EUROPEAN STANDARD EN ISO 10993-10 NORME EUROPÉENNE EUROPÄISCHE NORM August 2010 ICS 11.100.20 Supersedes EN ISO 10993-10:2009 English Version Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010) Évaluation biologique des dispositif...
EII ISO 10993-12:2012 EUROPEAN STANDARD EN ISO 10993..12 NORME EUROPEENNE EUROpAISCHE NORM July 2012 ICS 11 .100.20 Supersedes EN ISO 10993-12:2009 English Version Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012) Evaluation ...
THETESTRESULTSMAYNOTREFLECTTHEIMPLANTORMATERIALBEHAVIORINTHEBODYTHEDESCRIBEDCHEMICALMETHODOLOGIESAREAMEANSTOGENERATEDEGRADATIONPRODUCTSFORFURTHERASSESSMENTSTHISPARTOFISO10993ISNOTAPPLICABLETODEGRADATIONPRODUCTSINDUCEDBYAPPLIEDMECHANICALSTRESSNOTEMECHANICALLYINDUCEDDEGRADATION,SUCHASWEAR,MAYBECOVEREDINTHEAPPROPRIATEPRODUCTSPECIFIC...
5、ISO 10993-6:2007English VersionBiological evaluation of medical devices - Part 6: Tests for localeffects after implantation (ISO 10993-6:2007Évaluation biologique des dispositifs médicaux - Partie 6: Essais concernant les effets locaux après implantation(ISO 10993-6:2007Biologische Be 6、ur...
thelatesteditionofthereferenceddocument(includinganyamendments]applies. ISO7864,Sterilehypodermicneed阳forsingleuse-Requirementsandtestmethods ISO10993-1.Biologicalevaluationofmedicaldevices-Part1:Evaluationandtestingwithinarisk managementprocess ISO10993-4,Biologicalevaluationofmedicaldevices-Part4:Selectionoftestsforin...
thelatesteditionofthereferenceddocument(includinganyamendments)applies. ISO10993-1,Biologicalevaluationofmedicaldevices-Part1:Evaluationandtestingwithinarisk managementprocess ISO10993-4,Biologicalevaluationofmedicaldevices-Part4:Selectionoftestsforinteractionswithblood ...
新版标准参考IEC60601-1∶2005+A1∶2012[18] 和ISO 10993-1标准,对非植入部分的通用要求引 入风险分析评价管理,并新增软件生命周期过程 评价、非植入部分可用性评价、无线通信数据安 全和对非授权信息篡改的防护、风险管理通用要 求、有源植入式医疗器械各组成部分错误连接风 险评价等要求。新版标准更侧重于风险分...
生物兼容ISO 10993三类医疗MED4-4220 MSDS英文报告.pdf,MED4-4220 Part A Safety Data Sheet According to Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Rules and Regulations Revision Date:: 04/22/2022 Date of Issue: 05/02/2014 Version 4.0 SECTI
1999 ANSI/AAMI/ISO 10993-5:1999 Identical ISO 10993-6:2007 ANSI/AAMI/ISO 10993-6:2007 Identical ISO 10993-7:1995 ANSI/AAMI/ISO 10993-7:1995/(R)2001 Identical ISO 10993-9:1999 ANSI/AAMI/ISO 10993-9:1999/(R)2005 Identical ISO 10993-10:2002 and Amendment ANSI/AAMI BE78:2002 Minor ...
thedefinitionshavebeenalignedwiththelatestversionofIso11139; newrequirementsfortheevaluationofusabilityforasepticpresentationhavebeenadded; newrequirementsfortheinspectionofsterilebarriersystemintegritypriortousehavebeenadded; anewsubclausewithrequirementsforrevalidationinaccordancewithIs011607-2hasbeenadded; AnnexBhasbeen...