11.040.40 外科植入物、假体和矫形 标准查询与下载

ASTM F1088-23 植入式医疗器械用医用级β-磷酸三钙原料的标准规范

1.1 This specification covers chemical and crystallographic requirements for beta-tricalcium phosphate (β-TCP) raw materials intended for use in medical device applications. For a material to be identified as medical-grade beta-tricalcium phosphate, it must conform to this specification (see Appendix X1). 1.2 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 Medical-Grade Beta-Tricalcium Phosphate Raw Material for Implantable Medical Devices

ASTM F1185-23 外科植入物用医用级羟基磷灰石成分的标准规范

1.1 This specification covers chemical and crystallographic requirements for hydroxylapatite intended for surgical implants. For a material to be called medical-grade hydroxylapatite, it must conform to this specification. (See Appendix X1.) 1.2 The biological response to hydroxylapatite in soft tissue and bone has been characterized by a history of clinical use (1-3)2 and by laboratory studies (4-6). 1.3 This specification includes powder, particulate, and forms intended for use as surgical implants, components of surgical implants, or as raw materials for manufacturing processes such as thermal spray coating, electrophoretic deposition, physical vapor deposition, and so forth. 1.4 This specification specifically excludes hydroxylapatite coatings, amorphous calcium phosphate, ceramic-glasses, tribasic calcium phosphate, whitlockite, and alphaand betatricalcium phosphate (see Specification F1088). 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.6 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. 1.7 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 Composition of Medical-Grade Hydroxylapatite for Surgical Implants

ASTM F1295-23 外科植入物用锻造钛-6铝-7铌合金的标准规范（UNS R56700）

1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought annealed, cold-worked, or hot-worked titanium-6aluminum-7niobium alloy bar, wire, sheet, strip, and plate to be used in the manufacture of surgical implants (1-7).2 1.2 The SI units in this standard are the primary units. The values stated in either primary SI units or secondary inchpound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in nonconformance with the standard. 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-6Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700)

ASTM F1904-23 体内对医疗器械颗粒碎片和降解产物的生物反应测试标准指南

1.1 The purpose of this standard guide is to describe the principles and approaches to testing of medical device debris and degradation products from device materials (for example, particles from wear) for their potential to activate a cascade of biological responses at local and systemic levels in the body. In order to ascertain the role of device debris and degradation products in stimulating such responses, the nature of the responses and the consequences of the responses should be evaluated. This is an emerging area. The continuously updated information gained from the testing results and related published literature is necessary to improve the study designs, as well as predictive value and interpretation of the test results regarding debris/degradation product related responses. Some of the procedures listed here may, on further testing, not prove to be predictive of clinical responses to device-related debris and degradation products. However, only the continuing use of standard protocols will establish the most useful testing approaches with reliable study endpoints and measurement techniques. Since there are many possible and established ways of determining the debris/degradation product related responses in vivo, a single standard protocol is not stated. However, this recommended guide indicates which testing approaches are most applicable per expected biological responses and which necessary information should be supplied with the test results. To address the general role of chronic inflammation in exaggerating device-related foreign body response (FBR), the recommendations in this standard include the assessment of device-related pro-inflammatory responses and subsequent tissue remodeling potential. 1.2 This document is to provide the users with updated scientific knowledge that may help better characterize medical device debris related responses. It is to help the users to optimize their plans for particle characterization and biocompatibility assessment by considering the testing principles and methods available in published literature that are appropriate to their products. 1.3 This standard is not sufficient to address device-related degradation products that result in gas formation or that are exclusively represented by nanoparticles, or soluble species such as dissolved metal ions. 1.4 While devices should be designed and manufactured in such a way as to reduce as far as possible the risks posed by substances or particles (including wear debris, degradation products, and processing residues) that may be released from the device, this standard guide may help users to identify the presence of wear debris and degradation products and subsequent adverse reactions that may occur. 1.5 Although this guide is based on the available device debris-related knowledge that is largely based on orthopedic devices, most of the recommendations are also applicable to other (non-orthopedic) device areas. 1.6 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. 1.7 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 Guide for Testing the Biological Responses to Medical Device Particulate Debris and Degradation Products in vivo

