EN 13726:2023

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 vodne pare, vodoodpornosti ter raztegljivosti

Ta dokument določa preskusne metode za oceno vidikov absorpcije sanitetnega materiala za oskrbo rane, preskusne metode za oceno vidikov stopnje prepustnosti vodne pare v rano, oskrbljeno s prepustno filmsko oblogo in obliži za fiksiranje, in preskusne metode za oceno vodoodpornosti in raztegljivosti.

General Information

• Status: Published
• Publication Date: 19-Sep-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: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 20-Sep-2023
• Due Date: 22-May-2022
• Completion Date: 20-Sep-2023
• Ref Project: SIST EN 13726:2024 - Test methods for wound dressings - Aspects of absorption, moisture vapour transmission, waterproofness and extensibility

Relations

• Replaces: EN 13726-4:2003 - Non-active medical devices - Test methods for primary wound dressings - Part 4: Conformability
• Effective Date: 19-Jan-2023
• Replaces: EN 13726-3:2003 - Non-active medical devices - Test methods for primary wound dressings - Part 3: Waterproofness
• Effective Date: 19-Jan-2023
• Replaces: EN 13726-1:2002 - Test methods for primary wound dressings - Part 1: Aspects of absorbency
• Effective Date: 18-Jan-2023
• Replaces: 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
• Replaces: EN 13726-1:2002/AC:2003 - Test methods for primary wound dressings - Part 1: Aspects of absorbency
• Effective Date: 25-Sep-2019

Standards Content (Sample)

SLOVENSKI STANDARD
01-marec-2024
Nadomešča:
SIST EN 13726-1:2002
SIST EN 13726-1:2002/AC:2004
SIST EN 13726-2:2002
SIST EN 13726-3:2003
SIST EN 13726-4:2003
Preskusne metode za sanitetni material za oskrbo rane - Vidiki absorpcije,
prepustnosti vodne pare, vodoodpornosti ter raztegljivosti
Test methods for wound dressings - Aspects of absorption, moisture vapour
transmission, waterproofness and extensibility
Prüfverfahren für Verbandstoffe (Wundauflagen) - Aspekte des Saugverhaltens, der
Feuchtigkeitsdurchdringung, Wasserdichtheit und Anpassungsfähigkeit
Méthodes d’essai pour pansements en contact avec la plaie - Absorption, perméabilité à
la vapeur d’eau, imperméabilité à l’eau et extensibilité
Ta slovenski standard je istoveten z: EN 13726:2023
ICS:
11.120.20 Sanitetni materiali, obveze in Wound dressings and
komprese compresses
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN 13726
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2023
EUROPÄISCHE NORM
ICS 11.120.20 Supersedes 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 absorption,
moisture vapour transmission, waterproofness and
extensibility
Méthodes d'essai pour pansements en contact avec la Prüfverfahren für Verbandstoffe (Wundauflagen) -
plaie - Absorption, perméabilité à la vapeur d'eau, Aspekte des Saugverhaltens, der
imperméabilité à l'eau et extensibilité Feuchtigkeitsdurchdringung, Wasserdichtheit und
Anpassungsfähigkeit
This European Standard was approved by CEN on 17 April 2023.

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 CEN-CENELEC 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 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, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 13726:2023 E
worldwide for CEN national Members.

Contents Page
European foreword . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 Requirements . 9
5 Test methods . 9
Annex A (informative) Rationale for revision for EN 13726 parts 1–4 . 11
Annex B (normative) Free swell absorptive capacity . 16
B.1 Significance and use . 16
B.2 Equipment . 16
B.3 Procedure . 17
B.4 Calculation of results . 19
B.5 Test Report . 20
Annex C (informative) Fluid retention capacity . 21
C.1 Significance and use . 21
C.2 Equipment . 21
C.3 Procedure . 22
C.4 Calculation of results . 23
C.5 Test report . 23
Annex D (informative) Absorption under compression . 24
D.1 Significance and use . 24
D.2 Equipment . 24
D.3 Procedure . 25
D.4 Calculation of results . 27
D.5 Test report . 28
Annex E (normative) Fluid handling capacity (absorption plus moisture vapour loss (MVL),
liquid in contact . 29
E.1 Significance and use . 29
E.2 Equipment . 29
E.3 Procedure . 30
E.4 Calculation of results . 31
E.5 Test report . 32
Annex F (normative) Fluid donation of amorphous hydrogel dressings . 33
F.1 Significance and use . 33
F.2 Equipment . 33
F.3 Procedure . 34
F.4 Calculation of results . 35
F.5 Test report . 35
Annex G (normative) Dispersion characteristics of gelling dressings . 37
G.1 Significance and use . 37
G.2 Equipment . 37
G.3 Procedure . 38
G.4 Calculation of results . 38
G.5 Test report . 38
Annex H (normative) Moisture Vapour Transmission Rate (MVTR) of a wound dressing
when in contact with vapour . 39
H.1 Significance and use . 39
H.2 Equipment . 39
H.3 Procedure . 40
H.4 Calculation of results . 41
H.5 Test report . 41
Annex I (normative) Moisture Vapour Transmission Rate (MVTR) of a wound dressing
when in contact with liquid. 42
I.1 Significance and use . 42
I.2 Equipment . 42
I.3 Procedure . 43
I.4 Calculation of results . 44
I.5 Test report . 44
Annex J (normative) Waterproofness . 46
J.1 Significance and use . 46
J.2 Equipment . 46
J.3 Procedure . 47
J.4 Calculation of results . 47
J.5 Test report . 47
Annex K (normative) Extensibility and Permanent Set . 49
K.1 Significance and use . 49
K.2 Equipment . 49
K.3 Procedure . 49
K.4 Calculation of results . 50
K.5 Test report . 51
Annex L (normative) Test Solution A — Significance and use . 53
Annex M (normative) Test cylinder for Fluid Handling Capacity and MVTR testing —
Equipment .
...