kSIST FprEN 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 different performance characteristics of wound dressings, including absorbency, moisture vapour transmission rate, waterproofness and conformability.

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

Dieses Dokument legt die Prüfverfahren für die Bewertung der Aspekte der Saugverhaltens von Verbandstoffen (Wundauflagen), die Prüfverfahren für die Bewertung der Feuchtigkeitsdurchdringungsrate (Feuchtigkeitstransportrate) von durchlässigen Folienverbänden und IV-Katheterverbänden und die Prüfverfahren zum Beurteilen der Wasserdichtheit und Anpassungsfähigkeit fest.
Mit Ausnahme der Anforderungen an die Wasserdichtheit enthält dieses Dokument keine Leistungs-anforderungen für die Prüfverfahren.

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

Le présent document spécifie des méthodes d’essai pour l’évaluation des aspects relatifs au pouvoir absorbant des pansements en contact avec la plaie, des méthodes d’essai pour l’évaluation du taux de transmission de vapeur d’eau des pansements pour cathéter intraveineux et des films dermiques perméables, des méthodes d’essai pour l’évaluation de l’imperméabilité à l’eau et de la conformabilité.
Le présent document ne contient aucune exigence de performance applicable aux méthodes d’essai, sauf en ce qui concerne l’imperméabilité à l’eau.

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

General Information

• Status: Not Published
• Public Enquiry End Date: 19-Mar-2021
• ICS: 11.120.20 - Wound dressings and compresses
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 19-Dec-2023
• Due Date: 23-Feb-2024
• Ref Project: EN 13726:2023 - Test methods for wound dressings - Aspects of absorption, moisture vapour transmission, waterproofness and extensibility

Relations

• Revised: SIST EN 13726-3:2003 - Non-active medical devices - Test methods for primary wound dressings - Part 3: Waterproofness
• Effective Date: 19-Jan-2023
• Revised: SIST EN 13726-4:2003 - Non-active medical devices - Test methods for primary wound dressings - Part 4: Conformability
• Effective Date: 19-Jan-2023
• Revised: SIST EN 13726-2:2002 - Test methods for primary wound dressings - Part 2: Moisture vapour transmission rate of permeable film dressings
• Effective Date: 19-Jan-2023
• Revised: SIST EN 13726-1:2002 - Test methods for primary wound dressings - Part 1: Aspects of absorbency
• Effective Date: 19-Jan-2023
• Revised: SIST EN 13726-4:2003 - Non-active medical devices - Test methods for primary wound dressings - Part 4: Conformability
• Effective Date: 18-Jan-2023
• Revised: SIST EN 13726-2:2002 - Test methods for primary wound dressings - Part 2: Moisture vapour transmission rate of permeable film dressings
• Effective Date: 18-Jan-2023
• Revised: SIST EN 13726-1:2002 - Test methods for primary wound dressings - Part 1: Aspects of absorbency
• Effective Date: 18-Jan-2023
• Revised: SIST EN 13726-3:2003 - Non-active medical devices - Test methods for primary wound dressings - Part 3: Waterproofness
• Effective Date: 18-Jan-2023
• Revised: SIST EN 13726-1:2002/AC:2004 - Test methods for primary wound dressings - Part 1: Aspects of absorbency
• Effective Date: 01-Mar-2021
• Revised: SIST EN 13726-3:2003 - Non-active medical devices - Test methods for primary wound dressings - Part 3: Waterproofness
• Effective Date: 01-Mar-2021
• Revised: SIST EN 13726-4:2003 - Non-active medical devices - Test methods for primary wound dressings - Part 4: Conformability
• Effective Date: 01-Mar-2021
• Revised: SIST EN 13726-2:2002 - Test methods for primary wound dressings - Part 2: Moisture vapour transmission rate of permeable film dressings
• Effective Date: 01-Mar-2021
• Revised: SIST EN 13726-1:2002 - Test methods for primary wound dressings - Part 1: Aspects of absorbency
• Effective Date: 01-Mar-2021

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 .
...