C45 体外循环、人工脏器、假体装置 标准查询与下载

DIN EN ISO 21535:2017 非活性外科植入物.关节替代植入物.髋关节替代用植入物特殊要求(ISO 21535-2007+Amd 1-2016);德文版本EN ISO 21535-2009+A1-2016

Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:2007 + Amd 1:2016); German version EN ISO 21535:2009 + A1:2016

BS EN ISO 7198:2017 心血管植入物和体外系统. 血管内假体. 管状血管移植和血管补片

Cardiovascular implants and extracorporeal systems. Vascular prostheses. Tubular vascular grafts and vascular patches

BS EN ISO 25539-1:2017 心血管植入物.血管内设备.血管内假体

Cardiovascular implants. Endovascular devices. Endovascular prostheses

YY/T 1562-2017 组织工程医疗器械产品生物材料支架细胞活性试验指南

Guidelines for Cell Activity Testing of Biomaterial Scaffolds for Tissue Engineering Medical Device Products

YY/T 1561-2017 组织工程医疗器械产品动物源性支架材料残留α-Gal抗原检测

Detection of residual α-Gal antigen in animal-derived scaffold materials of tissue engineering medical device products

DIN EN ISO 9999:2017 残疾人用辅助产品.分类及专业术语(ISO 9999-2016);德文版本EN ISO 9999-2016

Assistive products for persons with disability - Classification and terminology (ISO 9999:2016); German version EN ISO 9999:2016

DIN EN ISO 5832-3:2017 外科植入物.金属材料.第3部分:6-铝4-钒合金变形钛(ISO 5832-3-2016);德文版本EN ISO 5832-3-2016

Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy (ISO 5832-3:2016); German version EN ISO 5832-3:2016

EN ISO 25539-1:2017 心血管植入物.血管内器械.第1部分:血管内假体

Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses

ISO 25539-1:2017 心血管植入物. 血管内器械. 第1部分: 血管内假体

This document specifies requirements for the evaluation of endovascular systems (prostheses and delivery systems) and requirements with respect to nomenclature, design attributes and information supplied by the manufacturer based upon current medical knowledge. Guidance for the development of in vitro test methods is included in an informative annex to this document. This document can be considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants. This document is applicable to endovascular systems used to treat aneurysms, stenoses or other vascular anomalies or pathologies (e.g. dissections, transections) or to create shunts between vessels [e.g. creation of transjugular intrahepatic portosystemic shunting (TIPS)]. Some of the requirements are specific to endovascular treatment of arterial aneurysms or stenoses. Although uses of endovascular systems other than treatment of arterial aneurysms or stenoses (e.g. dissections, transections, shunts) are within the scope of this document, the specific requirements and testing are not described. Similarly, specific prosthesis configurations (e.g. fenestrated, branched) are within the scope, but specific requirements and testing are not described for these devices. This document is not applicable to vascular occluders, with the exception of contra-lateral iliac artery occluders when used as an integral part of aorto-uni-iliac endovascular prosthesis. Although contra- lateral iliac artery occluders when used as an integral part of aorto-uni-iliac endovascular prosthesis are within the scope of this document, specific requirements and testing are not described for these devices. Balloons used to achieve adequate apposition of the prosthesis with the vessel wall or overlapping components are within the scope of this document, even if they are not integral to the endovascular system. This document provides requirements beyond the requirements of ISO 10555-4, specific to the use of balloons with endovascular prostheses. This document is not applicable to procedures and devices used prior to the introduction of the endovascular system, such as balloon angioplasty devices. The valve component of valved conduits constructed with an endovascular prosthesis component and the combination of the valved component and the endovascular prosthesis component are excluded from the scope of this document. This document can be helpful in identifying the appropriate evaluation of the endovascular prosthesis component of a valved conduit, but specific requirements and testing are not described for these devices. NOTE 1 Cardiac valved conduits are within the scope of ISO 5840-1. Pharmacological aspects of drug eluting or drug coated endovascular prostheses are not addressed in this document. NOTE 2 Vascular device-drug combination products are within the scope of ISO 12417. This document does not address the requirements for, and the evaluation of, viable tissues and non- viable biologic materials used in the construction of endovascular prostheses.  The requirements for, and the evaluation of, degradation and other time-dependant aspects of absorbable materials used in the construction of endovascular prostheses are not addressed in this document. NOTE 3 Absorbable materials are within the scope of ISO/TS 17137 and ISO/TR 37137.

Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses

BS EN ISO 7199:2017 心血管植入物和人造器官.血液-气体交换器(氧合器)

Cardiovascular implants and artificial organs. Blood-gas exchangers (oxygenators)

ETSI EN 302 510-2017 短程设备(SRD);超低功耗有源医用膜植入物(ULP-AMI-M)和外围设备(ULP-AMI-M-P),工作频率范围为30 MHz至37.5 MHz;涵盖2014/53/EU欧盟指令第3.2条的基本要求(V2.1.1)

Short Range Devices (SRD); Ultra Low Power Active Medical Membrane Implants (ULP-AMI-M) and Peripherals (ULP-AMI-M-P) operating in the frequency range 30 MHz to 37@5 MHz; Harmonised Standard covering the essential requirements of article 3.2 of the Direct

