11.040.40 外科植入物、假体和矫形 标准查询与下载

YY/T 0489-2023 一次性使用无菌引流导管及辅助器械

本文件规定了一次性使用无菌的引流导管、伤口和积液引流系统、手术引流导管和有关组件的要求，其中导管以手术或经皮方式放置于体腔或伤口中，用于将液体或空气引流到体外。引流导管留作自然引流或连接至吸引源（以加快组织肉芽形成）。本文件不适用于：抽吸导管；气管导管；导尿管；输尿管支架、胆道支架和其他支架；采用胃造口术经皮置入消化道的引流管；用于去除脑脊液的轴索导管；用于从胃肠道中去除溶液或物质的肠导管；涂层。

Disposable sterile drainage catheters and auxiliary devices

YY 0793.2-2023 血液透析和相关治疗用液体的制备和质量管理 第2部分：血液透析和相关治疗用水

本文件规定了制备透析浓缩液、透析用液体（用于血液透析、血液透析滤过或血液滤过）所用水的最低要求。本文件适用于制备透析浓缩液、透析用液体（用于血液透析、血液透析滤过或血液滤过）所用水。本文件不涉及水处理设备的使用，及水经处理后与浓缩物混合制成最终透析液的操作。这些操作由透析专业人员负责。本文件不适用于透析液再生系统。

Preparation and quality management of fluids for hemodialysis and related treatments Part 2: Water for hemodialysis and related treatments

T/GDMRS 001-2023 外科植入物 全髋关节假体 增材制造钛合金股骨柄假体

本文件规定了外科植入物 全髋关节假体 增材制造钛合金股骨柄假体的术语和定义、预期性能、设计属性、技术要求、试验方法、检验规则、制造、清洗、包装、灭菌、制造商提供的信息等。技术要求对增材制造钛合金股骨柄假体的材料、外观、尺寸与公差、致密度、拉伸性能、疲劳性能、多孔结构、生物相容性进行了规范。

Implant for surgery—Total hip joint prostheses—Additive manufacturing titanium alloy femoral stems

ASTM F3140-23 单髁膝关节置换物金属胫骨托组件循环疲劳测试的标准测试方法

1.1  This test method covers a procedure for the fatigue testing of metallic tibial trays used in partial knee joint replacements. 1.2  This test method covers the procedures for the performance of fatigue tests on metallic tibial components using a cyclic, constant-amplitude force. It applies to tibial trays which cover either the medial or the lateral plateau of the tibia. 1.3  This test method may require modifications to accommodate other tibial tray designs. 1.4  This test method is intended to provide useful, consistent, and reproducible information about the fatigue performance of metallic tibial trays with unsupported mid-section of the condyle. 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 Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements

YY/T 1920-2023 透析器血液相容性试验

本文件规定了透析器血液相容性的试验方法。本文件适用于以中空纤维膜为主体的血液透析器、血液滤过器、血液浓缩器等医疗器械的血液相容性试验。

Dialyzer hemocompatibility test

ASTM F2777-23 评估高屈曲下膝关节轴承（胫骨插入物）耐力和变形的标准测试方法

Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under High Flexion

ASTM F2886-17(2023) 外科植入物用金属注射成型钴-28铬-6钼部件的标准规范

Standard Specification for Metal Injection Molded Cobalt-28Chromium-6Molybdenum Components for Surgical Implant Applications

ASTM F981-23 医疗器械用长期植入材料对肌肉和骨组织反应评估的标准实施规程

Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices

ASTM F601-23 金属外科植入物的荧光渗透检验的标准实施规程

Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants

BS ISO 18242:2016+A1:2023 心血管植入物和体外系统 离心血泵

Cardiovascular implants and extracorporeal systems. Centrifugal blood pumps

BS ISO 22926:2023 用于手术的植入物 用于测试的合成解剖骨模型的规范和验证

Implants for surgery. Specification and verification of synthetic anatomical bone models for testing

ISO 18242:2016/Amd 1:2023 心血管植入物和体外系统离心式血泵修改件1:最坏试验条件

Cardiovascular implants and extracorporeal systems — Centrifugal blood pumps — Amendment 1: Worst-case conditions for testing

23/30456227 DC BS EN ISO 14607 非活性手术植入物 乳房植入物 具体要求

BS EN ISO 14607 Non-active surgical implants. Mammary implants. Specific requirements

