SIST EN 13726-4:2003
(Main)Non-active medical devices - Test methods for primary wound dressings - Part 4: Conformability
Non-active medical devices - Test methods for primary wound dressings - Part 4: Conformability
This European Standard describes a test method for measuring aspects of conformability of primary wound dressings.
Nichtaktive Medizinprodukte - Prüfverfarhen für primäre Verbandstoffe (Wundauflagen) - Teil 4: Anpassungsfähigkeit
Dispositifs médicaux non-actifs - Méthodes d'essai pour les pansements en contact avec la plaie - Partie 4: Conformabilité
La présente Norme européenne décrit une méthode d'essai permettant de mesurer les performances de conformabilité des pansements primaires en contact avec la plaie.
Neaktivni medicinski pripomočki – Preskusne metode za sanitetni material za primarno oskrbo rane - 4. del: Ustreznost
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Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Nichtaktive Medizinprodukte - Prüfverfarhen für primäre Verbandstoffe (Wundauflagen) - Teil 4: AnpassungsfähigkeitDispositifs médicaux non-actifs - Méthodes d'essai pour les pansements en contact avec la plaie - Partie 4: ConformabilitéNon-active medical devices - Test methods for primary wound dressings - Part 4: Conformability11.120.20Sanitetni materiali, obveze in kompreseWound dressings and compressesICS:Ta slovenski standard je istoveten z:EN 13726-4:2003SIST EN 13726-4:2003en01-september-2003SIST EN 13726-4:2003SLOVENSKI
STANDARD
SIST EN 13726-4:2003
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 13726-4April 2003ICS 11.120.20English versionNon-active medical devices - Test methods for primary wounddressings - Part 4: ConformabilityDispositifs médicaux non-actifs - Méthodes d'essai pour lespansements en contact avec la plaie - Partie 4:ConformabilitéNichtaktive Medizinprodukte - Prüfverfarhen für primäreVerbandstoffe (Wundauflagen) - Teil 4:AnpassungsfähigkeitThis European Standard was approved by CEN on 21 February 2003.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the Management Centre or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and UnitedKingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2003 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 13726-4:2003 ESIST EN 13726-4:2003
EN 13726-4:2003 (E)2ContentspageForeword.3Introduction.41Scope.52Terms and definitions.53Test method for conformability.53.1Test conditions.53.2Extensibility and permanent set.53.2.1Significance and use.53.2.2Equipment.63.2.2.1A tensile testing machine fitted with a load cell suitable for the range being measured capable ofmeasuring to ± 0,1 N.63.2.2.2A means of cutting a specimen (25,0 ± 0,5) mm wide.63.2.2.3Stopwatch.63.2.3Procedure.63.2.3.1Cut out a (25,0 ± 0,5) mm wide specimen representative of the material under test.63.2.3.2After removing the specimen from the roll or backing paper, allow it to relax for a minimum of300 s.63.2.3.3Place 2 parallel marks on the specime
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