Non-active medical devices — Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze
The European Standard EN 14079:2003 has the status of a British Standard
Licensed Copy: Shandong University User, Shandong University , Tue Sep 27 05:04:51 BST 2005, Uncontrolled Copy, (c) BSI
BRITISH STANDARD
BS EN 14079:2003
ICS 11.120.20
BSi British Standards
National foreword
This British Standard is the official English language version of EN 14079:2003.
The UK participation in its preparation was entrusted by Technical Committee CH/205, Non-active medical devices, to Subcommittee CH/205/1, Medical textiles, which has the responsibility to:
— aid enquirers to understand the text;
present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed;
monitor related international and European developments and promulgate them in the UK.
A list of organizations represented on this subcommittee can be obtained on request to its secretary.
Cross-references
The British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online.
This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.
Compliance with a British Standard does not of itself confer immunity from legal obligations.
Summary of pages
This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 18, an inside back cover and a back cover.
The BSI copyright date displayed in this document indicates when the document was last issued.
Amendments issued since publication
| Amd. No. | Date | Comments |
BS EN 14079:2003
Licensed Copy: Shandong University User, Shandong University , Tue Sep 27 05:04:51 BST 2005, Uncontrolled Copy, (c) BSI
This British Standard was published under the authority of the Standards Policy and Strategy Committee on 13 May 2003
© BSI 13 May 2003
ISBN 0 580 41801 4
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 performance et méthodes d'essais pour la gaze de coton absorbante et la gaze de coton et viscose absorbante
Nichtaktive Medizinprodukte - Leistungsanforderungen und Prüfverfarhen für Verbandmull aus Baumwolle und 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
Licensed Copy: Shandong University User, Shandong University , Tue Sep 27 05:04:51 BST 2005, Uncontrolled Copy, (c) BSI
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 14079
April 2003
© 2003 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members.
Ref. No. EN 14079:2003 E
Foreword..
Introduction .
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.
4.7 Minimum breaking load.
4.8 Sinking time.
4.9 Ether-soluble substances
4.10 Surface active substances.
4.11 Water-soluble substances
4.12 Starch and dextrin
4.13 Extractable colouring matter
4.14 Loss on drying
4.15 Sulphated ash. .8
5 Test methods. ..8
5.1 General. ..8
5.2 Fibre identification ..8
5.3 Test method for acidity or alkalinity ...9
5.4 Test method for foreign fibres .10
5.5 Test method for fluorescence.. ..10
5.6 Test method for thread count. ..10
5.7 Test method for mass per square metre ..10
5.8 Test method for minimum breaking load ..10
5.9 Test method for sinking time. ...11
5.10 Test method for ether soluble substances ..11
5.11 Test method for surface active substances ...11
5.12 Test method for water-soluble substances .11
5.13 Test method for starch and dextrin.. ...11
5.14 Test methods for extractable colouring matter ..12
5.15 Test method for loss on drying . ..12
5.16 Test method for sulphated ash. ..12
6 Test report . ....12
Annex A (normative) Reagents to determine the degree of coloration of liquids.. ...13
A.1 Primary solutions. .13
A.2 Standard solutions . ..14
A.3 Reference solutions. ..14
Annex B (normative) Preparation of test solution S.. ...17
Annex ZA (informative) Clauses of this European Standard addressing essential requirements or other
provisions of EU Directives. ...18
Licensed Copy: Shandong University User, Shandong University , Tue Sep 27 05:04:51 BST 2005, Uncontrolled Copy, (c) BSI
EN 14079:2003 (E)
Contents
page
2
Foreword
This document (EN 14079:2003) has been prepared by Technical Committee CEN /TC 205, "Non-active medical devices" the secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by October 2003, and conflicting national standards shall be withdrawn at the latest by October 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.
This standard is based on the European Pharmacopoeia monographs. As charged by CEN/TC 205 it is a mere reformatting of the monographs. It includes requirements and test methods as far as they are in line with the essential requirements as defined in Annex I of the Medical Device Directive 93/42/EEC. This standard does not describe the full state of the art and therefore will be revised immediately after finalization.
Annexes A and B are normative.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and the United Kingdom.
Licensed Copy: Shandong University User, Shandong University , Tue Sep 27 05:04:51 BST 2005, Uncontrolled Copy, (c) BSI
EN 14079:2003 (E)
3
Introduction
Absorbent cotton gauze, absorbent cotton ribbon gauze and absorbent cotton and viscose ribbon gauze were described in the European Pharmacopoeia. Due to the introduction of the Medical Device Directive 93/42/EEC, those monographs have been removed from the European Pharmacopoeia.
