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【CODEX翻译】YYT 0961-2014 脊柱植入物 脊柱内固定系统 组件及连接装置的静态及疲劳性能评价方法-中英双语

Date:2021-11-05
¥1113.30
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【CODEX】YYT 0961-2014 脊柱植入物 脊柱内固定系统

组件及连接装置的静态及疲劳性能评价方法


脊柱植入物 脊柱内固定系统组件及连接装置的静态及疲劳性能评价方法

Standard guide for evaluating the static and fatigue properties of

interconnection mechanisms and subassemblies used in spinal arthrodesis implants

 

1     范围Scope

 

本标准规定了脊柱内固定系统单轴静态及疲劳强度以及组件连接装置抗松动性的试验方法。本标准旨在为不同设计的脊柱植入物连接装置提供力学性能评价方法。不同的组件及连接装置应组合成脊柱植入物静态及疲劳试验结构。这些试验方法的目的不是分析脊柱植入物的整体及局部结构,也不是定义其性能等级,因为还没有足够的信息来预测使用某种设计植入物的结果。本标准列出了测试脊柱植入物组件连接装置强度的定义、可能的试验方法以及结果的报告。


This standard provides the test method for uniaxial static and fatigue strength, and resistance to loosening of the component interconnection mechanisms of spinal arthrodesis implants. The purpose of this standard is to provide a means of mechanically characterizing different designs of spinal implant interconnections. Ultimately, the various components and interconnections should be combines for static and fatigue testing of spinal implant construct. it is not the intention of these test methods to define levels of performance of spinal implants as insufficient knowledge is available to predict the consequences of the use of particular spinal implant designs. This standard sets out definitions for use in measuring the strength of component interconnections of spinal implants, possible test methods themselves, and the reporting of test results.

 

除角度的测量采用度或弧度的单位外,本标准采用国际单位制。


The values stated in SI units are to be regarded as standard, with the exception of angular measurements, which may be reported in terms of either degrees or radians.

 

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。确立适当的安全及健康规范,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。


This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the users of this international standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

 

2     规范性引用文件 Normative References

 

下列文件对于本文件的应用是必不可少的。凡是注日期的引用文件,仅注日期的版本适用于本文件。凡是不注日期的引用文件,其最新版本(包括所有的修改单)适用于本文件。


The following documents are indispensable for the application of this document. For dated references, only the dated edition is applicable to this document. For undated references, the latest edition (all revision lists included) is applicable to this document.

 

GB/T 16825.1静力单轴试验机的检验第1部分:拉力和(或)压力试验机测力系统的检验与校准(GB/T 16825.1—2008ISO 7500-1:2004,IDT)

GB/T 16825.1 Verification of static uniaxial testing machines-Part 1: Tension/compression testing machines-Verification and calibration of the force-measuring system (GB/T 16825.1—2008, ISO 7500-1:2004, IDT)

 

ASTM F 1582 与脊柱植入物相关的术语(Terminology relating to spinal implants)

ASTM F 1582 Terminology relating to spinal implants



      CODEX北京科译翻译有限公司是一家专业提供生命科学翻译和本地化服务的公司,作为中国专业的生命科学翻译公司之一以及国内为数不多的通过国际ISO17100: 2015认证的医学翻译提供商,CODEX科译拥有更多的医学资深语言专家,能实现40多种语言对的互译,接受更高难度的医学领域的项目挑战,并在最短时间内适应以给出最合理的解决方案。保证最高质量,100%按时交付,高效、完善的售后保障是CODEX科译给客户的用心承诺。

CODEX is a leading provider of cross-border communications based in Beijing. With our exclusive database in life science, and ISO 17100:2015 certified, CODEX has the required expertise and experience in localization, documentation, and medical literature to deliver a full range of end-to-end content and consulting services in many languages. We closely work with clients to deliver solutions to the challenges of engaging markets, consumers, and regulatory and patent environments worldwide.


