金属骨板检测

发布时间：2024-06-21 作者：中析研究所浏览：

YY/T 0119.3-2014脊柱植入物脊柱内固定系统部件第3部分:金属脊柱板

YY/T 0119的本部分规定了金属脊柱板的分类、材料及性能要求。本部分适用于脊柱内固定植入物中的纵向元件。

YY/T 0119.4-2014脊柱植入物脊柱内固定系统部件第4部分:金属脊柱棒

YY/T 0119的本部分规定了金属脊柱棒的分类、材料及性能要求。本部分适用于脊柱内固定植入物中的纵向元件。

YY/T 0509-2009生物可吸收内固定板和螺钉的标准要求和测试方法

本标准规定了可水解聚合物树脂为材料制成的矫形外科内固定板和螺钉相关力学性能和试验方法。本标准规定了可吸收外植入物尺寸和其他物理性能的常用术语，也定义了与可吸收医疗器械相关的性能术语。本标准规定了一些标准的试验方法，可以在规定的预处理、温度、湿度和测试装置速度等条件下，连续地测试可吸收植入物的力学性能。并非所有的可吸收医疗器械均适用于本标准。使用者应根据具体的可吸收医疗器械及其可能的应用领域来考虑本标准的适用性。本标准并非试图对所涉及的所有安全问题进行阐述，即便是那些与其使用有关的安全问题。确立适当的安全操作规范，以及在应用前明确管理限制的适用性，是本标准用户自身的责任。

YY/T 1503-2016外科植入物金属接骨板弯曲疲劳性能试验方法

本标准规定了金属接骨板(以下简称“接骨板”)弯曲疲劳性能试验方法。本标准旨在为不同设计的接骨板提供弯曲疲劳性能评价方法。本标准适用于骨科内固定用接骨板。

CNS 13382-15-1995外科植入物–金属骨板–螺丝孔适用不对称螺纹及球形下表面之螺丝

本标准适用于金属骨科，并提供其螺丝孔之尺寸及其许可差，以确保正确之使用。备考：1. 本标准并不制定骨板之尺寸和形状，以及螺丝孔之间距。2. 本标准制定螺丝、骨板及相关工具规格，如附件 A 。

CNS 13382-16-1995外科植入物–金属骨板–螺丝孔及槽适用于锥形下表面螺丝

本标准制定适用 CNS 13382-13 〔科植入物–具锥型下表面之头之金属螺丝–尺寸〕螺丝钉的骨板之螺丝孔的尺寸与许可差的规格。备考：本标准不制定骨板之尺寸，形状及孔与孔间距离之规格。

ASTM F382-1999金属骨板的静态弯曲特性的测试方法和标准规范

1.1 This test method covers static bend testing of metallic bone plates for strength, equivalent bending stiffness, and ductility. 1.2 The values stated in SI units are to be regarded as the standard. The inch-pound units given in parentheses are for information only. 1.3 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 and health practices and determine the applicability of regulatory limitations prior to use.

ASTM F382-1999(2003)金属骨板的标准规范和试验方法

1.1 This specification and test method is intended to provide a comprehensive reference for bone plates used in the surgical internal fixation of the skeletal system. The standard establishes consistent methods to classify, define the geometric characteristics, and performance characteristics of bone plates. The standard also presents a catalog of standard specifications that specify material; labeling and handling requirements; and standard test methods for measuring performance related mechanical characteristics determined to be important to the in vivo performance of bone plates.1.2 It is not the intention of the standard to define levels of performance or case-specific clinical performance for bone plates, as insufficient knowledge is available to predict the consequences or their use in individual patients for specific activities of daily living. Futhermore, it is not the intention of the standard to describe or specify specific designs for bone plates used in the surgical internal fixation of the skeletal system.1.3 This standard may not be appropriate for all types of bone plates. The user is cautioned to consider the appropriateness of the standard in view of a particular bone plate and its potential application.1.4 This standard includes the following test methods used in determining the following bone plate mechanical performance characteristics.1.4.1 Standard Test Method for Single Cycle Bend Testing of Metallic Bone Plates - Annex A1.1.4.2 Standard Test Method for Determining the Bending Fatigue Properties Of Metallic Bone Plates - Annex A2.1.5 Unless otherwise indicated, the values stated in SI units shall 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 and health practices and determine the applicability of regulatory limitations prior to use.

