hongbaoshu net B R I T I S H STANDARD BS E N 13726 4 2003 Non active medical devices — Test methods for primary wound dressings — Part 4 Conformability T h e E u r o p e a n S t a n d a r d EN 13726 4[.]
BRITISH STANDARD BS E N 13726-4:2003 Non-active medical devices — Test m e t h o d s for primary w o u n d dressings — Part 4: Conformability T h e E u r o p e a n S t a n d a r d EN 13726-4:2003 has t h e status of a British Standard ICS 11.120.20 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW British Standards BS EN 13726-4:2003 National foreword This B r i t i s h Standard is the official English language version of E N 13726-4:2003 The UK participation in its preparation was entrusted by Technical Committee C H / , N o n - a c t i v e m e d i c a l devices, t o S u b c o m m i t t e e C H / / , M e d i c a l textiles, w h i c h has the responsibility to: — aid enquirers to understand the text; — present to the responsible i n t e r n a t i o n a l / E u r o p e a n committee any e n q u i r i e s o n t h e i n t e r p r e t a t i o n , o r p r o p o s a l s f o r change, a n d k e e p t h e U K interests informed; — monitor related international a n d European developments a n d promulgate them in the U K A list of organizations represented on this subcommittee can be obtained on request to its secretary Cross-references The British Standards which implement international or European p u b l i c a t i o n s r e f e r r e d t o i n t h i s d o c u m e n t m a y b e f o u n d i n t h e BSI Catalogue u n d e r t h e section e n t i t l e d " I n t e r n a t i o n a l S t a n d a r d s Correspondence Index", or by u s i n g t h e " S e a r c h " f a c i l i t y of t h e BSI Electronic Catalogue or of B r i t i s h Standards Online T h i s p u b l i c a t i o n does n o t p u r p o r t t o i n c l u d e a l l t h e necessary p r o v i s i o n s o f a contract Users are responsible for its correct application Compliance with a British Standard d o e s not of itself confer i m m u n i t y from legal obligations This British Standard was published under the authority of the Standards Policy and Strategy Committee on 13 May 2003 S u m m a r y of p a g e s T h i s d o c u m e n t c o m p r i s e s a f r o n t cover, a n i n s i d e f r o n t cover, t h e E N t i t l e page, pages to a n d a b a c k cover The B S I copyright date displayed in this document indicates w h e n the d o c u m e n t w a s l a s t issued A m e n d m e n t s issued since publication A m d No I S B N 580 41800 Date Comments EUROPEAN STANDARD EN 13726-4 NORME EUROPEENNE EUROPAISCHE NORM April 2003 ICS 11.120.20 English version Non-active medical devices - Test methods for primary wound dressings - Part 4: Conformability Dispositifs m6dicaux non-actifs - M6thodes d'essai pour les pansements en contact avec la plaie - Partie 4: Conformability Nichtaktive Medizinprodukte - Prufverfarhen fur primare Verbandstoffe (Wundauflagen) - Teil 4: Anpassungsfahigkeit This 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 European Standard the status of a national standard without any alteration Up-to-date lists and bibliographical references concerning such national standards 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 translation under the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the official versions 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 United Kingdom EUROPEAN COMMITTEE FOR STANDARDIZATION COMITE EUROPEEN DE NORMALISATION E U R O P A I S C H E S K O M I T E E FUR N O R M U N G Management Centre: rue de Stassart, 36 © 2003 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members B-1050 Brussels Ref No EN 13726-4:2003 E EN 13726-4:2003 (E) Contents page Foreword Introduction Scope Terms and definitions 3.1 3.2 3.2.1 3.2.2 3.2.2.1 Test method for conformability Test conditions Extensibility and permanent set Significance and use Equipment A tensile testing machine fitted with a load cell suitable for the range being measured capable of measuring to ± 0,1 N A means of cutting a specimen (25,0 ± 0,5) mm wide Stopwatch Procedure Cut out a (25,0 ± 0,5) mm wide specimen representative of the material under test After removing the specimen from the roll or backing paper, allow it to relax for a minimum of 300 s Place parallel marks on the specimen, (100 ± 10) mm apart, such that the marks are at equal distances from the two ends Measure the distance between the two marks to the nearest 0,5 mm (L,) Clamp the specimen outside the marks into the jaws of the tensile testing machine and extend the specimen by 20 % using an extension rate of (300 ± 10) mm/min Record the maximum load (ML) to the nearest 0,1 N Hold the specimen at this extension for (60 ± 1) s then remove the specimen from the jaws and allow it to relax for (300 ± 15) s Re-measure the distance between the two marks on the specimen (L2) Repeat 3.2.3.1 to 3.2.3.6 on a further two specimens Repeat 3.2.3.1 to 3.2.3.7 with a second set of specimens taken perpendicular to the first set Calculation of results Calculate the extensibility using Formula 1: Calculate the permanent set using Formula 2: Test report 5 5 3.2.2.2 3.2.2.3 3.2.3 3.2.3.1 3.2.3.2 3.2.3.3 3.2.3.4 3.2.3.5 3.2.3.6 3.2.3.7 3.2.3.8 3.2.4 3.2.4.1 3.2.4.2 3.2.5 6 6 6 6 6 6 6 EN 13726-4:2003 (E) Foreword This document (EN 13726-4:2003) has been prepared by Technical Committee CEN /TC 205, "Non-active medical devices", the secretariat of which is held by BSI This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by October 2003, and conflicting national standards shall be withdrawn at the latest by October 2003 EN 13726 consists of the following Parts under the general title Non-active medical devices - Test methods for primary wound dressings: Part 1: Aspects of absorbency Part 2: Moisture vapour transmission rate of permeable film dressings Part 3: Waterproofness Part 4: Conformability Part 5: Bacterial barrier properties Part 6: Odour control According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and the United Kingdom EN 13726-4:2003 (E) Introduction EN 13726 gives a test method and does not contain performance requirements EN 13726-4 describes test methods for measuring aspects of conformability of primary wound dressings Test methods for other aspects of primary wound dressings are described in other parts of EN 13726 EN 13726-4:2003 (E) Scope This European Standard describes a test method for measuring aspects of conformability of primary wound dressings Terms and definitions For the purposes of this European Standard the following terms and definitions apply: 2.1 primary wound dressing material or combination of materials, in any shape, form or size that is intended to remain in direct contact with a wound NOTE They are used as mechanical barriers, for the absorption or transmission of exudates, to manage the microenvironment of the wound, and can enable the wound to heal by primary or secondary intent Devices which have a metabolic, pharmacological or immunological interaction as their primary intent are excluded 2.2 conformability of a wound dressing ability to adapt to the shape and movement of the body 2.3 extensibility force required to stretch a wound dressing to known extension 2.4 permanent set increase in the length of a sample after stretching and relaxing expressed as a percentage of the original length Test method for conformability 3.1 Test conditions Condition the sample for at least 16 h at (60 ± 15) % RH and a temperature of (21 ± 2) QC and carry out the test in the same environment 3.2 3.2.1 Extensibility and permanent set Significance and use This test is designed to assess the extensibility and permanent set conformability of a primary wound dressing by measuring its extensibility and permanent set NOTE When a dressing is applied in a region of movement e.g over a joint, it is important that it allows sufficient freedom of movement to avoid damage under the dressing A dressing which is easily extended and which returns close to its original length after extension, will be more comfortable for the patient to wear An adhesive product which extends sufficiently easily with the skin, helps to prevent subcutaneous shearing damage NOTE The test is particularly suitable for adhesive dressings but can also be applied to other dressings which are required to move with the skin EN 13726-4:2003 (E) 3.2.2 Equipment 3.2.2.1 A tensile testing machine fitted with a load cell suitable for the range being measured capable of measuring to ± 0,1 N 3.2.2.2 A means of cutting a specimen (25,0 ± 0,5) mm wide 3.2.2.3 Stopwatch 3.2.3 Procedure 3.2.3.1 Cut out a (25,0 ± 0,5) mm wide specimen representative of the material under test 3.2.3.2 After removing the specimen from the roll or backing paper, allow it to relax for a minimum of 300 s 3.2.3.3 Place parallel marks on the specimen, (100 ± 10) mm apart, such that the marks are at equal distances from the two ends Measure the distance between the two marks to the nearest 0,5 mm (L,) 3.2.3.4 Clamp the specimen outside the marks into the jaws of the tensile testing machine and extend the specimen by 20 % using an extension rate of (300 ± 10) mm/min Record the maximum load {ML) to the nearest 0,1 N 3.2.3.5 Hold the specimen at this extension for (60 ± 1) s then remove the specimen from the jaws and allow it to relax for (300 ± 15) s 3.2.3.6 Re-measure the distance between the two marks on the specimen (L2) 3.2.3.7 Repeat 3.2.3.1 to 3.2.3.6 on a further two specimens 3.2.3.8 Repeat 3.2.3.1 to 3.2.3.7 with a second set of specimens taken perpendicular to the first set 3.2.4 3.2.4.1 Calculation of results Calculate the extensibility using Formula 1: Extensibility (N-cm ) = 2,5 where ML = maximum load Express the result to the nearest 0,1 N-cm-1 and calculate the average result of each set 3.2.4.2 Calculate the permanent set using Formula 2: where L = distance between two marks before elongation L2 = distance between two marks after elongation (1) EN 13726-4:2003 (E) Express the result to the nearest % and calculate the average result of each set 3.2.5 Test report The report shall include at least the following information: a) type of dressing, including lot number; b) 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