ASTM F3141-17a 全膝关节置换载荷情况的标准指南

4.1 The purpose of this test guide is to provide load profile information on how one could test a total knee replacement in order to evaluate in vitro its function and wear during several types of knee motions as described in 4.2 and 4.3. 4.2 This test guide may help characterize the magnitude and location of implant wear as an implant is repetitively moved according to specified load and displacement waveforms. 4.3 This test guide may also help characterize the functional limitations of a total knee replacement as its motion is guided by these waveforms. These limitations may be observed as impingement, subluxation or high loading in the soft tissue constraints, whether they are represented physically or virtually. 4.4 The motions and load conditions in vivo will, in general, differ from the load and motions defined in this guide. The results obtained from this guide cannot be used to directly predict in vivo performance. However, this guide is designed to allow for comparisons in performance of different knee designs, when tested under similar conditions. 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 decent, 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......

Standard Guide for Total Knee Replacement Loading Profiles

ASTM F3140-17 单髁膝关节置换金属胫骨托盘部件循环疲劳试验的标准试验方法

4.1 This test method can be used to describe the effects of materials, manufacturing, and design variables on the fatigue performance of metallic tibial trays subject to cyclic loading for relatively large numbers of cycles. 4.2 The loading of tibial tray designs in vivo will, in general, differ from the loading defined in this practice. The results obtained here cannot be used to directly predict in vivo performance. However, this practice is designed to allow for comparisons between the fatigue performance of different metallic tibial tray designs, when tested under similar conditions. 4.3 In order for fatigue data on tibial trays to be comparable, reproducible, and capable of being correlated among laboratories, it is essential that uniform procedures be established. 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

ASTM F2847-17 一次性使用植入物残留物和一次性无菌器械报告和评估的标准实施规程

5.1 The quality and consequently the clinical performance of implants may be affected by residues. Residues may induce no tissue response, minor tissue irritations, or they may lead to local inflammation of tissues surrounding the implant which may lead to failure in short-term or long-term use. Residues may also cause harm at locations away from the implant. Residues may originate from manufacturing materials used in the course of processing or from the manufacturing environment, or may be the result of handling and packaging (1-3).10 5.2 This practice shall be used to report the results of testing for residue. All residues cannot necessarily be detected. It suggests standard techniques that may be applied for analysis, and provides suggestions for how limit values may be set. 5.3 Residues may be of inorganic, organic, or biological nature. They may exhibit as surface-bound substance, or as adsorbates (for example, electrostatically held), efflorescence, or mechanically held substances. Residues may be soluble in aqueous media, soluble in organic solvents, or may be insoluble particulates. 5.4 Data generated in validation processes (that is, cleaning validation or sterility validation) may be used as results or as basis for setting acceptance criteria in the report. 1.1 The purpose of this practice is to describe how the cleanliness of single-use implants as manufactured shall be reported. This practice proposes how to approach the identification of critical compounds and suggests different analytical methods. 1.2 The practice does not address substances which are intrinsic to the implant properties or design. In particular, it does not address substances released during implant resorption, implant coatings, or leachables by design. 1.3 This practice does not address the cleanliness of implants which are re-processed, re-cleaned after unpacking for re-use in the hospital or by the manufacturer. 1.4 This practice does not establish limit values for residues. 1.5 This practice suggests appropriate test methods for the general specification of residues and residue requirements of implants and single-use sterile instruments. This practice may also be used to characterize semi-finished components for implants. 1.6 The test methods suggested and described herein refer to established analytical methods and to existing standard methods for chemical, biochemical, or biological analysis. 1.7 This practice is intended solely to provide guidance regarding suitable test methods and reporting conventions for residues, which may or may not affect implant biocompatibility. This practice does ......

Standard Practice for Reporting and Assessment of Residues on Single-Use Implants and Single-Use Sterile Instruments

ASTM F2886-17 外科植入物用金属注射成形用钴-28铬-6钼成分的标准规格

1.1 This specification covers chemical, mechanical, and metallurgical requirements for metal injection molded (MIM) cobalt-28chromium-6molybdenum components to be used in the manufacture of surgical implants 1.2 The MIM components covered by this specification may have been densified beyond their as-sintered density by post-sinter processing. 1.3 Units—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, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard. 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 Metal Injection Molded Cobalt-28Chromium-6Molybdenum Components for Surgical Implant Applications

ASTM F2885-17 外科植入物用金属注射成形用钛-6铝-4钒成分的标准规格

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 non-conformance 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

DIN EN ISO 10328:2016 修复术.假下肢的结构试验.要求和试验方法(ISO 10328-2016).德文版本EN ISO 10328-2016

Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO 10328:2016); German version EN ISO 10328:2016

DIN EN ISO 22675:2016 假肢.脚踝装置和脚部件试验.要求和试验法(ISO 22675-2016).德文版本EN ISO 22675-2016

Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2016); German version EN ISO 22675:2016

BS EN ISO 5832-3:2016 外科植入物.金属材料.6-铝4-钒精细钛合金

Implants for surgery. Metallic materials. Wrought titanium 6-aluminium 4-vanadium alloy

BS EN ISO 9999:2016 残疾人用辅助产品.分类和术语

Assistive products for persons with disability. Classification and terminology