ASTM F90-23 外科植入物用锻造钴-20铬-15钨-10镍合金的标准规范（UNS R30605）

1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought cobalt-20chromium15tungsten-10nickel alloy used for surgical implants. The properties specified apply specifically to wrought bar, rod, wire, sheet, and strip, but do not apply to surgical fixation wire (see Specification F1091). 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 may not be exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of the 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 Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605)

ASTM F1983-23 植入物用可吸收生物材料的选定组织效应评估的标准实施规程

1.1 This practice provides experimental protocols for biological assays of tissue reactions to absorbable biomaterials for implant applications. This practice applies only to absorbable materials with projected clinical applications in which the materials will reside in bone or soft tissue longer than 30 days and less than three years. Other standards with designated implantation times are available to address shorter time periods. Careful consideration should be given to the appropriateness of this practice for slowly degrading materials that will remain for longer than three years. It is anticipated that the tissue response to degrading biomaterials will be different from the response to nonabsorbable materials. In many cases, a chronic inflammatory response may be observed during the degradation phase, but the local histology should return to normal after absorption; therefore, the minimal tissue response usually equated with biocompatibility may require long implantations. 1.2 The time period for implant absorption can depend on variables of chemical composition, implant size, implant location, and animal models. Therefore, the selected time points for assessing tissue effects may be selected based on the rate of absorption. 1.3 These protocols assess the effects of the material on the animal tissue in which it is implanted. They do not fully assess systemic toxicity, carcinogenicity, reproductive and development toxicity, or mutagenicity of the material. Other standards are available to address these issues. 1.4 To maximize use of the animals in the study protocol, some aspects of systemic toxicity, including effects of degradation products on different organs and tissues downstream of or surrounding the target site, can be addressed with this practice. 1.5 Because animal models are not identical to human biology, this practice cannot account for all potential biological hazards, for example the effect of the oligosaccharide a-Gal (Gala 1,3-Galb1-4GlcNAc-R), known as the “a-Gal” epitope present in xenogeneic materials on humans. See ISO 22442. 1.6 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. 1.7 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 Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications

BS ISO 29782:2022 假肢和矫形器 为下肢截肢者指定假肢时应考虑的因素

1   Scope This document lists factors to be considered when specifying a prosthesis for a person who has had a lower limb amputation.

Prostheses and orthoses. Factors to be considered when specifying a prosthesis for a person who has had a lower limb amputation

YY/T 1874-2023 有源植入式医疗器械 电磁兼容 植入式心脏起搏器、植入式心律转复除颤器和心脏再同步器械的电磁兼容测试细则

本文件规定了用于评价可与经静脉电极导线系统一起提供一种或多种心动过缓、心动过速和心脏再同步等治疗的有源植入式心血管器械的电磁兼容（EMC）试验方法。本文件规定了此类器械与可运行于下列两个EM频谱范围内的EM发射器发生相互作用时的性能界限：0 Hz ≤ f ＜ 385 MHz；385 MHz ≤ f ≤ 3000 MHz。本文件还规定了保护此类器械免受医疗环境EM场影响的要求，定义了所需的随附文件，并提供了关于EM发射器制造商与预期的抗扰度等级信息。本文件适用于可与经静脉电极导线系统一起提供一种或多种心动过缓、心动过速和心脏再同步等治疗的有源植入式心血管器械。

Electromagnetic compatibility of active implantable medical devices Electromagnetic compatibility test rules for implantable pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices

ASTM F1829-23 剪切中解剖型骨关节锁定机构静态评估的标准试验方法

1.1 This test method covers a method for determining the static shear disassembly force of modular anatomic glenoid components used in anatomic total shoulder arthroplasty prostheses. 1.2 Although the methodology described does not replicate all physiological force conditions, it is a means of in vitro comparison of modular anatomic glenoid component designs and the strength of the retention mechanism between the articular insert and glenoid backing under the stated test conditions. 1.3 This test method covers modular glenoid components comprised of a separate articular insert and backing. The insert and backing can be fabricated from any combination of the following materials: metal alloys, polymeric materials, composite materials. 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 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 Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear

