11.040.40 外科植入物、假体和矫形 标准查询与下载

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 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)

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

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)

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

MZ/T 195-2023 糖尿病足鞋垫配置服务

Diabetic foot insole configuration service

ASTM F641-09(2023) 可植入环氧电子密封剂标准规范

1.1 This specification covers thermoset plastics based on diglycidyl ethers of bisphenol A and amino functional curing agents or amine catalysts. 1.2 The epoxy encapsulants covered by this specification are intended to provide a tissue-compatible protective covering for implantable medical devices such as pulse generators, telemetry devices, and RF receivers. The biocompatibility of epoxy plastics has not been established. Epoxy plastic is a generic term relating to the class of polymers formed from epoxy resins, certain curing agents or catalysts, and various additives. Since many compositions and formulations fall under this category, it is essential that the fabricator ensure safety of implantability of the specific composition or formulation for the intended use by current state-of-the-art test methods. This specification can be used as a basis for standardized evaluation of biocompatibility for such implantable encapsulants. 1.3 The encapsulants covered by this specification are for use in devices intended as long-term implants. 1.4 Limitations—This specification covers only the initial qualification of epoxy encapsulants for implantable electronic circuitry. Some of the requirements are not applicable to routine lot-to-lot quality control. 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 Implantable Epoxy Electronic Encapsulants

KS P ISO 5832-5-2022 外科植入物.金属材料.第5部分:锻造钴铬钨镍

Implants for surgery — Metallic materials — Part 5: Wrought cobalt-chromium-tungsten-nickel

KS P ISO 13175-3-2022 外科植入物.磷酸钙.第3部分:羟基磷灰石和β-磷酸三钙骨替代品

Implants for surgery — Calcium phosphates — Part 3: Hydroxyapatite and beta-tricalcium phosphate bone substitutes

KS P ISO 5834-2-2022 外科植入物.超高分子量聚乙烯.第2部分:成型

Implants for surgery — Ultra-high molecular weight polyethylene — Part 2: Moulded forms

KS P ISO 8637-2-2022 血液净化用体外系统.第2部分:血液透析器、血液透析过滤器和血液过滤器用体外血液回路

Extracorporeal systems for blood purification — Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters

KS P ISO 5832-6-2022 外科植入物.金属材料.第6部分:锻造钴镍铬钼合金

Implants for surgery — Metallic materials — Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy

KS P ISO 5832-9-2022 外科植入物.金属材料.第9部分:锻造高氮不锈钢

Implants for surgery — Metallic materials — Part 9: Wrought high nitrogen stainless steel

KS P ISO 5834-5-2022 外科植入物.超高分子量聚乙烯.第5部分:形态评估方法

Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 5: Morphology assessment method

KS P ISO 14708-5-2022 外科植入物.有源植入式医疗装置.第5部分:循环支持装置

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

KS P ISO 5834-4-2022 外科植入物.超高分子量聚乙烯.第4部分:氧化指数测量方法

Implants for surgery — Ultra-high molecular weight polyethylene — Part 4: Oxidation index measurement method

KS P ISO 21535-2022 非活性外科植入物.关节置换植入物.髋关节置换植入件的特殊要求

Non-active surgical implants — Joint replacement implants — Specific requirements for hip-joint replacement implants

KS P ISO 8637-3-2022 血液净化用体外系统第3部分:血浆过滤器

Extracorporeal systems for blood purification Part 3: Plasmafilters