Licensed Copy: Shandong University User, Shandong University , Tue Sep 27 05:04:51 BST 2005, Uncontrolled Copy, (c) BSI
EN 14079:2003 (E)
4
1 Scope
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.
2 Normative references
This standard contains no normative references
3 Terms and definitions
For the purposes of this European Standard the following terms and definitions apply:
3.1
absorbent cotton gauze
cotton cloth of plain weave, bleached to a good white and purified, being white and practically odourless, containing not more than slight traces of leaf, pericap seed-coat or other impurities and reasonably free from weaving defects
3.2
absorbent cotton ribbon gauze
woven cloth supplied in continuous ribbons of various widths with fast selvedges, made from cotton threads that are purified, bleached and made absorbent either before or after weaving, being white and practically odourless, containing not more than slight traces of leaf, pericap seed-coat or other impurities and reasonably free from weaving defects
3.3
absorbent cotton and viscose ribbon gauze
woven cloth supplied in continuous ribbons of various widths with fast selvedges, having in the warp cotton threads and in the weft viscose threads or combined cotton and viscose threads, made from threads that are purified, bleached and made absorbent either before or after weaving, being white and practically odourless, containing not more than slight traces of leaf, pericarp seed-coat or other impurities and reasonably free from weaving defects
4 Requirements
4.1 Fibre Identification
4.1.1 Absorbent cotton gauze and absorbent cotton ribbon gauze
When tested according to 5.2.1 the cotton fibres shall conform to the IDENT tests A, B and C.
4.1.2 Absorbent cotton and viscose ribbon gauze
When tested according to 5.2.2 the cotton fibres shall conform to the IDENT tests A and C and the viscose fibres shall conform to IDENT test B.
If it is necessary to differentiate between lustrous or matt viscose, the IDENT test D shall be used.
4.2 Acidity and alkalinity
When tested according to 5.3 neither solution shall be pink.
Licensed Copy: Shandong University User, Shandong University , Tue Sep 27 05:04:51 BST 2005, Uncontrolled Copy, (c) BSI
EN 14079:2003 (E)
5
4.3 Foreign fibres
When tested according to 5.4 the cotton and viscose fibres shall conform to 5.4, only occasionally a few isolated foreign fibres being allowed.
4.4 Fluorescence
When tested according to 5.5 the cotton and viscose gauzes shall conform to 5.5.
4.5 Thread count
When tested according to 5.6 the thread counts per 100 mm shall be as given in Table 1 and Table 2.
(Table 1 — Textile and physical requirements for absorbent cotton gauze)
| Type (numberof threads percm²) | Threads inwarp per 100mm | Minimumbreaking loadin Newton per50 mm warpway | Threads in weftper 100 mm | Minimumbreakingload inNewton per50 mm weftway | Minimummass in g/m² |
| 12 | 73 ± 4 | 1 | 45 ± 4 | - | 13,0 |
| 13 light | 73 ± 4 | - | 57 ± 4 | - | 14,0 |
| 13 heavy | 70 ± 4 | 35 | 60 ± 4 | 20 | 17,0 |
| 17 | 100 ± 5 | 50 | 70 ± 4 | 30 | 23,0 |
| 18 | 100 ± 5 | 50 | 80 ± 5 | 30 | 24,0 |
| 20 | 120 ± 6 | 60 | 80 ± 5 | 35 | 27,0 |
| 22 | 120 ± 6 | 60 | 100 ± 5 | 40 | 30,0 |
| 24 a | 120 ± 6 | 60 | 120 ± 6 | 50 | 32,0 |
| 24 b | 140 ± 6 | 70 | 100 ± 6 | 40 | 32,0 |
Licensed Copy: Shandong University User, Shandong University , Tue Sep 27 05:04:51 BST 2005, Uncontrolled Copy, (c) BSI
EN 14079:2003 (E)
6
(Table 2 — Textile and physical requirements for absorbent cotton ribbon gauze and absorbent cotton and viscose ribbon gauze)
| Type (number ofthreads per cm²) | Threads in warpper 100 mm | Minimum breakingload in Newton per50 mm warp way | Threads in weft per100 mm | Minimum massin ${ \mathfrak { g } } / { \mathfrak { m } } ^ { 2 }$ |
| 22 a | $1 2 0 \pm 3 ^ { \circ }$ | 60 | 100 ± 5 | 33,5 |
| 22 b | $1 2 0 \pm 3 ^ { \circ }$ | 60 | 100 ± 5 | 44,0 |
| 24 a | $1 2 0 \pm 3 ^ { \circ }$ | 60 | 120 ± 6 | 36,0 |
$$ \mathrm { t o } \pm 4 $$
$$ \pm \nobreakspace 8 \nobreakspace $$
4.6 Mass per square metre
When tested according to 5.7 the mass per square metre in grams shall be as given in Table 1 and Table 2.
