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MessagePosté le: Dim 16 Oct - 05:58 (2016)    Sujet du message: Iso 10993-1 Pdf Free Download Répondre en citant




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In..general,..FDA..agrees..with..the..framework..established..in..ISO..10993-1..for..identification..of..the..nature..and..duration..of..contact..However,..FDA..has..made..several..modifications..to..the..evaluations..identified..in..that..standard,..states..the..FDA,..pointing..readers..to..Section..IV.D..and..Attachment..A..of..its..new..guidance..for..additional..details..of..these..modifications...^...."Use....of....International....Standard....ISO-10993,....'Biological....Evaluation....of....Medical....Devices....Part....1:....Evaluation....and....Testing'....(Replaces....#G87-1....#8294)....(blue....book....memo)"...........(For...in-depth...information...of...the...ISO...10993...standard...for...biocompatibility,...download...our...whitepaper...on...the...topic.)....The...FDA...casts...doubt...on...existing...testing...methods...ability...to...prove...that...a...device...is...completely...free...of...any...particular...allergen...or...toxic...substance,...and...instead...recommends...that...firms...use...the...phrase...Not...made...with...[substance.....FDA...

Available...risk...information:...Manufacturers...should...check...to...see...whether...existing...information...such...as...literature,...standards,...clinical...and...pre-clinical...data...can...adequately...identify...and...mitigate...risks...posed...by...their...own...devices...in...order...to...avoid...unnecessary...additional...testing....Risk....identification:....Manufacturers....should....account....for....potential....risks....including....not....only....chemical....toxicity....but....also....physical....device....characteristics....as....well....as....processing....parameters....that....may....pose....risks....to....patients....and....users.....Risk-based....approaches....to....biocompatibility.....Clear...connections...between...applicants...identified...biocompatibility...risks...and...data...available...to...mitigate...those...risks...should...be...made...in...these...submissions....List....of....ISO....standards.........Final...guidance...issued...by...the...US...Food...and...Drug...Administration...clarifies...and...expands...on...how...manufacturers...of...medical...devices...that...come...into...contact...with...the...human...body...should...comply...with...the...ISO...10993-1...standard...for...biological...evaluation...of...devices...within...risk...management...frameworks....FDA..versus..ISO..10993-1..compliance...ISO...10993-1:2009...Biological...evaluation...of...medical...devices...Part...1:...Evaluation...and...testing...in...the...risk...management...process...ISO...10993-2:2006...Biological...evaluation...of...medical...devices...Part...2:...Animal...welfare...requirements...ISO...10993-3:2014...Biological...evaluation...of...medical...devices...Part...3:...Tests...for...genotoxicity,...carcinogenicity...and...reproductive...toxicity...ISO...10993-4:2002/Amd...1:2006...Biological...evaluation...of...medical...devices...Part...4:...Selection...of...tests...for...interactions...with...blood...ISO...10993-5:2009...Biological...evaluation...of...medical...devices...Part...5:...Tests...for...in...vitro...cytotoxicity...ISO...10993-6:2007...Biological...evaluation...of...medical...devices...Part...6:...Tests...for...local...effects...after...implantation...ISO...10993-7:2008...Biological...evaluation...of...medical...devices...Part...7:...Ethylene...oxide...sterilization...residuals...ISO...10993-8:2001...Biological...evaluation...of...medical...devices...Part...8:...Selection...of...reference...materials...(withdrawn)...ISO...10993-9:1999...Biological...evaluation...of...medical...devices...Part...9:...Framework...for...identification...and...quantification...of...potential...degradation...products...ISO...10993-10:2010...Biological...evaluation...of...medical...devices...Part...10:...Tests...for...irritation...and...skin...sensitization...ISO...10993-11:2006...Biological...evaluation...of...medical...devices...Part...11:...Tests...for...systemic...toxicity...ISO...10993-12:2012...Biological...evaluation...of...medical...devices...Part...12:...Sample...preparation...and...reference...materials...(available...in...English...only)...ISO...10993-13:1998...Biological...evaluation...of...medical...devices...Part...13:...Identification...and...quantification...of...degradation...products...from...polymeric...medical...devices...ISO...10993-14:2001...Biological...evaluation...of...medical...devices...Part...14:...Identification...and...quantification...of...degradation...products...from...ceramics...ISO...10993-15:2000...Biological...evaluation...of...medical...devices...Part...15:...Identification...and...quantification...of...degradation...products...from...metals...and...alloys...ISO...10993-16:1997...Biological...evaluation...of...medical...devices...Part...16:...Toxicokinetic...study...design...for...degradation...products...and...leachables...ISO...10993-17:2002...Biological...evaluation...of...medical...devices...Part...17:...Establishment...of...allowable...limits...for...leachable...substances...ISO...10993-18:2005...Biological...evaluation...of...medical...devices...Part...18:...Chemical...characterization...of...materials...ISO/TS...10993-19:2006...Biological...evaluation...of...medical...devices...Part...19:...Physico-chemical,...morphological...and...topographical...characterization...of...materials...ISO/TS...10993-20:2006...Biological...evaluation...of...medical...devices...Part...20:...Principles...and...methods...for...immunotoxicology...testing...of...medical...devices...ISO/TR...15499:2012...Biological...evaluation...of...medical...devicesGuidance...on...the...conduct...of...biological...evaluation...within...a...risk...management...process.......

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