无源医疗器械技术文档和设计档案材料指南

taken from the final product or from materials processed in the same manner as the final product (if applicable provide LOT/REF. No., etc.)

对从成品中或从以同样的方式进行处理的材料中抽出的成品或代表性样品惊醒测试(如果适用,提供批号/参考编号等等)

??Rationale for the selection of the sample tested被测样品选择的基本原理 ??Statement on the sterile state of the test sample. If the test sample was not

sterilized, a rationale shall be given why sterilization has no influence on biocompatibility of the final device

关于被测样品无菌状态的陈述．如果测试样品不是无菌，应给出灭菌对成品的生物相容性不起作用的原因的基本原理．

??Assign appropriate tests to the biological effects. (Only such tests shall be performed which lead to evident results)指定适当的测试来测试生物性效应（只进行此类能产生明显结果的测试）

o Overview of tests to be performed in biological evaluation在生物学评价中所进行的测试的概观

??The selection and evaluation of any material or device intended for use in humans requires a structured programme of assessment (refer to ISO 10993-1 Annex B)

用于人体的任何材料或器械的选择和评估需要结构化的评估程序（参见ISO 10993-1中附录Ｂ）

o Justification for tests not performed未进行的测试的证实

??The quality and the extent of documentation as well as the assessment in regard to the intended use determine whether or not biological tests shall be performed with the final product and to what extent

关于预期用途的文件材料的质量和范围以及评估决定了是否对成品进行生物测试，以及进行到什么程度．

??Biological evaluation may include both a study of relevant experience and actual testing. Such an evaluation may result in the conclusion that no testing is

needed if the material has a documented history of use in a specified role that is equivalent to that of the device under design

生物评估包括相关经验和实际测试的研究．这样的评估可能导致以下的结论：

如果材料有文件化的使用历史并在指定的作用方面等同于正在设计中的器械的使用历史，那么不需要测试．

??Each device should be examined on its own features. Data may be available

from suppliers or in the literature. In this case full transferability is to be demonstrated. Test systems, test sensitivity and concentrations used should be taken into consideration

每种器械应根据其自身的特征进行检查．可从供应商或文献中获得数据．在此种情况下，将展示完全的可转移性．应考虑到用过的测试系统，测试敏感性和浓度． ??Waiving of tests shall be recorded弃权的测试应记录

??Biocompatibility test protocols (copies) 生物相容性测试协议(复印件) o Qualification of the test laboratory, i.e. accreditation测试实验室的资格验证，即认证 o Testing should be conducted according to appropriate good laboratory practices followed by evaluation by competent informed persons

测试应按照适当的良好实验室规范进行，然后由权威的知情人士进行评估 o For qualitative data: acceptance criteria对于定性数据：验收准则 ??Biocompatibility test reports (copies) 生物相容性测试报告（复印件） o For qualitative data/results: interpretation对于定性数据／结果：阐述 o Positive results – What to do?阳性反应－要做什么？ ??Verification of results结果的确认

??Chemical characterization of leachables滤出物的化学特性

??Overall interpretation of the biological evaluation of the device器械的生物学评价的总体阐述

??Relevance of clinical use临床使用的相关性

??Biocompatibility evaluation and summary report生物相容性评价和总结报告 o Compilation of tests performed in tabular form以表格的形式编制测试 Example例如:

Test测试

Protocol No.协议号 Project No./产品编号 Laboratory No.实验室编号 Report date 报告日期 Result结果 Conclusion结论 Cytotoxicity细胞毒性 Cytotoxicity test /细胞毒性测试 L 929-proliferation L 929-扩散 XY yyyy-mm-dd年－月－日 Growth analysis of cells cultured with the test extract showed no relevant growth inhibition of L929 cells.

测试提取的培养细胞的生长分析未显示相关的L929细胞的生长抑制 Sensitization致敏性

Murine Local Lymph鼠性鼠性鼠性局部淋巴 Node Assay节点化验 YZ yyyy-mm-dd 年－月－日 The stimulation indices were

calculated to be less than 3.0. 刺激指数要少于3.0.

o Further relevant information on the tests有关测试的更多相关信息

??Test sample (part tested) e.g. catheter shaft or tip, balloon, whole device 试样（部分测试）例如：管杆或导管尖端，气囊，整个器械

??Specification (polymer type, supplier, trade name, additives) e.g. PUR, Pellethane 2363-90A, 20% Ba2SO4

