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EUROPEAN STANDARD
DRAFT
NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2006
ICS Will supersede EN 14079:2003
English Version
Non-active medical devices - Properties for compresses and
wound packing products for medical use - Part 1: Test methods
and requirements for absorbent cotton gauze and absorbent
cotton and viscose gauzes used in the manufacturing of
compresses and wound packing products
Dispositifs médicaux inactifs - Propriétés pour des Nichtaktive Medizinprodukte - Eigenschaften von
compresses et produits d'emballage enroulés pour l'usage Kompressen und Tamponadematerial für den
médical - Partie 1: Examiner les méthodes et les conditions medizinischen Einsatz - Teil 1: Prüfverfahren für und
pour la gaze de coton absorbant et les gazes de coton Anforderungen an Verbandmull aus Baumwolle und
visqueuses absorbantes utilisées à la fabrication des Verbandmull aus Baumwolle und Viskose, die zur
compresses et des produits d'emballage de blessure Herstellung von Kompressen und Tamponadematerial
verwendet werden
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 Management Centre has the same
status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,
Slovakia, Slovenia, Spain, Sweden, Switzerland 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
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 14079-1:2006: E
worldwide for CEN national Members.

Contents Page
Foreword.3
1 Scope .4
2 Normative references .4
3 Terms and definitions .4
4 Test methods.6
5 Physical properties.6
6 Chemical properties .6
7 Requirements.6
Annex A (normative) Conditioning of test material.7
Annex B (normative) Test method for the determination of fluorescence .8
Annex C (normative) Test method for the determination of thread count in woven gauze.9
Annex D (normative) Test method for the determination of mass per square metre.10
Annex E (normative) Test method for the determination of the breaking load.11
Annex F (normative) Test method for the determination of the liquid absorbency time .12
Annex G (normative) Test method for the determination of liquid absorptive capacity.14
Annex H (normative) Test method for determination of opacity of x-ray component.16
Annex I (normative) Test method for determination of fibre identification .17
Annex J (normative) Test method for determination of acidity or alkalinity of aqueous extracts.20
Annex K (normative) Test method for determination of substances soluble in non-polar solvents.21
Annex L (normative) Test method for determination of water-soluble substances .23
Annex M (normative) Test method for determination of starch and dextrin .25
Annex N (normative) Test method for determination of sulphated ash.26
Annex O (normative) Test method for determination of colour-fastness of dyed gauze under
moist conditions .28
Annex P (normative) Test method for determination of surface active substances .30
Annex Q (normative) Requirements for gauzes used in the manufacturing of medical devices.31
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC Medical devices .33
Foreword
This document (prEN 14079-1:2006) 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 will supersede EN 14079:2003.
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, B, C or D, which is an integral part of this
document.
Annexes A, B, C, D, E, F, G, H, I, J, K, L, M, N, O, P and Q are normative.

Introduction
Absorbent cotton gauzes and absorbent cotton and viscose gauzes used in the manufacturing of compresses
and wound packing products shall not introduce unacceptable risks to health nor release under the conditions
of intended use, substances in quantities that will produce such a hazard, before and after sterilization.
The absorbent cotton gauzes and absorbent cotton and viscose gauzes shall be stable with or without agents
which are commonly used in wound management, including antiseptics and cleaning solutions.
NOTE Specific tests for finished compresses and wound packing products are covered in part two of EN 14079
which will be developed in parallel.
1 Scope
This European Standard describes the physical and chemical test methods with requirements for the
evaluation of absorbent cotton gauzes and absorbent cotton and viscose gauzes used as materials for
compresses and wound packing products for medical use. X-ray detectable components are included.
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.
ISO 565:1990, Test sieves ― Metal wire cloth, perforated metal plate and electroformed sheet ― Nominal
sizes of openings.
EN ISO 13934-1, Textiles ― Tensile properties of fabrics ― Part 1: Determination of maximum force and
elongation at maximum force using the strip method
3 Terms and definitions
For the purposes of this European Standard, the following terms and definitions apply.
3.1
absorbent cotton gauze
gauze consisting of cotton cloth, which is made absorbent and white by a bleaching process.