4.7 Minimum breaking load
When tested according to 5.8 the minimum breaking load in Newton per 50 mm shall be as given in Table 1 and Table 2.
4.8 Sinking time
When tested according to 5.9 the sinking time shall not exceed 10 s.
4.9 Ether-soluble substances
When tested according to 5.10 the amount of ether-soluble substances shall not be more than 0,50 % .
4.10 Surface active substances
When tested according to 5.11 the froth height above the surface of the liquid after 300 s shall not exceed 2 mm.
4.11 Water-soluble substances
When tested according to 5.12 the amount of water-soluble substances shall not be more than 0,50 % .
4.12 Starch and dextrin
When tested according to 5.13 the solution shall not show any blue, violet, reddish or brownish colour.
4.13 Extractable colouring matter
When tested according to 5.14 the liquid obtained shall not be more intensely coloured than reference solution ${ \mathsf { Y } } _ { 5 } ,$ $\mathsf { G Y } _ { 6 }$ or a reference solution prepared as follows: to 3,0 ml of blue primary solution add 7,0 ml of hydrochloric acid (1 % m/V HCl) and dilute 0,5 ml of this solution to 10,0 ml with hydrochloric acid (1 % m/V HCl).
NOTE See annex A for reference solutions.
4.14 Loss on drying
When tested according 5.15 the loss of mass shall not be more than 8,0 %.
Licensed Copy: Shandong University User, Shandong University , Tue Sep 27 05:04:51 BST 2005, Uncontrolled Copy, (c) BSI
EN 14079:2003 (E)
7
4.15 Sulphated ash
When tested according to 5.16 the amount of sulphated ash shall be as given in Table 3.
(Table 3 — Sulphated ash for different materials)
| Material | Sulphated ash |
| Absorbent cotton gauze | shall not exceed 0,40 % |
| Absorbent cotton gauze Type 13 light | shall not exceed 0,75 % |
| Absorbent cotton and matt viscose ribbon gauze | shall not exceed 1,20 % |
| Absorbent cotton and lustrous viscose ribbon gauze | shall not exceed 0,45 % |
5 Test methods
5.1 General
All tests shall be performed with the material in its final form i.e. sterile or non-sterile.
All reagents used shall be of analytical grade.
NOTE The preparation of test solution S is given in annex B.
5.2 Fibre identification
5.2.1 Absorbent cotton gauze and absorbent cotton ribbon gauze
5.2.1.1 Reagents
a) Zinc chloride solution, iodinated: Dissolve 20 g ± 0,5 g of zinc chloride and 6,5 g ± 0,1 g of potassium iodide in 10,5 ml $\pm \ 0 , 1$ ml of water. Add $\hphantom { - } 0 , 5 \ g \texttt { \pm } 0 , 0 5 \ g$ of iodine and shake for 15 min. Filter if necessary. Store protected from light.
b) Zinc chloride-formic acid solution: Dissolve 20 g ± 0,5 g of zinc chloride in 80 ${ \mathfrak { g } } \pm { \mathfrak { 1 } } { \mathfrak { g } }$ of an 85 % m/V solution of anhydrous formic acid.
5.2.1.2 Tests
Untwist a few threads in the warp and in the weft to free a few of the fibres to be examined and carry out IDENT tests A, B and C.
IDENT A: When examined under a microscope, the cotton fibre shall be flat, ribbon-like, 10 µm to 40 µm wide, with thickened ends and an irregularly shaped lumen.
IDENT B: When treated with iodinated zinc chloride solution, the fibres shall become violet.
IDENT C: To 0,1 g ± 0,05 g fibres add 10 ml ± 0,1 ml of zinc chloride-formic acid solution. Heat to $4 0 ~ ^ { \circ } \mathsf { C }$ and allow to stand for 2,5 h, shaking occasionally.
5.2.2 Absorbent cotton and viscose ribbon gauze
5.2.2.1 Reagent
Hydrogen peroxide solution, dilute: Contains not less than 2,5 % m/m and not more than 3,5 % m/m of hydrogen peroxide in water.
Licensed Copy: Shandong University User, Shandong University , Tue Sep 27 05:04:51 BST 2005, Uncontrolled Copy, (c) BSI
EN 14079:2003 (E)
8
预览结束 · 共 22 页
下载完整版