FprEN 13726

Test methods for wound dressings - Aspects of absorption, moisture vapour transmission, waterproofness and extensibility

This document specifies test methods for the evaluation of aspects of absorption of wound dressings, test methods for the evaluation of moisture vapour transmission rate of permeable film wound and fixation dressings, and test methods to assess waterproofness and extensibility.

Prüfverfahren für Verbandstoffe (Wundauflagen) - Aspekte des Saugverhaltens, der Feuchtigkeitsdurchdringung, Wasserdichtheit und Anpassungsfähigkeit

Dieses Dokument legt die Prüfverfahren für die Bewertung der Aspekte der Absorption von Verbandstoffen (Wundauflagen), die Prüfverfahren für die Bewertung der Feuchtigkeitsdurchdringungsrate (Feuchtigkeitstransportrate) von durchlässigen Folienwund- und  fixierverbänden und die Prüfverfahren zum Beurteilen der Wasserdichtheit und Dehnungskraft fest.

Méthodes d’essai pour pansements en contact avec la plaie - Absorption, perméabilité à la vapeur d’eau, imperméabilité à l’eau et extensibilité

Le présent document spécifie des méthodes d’essai pour l’évaluation des aspects relatifs à l’absorption des pansements en contact avec la plaie, des méthodes d’essai pour l’évaluation du taux de transmission de vapeur d’eau des pansements de fixation et des films dermiques perméables, et des méthodes d’essai pour l’évaluation de l’imperméabilité à l’eau et de l’extensibilité.

Preskusne metode za sanitetni material za oskrbo rane - Vidiki absorpcije, prepustnosti za vodno paro, odpornosti proti vodi ter raztegljivosti

General Information

• Status: Not Published
• Publication Date: 23-May-2023
• ICS: 11.120.20 - Wound dressings and compresses
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205/WG 15 - Antimicrobial wound care dressings
• Current Stage: 5060 - Closure of Vote - Formal Approval
• Start Date: 16-Mar-2023
• Due Date: 22-Feb-2022
• Completion Date: 16-Mar-2023
• Ref Project: kSIST FprEN 13726:2023 - Test methods for wound dressings - Aspects of absorption, moisture vapour transmission, waterproofness and extensibility

Relations

• Revised: EN 13726-1:2002/AC:2003 - Test methods for primary wound dressings - Part 1: Aspects of absorbency
• Effective Date: 25-Sep-2019
• Revises: EN 13726-1:2002 - Test methods for primary wound dressings - Part 1: Aspects of absorbency
• Effective Date: 18-Jan-2023
• Revises: EN 13726-2:2002 - Test methods for primary wound dressings - Part 2: Moisture vapour transmission rate of permeable film dressings
• Effective Date: 25-Sep-2019
• Revises: EN 13726-4:2003 - Non-active medical devices - Test methods for primary wound dressings - Part 4: Conformability
• Effective Date: 19-Jan-2023
• Revises: EN 13726-3:2003 - Non-active medical devices - Test methods for primary wound dressings - Part 3: Waterproofness
• Effective Date: 19-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN 13726:2021
01-marec-2021
Preskusne metode za sanitetni material za oskrbo rane - Vidiki absorpcije in
prepustnost za vodno paro, odpornost proti vodi ter ustreznost
Test methods for wound dressings - Aspects of absorbency and moisture vapour
transmission, waterproofness and conformability
Prüfverfahren für Verbandstoffe (Wundauflagen) - Aspekte des Saugverhaltens, der
Feuchtigkeitsdurchdringung, Wasserdichtheit und Anpassungsfähigkeit

Méthodes d’essai pour pansements en contact avec la plaie - Absorption et perméabilité