规格（聚合物类型，供应商，商品名，添加剂）例如：PUR, Pellethane 2363-90A, 20% Ba2SO4

??Status of test material (final product, sterile)

测试材料状态（成品，无菌）

??Type of body contact e.g. circulating blood 身体接触类型 例如：血液循环

??Contact duration e.g. limited contact duration (< 24 h) 接触持续时间 例如：限定的接触持续时间（＜24小时) ??Standard/norm e.g. EN ISO 10993-5: 1999 标准／规范 例如：EN ISO 10993-5: 1999

??Extract preparation (medium, surface/mass to volume ratio, temperature, time) 提取准备（媒介，表面／质量体积比，温度，时间）

??Test lab qualification e.g. competence under DIN EN ISO/IEC 17025, certification acc. to GLP

测试实验室资格 例如： DIN EN ISO/IEC 17025的资格认证，依据GLP的认证 ??Action taken on positive results as described above 上述的对阳性反应采取的措施 o Conclusion结论

??Biological evaluation shall be part of the risk management process 生物学评价应是风险管理过程的一部分．

??A final statement of the manufacturer is necessary. The manufacturer might conclude that in his opinion, based on the submitted documentation, the product safety is ensured

生产商的最终陈述是必要的．生产商可能根据自己的意见，在所提交的文件材料基础上得出产品安全是受到保障的结论．

4.4 Bio-stability Tests生物稳定性测试

Influence of the biological matrix on the device, i.e. 生物基质对器械的影响，即 ??Surface Stress Cracking on Polymers高分子材料的表面应力断裂 ??Corrosion of load-bearing metal screws承重金属螺丝的腐蚀性 ??Coating Stability涂层稳定性

4.5 Microbiological Safety, Animal Origin tissue微生物安全, 动物源性的组织

??Geographical origin and boarding of animals: Species, Country, Herd, Feeding, Age 动物的地理来源：物种，国家，兽群，饲养，年龄 ??Origin of material used/nature of starting tissue: 所用材料来源／组织的性质

??Specified risk material: organ, tissue, body fluid 指定危险物质：器官，组织，人体流体

??For TSE-relevant species: If available certificate of suitability of starting materials with respect to TSE issued by EDQM 对于与传染性海绵状脑病相关的物种：如果可获得与由EDQM签发的传染性海绵状脑病相关的原材料的适用性证书 ??Veterinary controls动物控制

??Certificate demonstrating conformance with veterinary inspection criteria indicating that the raw material was fit for human consumption.

符合指示原材料适合人类消费的兽医学检测标准的证明证书

??Certificate documenting that the applied techniques for stunning and slaughtering were suitable to avoid cross contamination with specified risk material.(References:

EN 12442-2/SSC guidelines/EC decisions.)

适用技术适合避免与规定的危险物质交叉污染的证书记录.（参见：EN 12442-2/SSC 向导/EC决定）

Risk analysis风险分析

??Risk analysis performed according to EN 14971 and EN 12442-1, including immunological,

toxicological, and liquid sterilization risks.

按照EN 14971和EN 12442-1所进行的风险分析,包括免疫学的,毒物学的, 液体杀菌风险.

??Sum of Category Numbers (SCN) for TSE-relevant material only obtained according to

the following scheme

与传染性海绵状脑病相关的物质的类别编号总概仅根据以下的模式包含在内:

Parameter Numbers of Risk categories风险类别的参数编号 1 2 3 4 CN GBR IV Incidence发生率 < 1:10000 GBR III

Incidence发生率 < 1:1 million百万 GBR II Others其它 GBR I No BSE, no Risk风险 Geographical Origin地理来源

Specified risk High risk Medium risk Low risk No risk规定的风险 高风险 中等风险 低风险 无风险

Material 物质

Inactivation钝化 None无 2-4 log 4-6 log > 6 log Quantity/dose > 100 g 1-100 g 10 mg – 1 g < 10 mg of raw material

原材料的数量/剂量 > 100 g 1-100 g 10 mg – 1 g < 10 mg Intracerebral大脑内的Other parenteral 其它肠胃外的 Mucous membrane黏膜

Route of administration给药途径 External skin外部皮肤

Sum of Category Numbers (SCN) 类别编号汇总:

Sum of Category Numbers (SCN) Significance and Consequences类别编号汇总意义和

后果

20 Highest possible score, virtually no risk 20最高的可能得分, 最终无风险