NOTE It is practically odorless, contains not more than slight traces of leaf, pericarp seed coat or other impurities and
is reasonable free from processing defects
3.2
absorbent cotton ribbon gauze
ribbon gauze consisting of cotton cloth supplied in continuous ribbons of various widths with fast edges
NOTE It is made absorbent and white by a bleaching process, either before or after processing. It is practically
odorless, contains not more than slight traces of leaf, pericarp seed coat or other impurities and is reasonable free from
processing defects
3.3
absorbent cotton and viscose ribbon gauze
ribbon gauze consisting of cloth supplied in continuous ribbons of various widths with fast edges and is
produced from a combination of cotton and viscose threads.
NOTE It is made absorbent and white by a bleaching process either before or after processing. It is practically
odorless, contains not more than slight traces of leaf, pericarp seed coat or other impurities and is reasonably free from
processing defects
3.4
absorbent cotton and viscose gauze
gauze consisting of cotton and viscose cloth, which is made absorbent and white by a bleaching process.
3.5
colored absorbent gauze
absorbent gauze that has been dyed to a specific color
3.6
gauze compress
piece or pieces of gauzes in any shape, form or size that is used for one or more of the following purposes;
 for cleansing skin or wounds;
 for absorbing body exudates during surgical procedures:
 for use with agents commonly used in wound management:
 to support organs, tissue, etc. during surgical procedures.
3.7
cross direction
direction perpendicular to the processing direction
3.8
machine direction
direction parallel to the processing direction
3.9
warp
yarns arranged lengthways on a loom, forming the threads through which the weft yarns are woven
3.10
weft
yarn woven across the width of the fabric through the lengthways warp yarn
3.11
wound packing product
medical device used to fill a wound to facilitate healing
3.12
x-ray detectable absorbent cotton gauze
absorbent cotton gauze with a clearly visible x-ray detectable component, fixed to the absorbent cotton gauze
in such a way that it shall not become detached
3.13
x-ray detectable absorbent cotton or x-ray detectable cotton and viscose ribbon gauze
ribbon gauze with a clearly visible x-ray detectable component, fixed to it in such a way that it shall not
become detached
3.14
x-ray detectable component
component that gives a clear x-ray opacity. It is free from loose fibers and particles and does not impair the
softness and flexibility of the absorbent gauze or ribbon gauze
4 Test methods
When required in the test method, samples shall be conditioned according to Annex A.
All reagents used in the test methods shall be of analytical grade.
5 Physical properties
Test methods are given for the determination of the following physical properties:
 fluorescence, according to Annex B;
 thread count in woven gauze, according to Annex C;
 mass per square metre, according to Annex D;
 breaking load, according to Annex E;
 liquid absorbency time, according to Annex F;
 liquid absorptive capacity, according to Annex G;
 opacity of x-ray component, according to Annex H;
 fibre identification, according to Annex I.
6 Chemical properties
Test methods are given for the determination of the following chemical properties:
 acidity or alkalinity of aqueous extracts, according to Annex J;
 substances soluble in non-polar solvents, according to Annex K;
 water soluble substances, according to Annex L;
 starch and dextrin, according to Annex M;
 sulphated ash, according to Annex N;
 color fastness of dyed gauze under moist conditions, according to Annex O;
 surface active substances, according to Annex P;
7 Requirements
Annex Q details the acceptance values for Annex B to Annex P.
NOTE These requirements have been historically accepted for gauzes used in the manufacturing of medical devices.
Annex A
(normative)
Conditioning of test material
A.1 Principle
The object of this procedure is to specify, if applicable, the conditioning atmosphere and the method of
conditioning gauzes before and during testing.
A.2 Conditioning atmosphere
A.2.1 Temperature: 20 °C + 2 °C.
A.2.2 Relative humidity: 65 % + 10 %.
A.3 Equipment
A.3.1 Test chamber and measuring instrumentation, provided with automatic equipment for bringing the air
to conditions of relative humidity and temperature given in A.2 and so circulating it that the condition at all
relevant points are uniformly maintained.
NOTE It is recommended that a recording hygrometer, periodically checked by a standard method (
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