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 ...
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
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...
BIODEGRADABILITYOFDENTALMETALALLOYSSTANDARDIZATIONOFELECTROCHEMICALTEST3ISO1099317,BIOLOGICALEVALUATIONOFMEDICALDEVICESPART17ESTABLISHMENTOFALLOWABLELIMITSFORLEACHABLESUBSTANCESUSINGHEALTHBASEDRISKASSESSMENT4ISO10271,DENTALMETALLICMATERIALSCORROSIONTESTMETHODSWWWBZFXWCOMBSENISO10993152009BSIGROUPHEADQUARTERS389CHISWICKHIGHROAD,LONDON...
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...
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 ...
ISO 10993-1:2018 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process (the 5th version) has been went into effect since August 20th, 2018. The latest version states: For gas pathway device ...
giveninISO10993-1.Forfurtherguidance,seeISO/TS16775. c)physicalandchemicalproperties; dcompatibilitywithrespecttoforming,sealingandassemblyprocesses; e)compatibilitywithrespecttotheintendedsterilizationprocess(es)(see5.3); f)anyusebydatelimitationsforpre-sterilizationstorageandshelf-lifelimitationsforpost- sterili...
2006 ANSI/AAMI/ISO TIR10993-20:2006 Identical ISO 11135:1994 ANSI/AAMI/ISO 11135:1994 Identical ISO 11137-1:2006 ANSI/AAMI/ISO 11137-1:2006 Identical ISO 11137-2:2006 (2006-08-01 ANSI/AAMI/ISO 11137-2:2006 Identical corrected version) ISO 11137-3:2006 ANSI/AAMI/ISO 11137-3:2006 ...