1.1 本规范和测试方法涵盖了骨科内固定用钢板和螺钉的机械特性。覆盖的设备由一种或多种水解可降解聚合物（从这一点开始称为“可吸收”）树脂或树脂复合材料制成。 1.2 本规范建立了一个通用术语来描述可吸收植入物的尺寸和其他物理特性，以及与可吸收装置性能相关的性能定义。 1.3 本规范规定了标准测试方法，以在预处理、温度、湿度和试验机速度的规定条件下进行测试时，一致地测量可吸收装置的性能相关机械特性。 1.4 本规范可能不适用于所有可吸收装置，特别是那些具有有限水解敏感性和降解性的装置 体内 主要通过酶作用。鉴于特定的可吸收装置及其潜在应用，用户应考虑该标准的适当性。 1.5 以国际单位制表示的值应被视为标准值。本标准不包括其他计量单位。 1.6 本标准包含多种测试方法。然而，用户不一定有义务使用所有描述的方法进行测试。相反，用户应该只选择适合特定设备设计的测试方法，并给出理由。 这可能只是本文所述测试方法的一个子集。 1.7 本标准并不旨在解决与其使用相关的所有安全问题（如果有的话）。本标准的使用者有责任在使用前建立适当的安全、健康和环境实践，并确定监管限制的适用性。 1.8 本国际标准是根据世界贸易组织技术性贸易壁垒委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认的标准化原则制定的。 =====意义和用途====== 4.1 可吸收装置一旦植入体内，就会随着时间的推移降解和吸收。这使得移除手术变得不必要，这对儿科患者尤其有利。 4.2 当聚合物由于与环境的水解反应而降解时，设备的机械性能也会恶化。开发基于可吸收装置的机械有效骨折固定系统的关键是在超过骨折愈合预期的时间范围内提供足够的固定强度和刚度。一旦骨折愈合，该装置可以被身体完全吸收。 通过在聚合物中掺入生物活性填料，可以增强该装置的生物性能，特别是在骨部位的应用。 4.3 可吸收装置将使用类似于评估传统金属装置的测试方法进行测试。应考虑可吸收装置的试验前调节要求、处理要求和随时间变化的机械性能评估。 4.4 本规范和随附的测试方法旨在补充指南中描述的可吸收聚合物植入物评估的一般考虑因素 F2902 .

1.1 This specification and test methods cover the mechanical characterization of plates and screws for orthopedic internal fixation. Covered devices are fabricated from one or more hydrolytically degradable polymer (from this point on referred to as “absorbable”) resins or resin composites. 1.2 This specification establishes a common terminology to describe the size and other physical characteristics of absorbable implants and performance definitions related to the performance of absorbable devices. 1.3 This specification establishes standard test methods to consistently measure performance-related mechanical characteristics of absorbable devices when tested under defined conditions of pretreatment, temperature, humidity, and testing machine speed. 1.4 This specification may not be appropriate for all absorbable devices, especially those that possess limited hydrolytic susceptibility and degrade in vivo primarily through enzymatic action. The user is cautioned to consider the appropriateness of the standard in view of the particular absorbable device and its potential application. 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 Multiple test methods are included in this standard. However, the user is not necessarily obligated to test using all of the described methods. Instead, the user should only select, with justification, test methods that are appropriate for a particular device design. This may be only a subset of the test methods described herein. 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. ====== Significance And Use ====== 4.1 Absorbable devices are intended to degrade and absorb over time once they are implanted into the body. This makes a removal operation unnecessary, which is especially advantageous for pediatric patients. 4.2 While the polymer degrades due to hydrolytic reaction with the environment, the mechanical performance of the device also deteriorates. The key to developing mechanically effective fracture fixation systems based on absorbable devices is to provide an adequate level of fixation strength and stiffness for a time frame that exceeds that expected for fracture healing. Once the fracture is healed, the device can be completely absorbed by the body. The biological performance of the device, particularly for application at a bony site, may be enhanced by incorporation of bioactive fillers in the polymer. 4.3 Absorbable devices will be tested using test methods that are similar to those used to evaluate conventional metallic devices. The pre-test conditioning requirements, handling requirements, and time-dependent mechanical property evaluations for absorbable devices shall be considered. 4.4 This specification and accompanying test methods are intended to complement the more general considerations for the assessment of absorbable polymeric implants that are described within Guide F2902 .