à la vapeur d’eau, imperméabilité à l’eau et conformabilité
Ta slovenski standard je istoveten z: prEN 13726
ICS:
11.120.20 Sanitetni materiali, obveze in Wound dressings and
komprese compresses
oSIST prEN 13726:2021 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN 13726:2021
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oSIST prEN 13726:2021
DRAFT
EUROPEAN STANDARD
prEN 13726
NORME EUROPÉENNE
EUROPÄISCHE NORM
January 2021
ICS 11.120.20 Will supersede EN 13726-1:2002, EN 13726-2:2002,
EN 13726-3:2003, EN 13726-4:2003
English Version
Test methods for wound dressings - Aspects of absorbency
and moisture vapour transmission, waterproofness and
conformability

Méthodes d'essai pour pansements en contact avec la Prüfverfahren für Verbandstoffe (Wundauflagen) -

plaie - Absorption et perméabilité à la vapeur d'eau, Aspekte des Saugverhaltens, der

imperméabilité à l'eau et conformabilité Feuchtigkeitsdurchdringung, Wasserdichtheit und

Anpassungsfähigkeit

This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee

CEN/TC 205.

If this draft becomes a European Standard, 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.

This draft European Standard was established by CEN 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 CEN-CENELEC

Management Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,

Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,

Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and

United Kingdom.

Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are

aware and to provide supporting documentation.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without

notice and shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 13726:2021 E

worldwide for CEN national Members.
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oSIST prEN 13726:2021
prEN 13726:2021 (E)
Contents Page

European foreword ...................................................................................................................................................... 5

1 Scope .................................................................................................................................................................... 6

2 Normative references .................................................................................................................................... 6

3 Terms and definitions ................................................................................................................................... 6

4 Requirements ................................................................................................................................................... 8

5 Test methods .................................................................................................................................................... 8

Annex A (informative) Rationale for revision of EN 13726 part 1-4 ........................................................ 9

Annex B (normative) Free swell absorptive capacity ................................................................................... 13

B.1 Significance and use ..................................................................................................................................... 13

B.2 Equipment ....................................................................................................................................................... 13

B.3 Procedure ........................................................................................................................................................ 14

B.4 Calculation of results ................................................................................................................................... 14

B.5 Test report ....................................................................................................................................................... 15

Annex C (informative) Free-swell absorptive and fluid retention capacity ......................................... 16

C.1 Significance and use ..................................................................................................................................... 16

C.2 Equipment ....................................................................................................................................................... 16

C.3 Procedure ........................................................................................................................................................ 17

C.4 Calculation of results ................................................................................................................................... 19

C.5 Test report ....................................................................................................................................................... 19

Annex D (informative) Absorbency under compression ............................................................................. 20

D.1 Significance and use ..................................................................................................................................... 20

D.2 Equipment ....................................................................................................................................................... 20

D.3 Procedure ........................................................................................................................................................ 21

D.4 Calculation of results ................................................................................................................................... 22

D.5 Test report ....................................................................................................................................................... 23

Annex E (normative) Fluid handling capacity (absorbency plus moisture vapour loss (MVL), liquid

in contact .......................................................................................................................................................... 24

E.1 Significance and use ..................................................................................................................................... 24

E.2 Equipment ....................................................................................................................................................... 24

E.3 Procedure ........................................................................................................................................................ 24

E.4 E.4 Calculation of results ............................................................................................................................ 26

E.5 Test report ....................................................................................................................................................... 26

Annex F (normative) Fluid donation of amorphous hydrogel dressings ............................................... 28

F.1 Significance and use ..................................................................................................................................... 28

F.2 Equipment ....................................................................................................................................................... 28

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F.3 Procedure ........................................................................................................................................................ 28

F.4 Calculation of results ................................................................................................................................... 29

F.5 Test report ....................................................................................................................................................... 29

Annex G (normative) Dispersion characteristics of gelling dressings .................................................... 31

G.1 Significance and use ..................................................................................................................................... 31

G.2 Equipment ....................................................................................................................................................... 31

G.3 Procedure ........................................................................................................................................................ 31

G.4 Calculation of results ................................................................................................................................... 32

G.5 Test report ....................................................................................................................................................... 32

