Bsi bs en 13726 4 2003

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[.]

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 E N 13726-4:2003 h a s t h e s t a t u s o f a

B r i t i s h S t a n d a r d

ICS 11.120.20

NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW

British Standards

BS EN 13726-4:2003

National foreword

T h i s B r i t i s h S t a n d a r d i s t h e o f f i c i a l E n g l i s h l a n g u a g e v e r s i o n o f

E N 13726-4:2003

T h e U K p a r t i c i p a t i o n i n i t s p r e p a r a t i o n w a s e n t r u s t e d b y T e c h n i c a l C o m m i t t e e

C H / 2 0 5 , 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 / 2 0 5 / 1 , M e d i c a l

t e x t i l e s , w h i c h h a s t h e r e s p o n s i b i l i t y to:

— a i d e n q u i r e r s t o u n d e r s t a n d t h e t e x t ;

— p r e s e n t t o t h e responsible i n t e r n a t i o n a l / E u r o p e a n c o m m i t t e e a n y

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 proposals for change, a n d keep t h e

U K i n t e r e s t s i n f o r m e d ;

— m o n i t o r r e l a t e d i n t e r n a t i o n a l a n d E u r o p e a n d e v e l o p m e n t s a n d

p r o m u l g a t e t h e m i n t h e U K

A l i s t o f o r g a n i z a t i o n s r e p r e s e n t e d o n t h i s s u b c o m m i t t e e c a n b e o b t a i n e d o n

r e q u e s t t o i t s secretary

Cross-references

T h e B r i t i s h S t a n d a r d s w h i c h i m p l e m e n t i n t e r n a t i o n a l o r E u r o p e a n

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 I n d e x " , o r

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

S t a n d a r d s O n l i n e

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

c o n t r a c t U s e r s are responsible f o r i t s correct a p p l i c a t i o n

Compliance with a British Standard does not of itself confer immunity from legal obligations

This British Standard was

published under the authority

of the Standards Policy and

Strategy Committee on

13 May 2003

T h e B S I c o p y r i g h t d a t e d i s p l a y e d i n t h i s d o c u m e n t i n d i c a t e s w h e n t h e

d o c u m e n t w a s l a s t issued

Summary of pages

T h i s d o c u m e n t comprises 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 2 to 7 a n d a b a c k cover

Amendment s issued since publication

A m d No D a t e C o m m e n t s

I S B N 0 580 41800 6

EUROPEAN STANDARD

NORME EUROPEENNE

EUROPAISCHE NORM

EN 13726-4

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 Nichtaktive Medizinprodukte - Prufverfarhen fur primare pansements en contact avec la plaie - Partie 4: Verbandstoffe (Wundauflagen) - Teil 4:

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

C O M I T E E U R O P E E N D E N O R M A L I S A T I O N

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 B-1050 Brussels

© 2003 CEN All rights of exploitation in any form and by any means reserved

worldwide for CEN national Members

Ref No EN 13726-4:2003 E

EN 13726-4:2003 (E)

3.2.2.1 A tensile testing machine fitted with a load cell suitable for the range being measured capable of

3.2.3.1 Cut out a (25,0 ± 0,5) mm wide specimen representative of the material under test 6 3.2.3.2 After removing the specimen from the roll or backing paper, allow it to relax for a minimum of

3.2.3.3 Place 2 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

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

3.2.3.5 Hold the specimen at this extension for (60 ± 1) s then remove the specimen from the jaws and

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 6

2

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

3

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

4

EN 13726-4:2003 (E)

1 Scope

This European Standard describes a test method for measuring aspects of conformability of primary wound dressings

2 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 micro-environment 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

3 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 Extensibility and permanent set

3.2.1 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 1 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 2 The test is particularly suitable for adhesive dressings but can also be applied to other dressings which are required

to move with the skin

5

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 2 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 Calculation of results

3.2.4.1 Calculate the extensibility using Formula 1:

Extensibility (N-cm1) =

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

L1= distance between two marks before elongation

L2 = distance between two marks after elongation

6

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) direction of the specimens taken;

c) any deviations from the test method;

d) individual and average results;

e) date of test;

f) identity of the person(s) who carried out the test.

