sterilizationprocess(seeEN556-1,ENISO11135,ENISO11137-1,ENISO14160,ENISO14937, ENISO17665-1,ENIS020857andENISO25424).Whenamedicaldeviceisintendedtobesterilebut cannotbeterminally-sterilized,asepticprocessingisthemethodofmanufacture(seeENISO13408-1). ...
validationandroutinecontrolofprocessesforthesterilizationofmedicaldevicesarespecifiedinENISO11135,ENISO 11137,EN15014160,EN15014937,EN1$017665·1,EN1$020857,EN15025424and1$022441. NOTE2Evidencethatamedicaldeviceissterilecomesfrom:i]theinitialvalidationofthesterilizationprocessand ...
40、ontrol of the processes used for the sterilization of medical devices have been prepared (see, for example, ISO 11135, ISO 11137 series and ISO 17665). However, it is important to be aware that exposure to a properly validated and accurately controlled sterilization process is not the onl...
International Standards specifying procedures for the validation and routine control of the processes used for the sterilization of medical devices have been prepared (see, for example, ISO 11135, ISO 11137 series and ISO 17665). However, it is important to be aware that exposure to a properly ...
9、EN 14299: 2004-08 DIN EN ISO 25539-2: 2009-01, 2009-08 DIN EN ISO 25539-2:2013-05 3 National Annex NA (informative) Bibliography DIN EN ISO 10993 (all parts), Biological evaluation of medical devices DIN EN ISO 11135-1, Sterilization of health care products Ethylene oxide Part 1...
Draftforcomment90/11135DC ISBN058021057X Cooperatingorganizations TheEuropeanCommitteeforStandardization(CEN),underwhosesupervision thisEuropeanStandardwasprepared,comprisesthenationalstandards organizationsofthefollowingcountries: AustriaOesterreichischesNormungsinstitut ...
sterilizationprocess(seeEN556-1,ENISO11135,ENISO11137-1,ENISO14160,ENISO14937, ENISO17665-1,ENIS020857andENISO25424).Whenamedicaldeviceisintendedtobesterilebut cannotbeterminally-sterilized,asepticprocessingisthemethodofmanufacture(seeENISO13408-1). ...
BS_EN_1422-2014 环氧乙烷灭菌器.pdf,BS EN 1422:2014 BSI Standards Publication Sterilizers for medical purposes — Ethylene oxide sterilizers — Requirements and test methods BS EN 1422:2014 BRITISH STANDARD National foreword This British Standard is the U