11.040.30 外科器械和材料 标准查询与下载

T/CSBME 055-2022 血液透析器中双酚A（BPA）溶出量的测定方法 气相色谱-质谱联用法

本文件规定了血液透析器中双酚A（BPA）溶出量的测定方法。 本文件适用于含BPA的血液透析器。

Method for measuring Bisphenol A(BPA) dissolution in hemodialyzer GC-MS(gas chromatography-mass spectrography)

T/GDWJ 007-2022 消毒供应服务包成本核算和定价方法通则

见标准文本正文。

General rule for accounting and pricing method of service disinfection package

YY/T 1769-2022 人类辅助生殖技术用医疗器械 人工授精导管

Medical devices for human assisted reproductive technology Artificial insemination catheters

YY/T 1629.3-2022 电动骨组织手术设备刀具 第3部分：钻头

Electric Bone Tissue Surgery Equipment Cutters Part 3: Drills

ASTM F700-93(2022) 颅内动脉瘤夹和仪器的护理和处理的标准实施规程

1.1 This practice covers recommended procedures for handling of neurosurgical intracranial aneurysm clips and the clip appliers (instruments). 1.2 This practice is intended to inform hospital receiving personnel, central supply personnel, operating room personnel, and other individuals who will handle intracranial aneurysm clips and the instruments related thereto of recommended care and handling procedures to prevent damage of intracranial aneurysm clips and instruments. 1.3 Handling and packaging procedures for the product are not a part of this practice and are covered in other practices. 1.4 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 Practice for Care and Handling of Intracranial Aneurysm Clips and Instruments

ASTM F1026-86(2022) 止血钳的一般工艺和性能测量标准规范

1.1 This specification covers general workmanship aspects of hemostatic forceps fabricated from stainless steel and intended for reuse in surgery. 1.2 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 General Workmanship and Performance Measurements of Hemostatic Forceps

ASTM F1079-87(2022) 插入式和非插入式外科剪刀的标准规范

1.1 This specification covers general workmanship aspects of inserted and noninserted stainless steel scissors fabricated from stainless steel and intended for reuse in surgery. 1.2 The following safety hazards caveat pertains only to the test method described in this specification: 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. 1.3 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 Inserted and Noninserted Surgical Scissors

YY/T 1805.3-2022 组织工程医疗器械产品 胶原蛋白 第3部分：基于特征多肽测定的胶原蛋白含量检测——液相色谱-质谱法

Tissue engineering medical device product collagen Part 3: Collagen content detection based on characteristic peptide determination - liquid chromatography-mass spectrometry

YY/T 1849-2022 重组胶原蛋白

Recombinant collagen

T/SHMHZQ 003-2022 外泌体提取试剂盒通用要求

4 分类  5 技术要求 6 试验方法  7 检验规则  8 标志、说明书、包装、运输和贮存

General requirements for exosome extraction kits

KS P 2001-2021 外科手术刀

Surgical knives

T/SHMHZQ 113-2021 一次性内窥镜穿刺器技术规范

4 规格和材料  5 要求 6 试验方法  7 检验规则  8 标志、说明书、包装、运输和贮存  附录 A  附录 B  附录 C  参考文献

Technical specification for disposable endoscopic puncture apparatus

ASTM F3046-21 外科植入物用锻造钛-3铝-2.5钒合金标准规范（UNS R56320）

1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought titanium-3aluminum

Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy for Surgical Implant Applications (UNS R56320)

YY/T 1764-2021 血管支架体外轴向、弯曲、扭转耐久性测试方法

Test methods for axial, bending and torsional durability of vascular stents in vitro

YY/T 1805.2-2021 组织工程医疗器械产品 胶原蛋白 第2部分：I型胶原蛋白分子量检测-十二烷基硫酸钠聚丙烯酰胺凝胶电泳法

Tissue engineering medical device product collagen Part 2: Type I collagen molecular weight detection-sodium dodecyl sulfate polyacrylamide gel electrophoresis method

YY/T 1797-2021 内窥镜手术器械 腔镜切割吻合器及组件

Endoscopic surgical instruments, endoscopic cutting staplers and components

YY/T 1704.3-2021 一次性使用宫颈扩张器 第3部分：球囊式

Disposable Cervical Dilators Part 3: Balloon Type

YY/T 1629.6-2021 电动骨组织手术设备刀具 第6部分：锉刀

Electric Bone Tissue Surgery Equipment Knives Part 6: Files

YY/T 1798-2021 一次性使用宫腔压迫球囊

Disposable uterine compression balloon

YY/T 1761-2021 透析管路消毒液

Dialysis line disinfectant