芬 州大学
卫生与环境技米研究所最终报告
University of Finland
Final report of the Institute of Health and Environmental Technology
报告编号：SDWH-M201502709-1 Report Number: SDWH-M201502709-1
参照 ISO 10993-5:2009 方法进行 Refer to ISO 10993-5:2009 methodology
砝橡胶的细胞毒性试验 Cytotoxicity test of weight rubber
MTT 法 MTT method
参照 ISO 10993-5:2009 方法进行 Refer to ISO 10993-5:2009 methodology
砝橡胶的细胞毒性试验 Cytotoxicity test of weight rubber
MTT 法 MTT method
委托单位 Entrusting unit
东莞市天桉硅胶科技有限公司 Dongguan Tianeucalyptus Silicone Technology Co., Ltd
制造商 manufacturer
东党市天桉硅胶科技有限公司 Dongdang Tianeucalyptus Silicone Technology Co., Ltd
制造商 manufacturer
东党市天桉硅胶科技有限公司 Dongdang Tianeucalyptus Silicone Technology Co., Ltd
妨州大学卫生与环境特米研究所 Temi Institute of Health and Environment, University of the Zochurian State
电话: 0512-65880038 传真: 0512-65880034 电子邮箱:sudaweihuan@mail.suda.edu.cn地址：中国苏州工业园区仁爱路 199 号 邮编：215123 http://yxbfzb.suda.edu.cn
Tel: 0512-65880038 Fax: 0512-65880034 E-mail: sudaweihuan@mail.suda.edu.cn Address: No. 199, Renai Road, Suzhou Industrial Park, China Zip code: 215123 http://yxbfzb.suda.edu.cn
Tel: 0512-65880038 Fax: 0512-65880034 E-mail: sudaweihuan@mail.suda.edu.cn Address: No. 199, Renai Road, Suzhou Industrial Park, China Zip code: 215123 http://yxbfzb.suda.edu.cn
目 录 Table of Contents
目 录 … 2 Table of Contents ... 2
检测报告说明 … 3 Test Report Description ... 3
试验确认与签名 … 4 Test Confirmation & Signature ... 4
1.0 摘 要 … 5
1.0 Executive Summary ... 5
2.0 目 的 … 6
2.0 Purpose ... 6
3.0 参考标准 … 6
3.0 Reference Standards ... 6
4.0 执行规范 … 6
4.0 Execution Specification ... 6
5.0 对照和试验样品确定 … 6 5.0 Determination of control and test samples ... 6
6.0 试验系统鉴别 … 7 6.0 Test System Identification ... 7
7.0 试验系统确认 … 7 7.0 Test System Validation ... 7
8.0 给药途径确认 … 7 8.0 Confirmation of route of administration ... 7
9.0 试验设计 … 7 9.0 Design of Experiments ... 7
9.1 试验和对照样品制备 … 7 9.1 Experimental and Control Sample Preparation ... 7
9.2 仪器设备 … 8 9.2 Instruments and equipment ... 8
9.3 试剂。 … 8 9.3 Reagents. … 8
9.4 试验方法 … 8 9.4 Test Methods ... 8
9.5 细胞形态结果 … 8 9.5 Cell morphology results ... 8
9.6 细胞活力结果 … 9 9.6 Cell viability results ... 9
9.7 统计方法 … 9 9.7 Statistical Methods ... 9
9.8 评价标准 … 9 9.8 Evaluation Criteria ... 9
9.9 结 论 … 9
9.9 Conclusion ... 9
10.0 记录存储 … 9
10.0 Record Storage ... 9
11.0 保密协议 … 9
11.0 Non-Disclosure Agreement ... 9
检测报告说明 … 3 Test Report Description ... 3
试验确认与签名 … 4 Test Confirmation & Signature ... 4
1.0 摘 要 … 5
1.0 Executive Summary ... 5
2.0 目 的 … 6
2.0 Purpose ... 6
3.0 参考标准 … 6
3.0 Reference Standards ... 6
4.0 执行规范 … 6
4.0 Execution Specification ... 6
5.0 对照和试验样品确定 … 6 5.0 Determination of control and test samples ... 6
6.0 试验系统鉴别 … 7 6.0 Test System Identification ... 7
7.0 试验系统确认 … 7 7.0 Test System Validation ... 7
8.0 给药途径确认 … 7 8.0 Confirmation of route of administration ... 7
9.0 试验设计 … 7 9.0 Design of Experiments ... 7
9.1 试验和对照样品制备 … 7 9.1 Experimental and Control Sample Preparation ... 7
9.2 仪器设备 … 8 9.2 Instruments and equipment ... 8
9.3 试剂。 … 8 9.3 Reagents. … 8
9.4 试验方法 … 8 9.4 Test Methods ... 8
9.5 细胞形态结果 … 8 9.5 Cell morphology results ... 8
9.6 细胞活力结果 … 9 9.6 Cell viability results ... 9
9.7 统计方法 … 9 9.7 Statistical Methods ... 9
9.8 评价标准 … 9 9.8 Evaluation Criteria ... 9
9.9 结 论 … 9
9.9 Conclusion ... 9
10.0 记录存储 … 9
10.0 Record Storage ... 9
11.0 保密协议 … 9
11.0 Non-Disclosure Agreement ... 9
检测报告说明 Description of the test report
一、对本报告有异议者，请于收到报告之日起十五天内提出复核申请。
1. If you have any objections to this report, please submit an application for review within 15 days from the date of receipt of the report.
二、检测报告涂改或无检测专用章无效。 2. The test report is invalid if it is altered or there is no special seal for testing.
三、检测报告无编制人、审核人及检测报告签发人签字无效。
3. The test report is invalid without the signature of the preparer, reviewer and issuer of the test report.
四、送样委托检验，本检验机构仅对来样负责。 Fourth, the sample is entrusted for inspection, and the inspection agency is only responsible for the sample.
五、未经本检验机构同意，不得部分复制本报告。 5. Without the consent of the inspection agency, this report shall not be partially reproduced.
1. If you have any objections to this report, please submit an application for review within 15 days from the date of receipt of the report.
二、检测报告涂改或无检测专用章无效。 2. The test report is invalid if it is altered or there is no special seal for testing.
三、检测报告无编制人、审核人及检测报告签发人签字无效。
3. The test report is invalid without the signature of the preparer, reviewer and issuer of the test report.
四、送样委托检验，本检验机构仅对来样负责。 Fourth, the sample is entrusted for inspection, and the inspection agency is only responsible for the sample.
五、未经本检验机构同意，不得部分复制本报告。 5. Without the consent of the inspection agency, this report shall not be partially reproduced.