11.040.40 外科植入物、假体和矫形 标准查询与下载

GSO ISO 14117:2024 有源植入式医疗器械 电磁兼容性 植入式心脏起搏器、植入式心律转复除颤器和心脏再同步装置的 EMC 测试协议

This document specifies test methodologies for the evaluation of the electromagnetic compatibility (EMC) of active implantable cardiovascular devices that provide one or more therapies for bradycardia, tachycardia and cardiac resynchronization in conjunction with transvenous lead systems. NOTE This document was designed for pulse generators used with endocardial leads or epicardial leads. At the time of this edition, the authors recognized the emergence of technologies that do not use endocardial leads or epicardial leads for which adaptations of this part will be required. Such adaptations are left to the discretion of manufacturers incorporating these technologies. It specifies performance limits of these devices, which are subject to interactions with EM emitters operating across the EM spectrum in the two following ranges: — 0 Hz ≤ ? < 385 MHz; — 385 MHz ≤ ? ≤ 3 000 MHz This document also specifies requirements for the protection of these devices from EM fields encountered in a therapeutic environment and defines their required accompanying documentation, providing manufacturers of EM emitters with information about their expected level of immunity.

Active implantable medical devices — Electromagnetic compatibility — EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices

GSO ISO 14708-6:2024 外科植入物 有源植入式医疗器械 第6部分：用于治疗心动过速的有源植入式医疗器械（包括植入式除颤器）的特殊要求

This document specifies requirements that are applicable to implantable cardioverter defibrillators and CRT-Ds and the functions of active implantable medical devices intended to treat tachyarrhythmia. The tests that are specified in ISO 14708 are type tests and are to be carried out on samples of a device to show compliance. This document was designed for tachyarrhythmia pulse generators used with either endocardial leads or epicardial leads. At the time of this edition, the authors recognized the emergence of technologies that do not use endocardial or epicardial leads for which adaptations of this part will be required. Such adaptations are left to the discretion of manufacturers incorporating these technologies. This document is also applicable to some non-implantable parts and accessories of the devices (see Note 1). The characteristics of the implantable pulse generator or lead shall be determined by either the appropriate method detailed in this document or by any other method demonstrated to have accuracy equal to, or better than, the method specified. In the case of dispute, the method detailed in this document shall apply. Any aspect of an active implantable medical device intended to treat bradyarrhythmias or cardiac resynchronization is covered by ISO 14708-2. NOTE 1 The device that is commonly referred to as an active implantable medical device can in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify some requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device. NOTE 2 In this document, terms printed in italics are used as defined in Clause 3. Where a defined term is used as a qualifier in another term, it is not printed in italics unless the concept thus qualified is also defined.

Implants for surgery — Active implantable medical devices — Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)

GSO ISO 6474-1:2024 外科植入物 陶瓷材料 第1部分：基于高纯度氧化铝的陶瓷材料

This document specifies the characteristics of, and corresponding test methods for bio-stable ceramic bone substitute material based on high purity alumina for use as bone spacers, bone replacements and components of orthopaedic joint prostheses. This document does not cover biocompatibility (see ISO 10993-1). It is the responsibility of the manufacturer to evaluate the biocompatibility of ceramic materials which are produced within the framework of this document.

Implants for surgery — Ceramic materials — Part 1: Ceramic materials based on high purity alumina

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 25539-4:2024 心血管植入物 血管内装置 第4部分：ISO 17327-1 对涂层血管内装置的应用

This document specifies the appropriate application of ISO 17327-1:2018 to coated endovascular prostheses, vascular stents, and vena cava filters. This document is intended to be used as a supplement to ISO 25539-1, ISO 25539-2, ISO 25539-3, ISO 12417-1 and ISO/TS 17137. The following coatings are within the scope of ISO 17327-1 and addressed in this document for endovascular devices: drug coatings (eluting and non-eluting), non-drug coatings (absorbable and non-absorbable), and chemistry-related surface modifications (oxide, such as TiO2, and non-oxide, such as amorphous silicon carbide and diamond-like carbon). This document is not applicable to coated delivery systems or coated ancillary devices (e.g. guidewires), as these coatings are not within the scope of ISO 17327-1, which is specifically directed to implant coatings. This document is not applicable to coverings of endovascular devices; however, if the covering of a device is coated, it is within the scope of this document. This document does not address the requirements for, and the evaluation of, viable tissues and non-viable biologic materials used as implant coatings.