      以上是免费内容,查看更多可立即购买



【CODEX】YYT 0961-2014 Standard guide for evaluating the static and fatigue properties of interconnection mechanisms and subassemblies used in spinal arthrodesis implants
Date:2021-11-05
¥1113.30
Download

【CODEX】YYT 0961-2014 脊柱植入物 脊柱内固定系统

组件及连接装置的静态及疲劳性能评价方法


脊柱植入物 脊柱内固定系统组件及连接装置的静态及疲劳性能评价方法

Standard guide for evaluating the static and fatigue properties of

interconnection mechanisms and subassemblies used in spinal arthrodesis implants

 

1     范围Scope

 

本标准规定了脊柱内固定系统单轴静态及疲劳强度以及组件连接装置抗松动性的试验方法。本标准旨在为不同设计的脊柱植入物连接装置提供力学性能评价方法。不同的组件及连接装置应组合成脊柱植入物静态及疲劳试验结构。这些试验方法的目的不是分析脊柱植入物的整体及局部结构,也不是定义其性能等级,因为还没有足够的信息来预测使用某种设计植入物的结果。本标准列出了测试脊柱植入物组件连接装置强度的定义、可能的试验方法以及结果的报告。


This standard provides the test method for uniaxial static and fatigue strength, and resistance to loosening of the component interconnection mechanisms of spinal arthrodesis implants. The purpose of this standard is to provide a means of mechanically characterizing different designs of spinal implant interconnections. Ultimately, the various components and interconnections should be combines for static and fatigue testing of spinal implant construct. it is not the intention of these test methods to define levels of performance of spinal implants as insufficient knowledge is available to predict the consequences of the use of particular spinal implant designs. This standard sets out definitions for use in measuring the strength of component interconnections of spinal implants, possible test methods themselves, and the reporting of test results.

 

除角度的测量采用度或弧度的单位外,本标准采用国际单位制。


The values stated in SI units are to be regarded as standard, with the exception of angular measurements, which may be reported in terms of either degrees or radians.

 

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。确立适当的安全及健康规范,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。


This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the users of this international standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

 

2     规范性引用文件 Normative References

 

下列文件对于本文件的应用是必不可少的。凡是注日期的引用文件,仅注日期的版本适用于本文件。凡是不注日期的引用文件,其最新版本(包括所有的修改单)适用于本文件。


The following documents are indispensable for the application of this document. For dated references, only the dated edition is applicable to this document. For undated references, the latest edition (all revision lists included) is applicable to this document.

 

GB/T 16825.1静力单轴试验机的检验第1部分:拉力和(或)压力试验机测力系统的检验与校准(GB/T 16825.1—2008ISO 7500-1:2004,IDT)

GB/T 16825.1 Verification of static uniaxial testing machines-Part 1: Tension/compression testing machines-Verification and calibration of the force-measuring system (GB/T 16825.1—2008, ISO 7500-1:2004, IDT)

 

ASTM F 1582 与脊柱植入物相关的术语(Terminology relating to spinal implants)

ASTM F 1582 Terminology relating to spinal implants



      CODEX北京科译翻译有限公司是一家专业提供生命科学翻译和本地化服务的公司,作为中国专业的生命科学翻译公司之一以及国内为数不多的通过国际ISO17100: 2015认证的医学翻译提供商,CODEX科译拥有更多的医学资深语言专家,能实现40多种语言对的互译,接受更高难度的医学领域的项目挑战,并在最短时间内适应以给出最合理的解决方案。保证最高质量,100%按时交付,高效、完善的售后保障是CODEX科译给客户的用心承诺。

CODEX is a leading provider of cross-border communications based in Beijing. With our exclusive database in life science, and ISO 17100:2015 certified, CODEX has the required expertise and experience in localization, documentation, and medical literature to deliver a full range of end-to-end content and consulting services in many languages. We closely work with clients to deliver solutions to the challenges of engaging markets, consumers, and regulatory and patent environments worldwide.


      以上是免费内容,查看更多可立即购买



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