oSIST prEN 14079-2:2006

Non-active medical devices - Properties for compresses and wound packing products for medical use - Part 2: Test methods for absorbent cotton gauze and absorbent cotton and viscose gauze

Part 2 of prEN14079 specifies physical and chemical tests for the evaluation of absorbent cotton gauze and absorbent cotton and viscose gauze compresses and wound packing products.
Specific tests and requirements for absorbent cotton gauze and cotton and viscose gauzes used in the manufacture of compresses and wound packing products are covered in prEN 14079-1, which can be used in conjunction with this part of the standard.
NOTE 1   Biocompatibility aspects are not covered in this standard, but are addressed in EN ISO 10993.
NOTE 2   Bioburden determination methods are not covered by this standard, but are addressed in EN XXX.

Nichtaktive Medizinprodukte - Eigenschaften von Kompressen und Tamponadematerial für den medizinischen Einsatz - Teil 2: Prüfverfahren für Verbandmull aus Baumwolle und Verbandmull aus Baumwolle und Viskose

Dispositifs médicaux inactifs - Propriétés pour des compresses et produits d'emballage enroulés pour l'usage médical - Partie 2: Examiner les méthodes pour la gaze de coton absorbant et la gaze de coton visqueuse absorbante

Neaktivni medicinski pripomočki - Lastnosti kompres (obvez) in izdelkov za zavijanje (tamponiranje) ran za uporabo v medicini - 2. del: Preskusne metode za vpojno bombažno gazo in vpojno bombažno in viskozno gazo

General Information

• Status: Not Published
• ICS: 11.120.20 - Wound dressings and compresses
• Technical Committee: VAZ - Healthcare
• Current Stage: 98 - Abandoned project (Adopted Project)
• Start Date: 03-Aug-2012
• Due Date: 08-Aug-2012
• Completion Date: 03-Aug-2012
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: prEN 14079-2 - Non-active medical devices - Properties for compresses and wound packing products for medical use - Part 2: Test methods for absorbent cotton gauze and absorbent cotton and viscose gauze

Relations

• Revised: SIST EN 14079:2003 - Non-active medical devices - Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze
• Effective Date: 18-Jan-2023
• Revised: SIST EN 14079:2003 - Non-active medical devices - Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze
• Effective Date: 22-Dec-2008

Standards Content (Sample)

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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 2: Test methods
for absorbent cotton gauze and absorbent cotton and viscose
gauze
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 2: Examiner les méthodes pour la gaze de medizinischen Einsatz - Teil 2: Prüfverfahren für
coton absorbant et la gaze de coton visqueuse absorbante Verbandmull aus Baumwolle und Verbandmull aus
Baumwolle und Viskose
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 14079-2:2006: E
worldwide for CEN national Members.

Contents Page
Foreword.3
Introduction .3
1 Scope .3
2 Normative references .3
3 Terms and definitions .4
4 Test conditions .4
5 Properties .5
Annex A (normative) Conditioning test for compress or wound packing product .6
A.1 Principle.6
A.2 Conditioning atmosphere .6
A.3 Equipment .6
A.4 Procedure .6
A.4.1 Conditioning.6
Annex B (normative) Test method for absorbent capacity.7
B.1 Principle.7
B.2 Equipment .7
B.3 Procedure .7
B.4 Test report .8
Annex C (normative) Test method for determination of absorption.9
C.1 Principle.9
C.2 Equipment .9
C.3 Procedure .9
C.4 Test report .9
Annex D (normative) Test method for construction strength .10
D.1 Principle.10
D.2 Equipment .10
D.3 Procedure .10
D.4 Test report .10
Annex E (normative) Test method for determination of opacity of x-ray component .11
E.1 Principle.11
E.2 Equipment .11
E.3 Procedure .11
E.4 Test report .11
Annex F (normative) Dimensions of compress .12
F.1 Principle.12
F.2 Equipment .12
F.3 Procedure .12
F.4 Calculation of results .12
F.4.1 Test reports .12

Foreword
This document (prEN 14079-2:2006) 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, which is an integral part of this document.
Annexes A, B, C, D, E, F are normative.
Annex ZA is informative.
Introduction
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 compresses and wound packing products shall be stable with or without agents, which are commonly
used in wound management including antiseptics and cleansing solutions.
1 Scope
Part 2 of prEN14079 specifies physical and chemical tests for the evaluation of absorbent cotton gauze and
absorbent cotton and viscose gauze compresses and wound packing products.
Specific tests and requirements for absorbent cotton gauze and cotton and viscose gauzes used in the
manufacture of compresses and wound packing products are covered in prEN 14079-1, which can be used in
conjunction with this part of the standard.
NOTE 1 Biocompatibility aspects are not covered in this standard, but are addressed in EN ISO 10993.
NOTE 2 Bioburden determination methods are not covered by this standard, but are addressed in EN XXX.
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-ISO 13934-1, Textiles — Tensile properties of fabrics — Part 1: Determination of maximum force and
elongation at maximum force using the strip method
ISO 565, Test sieves — Metal wire clothe, perforated metal and electroformed sheet – Nominal sizes of
openings.
EN ISO 3696, Water for analytical laboratory use – Specifications and test methods.
PrEN 14079-1, Non-active medical devices — test methods and requirements for compresses and wound
packing product for medical use — Part 1: Absorbent cotton gauzes and absorbent cotton and viscose gauzes
used in the manufacturing of compresses and wound packing product
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
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.
3.2
wound packing product
medical device used to fill a wound to facilitate healing
3.3
x-ray detectable absorbent gauze compress or wound packing product
absorbent gauze compress or wound packing product with a clearly visible x-ray detectable component, fixed
to the absorbent gauze in such a way that it shall not become detached
4 Test conditions
When required in the test method, samples shall be conditioned according to Annex A.
If the product is to be used sterile, the samples shall be sterilized according to the manufacturer’s instructions
prior to testing.
All reagents used in the test methods shall be of analytical grade.
5 Properties
Test methods are given for the determination of the following properties, which shall be considered:
 absorbent capacity, according to Annex B;
 rate of absorption, according to Annex C;
 construction strength, according to Annex D;
 x-ray opacity of the gauze compress or wound packing product according to Annex E;
 dimensions of the gauze compress or wound packing product include number of plies if applicable,
according to Annex F
 sewing thread and tape, if used, during the manufacturing of the compress and wound packing product
shall conform to the fluorescence physical requirements and all the chemical requirements of Part 1 of
prEN 14079 (clause 5 and 6).
Annex A
(normative)
Conditioning test for compress or wound packing product
A.1 Principle
The object of this procedure is to specify, if applicable, the conditioning atmosphere and the method of
conditioning compress or wound packing product before and during testing.
A.2 Conditioning atmosphere
 Temperature: 20 °C ± 2 °C.
 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 (e.g. with wet and
dry bulb thermometers) be kept in the test chamber to allow the air conditions to be checked.
A.3.2 Suitable
...