11.040.40 外科植入物、假体和矫形 标准查询与下载

22/30449648 DC BS EN ISO 23500-2 血液透析和相关治疗用液体的制备和质量管理 第 2 部分：血液透析应用和相关治疗的水处理设备

BS EN ISO 23500-2. Preparation and quality management of fluids for haemodialysis and related therapies - Part 2. Water treatment equipment for haemodialysis applications and related therapies

22/30449644 DC BS EN ISO 23500-1 血液透析及相关治疗用液体的制备和质量管理 第 1 部分：一般要求

BS EN ISO 23500-1. Preparation and quality management of fluids for haemodialysis and related therapies - Part 1. General requirements

22/30449652 DC BS EN ISO 23500-3 血液透析及相关治疗用液体的制备和质量管理 第 3 部分：血液透析及相关治疗用水

BS EN ISO 23500-3. Preparation and quality management of fluids for haemodialysis and related therapies - Part 3. Water for haemodialysis and related therapies

22/30449721 DC BS EN ISO 23500-5 血液透析及相关治疗用液体的制备和质量管理第5部分：血液透析及相关治疗用透析液的质量

BS EN ISO 23500-5. Preparation and quality management of fluids for haemodialysis and related therapies - Part 5. Quality of dialysis fluid for haemodialysis and related therapies

ASTM F1295-22 外科植入物用锻造钛-6铝-7铌合金标准规范（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 F452-76(2022) 预制颅骨成形术板

1.1 This specification covers preformed cranioplasty plates which do not require further alteration for covering skull defects. This specification covers compositional and physical performance and packaging requirements, but does not cover toxicity nor biocompatibility of the materials. 1.2 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 Preformed Cranioplasty Plates

ASTM F1828-22 输尿管支架标准规范

1.1 This specification covers the referee test methods for evaluating the performance characteristics of a single-use ureteral stent with retaining means at both ends, during short-term use for drainage of urine from the kidney to the bladder. These stents are typically available in diameters of 3.7 Fr to 14.0 Fr, and lengths of 8 cm to 30 cm, and are made of silicone, polyurethane, and other polymers. They are provided non-sterile for sterilization and sterile for single use. 1.2 Exclusions—Long-term indwelling usage (over 30 days) is encountered with this product, but not commonly, and is therefore considered an exception to this specification. Similarly, the use of ureteral stents for non-ureteral applications such as nephrostomy and ileostomy is excluded from the scope of this specification. Non-sterile ureteral stents are also excluded due to the variability of hospital sterilization equipment and processes and the resulting effects on ureteral stent characteristics. 1.3 The following precautionary statement pertains only to the test method portion, Section 5, of this 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 Ureteral Stents

22/30429541 DC BS ISO 22926 手术植入物 用于测试的合成解剖骨模型的规范和验证

BS ISO 22926. Implants for surgery. Specification and verification of synthetic anatomical bone models for testing

YY/T 1855-2022 组合式陶瓷股骨头疲劳性能试验方法

本文件规定了组合式陶瓷股骨头轴向疲劳性能试验和偏轴疲劳性能试验方法。本文件适用于组合式陶瓷股骨头结构（例如：股骨头/股骨颈的锥形连接）疲劳性能的测定。

Test method for fatigue performance of combined ceramic femoral head

YY/T 1859-2022 动物源性心血管植入物抗钙化评价 大鼠皮下植入试验

本文件规定了大鼠皮下植入评价动物源性心血管植入物抗钙化性能的试验方法。本文件适用于动物源性心血管植入物的大鼠体内抗钙化性能评价试验。

Evaluation of anti-calcification of animal-derived cardiovascular implants by subcutaneous implantation test in rats

YY/T 1877-2022 体外循环器械中双酚基丙烷（BPA）残留量测定方法

本文件规定了以双酚基丙烷（BPA）为原料生产的材料所制造的体外循环器械中BPA残留量测定方法。本文件适用于以BPA为原料生产的材料所制造的体外循环器械。

Method for determination of bisphenolpropane (BPA) residues in extracorporeal circulation equipment

YY/T 0989.5-2022 手术植入物 有源植入式医疗器械 第5部分：循环支持器械

本文件规定了有源植入式循环支持器械的型式试验、动物实验研究及临床评价的基本要求。本文件适用于心室辅助装置包括左心辅助、右心辅助，全人工心脏，双心室辅助装置，经皮辅助装置，儿科辅助装置等有源植入式循环支持器械。本文件同样适用于有源植入式循环支持器械的部分非植入部件和附件。本文件不适用于生产过程中的常规检验。

Surgical implants Active implantable medical devices Part 5: Circulatory support devices

ASTM F703-18(2022) 植入式乳房假体

1.1 This specification covers the requirements for silicone gel-filled and saline-inflatable silicone gel-filled implantable breast prostheses intended for use in surgical reconstruction, augmentation, or replacement of the breast. 1.2 Limitations—This specification does not cover custom fabricated implantable breast prostheses. 1.3 Single-use saline-inflatable, smooth and textured silicone shell implantable breast prostheses are addressed in Specification F2051. 1.4 The values stated in SI units are to be regarded as the standard. The inch-pound units given in parentheses are for information only. 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 Specification for Implantable Breast Prostheses