Annex H (normative) Moisture Vapour Transmission Rate (MVTR) of a wound dressing when in

contact with vapour ..................................................................................................................................... 33

H.1 Significance and use ..................................................................................................................................... 33

H.2 Equipment ....................................................................................................................................................... 33

H.3 Procedure ........................................................................................................................................................ 34

H.4 Calculation of results ................................................................................................................................... 34

H.5 Test report ....................................................................................................................................................... 35

Annex I (normative) Moisture Vapour Transmission Rate (MVTR) of a wound dressing when in

contact with liquid ........................................................................................................................................ 36

I.1 Significance and use ..................................................................................................................................... 36

I.2 Equipment ....................................................................................................................................................... 36

I.3 Procedure ........................................................................................................................................................ 36

I.4 Calculation of results ................................................................................................................................... 37

I.5 Test report ....................................................................................................................................................... 38

Annex J (normative) Waterproofness ................................................................................................................. 39

J.1 Significance and use ..................................................................................................................................... 39

J.2 Equipment ....................................................................................................................................................... 39

J.3 Procedure ........................................................................................................................................................ 39

J.4 Calculation of results ................................................................................................................................... 40

J.5 Test report ....................................................................................................................................................... 40

Annex K (normative) Conformability (Extensibility and Permanent Set) ............................................ 42

K.1 Significance and use ..................................................................................................................................... 42

K.2 Equipment ....................................................................................................................................................... 42

K.3 Procedure ........................................................................................................................................................ 42

K.4 Calculation of results ................................................................................................................................... 43

K.5 Test report ....................................................................................................................................................... 43

Annex L (normative) Test Solution A — Significance and use ................................................................... 45

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Annex M (normative) Test cylinder for Fluid Handling Capacity and MVTR testing — Equipment

............................................................................................................................................................................. 46

Annex N (informative) Gasket modification for test cylinder (Fluid Handling Capacity) ............... 48

N.1 Significance and use ..................................................................................................................................... 48

N.2 Equipment ....................................................................................................................................................... 48

N.3 Procedure ........................................................................................................................................................ 48

N.4 Test report ....................................................................................................................................................... 48

Annex O (informative) Air Expulsion for Fluid Handling Capacity Testing .......................................... 50

O.1 Significance and use ..................................................................................................................................... 50

O.2 Equipment ....................................................................................................................................................... 50

O.3 Procedure ........................................................................................................................................................ 50

O.4 Test report ....................................................................................................................................................... 51

Annex P (informative) Dressing Sizes ................................................................................................................ 53

P.1 General.............................................................................................................................................................. 53

P.2 Main elements of a dressing ...................................................................................................................... 53

P.2.1 General.............................................................................................................................................................. 53

P.2.2 Single component dressing ....................................................................................................................... 53

P.2.3 Dual component dressings ........................................................................................................................ 54

P.2.4 Multi-component dressings ...................................................................................................................... 54

P.3 Sizing method ................................................................................................................................................. 55

P.3.1 General.............................................................................................................................................................. 55

P.3.2 Single component dressings ..................................................................................................................... 55

P.3.3 Dual component dressings ........................................................................................................................ 56

P.3.4 Multi component dressings ....................................................................................................................... 56

Annex Q (informative) Future work .................................................................................................................... 57

Bibliography ................................................................................................................................................................. 58

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oSIST prEN 13726:2021
prEN 13726:2021 (E)
European foreword

This document (prEN 13726:2021) has been prepared by Technical Committee CEN/TC 205 “Non-active

medical devices”, the secretariat of which is held by DIN.
This document is currently submitted to the CEN Enquiry.

This document will supersede EN 13726-1:2002, EN 13726-2:2002, EN 13726-3:2003 and EN 13726-4:2003.

This document is a merger of the previously published EN 13726 series. Annex A has been included which

outlines the rational for the major revisions of EN 13726 parts 1-4.

