11.040.40 外科植入物、假体和矫形 标准查询与下载

GSO ISO 14708-3:2024 外科植入物 有源植入式医疗器械 第3部分：植入式神经刺激器

ISO 14708-3:2017 is applicable to active implantable medical devices intended for electrical stimulation of the central or peripheral nervous system. The tests that are specified in this document are type tests and are to be carried out on a sample of a device to assess device behavioural responses, and are not intended to be used for the routine testing of manufactured products.

Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators

GSO ISO 25539-3:2024 心血管植入物 血管内装置 第3部分：腔静脉过滤器

ISO 25539-3:2011 specifies requirements for vena cava filters, based upon current medical knowledge. With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer. ISO 25539-3:2011 supplements ISO 14630, which specifies general requirements for the performance of non-active surgical implants. The following are within the scope of ISO 25539-3:2011: vena cava filters used to prevent pulmonary embolism by mechanical filtration in the inferior vena cava: while ISO 25539-3:2011 might be useful with respect to filters implanted in other venous locations (e.g. superior vena cava, iliac veins), it does not specifically address use of filters in other implantation sites; sheath/dilator kits, providing that they comprise an integral component of the access, delivery or retrieval/conversion of the vena cava filter. delivery systems, providing that they comprise an integral component of the deployment of the vena cava filter. optional filters that can be retrieved or converted, and permanent filters together with their associated endovascular systems: while ISO 25539-3:2011 might be useful with respect to the evaluation of repositioning filters after chronic implantation, it does not specifically address filter repositioning. The following are outside the scope of ISO 25539-3:2011: temporary filters (e.g. tethered) that need to be removed after a defined period of time; coatings, surface modifications, and/or drugs; issues associated with viable tissues and non-viable biological materials; degradation and other time-dependent aspects of absorbable materials; procedures and devices (e.g. venous entry needle) used prior to the vena cava filter procedure.

Cardiovascular implants — Endovascular devices — Part 3: Vena cava filters

T/CAMDI 025-2024 增材制造 个性化医疗器械力学等效模型

本文件描述了增材制造个性化医疗器械力学等效模型的构建及分析、模型验证及模型结果输出的方法。 本文件适用于以三维模型数据为基础，采用增材制造方式制造的产品的力学等效模型。 本文件不涉及在疲劳寿命方面的分析。

Additive Manufacturing-Mechanical Equivalent Model of Personalized Medical Devices

T/CAMDI 027-2024 增材制造 匹配式人工颞下颌关节

本文件规定了增材制造匹配式人工颞下颌关节（以下简称“关节”）的术语和定义、产品组成、要求、试验方法、制造、清洗、灭菌、包装及制造商提供的信息。  本文件适用于口腔颌面外科、耳鼻喉科头颈外科、整形外科等手术中，对颞下颌关节及相邻骨组织的修复或重建的增材制造匹配式人工颞下颌关节。

Additive manufacturing Matched artificial temporomandibular joint

T/CASME 1442-2024 介入式左心室辅助系统

本文件规定了介入式左心室辅助系统的术语和定义、系统设计的原则、技术要求、试验方法以及标志、包装、运输和贮存等方面的要求。

Interventional left ventricular assist system

ASTM F2267-24 测量静态轴向压缩下椎间体融合装置负载引起的下沉的标准试验方法

Standard Test Method for Measuring Load-Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression

ISO 8637-2:2024 血液净化用体外系统.第2部分:血液透析器、血液透析过滤器、血液过滤器和血液浓缩器用体外血液和流体回路

Extracorporeal systems for blood purification — Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

BS ISO 5832-11:2024 用于手术的植入物 金属材料 锻制钛6-铝7-铌合金

1   Scope This document specifies the characteristics of, and corresponding test methods for, the wrought titanium alloy known as titanium 6-aluminium 7-niobium alloy (Ti-6Al-7Nb) for use in the manufacture of surgical implants. NOTE The mechanical properties of a sample obtained from a finished product made of this alloy can differ from those specified in this document.

Implants for surgery. Metallic materials - Wrought titanium 6-aluminium 7-niobium alloy