7

BSI — British Standards Institution

B S I is t h e independent n a t i o n a l body responsible for p r e p a r i n g

B r i t i s h Standards I t presents t h e U K v i e w o n standards i n Europe a n d a t the

i n t e r n a t i o n a l level I t i s incorporated b y R o y a l C h a r t e r

Revisions

B r i t i s h Standards are u p d a t e d by a m e n d m e n t or revision Users of

B r i t i s h Standards should m a k e sure t h a t t h e y possess t h e latest a m e n d m e n t s or editions

It is the constant a i m of B S I to i m p r o v e t h e q u a l i t y of our products a n d services

We w o u l d be g r a t e f u l if anyone finding an inaccuracy or a m b i g u i t y w h i l e u s i n g

t h i s B r i t i s h S t a n d a r d w o u l d i n f o r m t h e Secretary o f t h e technical c o m m i t t e e responsible, t h e i d e n t i t y of w h i c h can be f o u n d on t h e inside f r o n t cover

Tel: +44 (0)20 8996 9000 Fax: +44 (0)20 8996 7400

B S I offers members a n i n d i v i d u a l u p d a t i n g service called P L U S w h i c h ensures

t h a t subscribers a u t o m a t i c a l l y receive t h e latest editions of standards

Buying standards

Orders for a l l BSI, i n t e r n a t i o n a l a n d foreign standards publications should be addressed to Customer Services Tel: +44 (0)20 8996 9001

Fax: +44 (0)20 8996 7001 E m a i l : orders@bsi-global.com Standards are also available f r o m the B S I website a t http://www.bsi-global.com

In response to orders for i n t e r n a t i o n a l standards, it is B S I policy to supply t h e

B S I i m p l e m e n t a t i o n of those t h a t have been p u b l i s h e d as B r i t i s h Standards, unless otherwise requested

Information on standards

B S I provides a w i d e range of i n f o r m a t i o n on n a t i o n a l , E u r o p e a n a n d

i n t e r n a t i o n a l standards t h r o u g h its L i b r a r y a n d its Technical H e l p t o E x p o r t e r s Service V a r i o u s B S I electronic i n f o r m a t i o n services are also available w h i c h give details on a l l its products a n d services Contact t h e I n f o r m a t i o n Centre

Tel: +44 (0)20 8996 7111 Fax: +44 (0)20 8996 7048 E m a i l : info@bsi-global.com Subscribing members o f B S I are k e p t u p t o date w i t h standards developments

a n d receive s u b s t a n t i a l discounts on the purchase price of standards F o r details

of these a n d other benefits contact M e m b e r s h i p A d m i n i s t r a t i o n

Tel: +44 (0)20 8996 7002 Fax: +44 (0)20 8996 7001

E m a i l : membership@bsi-global.com

I n f o r m a t i o n r e g a r d i n g online access t o B r i t i s h Standards v i a B r i t i s h Standards

O n l i n e c a n be f o u n d at http://www.bsi-global.com/bsonline

F u r t h e r i n f o r m a t i o n about B S I i s available o n t h e B S I website a t

http://www.bsi-global.com

Copyright

C o p y r i g h t subsists i n a l l B S I publications B S I also holds t h e copyright, i n t h e

U K , of t h e publications of t h e i n t e r n a t i o n a l s t a n d a r d i z a t i o n bodies Except as

p e r m i t t e d u n d e r t h e Copyright, Designs a n d Patents A c t 1988 no extract m a y be reproduced, stored in a r e t r i e v a l system or t r a n s m i t t e d in any f o r m or by any means — electronic, photocopying, r e c o r d i n g or otherwise — w i t h o u t p r i o r w r i t t e n permission f r o m B S I

T h i s does not preclude t h e free use, in the course of i m p l e m e n t i n g t h e standard,

of necessary details such as symbols, a n d size, type or grade designations If these details are to be used for any other purpose t h a n i m p l e m e n t a t i o n t h e n the p r i o r

w r i t t e n permission of B S I m u s t be obtained

D e t a i l s a n d advice can be obtained f r o m t h e C o p y r i g h t & L i c e n s i n g M a n a g e r Tel: +44 (0)20 8996 7070 Fax: +44 (0)20 8996 7553

E m a i l : copyright@bsi-global.com