During the systematic review in 2012 it was apparent that no laboratory was performing the odour control

method published in EN 13726-6, and therefore this standard has been withdrawn per CEN/BT decision

c023/2020.

The test methods are listed as separate annexes and there are new methods covering Free-swell absorptive and

fluid retention capacity (Annex C) and Absorbency under compression (Annex D).

Test methods which were infrequently used (Gelling Characteristics and Dispersion/solubility of hydrogel

dressings) have been removed from the standard.

Modifications to previous methods have also been implemented to more closely simulate clinical use of the

wound dressings (Annex G - Dispersion characteristics of gelling dressings), and to eliminate artefacts which

have been introduced by the technical methods which would not be expected in the clinical setting (Annex E -

Fluid handling capacity i.e. modifications to the test apparatus to eliminate dressing doming during testing

which increases the test surface area leading to significant over-estimates of the dressings fluid handling

capacity).

EN 13726 now consists of a single part, under the general title Test methods for wound dressings: Aspects of

Absorbency and Moisture Vapour Transmission, Waterproofness and Conformability.Scope

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oSIST prEN 13726:2021
prEN 13726:2021 (E)
1 Scope

This document specifies test methods for the evaluation of aspects of absorbency of wound dressings, test

methods for the evaluation of moisture vapour transmission rate of permeable film wound and IV catheter

dressings, and test methods to assess waterproofness and conformability.

Except for the requirements for waterproofness, this document does not contain performance requirements

for test methods.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
3.1
single absorbent layer dressing
dressing incorporating a single type of absorbing materials

Note 1 to entry: for example this could include a dressing one or both of a backing film and an adhesive layer

3.2
multi absorbent layered dressing
dressing incorporating more than one type of absorbing material

Note 1 to entry: for example a dressing containing both a gelling fibre and foam layers

3.3
gelling dressing

single absorbent layer dressings that ‘gel’ freely when in contact with physiological fluid

Note 1 to entry: for example hydrogels, alginates and other gelling fibre dressings

3.4
foam dressing
single absorbent layer dressing incorporating an absorbent open cellular solid
Note 1 to entry: for example polyurethane based foams
3.5
film dressing

single component dressing consisting of a non-absorbing material which can also include an adhesive layer

Note 1 to entry: for example semi-permeable film materials
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oSIST prEN 13726:2021
prEN 13726:2021 (E)
3.6
super absorbent dressing
single absorbent layer dressing incorporating super absorbent polymer particles

Note 1 to entry: for example a polyacrylate, that can absorb several times their weight in liquid

3.7
amorphous hydrogel dressing
semi-solid gel that contains hydrophilic polymers and water
3.8
free swell absorptive capacity

total absorptive capacity in the presence of excess test liquid and in the absence of any applied load expressed

in g/cm of the absorbent area
3.9
fluid retention

absorbed fluid retained following application of load expressed in g/cm of the absorbent area

3.10
fluid absorbed (ABS)
fluid absorbed, expressed in g
3.11
moisture vapour loss (MVL)
fluid transpired through the dressing, expressed in g
3.12
fluid handling capacity (FHC)

sum of the fluid absorbed (ABS) and the moisture vapour loss (MVL) expressed in g/cm

3.13
moisture vapour transmission rate (MVTR)

general term used to describe the rate of permeability of materials to the passage of moisture vapour molecules

from the skin contact side to the external atmosphere under controlled conditions of humidity and temperature

expressed in g/cm /24h
3.14
fluid donation of a wound dressing
ability to donate fluid to a simulated wound
3.15
waterproofness
ability to withstand a hydrostatic head of 500mm
3.16
conformability of a wound dressing
ability to adapt to the shape and movement off the body
3.17
extensibility
force needed to stretch a dressing to a known extension expressed in N/cm
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oSIST prEN 13726:2021
prEN 13726:2021 (E)
3.18
permanent set

increase in length of a sample after stretching and relaxing, expressed as a percentage (%) of the original length

4 Requirements

At present the value of the standard is in standardising the methods of assessing dressing performance, but the

aim is to start to define performance requirements for different classes of dressings for future revisions.