Cardiovascular implants — Endovascular devices — Part 4: Application of ISO 17327-1 for coated endovascular devices

GSO ISO 5832-14:2024 外科植入物 金属材料 第14部分：锻造钛 15-钼 5-锆 3-铝合金

This document specifies the characteristics of, and corresponding test methods for, the wrought titanium 15-molybdenum 5-zirconium 3-aluminium alloy for use in the manufacture of surgical implants. This document applies to materials in bar form up to a maximum diameter of 100 mm. 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 — Part 14: Wrought titanium 15-molybdenum 5-zirconium 3-aluminium alloy

GSO ISO 14708-5:2024 外科植入物 有源植入式医疗器械 第5部分：循环支持装置

This document specifies requirements for safety and performance of active implantable circulatory support devices, including type tests, animal studies and clinical evaluation requirements. NOTE The device that is commonly referred to as an active implantable medical device can in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify main requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device. 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. Included in the scope of this document are: — ventricular assist devices (VAD), left or right heart support; — total artificial hearts (TAH); — biventricular assist devices (biVAD); — percutaneous assist devices; — paediatric assist devices.

Implants for surgery — Active implantable medical devices — Part 5: Circulatory support devices

GSO ISO 5840-2:2024 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物

This document is applicable to heart valve substitutes intended for implantation in human hearts, generally requiring cardiopulmonary bypass and generally with direct visualization. See Annex E for examples of surgical heart valve substitutes and their components. This document is applicable to both newly developed and modified surgical heart valve substitutes and to the accessory devices, packaging, and labelling required for their implantation and for determining the appropriate size of the surgical heart valve substitute to be implanted. This document establishes an approach for verifying/validating the design and manufacture of a surgical heart valve substitute through risk management. The selection of appropriate qualification tests and methods are derived from the risk assessment. The tests can include those to assess the physical, chemical, biological, and mechanical properties of surgical heart valve substitutes and of their materials and components. The tests can also include those for pre-clinical in vivo evaluation and clinical evaluation of the finished surgical heart valve substitute. This document defines operational conditions and performance requirements for surgical heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification. For some heart valve substitutes (e.g. sutureless), the requirements of both this document and ISO 5840-3:2021 can be relevant and are considered as applicable to the specific device design and are based on the results of the risk analysis.

Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted heart valve substitutes

GSO ISO 14708-7:2024 外科植入物 有源植入式医疗器械 第7部分：耳蜗和听觉脑干植入系统的特殊要求

This document specifies requirements that are applicable to those active implantable medical devices that are intended to treat hearing impairment via electrical stimulation of the auditory pathways. Devices which treat hearing impairment via means other than electrical stimulation are not covered by this document. The tests that are specified in this document are type tests and are to be carried out on samples of a device to show compliance. This document is also applicable to non-implantable parts and accessories of the devices (see NOTE). The electrical characteristics of the implantable part are determined by either the appropriate method detailed in this document or by any other method demonstrated to have an accuracy equal to, or better than, the method specified. In the case of dispute, the method detailed in this document applies. NOTE A device that is commonly referred to as an active implantable medical device can in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, this document specifies those requirements of non-implantable parts and accessories which could affect the safety or performance of the implantable part.

Implants for surgery — Active implantable medical devices — Part 7: Particular requirements for cochlear and auditory brainstem implant systems

GSO ISO 24562:2024 假肢 下肢假肢适配器的几何方面

This document specifies dimensions of the adult modular systems adapters used in lower limb prosthetic.

Prosthetics — Geometrical aspects of lower limb prosthetic adapters

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/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/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

1.1 This test method specifies the materials and methods for the axial compressive subsidence testing of non-biologic intervertebral body fusion devices, spinal implants designed to promote arthrodesis at a given spinal motion segment. 1.2 This test method is intended to provide a basis for the mechanical comparison among past, present, and future nonbiologic intervertebral body fusion devices. This test method is intended to enable the user to mechanically compare intervertebral body fusion devices and does not purport to provide performance standards for intervertebral body fusion devices. 1.3 This test method describes a static test method by specifying a load type and a specific method of applying this load. This test method is designed to allow for the comparative evaluation of intervertebral body fusion devices. 1.4 Guidelines are established for measuring test block deformation and determining the subsidence of intervertebral body fusion devices. 1.5 Since some intervertebral body fusion devices require the use of additional implants for stabilization, the testing of these types of implants may not be in accordance with the manufacturer’s recommended usage. 1.6 Units—The values stated in SI units are to be regarded as the standard with the exception of angular measurements, which may be reported in terms of either degrees or radians. 1.7 The use of this standard may involve the operation of potentially hazardous equipment. 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. 1.8 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 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

This document specifies requirements for disposable extracorporeal blood and fluid circuits and accessories used in combination with haemodialysis equipment intended for extracorporeal blood treatment therapies such as, but not limited to, haemodialysis, haemodiafiltration, haemofiltration. This document does not apply to: — haemodialysers, haemodiafilters or haemofilters; — plasmafilters; — haemoperfusion devices; — vascular access devices. NOTE 1 Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in NOTE 2 Requirements for plasmafilters are specified in ISO 8637-3.

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)