SIST EN 17854:2024
(Main)Antimicrobial wound dressings - Requirements and test method
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
Ta dokument določa minimalne zahteve in preskusno metodo za antimikrobno (mikrobicidno oziroma mikrostatično) aktivnost sanitetnega materiala. Uporablja se za vse vrste sanitetnega materiala, za katere je izrecno navedena antimikrobna aktivnost v skladu s tem dokumentom.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
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 . 11
5.2.1 Volumes . 11
5.2.2 Agar plates . 11
5.3 Materials and reagents . 11
5.3.1 Test organism strains . 11
5.3.2 Reagents and culture media . 12
5.3.3 Test apparatus. 14
5.4 Preparation of test and negative control dressings . 15
5.5 Calculation of saturation volume and working volume . 15
5.6 Preparation of test organism suspensions . 17
5.6.1 Bacteria . 17
5.6.2 Yeast . 18
5.6.3 Preparation of STOCK A . 18
5.7 Neutralization validation . 19
5.7.1 General . 19
5.7.2 Preparation of inoculum . 19
5.7.3 Neutralizer toxicity . 20
5.7.4 Test organism viability . 20
5.7.5 Neutralizer efficacy . 20
5.7.6 Interpretation of data . 21
5.8 Procedure. 23
5.8.1 Exposing the test and negative control dressings to test organisms . 23
5.8.2 Recovery and enumeration of test organisms . 25
5.8.3 Calculation and expression of results . 26
5.8.4 Calculation of the detection limit of the test . 28
5.8.5 Judgement of test validity . 29
5.9 Test report . 29
Annex A (informative) Referenced test organism strains in other national collections . 31
Annex B (informative) Validation of neutralization . 32
B.1 Principle . 32
B.2 Neutralizer selection . 32
Annex C (informative) Neutralizers . 33
Annex D (informative) Rationale . 34
D.1 General . 34
D.2 Title . 34
D.3 Test organism strains. 34
D.4 Preparation of test organism suspensions . 35
D.5 Cutting dressings . 35
D.6 Positive control . 35
D.7 Performance requirements . 35
D.8 Media . 36
D.9 Incubation temperatures . 36
D.10 Dressing classification . 36
D.11 Saturation volume . 36
D.12 Procedure . 36
D.13 Exposure times . 37
D.14 Pre-conditioning and repeat challenge testing. 37
D.15 Humidity . 37
D.16 Recovery of test organisms from dressings . 37
Annex E (informative) Replicates . 38
Annex F (informative) Test method illustrations . 39
Annex G (informative) Example Test Report Tables. 44
Bibliography . 46
European foreword
This document (EN 17854:2024) has been prepared by Technical Committee CEN/TC 205 “Non-active
medical devices” the secretariat of which is held by DIN.
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 September 2024 and conflicting national standards shall
be withdrawn at the latest by September 2024.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national standards body.
A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: 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 the United
Kingdom.
Introduction
This document specifies a test method for establishing whether a wound dressing exerts antimicrobial
activity.
This edition of the document is considered to be most suited for wound dressing types that have been
tested as part of the inte
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