KS P 8511-2024 电动假手抓握功能耐久性的试验方法

Test methods for the durability of grasping function of powered prosthetic hands

ASTM F1538-24 植入用玻璃和玻璃陶瓷生物材料的标准规范

1.1  This specification covers the material requirements and characterization techniques for glass and glass-ceramic biomaterials intended for use as bulk porous or powdered surgical implants, or as coatings on surgical devices, but not including drug delivery systems. 1.2  The biological response to glass and glass-ceramic biomaterials in bone and soft tissue has been demonstrated in clinical use (1- 12 ) 2 and laboratory studies (13- 17 ) . 1.3  This specification excludes synthetic hydroxylapatite, hydroxylapatite coatings, aluminum oxide ceramics, alpha- and beta-tricalcium phosphate, and whitlockite. 1.4  Warning— Mercury has been designated by EPA and many state agencies as a hazardous material that can cause central nervous system, kidney, and liver damage. Mercury, or its vapor, may be hazardous to health and corrosive to materials. Caution should be taken when handling mercury and mercury-containing products. See the applicable product Material Safety Data Sheet (MSDS) for details and EPA’s website (http://www.epa.gov/mercury/faq.htm) for additional information. Users should be aware that selling mercury or mercury-containing products, or both, in your state may be prohibited by state law. 1.5  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 Glass and Glass-Ceramic Biomaterials for Implantation

T/GDAAV 1011-2024 外科植入物 兽用髋关节置换植入物技术规范

分类和尺寸标注，预期性能：股骨部件与髋臼部件间角运动范围，设计属性，材料，机械性能评估、磨损性能评估、生物相容性等方面。

Implant for surgery–Technical specifications for veterinary hip-joint replacement implants

ASTM F1295-24 外科植入物用锻造钛-6铝合金-7铌合金的标准规范 (UNS R56700)

Standard Specification for Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700)

ASTM F1350-24 锻造 18 铬-14 镍-2.5 钼不锈钢手术固定丝的标准规范 (UNS S31673)

Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673)

BS EN ISO 12417-1:2024 心血管植入物和体外系统 血管装置-药物组合产品一般要求

Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products - General requirements

YY/T 1925-2024 心血管植入器械 神经血管取栓支架

本文件规定了神经血管取栓支架（简称取栓支架）的通用要求、预期性能、设计属性、材料、实验室设计评估、上市后监督、制造、灭菌、包装的要求。本文件适用于预期用于移除缺血性脑卒中患者神经血管中的血栓，从而恢复血管血流畅通的取栓支架。本文件不适用于取栓术中其他可能用到的器械和/或辅件，如球囊导管、微导丝、微导管等。

Cardiovascular Implantable Devices Neurovascular Thrombectomy Stents

YY/T 1927-2024 运动医学植入器械 带袢固定板

本文件规定了运动医学植入器械带袢固定板（以下简称带袢固定板）的性能要求，描述了相应的试验方法，并规定了制造、灭菌、生物学安全性评价、包装和制造商提供的信息等方面的内容。本文件适用于供软组织与骨或骨与骨连结固定用的带袢固定板的测试评价。

Sports medicine implant device with loop fixation plate

24/30483878 DC BS EN ISO 5840-1:2021/Amd 1 心血管植入物 心脏瓣膜假体 第1部分：一般要求 修改件1

BS EN ISO 5840-1:2021/Amd 1 Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements. Amendment 1

24/30483882 DC BS EN ISO 5840-2:2021/Amd 1 心血管植入物 心脏瓣膜假体 第2部分：手术植入的心脏瓣膜替代品 修改件1

BS EN ISO 5840-2:2021/Amd 1 Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes. Amendment 1

YY/T 0663.2-2024 心血管植入器械 血管内器械 第2部分：血管支架

本文件规定了支架系统（血管支架和输送系统）的通用要求、预期性能、设计属性、材料、设计评价、上市后监管、生产、灭菌、包装的要求。本文件适用于治疗血管狭窄或其他血管异常或病变的血管支架（含可吸收性血管支架）。本文件适用于与血管内假体联用以完成对病变治疗的支架，包括桥接支架（例如，开窗型血管内假体释放后在肾动脉内放置的支架），但并未描述联用时的测试方法。本文件适用于具有表面改性（例如，药物和/或其他涂层）的血管支架。本文件适用于支架系统内所含的球囊。本文件包括用于局部治疗血管成形术后夹层的定位器械、弹簧圈支撑器械以及血流导向装置，但并未对这些器械的要求和测试进行全面描述。本文件适用于药物洗脱支架，但并未对这些器械的药物洗脱特性进行全面描述。本文件适用于可吸收支架和可吸收涂层支架，但并未对这些器械的可吸收特性进行全面描述。本文件适用于涂层支架和涂层支架系统，但并未对涂层特性进行全面描述。本文件不适用于血管支架置入之前的程序和器械，如球囊血管成形术器械。本文件不适用于有关血管支架制造用活性组织和非活性生物材料的要求和评价。

Cardiovascular implantable devices Intravascular devices Part 2: Vascular stents

24/30483886 DC BS EN ISO 5840-3:2021/Amd 1 心血管植入物 心脏瓣膜假体 第3部分：通过经导管技术植入的心脏瓣膜替代物 修改件1

BS EN ISO 5840-3:2021/Amd 1 Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques. Amendment 1