11.040.30 外科器械和材料 标准查询与下载

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 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 F1744:2023 不锈钢手术器械保养和操作的标准指南

This guide is intended to provide a better understanding of the care of stainless steel surgical instruments intended for reuse. This guide is not intended for use with electrical, pneumatic, or other powered surgical instruments. The stainless steels most used are martensitic and austenitic types. The instruments shall be used only for their intended purpose, such as cutting, holding, clamping, retracting, and so forth. Undue stress or strain should be avoided when handling and cleaning. The guide includes care in particular for hemostatic forceps, needle holders, scissors, microsurgical instruments, instrument kits, and other sharp instruments. The instrument care specified includes cleaning, lubrication, and inspection. Testing, repair and restoration, and sterilization are specified.

Standard Guide for Care and Handling of Stainless Steel Surgical Instruments

GSO ASTM F3014:2023 手术缝合针刺穿测试的标准测试方法

  Scope is not provided for this standard

Standard Test Method for Penetration Testing of Needles Used in Surgical Sutures

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

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 F565:2023 骨科植入物和器械护理和处理的标准实践

This practice covers recommended procedures for the handling of orthopedic implants and instruments. Hospital receiving personnel, central supply personnel, operating room personnel, surgeons, and occasionally other individuals will handle orthopedic implants and instruments. All personnel should be informed of recommended care and handling procedures to prevent damage of orthopedic implants and instruments. Many implants are wrapped in special sterilizable or pre-sterilized packages, envelopes, or other containers. These wrappings should not be removed by the receiving personnel. Perform transport in a manner to preclude any damage or alteration to the received condition of the implant or instrument. Store implants or instruments prior to use in such a manner as to maintain the device’s surface finish or configuration, or both. Maintain orthopedic implants and instruments of different metals separately to avoid the possibility of mixing during surgery. Prior to initial sterilization and promptly following each surgical procedure, thoroughly and carefully clean all instruments and implants. Dispose of orthopedic implants that exhibit surface or configuration damage. Avoid the reimplantation of previously implanted orthopedic implants.

Standard Practice for Care and Handling of Orthopedic Implants and Instruments

GSO IEC 80601-2-77:2023 医用电气设备 第2-77部分：机器人辅助手术设备基本安全和基本性能的特殊要求

IEC 80601-2-77:2019 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT (RASE) and ROBOTICALLY ASSISTED SURGICAL SYSTEMS (RASS), referred to as ME EQUIPMENT and ME SYSTEMS together with their INTERACTION CONDITIONS and INTERFACE CONDITIONS.

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

ASTM D3579-77(2023) Penrose型外科橡胶引流管的标准规范

1.1 This specification covers Penrose-type rubber tubes used in performing certain surgical drainage procedures. 1.2 The specification provides for packaged sterile rubber tubes and packaged or bulk nonsterile rubber tubes. 1.3 This standard does not purport to address all of the safety problems, 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. 1.4 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 Specification for Rubber Surgical Drainage Tubes, Penrose-Type

23/30473261 DC BS ISO 7151 手术器械 非切割、铰接式器械 一般要求和测试方法

BS ISO 7151. Surgical instruments. Non-cutting, articulated instruments. General requirements and test methods

T/WHAS 050-2023 双极电凝镊镊片模具成型制作工艺规范

本文件规定了双极电凝镊镊片模具成型制作的术语和定义、原材料、设备、工艺、试验方法、作业过程记录的要求。 本文件适用于双极电凝镊镊片（以下简称“镊片”）的模具成型制作工艺规范。

Clamp sheet of bipolar electric coagulation tweezer mold forming production specifications

ASTM F2066-23 外科植入物用锻造钛-15钼合金的标准规范（UNS R58150）

1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought titanium-15 molybdenum alloy to be used in the manufacture of surgical implants (1).2 1.2 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system are not necessarily exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of each other, and values from the two systems shall not be combined. 1.3 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. 1.4 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 Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150)

YY/T 1866-2023 一次性使用无菌肛肠套扎器 胶圈或弹力线式

本文件规定了一次性使用无菌肛肠套扎器胶圈或弹力线式（以下简称套扎器）的结构和材料、要求、试验方法、标签、说明书和包装。本文件适用于套扎治疗各期内痔及混合痔或直肠良性息肉的套扎器。

Disposable sterile anorectal ligation device with rubber ring or elastic wire

T/CIPR 088-2023 子宫托固定器

本文件规定了子宫托固定器的结构型试、型号与规格、要求、试验方法、标志与使用说明书、包装、运输和贮存及有效期。 本文件适用于手术治疗用的子宫托固定器。

pessary retainer

IEC 60601-2-2:2017/AMD1:2023 修改件1.医用电气设备.第2-2部分:高频外科设备和高频外科附件的基本安全和基本性能的特殊要求

Amendment 1 - Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessori

IEC 60601-2-2:2017+AMD1:2023 CSV 医用电气设备.第2-2部分:高频外科设备和高频外科附件的基本安全和基本性能的特殊要求

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

ASTM F1325-91(2023) 不锈钢缝合针夹的一般工艺要求和相应的试验方法

1.1 This specification covers general workmanship aspects of stainless steel suture needle holders 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 Stainless Steel Suture Needle Holders—General Workmanship Requirements and Corresponding Test Methods

ASTM F3212-16(2023) Huber针取芯试验的标准试验方法

1.1 This test method covers the qualitative measurement of Huber-type needles’ potential to remove septum material during implantable port access (1).2 1.2 This test method does not address other issues that may include, but are not limited to, force measurement during the perforation/withdrawal, septum integrity, and any safety issues. 1.3 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. 1.4 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 Test Method for Coring Testing of Huber Needles

ASTM F1613-95(2023) 外科组织/敷料/拾取钳（拇指型）标准规范

1.1 This specification covers general workmanship aspects of spring-action, tissue, dressing, or pick-up forceps (thumbtype) intended for the retraction, grasping, or dissection of tissue during surgical procedures. 1.2 The values stated in inch-pound units are to be regarded as the standard. The values given in parentheses are for information only. 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 Surgical Tissue/Dressing/Pick-Up Forceps (Thumb Type)