ASTM F1875-98(2022) 模块化植入物界面微动腐蚀试验的标准实施规程:髋股骨头孔和锥度界面

1.1 This practice describes the testing, analytical, and characterization methods for evaluating the mechanical stability of the bore and cone interface of the head and stem junction of modular hip implants subjected to cyclic loading by measurements of fretting corrosion (1-5).2 Two test methods described are as follows: 1.1.1 Method I—The primary purpose of this method is to provide a uniform set of guidelines for long-term testing to determine the amount of damage by measurement of the production of corrosion products and particulate debris from fretting and fretting corrosion. Damage is also assessed by characterization of the damage to the bore and cone surfaces (4, 5). 1.1.2 Method II—This method provides for short-term electrochemical evaluation of the fretting corrosion of the modular interface. It is not the intent of this method to produce damage nor particulate debris but rather to provide a rapid method for qualitative assessment of design changes which do not include material changes (1-4). 1.2 This practice does not provide for judgment or prediction of in-vivo implant performance, but rather provides for a uniform set of guidelines for evaluating relative differences in performance between differing implant designs, constructs, or materials with performance defined in the context of the amount of fretting and fretting corrosion. Also, this practice should permit direct comparison of fretting corrosion data between independent research groups, and thus provide for building of a data base on modular implant performance. 1.3 This practice provides for comparative testing of manufactured hip femoral heads and stems and for coupon-type specimen testing where the male taper portion of the modular junction does not include the entire hip implant, with the taper portion of the coupon identical in design, manufacturing, and materials to the taper of the final hip implant (4, 5). 1.4 Method I of this practice permits simultaneous evaluation of the fatigue strength of a femoral hip stem (in accordance with Practice F1440) and the mechanical stability and debris generated by fretting and fretting corrosion of the modular interface. 1.5 The general concepts and methodologies described in this practice could be applied to the study of other modular interfaces in total joint prostheses. 1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.7 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 Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface

ASTM F2051-00(2022) 可植入的含盐乳房假体

1.1 This specification covers the requirements for singleuse, saline inflatable, smooth and textured silicone shell implantable breast prostheses intended for use in surgical reconstruction, augmentation, or replacement of the breast. 1.2 Limitations: 1.2.1 This specification does not cover custom fabricated implantable breast prostheses. 1.2.2 This specification does not cover gel/saline type implants, which are within the scope of Specification F703. 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 Implantable Saline-Filled Breast Prostheses

ASTM F881-94(2022) 硅弹性体面部植入物标准规范

1.1 This specification covers the requirements for silicone elastomer implants used in facial surgery (that is, chin, nasal, malar, and ear implants). 1.2 Limitations—This specification does not cover implants containing silicone gels or other gels or liquids. It does not necessarily cover any custom fabricated prosthesis manufactured to any other specification. 1.3 The following safety hazards caveat pertains only to the mechanical testing and test methods portion, Section 7, of this specification: 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 Silicone Elastomer Facial Implants

ASTM F2257-22 外科植入物 (UNS S31673) 用锻造无缝或焊接和拉拔18铬-14镍-2.5钼不锈钢小直径管件的标准标准规格

1.1 This specification covers the requirements for wrought 18chromium-14nickel-2.5molybdenum stainless steel tubing used for the manufacture of surgical implants. Material shall conform to the applicable requirements of Specification F138 (for seamless) or Specification F139 (for welded and drawn). This specification addresses those product variables that differentiate small-diameter medical grade tubing from the bar, wire, sheet, and strip product forms covered in these specifications. 1.2 This specification applies to cold finished straight length tubing with 3 mm [0.125 in.] and smaller nominal outside diameter (OD) and 0.5 mm [0.020 in.] and thinner nominal wall thickness. 1.3 The specifications in 2.1 are referred to as the ASTM material standard(s) in this specification. 1.4 The values stated in either SI units or inch-pound units are to be regarded separately as standard. Inch-pound units are shown in brackets. 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. 1.5 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 Specification for Wrought Seamless or Welded and Drawn 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Small Diameter Tubing for Surgical Implants (UNS S31673)

ASTM F647-22 神经外科用可植入分路组件的评定和确定的标准实施规程

1.1 This practice covers requirements for the evaluation and specification of implantable shunts as related to resistance to flow, direction of flow, materials, radiopacity, mechanical properties, finish, sterility, and labeling of shunt assemblies. 1.2 Devices to which this practice is applicable include, but are not limited to, those that are temporarily implanted to effect external drainage; or permanently implanted to effect shunting of fluid from a cerebral ventricle, a cyst, the subarachnoid space to the peritoneal cavity, the venous circulation, or some other suitable internal delivery site, and intracranial bypass. 1.3 Limitations—Although this practice includes a standard test method for the evaluation of pressure/flow characteristics of shunts or shunt components, it does not include specific pressure/flow requirements. 1.4 The following components that individually or in combination comprise shunt assemblies are considered to be within the scope of this practice: catheters (such as atrial, peritoneal, ventricular), connectors, implantable accessory devices (such as antisiphon devices and reservoirs), valved catheters, and valves. NOTE 1—The standards in Section 2 contain provisions that, through reference in this text, constitute provisions of this practice. At the time of publication, the editions indicated are valid. All standards are subject to revision, and parties to agreements based on this practice are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below. Devices or components, or both, whose structures are comparable to that outlined in these standards are acceptable. 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 1 This practice is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.31 on Neurosurgical Standards. Current edition approved Oct. 1, 2022. Published October 2022. Originally approved in 1979. Last previous edition approved in 2014 as F647 – 94 (2014). DOI: 10.1520/F0647-22. 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 Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application

T/CIRA 35-2022 自体颅骨组织库

本标准主要内容如下：范围、规范性引用文件、术语和定义、基本要求、工作要求、运行、质量管理。此外，还包括附录A“ACB的布局”、附录B“ACB洁净区的环境要求和监测”、附录C“自体颅骨辐射灭菌剂量的确定及维持”

Autologous cranium bank

22/30399894 DC BS EN ISO 14630 非活性手术植入物 一般要求

BS EN ISO 14630. Non-active surgical implants. General requirements