ISO10993系列适用于具有适当培训和经验的专业人员,他们能够解释其要求并判断每种医疗器械的评估结果,同时考虑 与医疗器械相关的所有因素、其预期用途以及通过审查科学文献和以往临床经验提供的医疗器械的当前知识。 InformativeAnnexAcontainsatablethatisgenerallyhelpfulinidentifyingendpointsrecommendedinthe biocompatibilityevaluati...
Specific safety evaluation programs follow International Organization for Standardization (ISO) 10993 standards and Food and Drug Administration (FDA) guidance (May 1, 1995). The table is based on ISO 10993-1 Evaluation and testing, 2009 edition. While the table has been developed as a guideline ...
特别是在EN/ISO 10993-1:2018新版标准发行实施之后,医疗器械生物学评价的测试将脱离由原来的采用以接触时间与接触部位选择测试的分析模式,转变为基于风险管理流程的精神进行相关的风险评估与测试,新版标准已明确要求医疗器械制造商需透过风险评估之原则下,...
以上表格参考ISO10993-1 Table A.1 1) 产品选用材料的物理性及化学性资料必须先搜集及进行风险评估; 2) 新版标准测试项目增加了热原性(Materialmediated Pyrogenicity)、慢毒性(Chronictoxicity)、致癌性(Carcinogenicity) 、生殖毒性及可降解性(新材料需评估); 3)X表示生物学风险评估的前置信息,E表示要在风险评估中...
10993—1:2009inorderthatitmayprovide USwithbetterserviceson processingbiological evaluationfor medicaldevices. 【Keyword】medicaldevice;biologicalevaluation;biologicaltest;literaturereview;riskmanagement 作为在全球范围内实施的医疗器械生物学评价 标准,ISO10993系列标准在保护人类免受生物学危 ...
The different categories are shown in the table below. Thereby, you can decide in which category your medical device may be classified and identify the corresponding tests on biocompatibility to be performed for market authorization.Tests to consider (ISO 10993-1: Biological Evaluation of Medical ...
它还包含了ISO10993-4:2002/Amd1:2006修正案。 Thefollowingchangesweremade: 进行了以下更改: a)somedefinitionshavebeenrevisedandnewdefinitionshavebeenadded; a)修订了部分定义,增加了新的定义; PAGE:3©ISO2019–Allrightsreserved ISO10993-4:2017(E)中英文版 b)Tables1and2havebeenconsolidatedintoasinglenew...
This document replaces: EN ISO 10993-12:2009 This document is based on: Published: EN ISO 10993-12:2012 9 July, 2012 ICS number: This document was published under the authority of the NSAI 11.100.20 and comes into effect on: 9 July, 2012 NSAI T +353 1 807 3800 Sa.les: 1 Swift ...
COMPLIANCEWITHTHECLAUSESOFTHISSTANDARDGIVENINTABLEZACONFERS,WITHINTHELIMITSOFTHESCOPEOFTHISSTANDARD,APRESUMPTIONOFCONFORMITYWITHTHECORRESPONDINGESSENTIALREQUIREMENTSOFTHATDIRECTIVEANDASSOCIATEDEFTAREGULATIONSTABLEZACORRESPONDENCEBETWEENTHISEUROPEANSTANDARDANDDIRECTIVE93/42/EECONMEDICALDEVICESCLAUSES/SUBCLAUSESOFTHISENESSENTIAL...
标准号:GB/T 16886.5-2017/ISO 10993-5中文标准名称:医疗器械生物学评价 第 5 部分:体外细胞毒性试验GB/T 16886.5-2017/ISO 10993-5:2009发布日期:2020/6/5 12:00:00有效日期:2024/11/1 12:00:00 相关标准 《GB4824-2013cl.6,cl.7》工业、科学和医疗设备 射频骚扰特性 限值和测量方法《EN12015:20206....