23/30440702 DC BS EN ISO 7199 心血管植入物和人造器官 血气交换器（氧合器）

BS EN ISO 7199. Cardiovascular implants and artificial organs. Blood-gas exchangers (oxygenators)

ASTM F1609-23 植入式材料用磷酸钙涂层的标准规范

1.1 This specification covers the material requirements for calcium phosphate coatings for surgical implant applications. 1.2 In particulate and monolithic form, the calcium phosphate materials system has been well characterized regarding biological response (1, 2)2 and laboratory characterization (2-4). Several publications (5-10) have documented the in vitro and in vivo properties of selected calcium phosphate coating systems. 1.3 This specification covers hydroxylapatite coatings, other calcium phosphate (for example, octacalcium calcium phosphate, amorphous calcium phosphate, dicalcium phosphate dihydrate) coatings, or a coating containing a combination of two or more calcium phosphate phases, with or without intentional minor additions of other elements or compounds (for example, fluorine, manganese, magnesium, carbonate),3 and applied by methods including, but not limited to, the following: (1) plasma spray deposition, (2) solution precipitation, (3) dipping/sintering, (4) electrophoretic deposition, and (5) sputtering. 1.4 For a coating containing two or more calcium phosphate phases, one or more of which will be a major phase or major phases in the coating, while the other phase(s) may occur as a second or minor phases, the phase composition(s) of the coating should be determined against each corresponding crystalline phase, respectively. See X1.2. 1.5 Substrates may include smooth, porous, textured, and other implantable topographical forms. 1.6 This specification excludes organic coatings that may contain calcium and phosphate ionic species. 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 Calcium Phosphate Coatings for Implantable Materials

ISO 22926:2023 手术植入物 用于测试的合成解剖骨模型的规范和验证

Implants for surgery — Specification and verification of synthetic anatomical bone models for testing

ASTM F3047M-23 高要求髋关节模拟器硬对硬关节磨损测试标准指南

1.1 The objective of this guide is to advise researchers on the possible high demand wear test features that should be included in evaluation of hard-on-hard articulations. This guide makes suggestions for high demand test features that may need to be added to an overall wear test regime. Device articulating components manufactured from other metallic alloys, ceramics, or with coated or elementally modified surfaces without significant clinical use could possibly be evaluated with this guide. However, such materials may include risks and failure mechanisms that are not addressed in this guide. 1.2 Hard-on-hard hip bearing systems include metal-onmetal (for example, Specifications F75, F799, and F1537; ISO 5832-4, ISO 5832-12), ceramic-on-ceramic (for example, ISO 6474-1, ISO 6474-2, ISO 13356), ceramic-on-metal, or any other bearing systems where both the head and cup components have high surface hardness. An argument has been made that the hard-on-hard THR articulation may be better for younger, more active patients. These younger patients may be more physically fit and expect to be able to perform more energetic activities. Consequently, new designs of hard-onhard THR articulations may have some implantations subjected to more demanding and longer wear performance requirements. 1.3 Total Hip Replacement (THR) with metal-on-metal articulations have been used clinically for more than 50 years (1, 2).2 Early designs had mixed clinical results. Eventually they were eclipsed by THR systems using metal-onpolyethylene articulations. In the 1990s the metal-on-metal articulation again became popular with more modern designs (3), including surface replacement. 1.4 In the 1970s the first ceramic-on-ceramic THR articulations were used. In general, the early results were not satisfactory (4, 5). Improvement in alumina, and new designs in the 1990s improved the results for ceramic-on-ceramic articulations (6). 1.5 The values stated in SI units are to be regarded as the 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 Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations

