GRI-JX-067-00生物相容性试验程序20091216

Issued by: Title: RA/QA Specialist Date: 2009-12-15 Verified by: Title: Director of RA&QA Date: 2009-12-15 Approved by: Title: Director of RA&QA Date: 2009-12-15标题：生物相容性试验程序1. 目的Purpose1.1 为本公司医疗器械产品进行生物相容性评估和测试的过程建立程序，确保产品地使用安全性。

To establish operations for conducting the biological evaluation& testing for medical devices produced by GRI, assuring the safety of these devices.1.2 为本公司预期将带有”CE”标志的医疗器械进行生物相容性测试建立程序，使其符合欧盟《医疗器械指令》93/42/EEC以及相关协调标准的要求，确保产品的使用安全性。

To establish operations for the devices which are intended to be CE certified when conducting biological evaluation& testing, assuring the operations are in compliance with the requirements specified in “Medical Device Directive 93/42/EEC” and the relevant EU harmonious standards.2. 适用范围Scope2.1 此程序适用于世源预期将带有“CE”标志的医疗器械，对于将不带有 ”CE” 标志的器械，也可应用此程序进行生物相容性评价和测试。

This OP applies to medical devices which are intended to be “CE” certified, for “non-CE marked”devices, this procedure can also be applied for biological evaluation or testing.2.2 此程序仅适用于预期使用时将与病人的身体部位有直接或间接接触的器械或原材料，对于无论直接或间接的方式都不会与病人的身体部位接触的医疗器械，此程序不适用。

This OP is not applicable for the testing of devices or materials that do not come into direct or indirect contact with the patient’s body during their anticipated period of use.3. 参考Reference欧盟《医疗器械指令》93/42/EEC EU 《Medical Device Directive》 93/42/EECISO 10993-1:2009 《Biological evaluation of medical devices—Part 1: Evaluation and testing》4. 职责及工作流程Responsibilities and Work Flow4.1 鉴于生物相容性评价通常发生在产品设计开发或变更控制阶段，因此世源开发部负责按照本程序中所述的器械评估和选择测试的原则来确定需要进行的生物相容性测试的项目、测试样本数、测试要求、测试标准等信息，并负责准备样品，将信息以书面形式会同样品提交给指定的实验室。

Whereas the biological evaluation happens in the stage of product development or change control processes, GRI Product Development shall be responsible for determing the selection of biologicaltesting required, sample size, testing requirements, applicable standards, etc, as well as the preparation of samples following the principles stated in this procedure. The information in a written manner along with the samples shall be submitted to the designated lab.4.2 测试结束后，测试报告的原件须送交质量部保存。

开发部负责根据测试结果就器械的生物相容性进行评价，并作出结论。

Upon the completion of the testing, the original copy of test report shall be sent to QA to retain. PD shall make the bi-compatibility assessment and appropriate conclusions based on the testing results.5. 器械的分类Categorization of Medical Devices5.1 分类原则: 器械依据使用时和身体部位接触的性质和接触持续时间为大体原则来进行分类。

如上所述，无论直接或间接都不会与身体部位进行接触的器械不属于此程序的范畴。

Principles of Categorization: Medical devices shall be categorized according to the nature and duration of body contact.As stated above, devices that don’t contact direct or indirect with the body are not in the scope of this SOP.5.2 分类标准：器械按使用时与身体部位接触的性质分为与身体表面接触的器械、外部接入器械和植入器械；按接触时间分为短期接触A类、长期接触B类和持久接触C类。

详细的分类原则参照ISO 10993-1中所述的标准。

By nature of body contact, the devices shall be categorized to surface-contacting devices, external communicating devices and implant devices; by duration of contact, the devices shall be categorized to limited exposure (A), prolonged exposure (B), and permanent contact (C). ISO 10993-1, the most recent version shall be followed to category the devices.5.3 特殊情况的分类原则Categorization for special cases5.3.1 在有些情况下，器械或材料有可能不属于任何一种类别，则在进行生物学评价试验时依ISO10993-1中所述的选择生物相容性试验的基本原则来进行；某些情况下，器械或材料可能兼属几类，则须考虑所属的各类所需要进行的相应的试验；The testing of any device that doesn’t fall into one of the categories shall follow the generalprinciples specified in ISO 10993-1. Certain devices may fall into more than one category,in which case testing appropriate to each category shall be considered.5.3.2 如果一种器械或材料兼属两种或以上的时间分类，则须执行较严格的试验要求；对于多次使用的器械，则须考虑潜在的累积作用，按这些接触的累积时间对器械进行分类；If a material or device may be placed in more than one category, the more rigorous testingrequirements shall apply. With multiple exposures to the device, the decision into whichcategory a device is place should take into account the potential cumulative effect, bearingin mind the period of time over which these exposure occur.6. 测试程序Testing Procedure6.1 在确定了器械的分类后，原则上须依据ISO 10993-1中所述的基于器械分类的测试选择标准来决定所须要进行的测试种类。

由于对器械进行生物相容性评价和测试是一个综合到器械本身，特别是器械所使用的原材料（如原材料本身所具有的物理和化学特性、毒理学特征、电学及形态学或力学等特性），器械加工及各种后处理过程（如加工过程中添加剂等污染物的引入）等各方面知识的决定，因此实际所须要进行的测试种类有时会超出器械分类测试选择标准而考虑多做。

这些考虑须结合到器械的总体设计、尺寸、历史经验、文献、临床资料等信息来确保器械的使用安全。

相反，如果器械所使用的材料在具体应用中具有可论证的使用史、安全的临床数据，则有可能少做、甚至不必做任何测试。

In principle, the selection of testing should follow the principles based on the device and duration category specified in ISO 10993-1 after the device categorization has been finalized. Whereas the biological evaluation and testing shall incorporate the considerations which include devices and the material used (with regard to the physical and chemical properties which may include toxicological, electrical, morphological and mechanical properties), manufacturing and various processing steps (ie. Process contaminants and residues, additives), the additional test which is not required in these principles may be necessary. The considerations shall take into account the overall device design, dimensions, historical experience, available information, and clinical data so that the safety of device is ensured. On the other hand, it may be concluded that no testing is needed if a material has a demonstrable history of use in a specified role that is equivalent to that of the device under design.6.2 世源开发部须充分收集与6.1中所述相关的信息，以使得对测试项目的选择能够确保器械的安全的同时节省不必要的测试。