EN13795-1-2019（部分）

BSEN13795-1:2019EN13795-1:2019E)4 Performance requirementsTo comply with this document,products shall meet all the requirements specified in this documentincluding Tables 1 or 2 (as appropriate to the product),when tested according to Annex A of thisdocument throughout their useful life.The biocompatibility of the product shall be evaluated and approved for acceptable risk.If the manufacturer does not differentiate product areas,all areas shall meet the requirements forcritical product areas.If the intended purpose of a medical device specifies the use as a sterile field the requirements forsurgical drapes and equipment covers apply as per Table 2.For general information on testing and details on the test methods given in this clause includingTables 1 and 2 and their application for the purpose of this document,see Annex A.NOTE 1 Performance requirements are specified depending on product area and performance level.However,for some characteristics the performance requirement will apply for all performance levels and product areas ofthe medical device.NOTE 2 Information on characteristics,which cannot be properly evaluated (as 'adhesion for fixation for thepurpose of wound isolation'or 'liquid control')or which are not regarded normative (as'comfort)is given inAnnex C.Table 1-Characteristics to be evaluated and performance requirements for surgical gownsRequirementTest methodStandard performanceHigh performance(for normativeCharacteristicUnitreferences seeLessLessCriticalCriticalClause 2)criticalcriticalproductproductproductproductareaareaareaareaMicrobial penetrationENIS022612NotNot-DryCFUrequired≤300arequired≤300aMicrobial penetrationNotNot-WetENIS022610B≥2,8brequired6,0bcrequiredCleanliness microbialCFU/ENIS011737-1≤300≤300≤300≤300Bioburden100cm21og10Particle releaseENIS09073-10(lint≤4,0≤4,0≤4,0≤4,0count)Liquid penetrationEN ISO 811cm H20220≥102100210Bursting strength一ENIS013938-1kPa240240≥40≥40Dry11Copyright Bit临nStindard IinstiLtion