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

Overview

prEN 14079-2 (CEN) - "Non-active medical devices - Properties for compresses and wound packing products for medical use - Part 2" defines test methods for evaluating absorbent cotton gauze and absorbent cotton & viscose gauze used as compresses and wound packing products. This draft European standard focuses on physical and chemical test procedures (conditioning, absorbent capacity, absorption rate, construction strength, x‑ray opacity, dimensions) to support product evaluation, quality control and regulatory conformity in the EU market. Note: biocompatibility and bioburden are addressed in separate standards (EN ISO 10993 and EN XXX respectively).

Key Topics and Requirements

• Scope: Test methods for compresses and wound packing products made from absorbent cotton gauze and cotton/viscose blends; intended to be used in conjunction with prEN 14079-1 for material-specific requirements.
• Conditioning (Annex A): Standard atmospheric conditions for testing - 20 °C ± 2 °C and 65 % ± 10 % relative humidity; procedure for stabilising sample mass before testing.
• Absorbent capacity (Annex B): Water retention test using a perforated stainless steel tray (perforations 3 mm diameter, 5 mm centre spacing), controlled immersion/drain procedure and a defined metal weight to express retention as grams liquid per gram product. Test report must include batch identification, individual results, mean value, deviations and tester identity.
• Absorption rate (Annex C): Time-to-sink / time-to-wet test in deionised water at 20 °C ± 2 °C, measured with stopwatch; repeat measurements and mean reporting.
• Construction strength (Annex D): Methods to assess the mechanical reliability and integrity of the compress/wound packing construction (see standard for specified test set-up).
• X-ray opacity (Annex E) and Dimensions & plies (Annex F): Tests to verify the presence and attachment of x‑ray detectable components and dimensional conformity including number of plies.
• Test reporting: Clear requirements for documenting product type/batch, measured values, deviations and responsible personnel.

Applications and Who Uses It

• Medical device manufacturers: product design verification, supplier control and production quality assurance for gauze compresses and wound packing products.
• Testing and certification laboratories: standardized test procedures for conformity assessment and routine batch testing.
• Regulatory and compliance teams: evidence for CE-marking and to demonstrate alignment with EU directives (see informative Annex ZA).
• Procurement and clinical engineers: specification writing and acceptance testing of sterile or non‑sterile gauze products.

Related Standards

• prEN 14079-1 - material‑specific tests and requirements for absorbent gauzes (use in conjunction).
• EN ISO 10993 - biological evaluation (biocompatibility).
• EN‑ISO 13934-1, ISO 565, EN ISO 3696 - referenced test methods and laboratory practices.

Keywords: prEN 14079-2, absorbent cotton gauze, wound packing products, test methods, absorbent capacity, construction strength, x‑ray opacity, CEN, non-active medical devices.

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 gau
...