11.040.30 外科器械和材料 标准查询与下载

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

T/ZZB 2410-2021 粘胶型石膏绷带

本文件规定了粘胶型石膏绷带(以下简称石膏绷带)的术语和定义、型式和规格、基本要求、技术要求、试验方法、检验规则、标签、说明书、包装、运输及贮存和质量承诺。 本文件适用于采用熟石膏、胶质材料、纱布等材料制成的粘胶型绷带（不含粉剂），主要用于矫形、骨折固定等。

Plaster of paris bandage-Viscose form

ASTM F1813-21 外科植入物用锻制钛-12钼-6锆-2铁合金标准规范（UNS R58120）

1.1?This specification covers the chemical, mechanical, and metallurgical requirements for wrought titanium-12molybdenum-6zirconium-2iron alloy mill products to be used in the manufacture of surgical implants.2 1.2?The values stated in either SI units or inch-pound units are to

Standard Specification for Wrought Titanium-12Molybdenum-6Zirconium-2Iron Alloy for Surgical Implant (UNS R58120)

GSO ISO 7153-1:2021 手术器械 材料 第1部分：金属

ISO 7153-1:2016 specifies metals commonly used to manufacture various types of standard surgical instruments, including but not limited to those used in general surgery, orthopaedics and dentistry. While ISO 7153-1:2016 is not intended for surgical instruments used in special applications, such as implantology and minimally invasive surgery, parts of it might be applicable to those instruments.

Surgical instruments — Materials — Part 1: Metals

GSO ASTM F899:2021 手术器械用锻造不锈钢的标准规范

This specification covers the chemical requirements for wrought stainless steels used for the manufacture of surgical instruments. Classes of stainless steels covered here are Class 3 (austenitic stainless steel), Class 4 (martensitic stainless steel), Class 5 (precipitation hardening stainless steel), and Class 6 (ferritic stainless steel). The data contained in this specification, such as typical hardness values, common heat treating cycles, and examples of selected stainless steels that have been used for surgical instruments, are provided for reference only. Mechanical property, heat treatment, hardness, and all other requirements except for chemical composition, are governed by the appropriate material standards as specified or as agreed upon between purchaser and supplier.

Standard Specification for Wrought Stainless Steels for Surgical Instruments

GSO IEC 60601-2-2:2021 医用电气设备 第2-2部分：高频手术设备和高频手术附件基本安全和基本性能的特殊要求

IEC 60601-2-2:2017 is also available as IEC 60601-2-2:2017 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition. IEC 60601-2-2:2017 applies to the basic safety and essential performance of HF surgical equipment and HF surgical accessories. HF surgical equipment having a rated output power not exceeding 50 W (for example for micro-coagulation, or for use in dentistry or ophthalmology) is exempt from certain of the requirements of this particular standard. These exemptions are indicated in the relevant requirements. The object of this particular standard is to establish particular basic safety and essential performance requirements for HF surgical equipment and HF surgical accessories. This sixth edition cancels and replaces the fifth edition published in 2009. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: - refinement and additions to the defined terms; - additional separation of the requirements for HF surgical equipment and HF surgical accessories; - a new requirement for adult neutral electrodes to be contact quality monitoring neutral electrodes; - new requirements for devices that have or use a high current mode.

Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories