EN 14079:2003

Non-active medical devices - Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze

This standard describes the requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauzes. The standard does not consider gauzes impregnated with a pharmaceutical substance.

Nichtaktive Medizinprodukte - Leistungsanforderungen und Prüfverfarhen für Verbandmull aus Baumwolle und Verbandmull aus Baumwolle und Viskose

Dispositifs médicaux non actifs - Exigences de performance et méthodes d'essais pour la gaze de coton absorbante et la gaze de coton et viscose absorbante

La présente Norme européenne décrit les exigences et les méthodes d'essai applicables à la gaze de coton absorbante et à la gaze de coton et viscose absorbante. Elle ne prend pas en considération les gazes imprégnées de substances pharmaceutiques.

Neaktivni medicinski pripomočki - Zahtevane lastnosti in preskusne metode za vpojno bombažno gazo in viskozno gazo

General Information

• Status: Published
• Publication Date: 22-Apr-2003
• Withdrawal Date: 30-Oct-2003
• ICS: 11.120.20 - Wound dressings and compresses
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205/WG 9 - Test methods for materials for use in compresses
• Current Stage: 9093 - Decision to confirm - Review Enquiry
• Completion Date: 28-Jan-2023
• 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: SIST EN 14079:2003 - Non-active medical devices - Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze

Relations

• Revised: 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
• Effective Date: 19-Jan-2023
• Revised: prEN 14079-1 - 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
• Effective Date: 22-Dec-2008

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 14079:2003
01-september-2003
1HDNWLYQLPHGLFLQVNLSULSRPRþNL=DKWHYDQHODVWQRVWLLQSUHVNXVQHPHWRGH]D
YSRMQRERPEDåQRJD]RLQYLVNR]QRJD]R
Non-active medical devices - Performance requirements and test methods for absorbent
cotton gauze and absorbent cotton and viscose gauze
Nichtaktive Medizinprodukte - Leistungsanforderungen und Prüfverfarhen für
Verbandmull aus Baumwolle und Verbandmull aus Baumwolle und Viskose
Dispositifs médicaux non actifs - Exigences de performance et méthodes d'essais pour
la gaze de coton absorbante et la gaze de coton et viscose absorbante
Ta slovenski standard je istoveten z: EN 14079:2003
ICS:
11.120.20 Sanitetni materiali, obveze in Wound dressings and
komprese compresses
SIST EN 14079:2003 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 14079:2003

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SIST EN 14079:2003
EUROPEAN STANDARD
EN 14079
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2003
ICS 11.120.20
English version
Non-active medical devices - Performance requirements and
test methods for absorbent cotton gauze and absorbent cotton
and viscose gauze
Dispositifs médicaux non actifs - Exigences de Nichtaktive Medizinprodukte - Leistungsanforderungen und
performance et méthodes d'essais pour la gaze de coton Prüfverfarhen für Verbandmull aus Baumwolle und
absorbante et la gaze de coton et viscose absorbante Verbandmull aus Baumwolle und Viskose
This European Standard was approved by CEN on 21 February 2003.
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 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 Management Centre has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2003 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 14079:2003 E
worldwide for CEN national Members.

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SIST EN 14079:2003
EN 14079:2003 (E)
Contents page
Foreword.3
Introduction .4
1 Scope .5
2 Normative references .5
3 Terms and definitions.5
4 Requirements .5
4.1 Fibre Identification.5
4.2 Acidity and alkalinity .5
4.3 Foreign fibres .6
4.4 Fluorescence.6
4.5 Thread count .6
4.6 Mass per square metre.7
4.7 Minimum breaking load.
...