ASTM F3141-23 全膝关节置换负荷曲线标准指南

1.1 Motion path, load history, and loading modalities all contribute to the wear, degradation, and damage of implanted prosthetics. Simulating a variety of functional activities promises more realistic testing for wear and damage mode evaluation. Such activities are often called activities of daily living (ADLs). ADLs identified in the literature include walking, stair ascent and descent, sit-to-stand, stand-to-sit, squatting, kneeling, cross-legged sitting, into bath, out of bath, turning, and cutting motions (1-7).2 Activities other than walking gait often involve an extended range of motion and higher imposed loading conditions, which have the ability to cause damage and modes of failure other than normal wear (8-10). 1.2 This document provides guidance for functional simulation that could be used to evaluate in vitro the durability of knee prosthetic devices under force control. 1.3 Function simulation is defined as the reproduction of loads and motions that might be encountered in activities of daily living, but it does not necessarily cover every possible type of loading. Functional simulation differs from typical wear testing in that it attempts to exercise the prosthetic device through a variety of loading and motion conditions such as might be encountered in situ in the human body in order to reveal various damage modes and damage mechanisms that might be encountered throughout the life of the prosthetic device. 1.4 Force control is defined as the mode of control of the test machine that accepts a force level as the set point input and which utilizes a force feedback signal in a control loop to achieve that set point input. For knee simulation, the flexion motion is placed under angular displacement control, internal and external rotation is placed under torque control, and axial load, anterior-posterior shear, and medial-lateral shear are placed under force control. 1.5 This document establishes kinetic and kinematic test conditions for several activities of daily living, including walking, turning navigational movements, stair climbing, stair descent, and squatting. The kinetic and kinematic test conditions are expressed as reference waveforms used to drive the relevant simulator machine actuators. These waveforms represent motion, as in the case of flexion extension, or kinetic signals representing the forces and moments resulting from body dynamics, gravitation, and the active musculature acting across the knee. 1.6 This document does not address the assessment or measurement of damage modes, or wear or failure of the prosthetic device. 1.7 This document is a guide. As defined by ASTM in their “Form and Style for ASTM Standards” book in section C15.2, “A standard guide is a compendium of information or series of options that does not recommend a specific course of action. Guides are intended to increase the awareness of information and approaches in a given subject area. Guides may propose a series of options or instructions that offer direction without recommending a definite course of action. The purpose of this type of standard is to offer guidance based on a consensus of viewpoints but not to establish a standard practice to follow in all cases.” The intent of this guide is to provide loading profiles and test procedures to develop testing that might be used for wear, durability, or other types of testing of total knee replacements. As noted in this definition, a guide provides guidance on testing, but does not require specific testing. Thus, for example, if a user is unable to control one mode of force control given in the load profiles, that user is not required to perform that mode of loading. 1.8 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. 1.9 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. 1 This guide is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.22 on Arthroplasty. Current edition approved June 1, 2023. Published June 2023. Originally approved in 2015. Last previous edition approved in 2017 as F3141 – 17a. DOI: 10.1520/F3141-23. 2 The boldface numbers in parentheses refer to the list of references at the end of this standard. Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States 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. 1 2. Reference Frame System (see Fig. 1)

Standard Guide for Total Knee Replacement Loading Profiles

ASTM F543-23 金属医用接骨螺钉的标准规范和测试方法

1.1 This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. The dimensions and tolerances in this specification are applicable only to metallic bone screws described in this specification. 1.2 This specification provides performance considerations and standard test methods for measuring mechanical properties in torsion of metallic bone screws that are implanted into bone. These test methods may also be applicable to other screws besides those whose dimensions and tolerances are specified here. The following annexes are included: 1.2.1 Annex A1—Test Method for Determining the Torsional Properties of Metallic Bone Screws. 1.2.2 Annex A2—Test Method for Driving Torque of Medical Bone Screws. 1.2.3 Annex A3—Test Method for Determining the Axial Pullout Load of Medical Bone Screws. 1.2.4 Annex A4—Test Method for Determining the SelfTapping Performance of Self-Tapping Medical Bone Screws. 1.2.5 Annex A5—Specifications for Type HA and Type HB Metallic Bone Screws. 1.2.6 Annex A6—Specifications for Type HC and Type HD Metallic Bone Screws. 1.2.7 Annex A7—Specifications for Metallic Bone Screw Drive Connections. 1.3 This specification is based, in part, upon ISO 5835, ISO 6475, and ISO 9268. 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 Multiple test methods are included in this standard. However, the user is not necessarily obligated to test using all of the described methods. Instead, the user should only select, with justification, test methods that are appropriate for a particular device design. This may only be a subset of the herein described test methods. 1.6 This standard may involve the use of hazardous materials, operations, and 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. 1.7 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 and Test Methods for Metallic Medical Bone Screws

ISO 21536:2023 非主动外科植入物 关节置换植入物 膝关节置换植入物的特殊要求

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