试技术规范

本文件描述了丝素蛋白膜 碳酸钠残留测试技术规范的术语和定义、原理、试剂及仪器设备、测试条件、测试样品、测试步骤、结果判定分析、测试报告。  本文件适用于丝素蛋白膜的碳酸钠残留测试。

Technical specifications for testing sodium carbonate residue in silk fibroin membranes

T/QGCML 1837-2023 丝素蛋白膜 孔隙率测试技术规范

本文件描述了丝素蛋白膜 孔隙率测试技术规范的术语和定义、原理、试剂及仪器设备、测试条件、测试样品、测试步骤、结果判定分析、测试报告。  本文件适用于丝素蛋白膜的孔隙率测试。

Technical specifications for testing porosity of silk fibroin membranes

T/QGCML 1838-2023 丝素蛋白膜 拉伸强度测试技术规范

本文件描述了丝素蛋白膜 拉伸强度测试技术规范的术语和定义、试剂及仪器设备、测试条件、测试样品、测试步骤、结果判定分析、测试报告。  本文件适用于丝素蛋白膜的拉伸强度测试。 

Technical specifications for tensile strength testing of silk fibroin membranes

T/QGCML 1333-2023 消融电极装置

本文件规定了消融电极装置的术语定义、结构组成、技术要求、试验方法、检验规则、标志、包装、运输及贮存。 本文件适用于消融电极装置的生产和检验。

ablation electrode device

YY/T 1914-2023 人类辅助生殖技术用医疗器械 器具类产品通用要求

本文件规定了人类辅助生殖技术用医疗器械器具类产品的通用要求，包括要求和试验方法。本文件适用于人类辅助生殖技术用医疗器械器具类产品，包括辅助生殖导管、辅助生殖穿刺取卵/取精针，以及辅助生殖微型工具。

General requirements for medical devices and appliances used in human assisted reproductive technology

YY/T 1906-2023 一次性使用无菌闭合夹

本文件规定了一次性使用无菌闭合夹（以下简称闭合夹）的结构和材料、要求、标签、说明书，描述了相应的试验方法。本文件适用于外科手术中夹闭血管或闭合管状组织（包括中小动静脉、胆管等，不适用于大动脉和大静脉）的闭合夹。本文件不适用于金属夹、可吸收性闭合夹、连发闭合夹和术中临时夹闭组织或血管、术后取出的闭合夹。

Disposable sterile closure clips

YY/T 1913-2023 医用聚碳酸酯材料中2,2-二（4-羟基苯基）丙烷（双酚A）残留量测定方法

本文件描述了医用聚碳酸酯材料中2,2-二（4-羟基苯基）丙烷（双酚A）残留量测定方法。本文件适用于医用聚碳酸酯材料中2,2-二（4-羟基苯基）丙烷（双酚A）残留量测定。

Method for determination of 2,2-bis(4-hydroxyphenyl)propane (bisphenol A) residue in medical polycarbonate materials

YY/T 1909-2023 医用增材制造 金属粉末床电子束熔融工艺控制和确认要求

本文件规定了以电子束作为能量源的金属材料粉末床熔融增材制造工艺常规控制和过程确认的一般要求。本文件适用于采用金属材料粉末床电子束熔融技术制造的医疗器械加工过程。

Medical additive manufacturing metal powder bed electron beam melting process control and validation requirements

YY/T 1910-2023 用于增材制造的医用β-磷酸三钙粉末

本文件规定了用于增材制造的医用β-磷酸三钙粉末的性能要求、试验方法、标识、包装、运输和贮存。本文件适用于光固化、挤出式和铺粉增材制造工艺的医用β-磷酸三钙粉末。

Medical beta-tricalcium phosphate powder for additive manufacturing

ASTM F2026-23 外科植入物用聚醚醚酮（PEEK）聚合物的标准规范

1.1 This specification covers polyetheretherketone (PEEK) polymer in virgin forms (for example, pellets, granules, powder, filaments used in additive manufacturing) and fabricated forms. It provides requirements and associated test methods for these thermoplastics when they are to be used in the manufacture of intracorporeal devices such as surgical implants or components of surgical or dental devices. 1.2 The properties included in this specification are those applicable for PEEK polymers only. Indicated properties are for fabricated forms. Materials or forms containing colorants, fillers, processing aids, or other additives, as well as polymer blends which contain PEEK, or reclaimed materials, are not covered by this specification. 1.3 This specification is designed to recommend physical, chemical, and biological test methods to establish a reasonable level of confidence concerning the performance of virgin PEEK polymers for use in medical implant devices. 1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.5 When evaluating material in accordance with this specification, hazardous materials, operations, and equipment may be involved. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications

GSO ASTM F1026:2023 止血钳一般工艺和性能测量的标准规范

This specification covers general workmanship aspects of hemostatic forceps fabricated from stainless steel and intended for reuse in surgery. All of the component parts of the instruments shall be made of martensitic stainless steel of Type 410, 410X, 416, 416MOD, 420A, or 420B. Materials shall be tested and the individual grades shall conform to physical requirements such as heat treatment, hardness, and passivation; performance requirements such as finger rings, jaw serrations and teeth, box lock, clearance, ratchets, jaw and rachet setting, elasticity, and corrosion resistance. Workmanship, finish, and appearance, are also detailed.

Standard Specification for General Workmanship and Performance Measurements of Hemostatic Forceps

GSO ASTM F2063:2023 医疗器械和外科植入物用锻制镍钛形状记忆合金的标准规范

This specification covers the chemical, physical, mechanical, and metallurgical requirements for wrought nickel-titanium bar, flat rolled products, and tubing containing nominally 54.5 % to 57.0 % nickel and used for the manufacture of medical devices and surgical implants. The material shall be made from ingot made from nickel and titanium with no other intentional alloy additions. The material shall be vacuum or inert atmosphere melted to control metallurgical cleanliness and alloy chemistry. Bar, plate, and tubing shall be supplied as hot finished or cold finished and annealed or heat treated. Surface condition may be oxidized, descaled, pickled, blasted, machined, ground, mechanically polished, or electropolished. Major elements shall be analyzed by direct current plasma spectrometry, atomic absorption, inductively coupled plasma spectrometry, X-ray spectrometer, glow discharge mass spectrometry, or an equivalent method. Carbon shall be measured by combustion and hydrogen shall be measured by inert gas fusion or vacuum hot extraction. Nitrogen and oxygen shall be measured by inert gas fusion. The nickel and titanium contents of nickel-titanium shape memory alloys cannot be measured to a precision required to guarantee shape memory or superelastic properties. Calorimetry or an equivalent thermomechanical test method must be used to assure the alloy formulation in terms of transformation temperature. Mechanical properties of the samples such as tensile strength and elongation shall be determined after annealing.

Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants