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1、BRITISH STANDARD BS EN 13726-2:2002 Test methods for primary wound dressings Part 2: Moisture vapour transmission rate of permeable film dressings The European Standard EN 13726-2:2002 has the status of a British Standard ICS 11.120.20 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIG
2、HT LAW Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:52:17 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 13726-2:2002 This British Standard, having been prepared under the direction of the Health and Environment Sector Policy and Strategy Committee, was published under the authority o
3、f the Standards Policy and Strategy Committee on 15 April 2002 BSI 15 April 2002 ISBN 0 580 39511 1 National foreword This British Standard is the official English language version of EN 13726-2:2002. The UK participation in its preparation was entrusted by Technical Committee CH/117, Medical textil
4、es, to Subcommittee CH/117/1, Test methods for non-wovens for use in compresses, which has the responsibility to: 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 pub
5、lications referred to in this document may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary pr
6、ovisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible European committee any enquiries on the int
7、erpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 9 and a back cover. The BSI co
8、pyright date displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. DateComments Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:52:17 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROP?ENNE EUROPISCHE NORM
9、 EN 13726-2 March 2002 ICS 11.120.20 English version Test methods for primary wound dressings - Part 2: Moisture vapour transmission rate of permeable film dressings Mthodes dessai pour les pansements primaires en contact avec la plaie - Partie 2: Permabilit ? la vapeur deau des pansements comprenan
10、t un film permable Pr?fverfahren f?r prim?re Verbandstoffe (Wundauflagen) - Teil 2: Feuchtigkeitsdurchdringungsrate durchl?ssiger Folienverb?nde This European Standard was approved by CEN on 22 February 2002. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate t
11、he 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
12、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 A
13、ustria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT? EUROP?EN DE NORMALISATION EUROPISCHES KOMITEE F?R NORMUN
14、G Management Centre: rue de Stassart, 36 B-1050 Brussels 2002 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 13726-2:2002 E Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:52:17 GMT+00:00 2006, Uncontrolled Copy, (c) BSI
15、EN 13726-2:2002 (E) 2 Contents page Foreword3 Introduction.4 1Scope 5 2Terms and definitions5 3Test methods for moisture vapour transmission rate (MVTR)5 3.1Test conditions 5 3.2MVTR of a wound dressing when in contact with water vapour.5 3.3MVTR of a wound dressing when in contact with liquid .7 Li
16、censed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:52:17 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 13726-2:2002 (E) 3 Foreword This document EN 13726-2:2002 has been prepared by Technical Committee CEN/TC 205 “Non-active medical devices“, the secretariat of which is held by BSI. This Europe
17、an Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by September 2002, and conflicting national standards shall be withdrawn at the latest by September 2002. This document has been prepared under a mandate given to
18、 CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). EN 13726 will consist of the following parts under the general title Test methods for primary wound dressings: - Part 1 : Aspects of absorbency - Part 2 : Moisture vapour
19、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 implement
20、 this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:52:17 GMT+00:0
21、0 2006, Uncontrolled Copy, (c) BSI EN 13726-2:2002 (E) 4 Introduction EN 13726 specifies test methods and does not contain performance requirements. Part 2 of this standard describes test methods for the determination of the moisture vapour transmission rate of permeable film dressings. Test methods
22、 for other aspects of primary wound dressings are described in other parts of EN 13726. Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:52:17 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 13726-2:2002 (E) 5 1 Scope Part 2 of EN 13726 describes test methods recommended for the evaluation of
23、 moisture vapour transmission rate of permeable film primary wound dressings. 2 Terms and definitions For the purposes of this standard the following terms and definitions apply. 2.1 moisture vapour transmission rate (MTVR) permeability of materials to the passage of water molecules from the skin co
24、ntact side to the external atmosphere under controlled conditions of humidity and temperature 2.2 permeable wound dressing wound dressing that permits water vapour to pass from the skin or wound through it to the external atmosphere 2.3 primary wound dressing material or combination of materials, in
25、 any shape, form or size that is intended to remain in direct contact with a wound NOTE Primary wound dressings are used as mechanical barriers, for the absorption or transmission of exudates, to manage the micro-environment of the wound, and can enable the wound to heal by primary or secondary inte
26、nt. Devices which have a metabolic, pharmacological or immunological interaction as their primary intent are excluded. 3 Test methods for moisture vapour transmission rate (MVTR) 3.1 Test conditions Unless otherwise stated, condition the test samples and carry out the tests at a temperature of (21 2
27、) ?C and a relative humidity of 60 % RH 15 % RH. 3.2 MVTR of a wound dressing when in contact with water vapour 3.2.1 Significance and use The test is intended for the evaluation of the MVTR of a wound dressing when it is in contact with water vapour. This test measures moisture vapour transmission
28、through dressings by mass differential. Entrapment of fluid can lead to serious consequences for skin integrity. Dressings should have sufficient permeability to moisture vapour to prevent fluid collecting under the dressings. NOTE The test is suitable for use with, for example, thin film wound dres
29、sings. 3.2.2 Equipment 3.2.2.1Five clean, dry cylinders, made of corrosion-resistant material with an internal diameter of (35,7 0,1) mm (cross-sectional area 10 cm2) having a flange at each end and able each to accommodate 20 ml of deionised water. (An example of a cylinder that has been found to b
30、e adequate is given in Figure 1). At one end of the cylinder is an annular clamping plate with an orifice area of 10 cm2. At the other end of the cylinder is a solid metal plate the full diameter of the flange. A sealing ring is also advisable to ensure an effective seal against the flange. The plat
31、es at both ends are clamped in position against the flanges. Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:52:17 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 13726-2:2002 (E) 6 3.2.2.2Balance, capable of weighing 100 g with an accuracy of 0,000 1 g. 3.2.2.3Humidity meter, capable of det
32、ecting whether or not the 20 % RH limit has been exceeded. 3.2.2.4Oven or incubator, having a circulating fan and capable of maintaining a temperature of (37 1) C, and being of a design to distribute the air evenly throughout the oven or incubator so as to maintain humidity at less than 20 % RH thro
33、ughout the test. 3.2.2.5Scalpel, or alternative cutting equipment. 3.2.3 Procedure 3.2.3.1Using the flange of clamping plate as a template, cut out a sample of the material to be tested. 3.2.3.2Add sufficient deionised water at room temperature (minimum 20 C) to leave an air gap of (5 1) mm between
34、the liquid surface and the sample when clamped in place. 3.2.3.3Place the circular sample exactly over the flange of the test container. Clamp it in place without stretching the sample, using the clamping plate / clamps to give a watertight seal. If the specimen has an adhesive coated surface, place
35、 the adhesive side to the cylinder flange. For non-adhesive or pattern coated materials, take care to ensure a complete seal. Repeat the procedure four times so as to prepare five samples. NOTE To ensure a good seal a small amount of sealant such as petrolatum can be applied to the flange. 3.2.3.4We
36、igh and record the mass of the container, sample and liquid (W1) to the nearest 0,000 1 g. 3.2.3.5Place the container in the oven / incubator at temperature of (37 1) C with the sample uppermost. 3.2.3.6After 18 h to 24 h remove the container from the oven / incubator and record the test period (T)
37、to the nearest 5 min. 3.2.3.7Immediately reweigh the container and sample and liquid and record the mass (W2) to the nearest 0,000 1 g. 3.2.4 Calculation of results 3.2.4.1Calculate the MTVR using the formula: X = (W1 - W2) ? 1 000 ? 24/T where X is MVTR (g?m-2?24 h-1); W1 is the mass of the contain
38、er, sample and liquid; W2 is the mass of the container, sample and liquid after test period; T is the test period in hours. 3.2.4.2Calculate the mean result of at least five samples. 3.2.4.3Discard values differing by more than 20 % from the mean and repeat the test. 3.2.4.4The test is invalid if th
39、e humidity levels within the oven / incubator rise to more than 20 % RH during the test period. 3.2.5 Test report The report shall include at least the following information: Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:52:17 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 13726-2:2002 (E
40、) 7 a) type of dressing, including lot number; b) any deviations from the test method; c) individual and average results; d) date of test; e) identity of the person(s) who carried out the test. 3.3 MVTR of a wound dressing when in contact with liquid 3.3.1 Significance and use This test is intended
41、for the evaluation of the MVTR of a waterproof wound dressing when it is in contact with liquid. It measures the MVTR through dressings by mass differential. Entrapment of liquid can lead to serious consequences for skin integrity. 3.3.2 Equipment 3.3.2.1Five clean, dry cylinders, as specified in 3.
42、2.2.1. 3.3.2.2Balance, as specified in 3.2.2.2. 3.3.2.3Humidity meter, as specified in 3.2.2.3. 3.3.2.4Oven or incubator, as specified in 3.2.2.4. 3.3.2.5Cutting equipment, as specified in 3.2.2.5. 3.3.3 Procedure 3.3.3.1Perform the procedures described in 3.2.3.1 to 3.2.3.4. 3.3.3.2Invert the conta
43、iner and place it in the oven / incubator at temperature of (37 1) ?C so that the deionised water is in contact with the sample. Ensure there is a sufficient gap between the surface of the sample and the surface of the oven/incubator shelf to allow good airflow across the surface of the sample. 3.3.
44、3.3After approximately 4 h remove the container from the oven / incubator and record the test period (T) to the nearest 5 min. 3.3.3.4Immediately reweigh the container and sample and record the mass (W2) to the nearest 0,000 1 g. 3.3.4 Calculation of results 3.3.4.1Calculate the results as described
45、 in 3.2.4.1 to 3.2.4.4. 3.3.4.2If the MVTR of the test sample is less than 1 000 gm-2 24h-1, repeat the test using a time of 18 h to 24 h in 3.3.3.3. 3.3.5 Test report The report shall include at least the following information: Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:52:17 GMT+00:
46、00 2006, Uncontrolled Copy, (c) BSI EN 13726-2:2002 (E) 8 a) type of dressing, including lot number; b) any deviations from the test method; c) individual and average results; d) date of test; e) identity of the person(s) who carried out the test. Licensed Copy: sheffieldun sheffieldun, na, Sun Oct
47、29 08:52:17 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 13726-2:2002 (E) 9 Dimensions in millimetres 55,6 0,1 32 41 35,7 0,1 1 AA A - A Key 1 Sealing ring Figure 1 ? ? Example of a cylinder that has been found to be adequate Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:52:17 GMT+00:00
48、 2006, Uncontrolled Copy, (c) BSI BS EN 13726-2:2002 BSI 389 Chiswick High Road London W4 4AL BSI British Standards Institution BSI is the independent national body responsible for preparing British Standards. It presents the UK view on standards in Europe and at the international level. It is incor
49、porated by Royal Charter. Revisions British Standards are updated by amendment or revision. Users of British Standards should make sure that they possess the latest amendments or editions. It is the constant aim of BSI to improve the quality of our products and services. We would be grateful if anyone finding an inaccuracy or ambiguity while using this British Standard would inform the Secretary of the technical committee responsible, the identity of which can be found on the inside front cover. Tel: +44 (0)20 8996 9000. Fax: +44
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