prEN 16756
(Main)Antimicrobial wound dressings - Requirements and test methods
Antimicrobial wound dressings - Requirements and test methods
This standard specifies requirements and test methods for the antimicrobial activity of antimicrobial wound dressings. It is designed for microbicidal and microbistatic dressings.
Test methods specifically for microbial binding are not included in the standard.
Antimikrobielle Wundauflagen - Anforderungen und Prüfverfahren
Diese Norm legt Anforderungen und Prüfverfahren für die antimikrobielle Wirkung antimikrobieller Wundauflagen fest. Sie ist vorgesehen für mikrobizide und mikrobistatische Auflagen.
Prüfverfahren speziell für mikrobielle Bindungen sind nicht in dieser Norm enthalten.
Pansements antimicrobiens - Exigences et méthodes d'essai
La présente norme spécifie les exigences et méthodes d’essai applicables à l’activité antimicrobienne de pansements antimicrobiens. Elle s’applique aux pansements microbicides et microbiostatiques.
Les méthodes d’essai spécialement applicables à la fixation microbienne ne sont pas incluses dans la norme.
Antimikrobni sanitetni material - Zahteve in preskusne metode
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2014
Antimikrobni sanitetni material - Zahteve in preskusne metode
Antimicrobial wound dressings - Requirements and test methods
Antimikrobielle Wundauflagen - Anforderungen und Prüfverfahren
Pansements antimicrobiens - Exigences et méthodes d'essai
Ta slovenski standard je istoveten z: prEN 16756
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.
EUROPEAN STANDARD
DRAFT
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2014
ICS 11.120.20
English Version
Antimicrobial wound dressings - Requirements and test methods
Pansements antimicrobiens - Exigences et méthodes 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, 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: Avenue Marnix 17, B-1000 Brussels
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 16756:2014 E
worldwide for CEN national Members.
Contents
Page
Foreword . iv
Introduction .v
1 Scope .6
2 Normative references .6
3 Terms and definitions .6
4 Classification .7
5 Requirements .7
5.1 Microbicidal dressings .7
5.2 Microbistatic dressings .7
5.3 Performance Table.7
6 Information to be supplied .7
Annex A (normative) Validation of dilution-neutralisation .9
A.1 Principle .9
A.2 Neutralizer selection .9
A.3 Preparation of microbial suspension .9
A.4 Test validation .9
A.5 Neutralizer toxicity . 10
A.6 Test organism viability . 11
A.7 Neutralisation Effectiveness . 11
A.8 Interpretation of data . 12
Annex B (informative) Neutralizers . 13
Annex C (informative) Rationale . 14
C.1 Title . 14
C.2 Microbial strains . 14
C.3 Cutting dressings . 15
C.4 Positive control . 15
C.5 Microbistatic requirements . 15
C.6 Performance Requirements . 15
C.7 Test method Information . 15
C.8 Media . 16
C.9 Incubation Temperatures . 16
C.10 Dressing Classification . 16
Annex D (informative) Apparatus . 17
Annex E (informative) Reagents and culture media . 18
E.1 General . 18
E.2 Water . 18
E.3 Tryptone Soya Agar . 18
E.4 Maximum recovery diluent . 18
E.5 Simulated Wound Fluid (SWF) . 18
E.6 Sabouraud agar (SAB) . 19
E.7 Neutralizer . 19
Annex F (informative) Reference strains. 20
F.1 Storage of strains . 20
F.2 Bacterial strains . 20
F.3 Yeasts and molds . 20
F.4 Other Strains . 20
Annex G (informative) Preparation of microbial suspensions . 21
G.1 Stock Cultures . 21
G.2 Working Culture . 21
Annex H (normative) Test methods . 22
H.1 Introduction . 22
H.2 Equilibration of reagents . 22
H.3 Neutralizer . 22
H.4 Choice of experimental conditions . 22
H.5 Sample Size . 23
H.6 Direct contact test method . 23
H.7 Shaking method . 24
H.8 Two compartment method . 25
H.9 Recovery and enumeration of test organisms . 26
H. 10 Calculation and expression of results . 26
H.11 Test report . 29
Annex I (informative) Figures and illustrations . 30
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/92/EEC on medical devices . 32
Bibliography . 33
iii
Foreword
This document (prEN 16756:2014) 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 has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document.
Introduction
This standard describes a range of test methods for establishing whether a wound dressing exerts
antimicrobial activity.
The laboratory tests attempt to simulate conditions of application, through the use of appropriate test fluids,
temperature, organisms, and contact times reflecting the parameters found in clinical situations. Conditions
which may influence the action of wound dressings having antimicrobial properties should be included.
The conditions are intended to cover general purposes and to allow comparison between laboratories and
product types.
v
1 Scope
This standard specifies requirements and test methods for the antimicrobial activity of antimicrobial wound
dressings. It is designed for microbicidal and microbistatic dressings.
Test methods specifically for microbial binding are not included in the standard.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
EN 12353, Chemical disinfectants and antiseptics — Preservation of test organisms used for the
determination of ba
...
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