Therefore, we would welcome proposals from stakeholders once they have gained experience and test data

from the revised methods.
5 Test methods
Where required, test conditions are specified in individual Annexes.

• Wound dressings that handle fluid via absorbency can be tested as per Annex B-D of this standard.

• Wound dressings that handle fluid via absorbency and moisture vapour loss (known as fluid handling

capacity) should be tested as per Annex E of this standard.

• The fluid donation of amorphous hydrogels should be measured using Annex F of this standard.

• The dispersion characteristics of gelling dressings should be tested using Annex G of this standard.

• Wound dressings which do not have an absorbing function, but which handle fluid via moisture vapour

transmission, should be tested to Annex H-I of this standard.

• Wound dressings that claim to be waterproof should be tested to Annex J of this standard.

• To assess a wound dressing conformability, measure the extensibility and permanent set using Annex K of

this standard.

• The test solution used for absorbency, fluid handling capacity and MVTR is specified in Annex L.

• The test cylinder used for fluid handling capacity (Annex E) and moisture vapour transmission rate

(Annexes H-I) is described in Annex M.

• Modifications of the test cylinder for testing multi-layer construction dressings that are prone to leakage is

detailed in the informative Annex N.

• A method to remove entrapped air in dressings for fluid handling capacity testing is described in the

informative Annex O.

• An informative section that discusses wound dressing size labelling on packaging and suggestions for

greater clarity is presented in Annex P.

• Informative Annex Q is included that discusses possible future work programmes.

Any deviations from the test parameters listed in this standard shall be validated by the laboratory undertaking

the test, and deviations noted in the test report.
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oSIST prEN 13726:2021
prEN 13726:2021 (E)
Annex A
(informative)
Rationale for revision of EN 13726 part 1-4

Since EN 13726 parts 1, 2, 3 and 4 were published, dressings technology has changed significantly. Test method

parameters which seemed reasonable when the standard was first drafted are now causing operational

difficulties for test houses, manufacturers and purchasers.

During the same period, European procurement legislation has also changed, and it is increasingly common for

contracts to specify that data be provided in compliance with EN 13726. However, the technical issues now

inherent in the standard mean that the usefulness of some of this data is questionable, and in fact can be

misleading.
The technical issues include the following:

1. The term primary has been removed as the tests are applicable to both primary (direct contact with

wound) and secondary (indirect contact with wound) dressings. A good example would be film dressings,

which are often used on top of an absorbent layer.

2. There is similarity between EN 13726 parts 1 and 2, and therefore both parts have been merged into a

single document. Individual tests are now presented as separate Annexes.

3. Many dressings are now designed to be used under compression bandages/hosiery, and have the ability to

absorb under compression, but EN 13726 had no option to test in this manner. The revised standard now

includes additional tests assessing Free-Swell Absorptive /Fluid Retention Capacity (Annex C – this test

simulates a dressing which has absorbed and then exposed to pressure such as a patient rolling over onto

the dressing e.g. sacral or thigh wound) and Absorbency Under Compression (Annex D – simulate a

dressing under pressure before absorbing fluid e.g. dressings under compression bandages).

4. Some of the test methods in the standard were being used for classes of dressings where they are

inappropriate (for example, the free swell test is being used for super-absorbents). This requires sectioning

of the dressings which can cause leaching of the super-absorbent from the dressing and thus lower than

expected absorbency results. New test methods detailing Free-Swell Absorptive/Fluid Retention Capacity

and Absorbency Under Compression of intact dressings are detailed in Annex C and D respectively.

5. Incubation times (30 mins) for Annex C and D are based on previous work the UK has undertaken and a

report is available online see [1] in bibliography.

6. The temperature requirements for Annexes B, C and D relate to measurement of air temperature in the

incubator rather than test fluid temperature. Testing performed by members of the working group has

shown no statistical difference in dressing absorbenc
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