生物相溶等效性报告
ISO 10993-1：2009第4.1条规定：“评估可能包括对相关临床前和临床经验的研究以及实际测试。这种评估可能会得出这样的结论，即如果材料在指定的作用和物理形式中具有与所设计设备等效的可证明的安全使用历史，则无需测试。
为了得出结论，不需要额外的生物相容性测试，申办者应提供证据证明，对于每种材料，组织接触的类型和持续时间，物理形式，配方，加工，组分相互作用和储存条件与比较器设备相同，或者与拟议的设备相比，比较器设备被证明是“最坏情况”。在存在差异的情况下，应解释并证明这些差异如何适用于先前的数据以支持医疗器械的最终成品形式的生物相容性评估。
如果动物实验/临床实验中搜集到的关于生物相容性的数据不够，那就不能作为强有力的支持。
ISO 10993-1:2009, Clause 4.1 states that “Evaluation may include both a study of relevant preclinical and clinical experience and actual testing. Such an evaluation might result in the conclusion that no testing is needed if the material has a demonstrable safe history of use in a specified role and physical form that is equivalent to that of the device under design.
To conclude that no additional biocompatibility testing is needed, the sponsor should provide evidence that for each material, the type and duration of tissue contact, physical form, formulation, processing, component interactions, and storage conditions are the same as for the comparator device(s), or the comparator device is demonstrated to be “worst case” compared to the proposed device. In cases where there are differences, such differences should be explained and justified as to how prior data are applicable to support a biocompatibility assessment of the medical device in its final finished form
In vivo animal data and/or clinical data may be of limited utility (as discussed previously in Section III, ISO10993-1) if specific biocompatibility endpoints are not included as part of the data collected for these studies.
参考文献：Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"
