金屬骨板檢測

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YY/T 0119.3-2014脊柱植入物 脊柱內固定系統部件 第3部分:金屬脊柱板

YY/T 0119的本部分規定了金屬脊柱板的分類、材料及性能要求。本部分適用于脊柱內固定植入物中的縱向元件。

YY/T 0119.4-2014脊柱植入物 脊柱內固定系統部件 第4部分:金屬脊柱棒

YY/T 0119的本部分規定了金屬脊柱棒的分類、材料及性能要求。本部分適用于脊柱內固定植入物中的縱向元件。

YY/T 0509-2009生物可吸收內固定板和螺釘的標準要求和測試方法

本標準規定了可水解聚合物樹脂為材料制成的矯形外科內固定板和螺釘相關力學性能和試驗方法。本標準規定了可吸收外植入物尺寸和其他物理性能的常用術語，也定義了與可吸收醫療器械相關的性能術語。本標準規定了一些標準的試驗方法，可以在規定的預處理、溫度、濕度和測試裝置速度等條件下，連續地測試可吸收植入物的力學性能。并非所有的可吸收醫療器械均適用于本標準。使用者應根據具體的可吸收醫療器械及其可能的應用領域來考慮本標準的適用性。本標準并非試圖對所涉及的所有安全問題進行闡述，即便是那些與其使用有關的安全問題。確立適當的安全操作規范，以及在應用前明確管理限制的適用性，是本標準用戶自身的責任。

YY/T 1503-2016外科植入物 金屬接骨板彎曲疲勞性能試驗方法

本標準規定了金屬接骨板(以下簡稱“接骨板”)彎曲疲勞性能試驗方法。本標準旨在為不同設計的接骨板提供彎曲疲勞性能評價方法。本標準適用于骨科內固定用接骨板。

CNS 13382-15-1995外科植入物–金屬骨板–螺絲孔適用不對稱螺紋及球形下表面之螺絲

本標準適用于金屬骨科，并提供其螺絲孔之尺寸及其許可差，以確保正確之使用。備考：1. 本標準并不制定骨板之尺寸和形狀，以及螺絲孔之間距。2. 本標準制定螺絲、骨板及相關工具規格，如附件 A 。

CNS 13382-16-1995外科植入物–金屬骨板–螺絲孔及槽適用于錐形下表面螺絲

本標準制定適用 CNS 13382-13 〔科植入物–具錐型下表面之頭之金屬螺絲–尺寸〕 螺絲釘的骨板之螺絲孔的尺寸與許可差的規格。備考：本標準不制定骨板之尺寸，形狀及孔與孔間距離之規格。

ASTM F382-1999金屬骨板的靜態彎曲特性的測試方法和標準規范

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)金屬骨板的標準規范和試驗方法

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金屬骨板的靜態彎曲特性的測試方法和標準規范

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(2008)金屬骨板的標準規范和試驗方法

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金屬骨板的檢測及標準規范

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金屬骨板的標準規格和試驗方法

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金屬骨板的標準規格和試驗方法

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 F3437-2023小型骨折固定用金屬骨板的標準試驗方法

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外科植入物金屬骨板與非對稱螺紋和球面螺釘相對應的孔

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外科植入物金屬骨板孔和槽與錐形下表面螺釘相對應

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穩定性外科植入物.接骨術植入物.詳細要求

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.