Certificate of Compliance
ISO 10993 Biological Tests
[INCLUSNE OF ADDIT10NAL USP PHYS1COCHE rrCAL TEST G]
Test Article: Loctite @ 3311
Bulk Number: IDH# 313520
Lot Number: L38K001498
INTRACUTANEOUS IN JECTION (ISO ) - Toxikon Project 08-4968-G1: The purpo of this test is to evaluate the irritation potential of the test article extracts in rabbits after intracutaneous injection. Test article extract in saline ,cottoned oil, polyethylene glycol 400 and alcohol in saline did not produce a significantly greater biological reaction than blank extract when injected intracutaneously into rabbits. Additional extracts (PEG & Alcoh
ol in Saline) were ud to cover the requirements of United States Pharmacopeia 31, National Formulary 26,2008; Monograph<88>: Biological Reactivity Tests in Vivo. Bad on the criteria t forth by the protocol, the test artic1e is considered negligible or slight irritant conforms. Reference: Biological Evaluation of Medical Devices - Part 10: Irritation and Delayed type hypernsitivity, ISO 10993-10,2002,as amended 2006.
皮内的在注射(ISO)——Toxikon项目08 - 4968 - g1:这个测试的目的是评估的刺激潜力测试后提取条兔子皮内的注入。测试提取条盐水、棉籽油、聚乙二醇神舟八号飞船400和酒精生理盐水没有产生明显比空白更大的生物反应皮内的注入兔子时提取。额外的提取物(挂钩&酒精生理盐水)被用来覆盖美国药典的要求31日国家规定的26,2008;专著< 88 >:生物体内反应性测试。根据设定的标准协议,测试artic1e被认为是微不足道的或轻微的刺激符合。参考:安全生产考核制度医疗器械生物学评价-第10部分:刺激和延迟类型超敏反应,ISO 10993 - 10,2002年,2006年修订。
ACUTE SYSTEMIC INJECTION ( ISO ) - Toxikon Project 08-4968-G2: The purpo of this assay is to evaluate the test article extracts for potential toxic effects as a result .of single do systemic injection in mice. Test article extracted in saline ,cottoned oil,
关于阅读的手抄报polyethylene glycol 400 and alcohol in saline did not produce a significantly greater biological reaction than blank extract when injected into mice. Additional extracts (PEG & Alcohol in Saline) were ud to cover the requirements of United States Pharmacopeia 31,National Formulary 26,2008; Monograph <88>:Biological Reactivity Tests, In Vivo. The test article did not show greater biological reactivity compared to the control material conforms.
挣外快Reference: Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity,IS0
10993-11:2006.
急性系统性注入(ISO)- Toxikon项目08 - 4968 - g2:本试验的目的是评估测试结果提取条潜在的毒性作用。单剂量系统性注入老鼠体内。测试提取条盐水、棉籽油、聚乙二醇400和酒精生理盐水没有产生生物反应明显大于空白提取时注入老鼠。额外的提取物酸菜白肉的做法(挂钩&酒精生理盐水)被用来覆盖美国药典的要求31日国家规定的26,2008;专著< 88 >:生物活性测试,鸡犬不留体内。测试条没有显示更大的生物反应相比,控制材料符合。
参考:医疗器械生物学评价- 11部分:测试系统毒性、IS0
10993 - 11:2006。
CYTOTOXICITY (ISO) – Toxikon Project 08-4968-G3: The purpo of the MEM Elution is to determine biological reactivity of monolayer cell culture (L929) in repon to the test article. The test article is considered non cytotoxic and meets the requirements of the MEM Elution Test, ISO
10993-5.
Reference: Biological Evaluation of Medical Devices Part 5: Tests for in Vitro Cytotoxicity , IS0
10993-5:1999.
细胞毒性(ISO)——Toxikon项目08 - 4968 - g3:MEM洗脱的目的是确定生物反应的单层细胞培养(L929)测试文章的反馈。测试被认为是条非细胞毒性和满足需求的MEM洗脱测试,ISO
10993 - 5。
爱上夏天参考:医疗器械生物学评价第5部分:IS0体外细胞毒性测试
10993 - 5:1999。
Certificate of Compliance
ISO 10993 Biological Tests
[INCLUSIVE OF ADDITIONAL USP PHYSICOCHEMICAL TESTING]
BEMOCOMPATIBILITY (lSO) -Toxikon Project 08-4968 G4:
溶血Hemolysis: This assay is designed to evaluate the hemolytic potential of the test article extract s. H emol ytic activity of the test article with rabbit blood indicated that the te st article was nOll hemolyti c (<5%).溶血试验：无溶血反应
Reference: Biological Evα/uαtion of Medical Devices Pa1't 4: Selection of Tests 101'Interαctions
with BloodISO 10993-42002 αmended 2006. :医疗器械生物学评价第4部分：与血液相互作用试验选择10993 - 4:2002
III Vitro Hemocompatibility Assay - Toxikon Project 08-4968-G5: lis assay is designed to ensme that the test material extract doe s not adverly affect the cel1ular components o f blood. The test artic1e was evaluated for its potential to adverly affect lected hematological parameters. The hematological parameters tested included complete blood count including platel etshematocrit erythrocyte indicesand platelet count.The test article extract did not have
an y adver effects on any of the hematol ogical parameters tested .
Rfe 1'ence: Biological Evaluation of Medical Devices - Pα 1't 4: Selection 01Testsfo1'Inte1'αctiOI1S凤凰传奇唱的歌
with Blood ISO 10993-4:2002αsαmended 2006. 与血液相互作用试验选择10993 - 4:2002
IMPLANTATION TEST (lSO) - Toxikon Project 08-4968-G7: The results indicated the test article does not demonstrate any remarkable differences for the macroscopic and histological reactions of the test articleimplanted in rabbit muscle for 2 weeks was not significant when compared to negative control sites-
肌肉注射家兔血小板比容不比阴性对照有显著反应。
confomls.
R ference: Biological Evaluation of Medical Devic - pα1't 6: 1i ts for Local E_cts After
ImplantationISO 10993-6: 2007.植入后局部反应试验
PHYSICOCHEMICAL TEST (USP) - Toxikon Project 08-4968-G6: This test detemlnes the physical and chemical propeliies of extracts of test material. The test cle pass the USP Physicochemical Tests for plastics.