23/30445218 DC BS EN ISO 5832-1 用于手术的植入物 金属材料 第 1 部分：锻造不锈钢

BS EN ISO 5832-1. Implants for surgery. Metallic materials - Part 1. Wrought stainless steel

23/30444753 DC BS ISO 5832-4 用于手术的植入物 金属材料 第4部分：钴铬钼铸造合金

BS ISO 5832-4. Implants for surgery. Metallic materials - Part 4. Cobalt-chromium-molybdenum casting alloy

23/30444756 DC BS ISO 5832-11 用于手术的植入物 金属材料第11部分：锻制钛6-铝合金7-铌合金

BS ISO 5832-11. Implants for surgery. Metallic materials - Part 11. Wrought titanium 6-aluminium 7-niobium alloy

23/30445222 DC BS EN ISO 5832-7 用于手术的植入物 金属材料 第 7 部分：可锻造和冷成型钴铬镍钼铁合金

BS EN ISO 5832-7. Implants for surgery. Metallic materials - Part 7. Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy

ASTM F1357-23 关节式全腕关节植入物标准规范

1.1 This specification describes total wrist implants used to provide functioning articulation by employing radial and carpal components. 1.2 This specification excludes those implants with ceramiccoated or porous-coated surfaces, one-piece elastomeric implants (with or without grommets), and those devices used for custom applications. 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.4 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. 1.5 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 Articulating Total Wrist Implants

ASTM F2885-17(2023) 外科植入物用金属注射成型的钛-6铝-4钒部件的标准规范

1.1 This specification covers chemical, mechanical, and metallurgical requirements for two types of metal injection molded (MIM) titanium-6aluminum-4vanadium components to be used in the manufacture of surgical implants. 1.2 The Type 1 MIM components covered by this specification may have been densified beyond their as-sintered density by post sinter processing. 1.3 Units—The values in either inch-pound or SI are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independent of the other. Combining values from the two systems may result in nonconformance with the specification. 1.4 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. 1.5 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 Metal Injection Molded Titanium-6Aluminum-4Vanadium Components for Surgical Implant Applications

ASTM F1472-23 外科植入物用锻造钛-6铝-4钒合金标准规范（UNS R56400）

1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought annealed titanium6aluminum-4vanadium alloy (UNS R56400) to be used in the manufacture of surgical implants. 1.2 Units—The values stated in either SI units or inchpound 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 the other, and values from the two systems shall not be combined. 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 Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)

YY/T 1867-2023 运动医学植入器械 带线锚钉

本文件规定了运动医学植入器械带线锚钉（以下简称带线锚钉）的性能要求，给出了相应的试验方法，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。本文件适用于供运动医学手术中软组织和骨连接固定用的带线锚钉的测试评价。本文件也适用于非预置缝线的锚钉和全缝线锚钉的测试评价。

Sports medicine implant device with wire anchor

YY 0054-2023 血液透析设备

本文件规定了血液透析设备的分类、要求，描述了试验方法。本文件适用于自动配液的血液透析设备。本文件不适用于血液透析用水处理设备，腹膜透析设备，血液灌流、血浆置换、血浆吸附设备，连续性血液净化设备，中央供液系统，透析液可再生的血液透析设备。

hemodialysis equipment

YY/T 0730-2023 心血管外科植入物和人工器官 心肺旁路和体外膜肺氧合（ECMO）使用的一次性使用管道套包的要求

本文件规定了心肺旁路和体外膜肺氧合（ECMO）使用的一次性使用管道套包的要求。本文件适用于所有预期用于心肺旁路（CPB）以及/或者体外膜肺氧合（ECMO）的医用管道，但在CPB手术（短期，即6h以下）或ECMO(长期，即24h以上）期间预期与血泵一起使用的管道，有特定要求和测试方法。本文件中有关无菌及无热原的条款适用于标有“无菌”字样的管道套包。本文件仅适用于多功能系统的管道，该多功能系统可具备完整的部件，如血气交换器（氧合器）、贮血器、血液微栓过滤器、祛沫剂、血泵等。

Requirements for single-use tubing kits for cardiovascular surgical implants and artificial organs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)

MZ/T 195-2023 糖尿病足鞋垫配置服务

Diabetic foot insole configuration service