ASTM F382-1999(2003)e1金属骨板的静态弯曲特性的测试方法和标准规范

ASTM F382-1999(2008)金属骨板的标准规范和试验方法

A2.5.1 The test method establishes a uniform four-point bending fatigue test to characterize and compare the fatigue performance of different bone plate designs. This test method may be used to determine a bone plate's fatigue life at either a specific or over a range of maximum bending moment conditions. Additionally, the test method may be alternatively used to estimate a bone plate's fatigue strength for a specified number of fatigue cycles. A2.5.2 The test method utilizes a simplified bone plate load model that may not be exactly representative of the in-situ loading configuration. The user should note that the test results generated by this test method can not be used to directly predict the in vivo performance of the bone plate being tested. The data generated from this test method can be used to conduct relative comparisons of different bone plate designs. A2.5.3 This test method may not be appropriate for all types of implant applications. The user is cautioned to consider the appropriateness of the method in view of the devices being tested and their potential application. A2.5.4 This test method assumes that the bone plate is manufactured from a material that exhibits linear-elastic material behavior. Therefore, the method is not applicable for testing bone plates made from materials that exhibit non-linear elastic behavior. A2.5.5 This test method is restricted to the testing of bone plates within the materials' linear-elastic range. Therefore, the test method is not applicable for testing bone plates under conditions that would approach or exceed the bending strength of the bone plate being tested.1.1 This specification and test method is intended to provide a comprehensive reference for bone plates used in the surgical internal fixation of the skeletal system. The standard establishes consistent methods to classify, define the geometric characteristics, and performance characteristics of bone plates. The standard also presents a catalog of standard specifications that specify material; labeling and handling requirements; and standard test methods for measuring performance related mechanical characteristics determined to be important to the in vivo performance of bone plates. 1.2 It is not the intention of the standard to define levels of performance or case-specific clinical performance for bone plates, as insufficient knowledge is available to predict the consequences or their use in individual patients for specific activities of daily living. Futhermore, it is not the intention of the standard to describe or specify specific designs for bone plates used in the surgical internal fixation of the skeletal system. 1.3 This document may not be appropriate for all types of bone plates. The user is cautioned to consider the appropriateness of the standard in view of a particular bone plate and its potential application. 1.4 This document includes the following test methods used in determining the following bone plate mechanical performance characteristics. 1.4.1 Standard Test Method for Single Cycle Bend Testing of Metallic Bone Platesx2014;Annex A1. 1.4.2 Standard Test Method for Determining the Bending Fatigue Properties Of Metallic Bone Platesx2014;Annex A2. 1.5 The values stated in SI units are to be regarded as standard. The values given in parentheses are mathematical conversions to inch-pound units that are provided for information only and are not considered 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 t......

ASTM F382-1999(2008)e1金属骨板的检测及标准规范

A2.5.1 The test method establishes a uniform four-point bending fatigue test to characterize and compare the fatigue performance of different bone plate designs. This test method may be used to determine a bone plate's fatigue life at either a specific or over a range of maximum bending moment conditions. Additionally, the test method may be alternatively used to estimate a bone plate's fatigue strength for a specified number of fatigue cycles. A2.5.2 The test method utilizes a simplified bone plate load model that may not be exactly representative of the in-situ loading configuration. The user should note that the test results generated by this test method can not be used to directly predict the in vivo performance of the bone plate being tested. The data generated from this test method can be used to conduct relative comparisons of different bone plate designs. A2.5.3 This test method may not be appropriate for all types of implant applications. The user is cautioned to consider the appropriateness of the method in view of the devices being tested and their potential application. A2.5.4 This test method assumes that the bone plate is manufactured from a material that exhibits linear-elastic material behavior. Therefore, the method is not applicable for testing bone plates made from materials that exhibit non-linear elastic behavior. A2.5.5 This test method is restricted to the testing of bone plates within the materials' linear-elastic range. Therefore, the test method is not applicable for testing bone plates under conditions that would approach or exceed the bending strength of the bone plate being tested.1.1 This specification and test method is intended to provide a comprehensive reference for bone plates used in the surgical internal fixation of the skeletal system. The standard establishes consistent methods to classify, define the geometric characteristics, and performance characteristics of bone plates. The standard also presents a catalog of standard specifications that specify material; labeling and handling requirements; and standard test methods for measuring performance related mechanical characteristics determined to be important to the in vivo performance of bone plates. 1.2 It is not the intention of the standard to define levels of performance or case-specific clinical performance for bone plates, as insufficient knowledge is available to predict the consequences or their use in individual patients for specific activities of daily living. Futhermore, it is not the intention of the standard to describe or specify specific designs for bone plates used in the surgical internal fixation of the skeletal system. 1.3 This document may not be appropriate for all types of bone plates. The user is cautioned to consider the appropriateness of the standard in view of a particular bone plate and its potential application. 1.4 This document includes the following test methods used in determining the following bone plate mechanical performance characteristics. 1.4.1 Standard Test Method for Single Cycle Bend Testing of Metallic Bone PlatesAnnex A1. 1.4.2 Standard Test Method for Determining the Bending Fatigue Properties Of Metallic Bone PlatesAnnex A2. 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 and health practices and determine the applicability of regulatory limitations p......

