Antimicrobial wound dressings - Requirements and test method

This document specifies minimum requirements and a test method for the antimicrobial (microbicidal or microbistatic) activity of wound dressing products. It applies to all wound dressing products that specifically claim antimicrobial activity according to this document.

Antimikrobielle Wundauflagen - Anforderungen und Prüfverfahren

Dieses Dokument legt Mindestanforderungen und ein Prüfverfahren für die antimikrobielle (mikrobizide oder mikrobiostatische) Wirkung von Wundauflagen fest. Es gilt für alle Wundauflagen, die ausdrücklich eine antimikrobielle Wirkung nach diesem Dokument für sich beanspruchen.

Pansements antimicrobiens - Exigences et méthode d’essai

Le présent document spécifie les exigences minimales et une méthode d’essai pour l’activité antimicrobienne (microbicide ou microbiostatique) des produits de pansement. Il s’applique à tous les produits de pansement qui revendiquent spécifiquement une activité antimicrobienne conformément au présent document.

Protimikrobni sanitetni material - Zahteve in preskusne metode

General Information

Status
Published
Public Enquiry End Date
15-Sep-2022
Publication Date
16-Apr-2024
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
09-Apr-2024
Due Date
14-Jun-2024
Completion Date
17-Apr-2024

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 17854:2024
01-junij-2024
Protimikrobni sanitetni material - Zahteve in preskusne metode
Antimicrobial wound dressings - Requirements and test method
Antimikrobielle Wundauflagen - Anforderungen und Prüfverfahren
Pansements antimicrobiens - Exigences et méthode d’essai
Ta slovenski standard je istoveten z: EN 17854:2024
ICS:
11.120.20 Sanitetni materiali, obveze in Wound dressings and
komprese compresses
SIST EN 17854:2024 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN 17854:2024

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SIST EN 17854:2024


EN 17854
EUROPEAN STANDARD

NORME EUROPÉENNE

March 2024
EUROPÄISCHE NORM
ICS 11.120.20
English Version

Antimicrobial wound dressings - Requirements and test
method
Pansements antimicrobiens - Exigences et méthode Antimikrobielle Wundauflagen - Anforderungen und
d'essai Prüfverfahren
This European Standard was approved by CEN on 14 August 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
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 17854:2024 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------
SIST EN 17854:2024
EN 17854:2024 (E)
Contents Page
European foreword . 4
Introduction . 4
1 Scope . 6
2 Normative references . 6
3 Terms, definitions, symbols and abbreviated terms . 6
3.1 Terms and definitions . 6
3.2 Symbols and abbreviated terms . 8
4 Requirements . 9
4.1 Documentation and training . 9
4.2 Microbicidal dressings . 10
4.3 Microbistatic dressings . 10
4.4 Performance table . 10
5 Test method . 10
5.1 Principle . 10
5.2 General conditions .
...

SLOVENSKI STANDARD
oSIST prEN 17854:2022
01-september-2022
Antimikrobni sanitetni material - Zahteve in preskusne metode
Antimicrobial wound dressings - Requirements and test method
Antimikrobielle Wundauflagen - Anforderungen und Prüfverfahren
Pansements antimicrobiens - Exigences et méthode d’essai
Ta slovenski standard je istoveten z: prEN 17854
ICS:
11.120.20 Sanitetni materiali, obveze in Wound dressings and
komprese compresses
oSIST prEN 17854:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN 17854:2022

---------------------- Page: 2 ----------------------
oSIST prEN 17854:2022


DRAFT
EUROPEAN STANDARD
prEN 17854
NORME EUROPÉENNE

EUROPÄISCHE NORM

June 2022
ICS 11.120.20
English Version

Antimicrobial wound dressings - Requirements and test
method
Pansements antimicrobiens - Exigences et méthode Antimikrobielle Wundauflagen - Anforderungen und
d'essai Prüfverfahren
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
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 17854:2022 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------
oSIST prEN 17854:2022
prEN 17854:2022 (E)
Contents Page
European foreword . 4
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms, definitions, symbols and abbreviated terms . 6
3.1 Terms and definitions . 6
3.2 Symbols and abbreviated terms . 8
4 Requirements . 9
4.1 Documentation and training . 9
4.2 Microbicidal dressings . 10
4.3 Microbistatic dressings . 10
4.4 Performance table . 10
5 Test method .
...

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