1.1 本规程旨在描述如何报告一次性植入物的清洁度。本实践提出了如何识别关键化合物，并提出了不同的分析方法。 1.2 本规程不涉及植入物特性或设计固有的物质。特别是，它不涉及植入物再吸收过程中释放的物质、植入物涂层或设计上的浸出物。 1.3 本规程不涉及重新加工的植入物的清洁度，这些植入物在拆开包装后在医院或制造商处重新使用。 1.4 本规程不确定残留物的极限值。 1.5 本规程建议了植入物和单个植入物残留物和残留物要求的一般规范的适当测试方法- 使用无菌器械。该实践也可用于表征植入物的半成品组件。 1.6 本文建议和描述的试验方法是指已建立的分析方法和现有的化学、生物化学或生物分析标准方法。 1.7 本规程旨在为可能影响或不影响植入物生物相容性的残留物的适当测试方法和报告惯例提供指导。本规程不建议或推荐生物相容性的测试方法，这在实践中可能会发现 F748 或ISO 10993-1。 1.8 本标准并非旨在解决与其使用相关的所有安全问题（如有）。本标准的用户有责任在使用前制定适当的安全、健康和环境实践，并确定监管限制的适用性。 1.9 本国际标准是根据世界贸易组织技术性贸易壁垒（TBT）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》中确立的国际公认标准化原则制定的。 ====意义和用途====== 5.1 植入物的质量和临床性能可能会受到残留物的影响。残留物可能不会引起组织反应、轻微的组织刺激，或者可能导致植入物周围组织的局部炎症，从而导致短期或长期使用失败。残留物也可能在远离植入物的位置造成伤害。残留物可能来自加工过程中使用的制造材料或制造环境，也可能是搬运和包装的结果 ( 1- 3. ) . 10 5.2 本规程应用于报告残留物测试结果。不一定能检测到所有残留物。它提出了可用于分析的标准技术，并提供了如何设置极限值的建议。 5.3 残留物可能具有无机、有机或生物性质。它们可能表现为表面结合物质，或吸附物（例如，静电吸附）、风化或机械吸附物质。残留物可溶于水介质、有机溶剂或不溶性颗粒。 5.4 验证过程（即清洁验证或无菌验证）中生成的数据可作为结果或报告中设置验收标准的依据。

1.1 The purpose of this practice is to describe how the cleanliness of single-use implants as manufactured shall be reported. This practice proposes how to approach the identification of critical compounds and suggests different analytical methods. 1.2 The practice does not address substances which are intrinsic to the implant properties or design. In particular, it does not address substances released during implant resorption, implant coatings, or leachables by design. 1.3 This practice does not address the cleanliness of implants which are re-processed, re-cleaned after unpacking for re-use in the hospital or by the manufacturer. 1.4 This practice does not establish limit values for residues. 1.5 This practice suggests appropriate test methods for the general specification of residues and residue requirements of implants and single-use sterile instruments. This practice may also be used to characterize semi-finished components for implants. 1.6 The test methods suggested and described herein refer to established analytical methods and to existing standard methods for chemical, biochemical, or biological analysis. 1.7 This practice is intended solely to provide guidance regarding suitable test methods and reporting conventions for residues, which may or may not affect implant biocompatibility. This practice does not suggest or recommend test methods for biocompatibility, which may be found in Practice F748 or in ISO 10993-1. 1.8 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. 1.9 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 ====== 5.1 The quality and consequently the clinical performance of implants may be affected by residues. Residues may induce no tissue response, minor tissue irritations, or they may lead to local inflammation of tissues surrounding the implant which may lead to failure in short-term or long-term use. Residues may also cause harm at locations away from the implant. Residues may originate from manufacturing materials used in the course of processing or from the manufacturing environment, or may be the result of handling and packaging ( 1- 3 ) . 10 5.2 This practice shall be used to report the results of testing for residue. All residues cannot necessarily be detected. It suggests standard techniques that may be applied for analysis, and provides suggestions for how limit values may be set. 5.3 Residues may be of inorganic, organic, or biological nature. They may exhibit as surface-bound substance, or as adsorbates (for example, electrostatically held), efflorescence, or mechanically held substances. Residues may be soluble in aqueous media, soluble in organic solvents, or may be insoluble particulates. 5.4 Data generated in validation processes (that is, cleaning validation or sterility validation) may be used as results or as basis for setting acceptance criteria in the report.