ASTM F382-2014金属骨板的标准规格和试验方法

A2.5x00a0;Significance and Use A2.5.1x00a0;This test method establishes a uniform four-point bending fatigue test to characterize and compare the fatigue performance of different bone plate designs. This test method may be used to determine a fatigue life of the bone plate at either a specific maximum bending moment or over a range of maximum bending moment conditions. Alternatively, the test method may be used to estimate a bone plate's fatigue strength for a specified number of fatigue cycles. A2.5.2x00a0;This test method utilizes a simplified bone plate load model that may not be exactly representative of the in-situ loading configuration. The user should note that the test results generated by this test method can not be used to directly predict the in vivo performance of the bone plate being tested. The data generated from this test method can be used to conduct relative comparisons of different bone plate designs. A2.5.3x00a0;This test method may not be appropriate for all types of implant applications. The user is cautioned to consider the appropriateness of the method in view of the devices being tested and their potential application. A2.5.4x00a0;This test method assumes that the bone plate is manufactured from a material that exhibits linear-elastic material behavior. Therefore, the method is not applicable for testing bone plates made from materials that exhibit non-linear elastic behavior. A2.5.5x00a0;This test method is restricted to the testing of bone plates within the lnear-elastic range of the material. . Therefore, the test method is not applicable for testing bone plates under conditions that would approach or exceed the bending strength of the bone plate being tested. 1.1x00a0;This specification and test method is intended to provide a comprehensive reference for bone plates used in the surgical internal fixation of the skeletal system. The standard establishes consistent methods to classify and define the geometric and performance characteristics of bone plates. The standard also presents a catalog of standard specifications that specify material; labeling and handling requirements; and standard test methods for measuring performance related mechanical characteristics determined to be important to the in vivo performance of bone plates. 1.2x00a0;It is not the intention of the standard to define levels of performance or case-specific clinical performance for bone plates, as insufficient knowledge is available to predict the consequences or their use in individual patients for specific activities of daily living. Futhermore, it is not the intention of the standard to describe or specify specific designs for bone plates used in the surgical internal fixation of the skeletal system. 1.3x00a0;This document may not be appropriate for all types of bone plates. The user is cautioned to consider the appropriateness of the standard in view of a particular bone plate and its potential application.

ASTM F382-2017金属骨板的标准规格和试验方法

ASTM F3437-2023小型骨折固定用金属骨板的标准试验方法

1.1?This standard is intended to provide guidance for the static testing of small bone metallic plates used for fracture fixation. Small bone plates referred to in this standard would be used in minimally load-bearing anatomical areas of the far extremities, such as the fingers and toes, and in the cranium and upper face. Lower face/mandible, wrist, and ankle fixation plates would generally be larger and carry a substantial amount of load and should not be evaluated under this standard. 1.2?ASTM Specification F382 and ISO 9585 are currently available for the testing of metallic bone plates as well, so the user can choose to use any of the tests in these standards for small bone plates. However, due to plate size, Specification F382 and ISO 9585 test setup and execution difficulty can be increased for small bone plates. Thus, this standard offers alternative test methods that are more appropriate for metallic bone plates used in small bone fracture fixation. 1.3?This standard is not intended to address the mechanical performance of the plating construct or accessory components (for example, screws and wires). 1.4?This standard is intended to provide a basis for the mechanical comparison of small bone plates. Due to the complex and varying biomechanics found in the areas of the body where these plates are used, this standard should only be used to compare the in vitro mechanical performance of small bone plates and not used to infer in vivo performance characteristics. 1.5?This standard describes static tests by specifying load types and specific methods of applying these loads. Tests for evaluating and characterizing these loads include the following: static torsion, static cantilever beam bending, static lateral bending, and static three-point bending. 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?Multiple tests are cited in this standard. However, it must be noted that the user is not obligated to test using all of the described methods. Instead, the user should only

GSO ISO 5836-2016外科植入物金属骨板与非对称螺纹和球面螺钉相对应的孔

This International Standard specifies the dimensions and tolerances of holes in bone plates used as surgical implants so as to facilitate correct fixing using screws complying with ISO 5835. NOTES 1 This International Standard does not deal with the shape and dimensions of the plates or with the spacing (centre-to-centre distance) of the holes. 2 The interrelationship of International Standards dealing with bone screws, bone plates and relevant tools is shown for information in annex A.

GSO ISO 9269-2016外科植入物金属骨板孔和槽与锥形下表面螺钉相对应

This International Standard specifies the dimensions and tolerances of holes and slots in bone plates used as surgical implants so as to facilitate correct fixing using screws complying with ISO 9268. NOTES 1 This International Standard does not deal with the shape and dimensions of the plates or with the spacing (centre-to-centre distance) of the holes and slots. 2 The interrelationship of International Standards dealing with bone screws, bone plates and relevant tools is shown in annex A.

DIN EN ISO 14602-2012稳定性外科植入物.接骨术植入物.详细要求

This International Standard specifies particular requirements for non-active surgical implants for osteosynthesis. In addition to ISO 14630, this International Standard gives particular requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging, and information supplied by the manufacturer.