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EUROPEAN STANDARD
DRAFT
prEN 14079-1
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.
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prEN 14079-1:2006 (E)
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
2
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prEN 14079-1:2006 (E)
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.
3
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prEN 14079-1:2006 (E)
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.
4
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prEN 14079-1:2006 (E)
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
5
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prEN 14079-1:2006 (E)
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.
6
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prEN 14079-1:2006 (E)
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 (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 balance, capable of measurement in grams to two decimal places
A.4 Procedure
A.4.1 Conditioning
A.4.1.1 Place the test specimen in the conditioning atmosphere.
A.4.1.2 Suspend or support the test specimen so that the conditioning atmosphere has free access to its
whole surface.
A.4.1.3 After at least 1 h weigh the test specimen to 2 decimal places and repeat this after 1 h more, the
two weighing shall not differ by more than 0,25 % of the total mass of the last specimen. If it differs repeat the
weight after 1 h more.
7
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prEN 14079-1:2006 (E)
Annex B
(normative)
Test method for the determination of fluorescence
B.1 Principle
This test method evaluates the fluorescence of gauze by observing for fluorescence under ultra violet light.
B.2 Equipment
Ultra violet lamp, having a maximum output at a wavelength of 365 nm.
B.3 Procedure
Examine at least a two-ply layer of the gauze under the ultra violet lamp.
B.4 Test report
The report shall include at least the following information:
a) type and batch number of gauze;
b) record whether or not the gauze fluoresces;
c) identification of person carrying out the test.
NOTE For routine in-house testing the signature of the person carrying out the test can be omitted
8
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prEN 14079-1:2006 (E)
Annex C
(normative)
Test method for the determination of thread count in woven gauze
C.1 Principle
This test method determines the number of warp and weft threads per 100 mm in cotton gauze.
C.2 Equipment
C.2.1 Magnifying glass, if necessary.
C.2.2 Ruler, divided in mm.
C.3 Procedure
C.3.1 For absorbent cotton gauze count the number of threads in the warp and in the weft in a square piece
with 100 mm sides, well away from the edges. Repeat both counts twice in 2 different places so that the 3
counts in both directions are well distributed over the sample to be tested.
C.3.2 For absorbent cotton and absorbent cotton and viscose ribbon gauze count the number of threads in
the warp and the weft over a length of 100 mm: If the width of the ribbon gauze is less than 100 mm, count the
number of threads over the whole of the width. Calculate the number of threads per 100 mm on the basis of
the declared width. If the width of the ribbon gauze is greater than 100 mm, do not include the selvedge in the
count. Repeat both counts twice in 2 different places so that the 3 counts in both directions are well distributed
over the sample to be tested. If the width of the ribbon gauze is less than 100 mm, the warp count shall only
be performed once.
C.4 Calculation of results
Calculate the average of the three individual counts for both the warp and weft directions.
C.5 Test Report
The report shall include at least the following information:
a) type and batch number of gauze;
b) if applicable, width of ribbon gauze;
c) individual and average warp threads per 100 mm;
d) individual and average weft threads per 100 mm;
e) if applicable, classification of the sample according to Table Q.1 or Table Q.2;
f) identification of person carrying out the test.
NOTE For routine in-house testing the signature of the person carrying out the test can be omitted
9
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prEN 14079-1:2006 (E)
Annex D
(normative)
Test method for the determination of mass per square metre
D.1 Principle
This test method determines the mass per square metre of gauzes.
D.2 Equipment
D.2.1 Suitable balance, capable of measurement in grams to two decimal places
D.2.2 Ruler divided in mm.
D.3 Procedure
D.3.1 Condition the samples in accordance with Annex A.
D.3.2 Weigh a piece of absorbent cotton gauze 1 m ± 0,01 m in length using the full width or, for smaller
samples, pieces not less than 2500 mm² to give a total surface of at least 50 000 mm².
D.3.3 For absorbent cotton or absorbent cotton and viscose ribbon gauze, weigh the total mass and then
determine the weight per square metre by multiplying the nominal width of the ribbon by the length, measured
on the unrolled and flattened gauze.
D.4 Test Report
The report shall include at least the following information:
a) type and batch number of gauze;
b) the calculated weight in grams per square metre of the gauze;
c) if applicable, classification of the sample according to Table Q.1 or Table Q.2;
d) any deviation from the test method;
e) identification of person carrying out the test.
NOTE For routine in-house testing the signature of the person carrying out the test can be omitted
10
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prEN 14079-1:2006 (E)
Annex E
(normative)
Test method for the determination of the breaking load
E.1 Principle
This test method evaluates the breaking load of gauze when subjected to tensile stress.
E.2 Equipment
E.2.1 Tensile testing machine, as specified in EN 13934-1.
E.2.2 Ruler divided in mm.
E.3 Procedure
E.3.1 Condition the samples in accordance with Annex A.
E.3.2 For absorbent cotton gauze, prepare 10 specimens, 5 cut in the machine direction and 5 in the cross
direction. Each specimen shall be cut not less than 50 mm from the edges to avoid folded or fraying edges.
Each specimen shall be 50 mm wide and sufficiently long to allow the clamps of the machine to be 200 mm
apart when the specimen is inserted. Clamp each specimen in turn between the jaws of a constant rate of
traverse the tensile testing machine and apply a speed of movement of 100 mm + 10 mm per min.
E.3.3 For absorbent cotton ribbon gauze and absorbent cotton and viscose ribbon gauze of width greater
than 50 mm, make 2 cuts parallel to the machine direction so as to obtain from the centre of the ribbon,
specimens at least 60 mm wide. Remove threads from the two machine direction sides so as to leave fringes
about 5 mm long and to obtain a width of the specimens of 50 mm. For ribbon gauze 50 mm or less in width,
test the sample using the full width and calculate with respect to a 50 mm width. Prepare 5 specimens of
ribbon gauze of sufficient length to allow the distance between the clamps of the machine to be 200 mm.
Clamp each specimen in turn between the jaws of a constant rate of traverse the tensile testing machine and
apply a speed movement of 100 mm + 10 mm per min.
E.4 Test Report
The report shall include at least the following information:
a) type and batch number of gauze;
b) if applicable, width of ribbon gauze;
c) any deviation from the test method;
d) the calculated average breaking load in both directions;
e) if applicable, classification of the sample according to Table Q.1 or Table Q.2;
f) identification of person carrying out the test.
NOTE For routine in-house testing the signature of the person carrying out the test can be omitted
11
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prEN 14079-1:2006 (E)
Annex F
(normative)
Test method for the determination of the liquid absorbency time
F.1 Principle
This test method evaluates the liquid absorbency time of gauze, that is the time required for a test specimen
of gauze to become completely wetted by the test liquid and imbibe test liquid into its interior structure.
The liquid absorbency time test measures the time required for the complete wetting of a test specimen (of
mass 1 g) plied into sixteen folds and dropped onto the surface of the liquid.
In this method the liquid comes into contact with all surfaces of the test specimen.
F.2 Equipment
F.2.1 Beaker of 110 mm-120mm in diameter to a minimum depth of 120 mm
F.2.2 Stopwatch.
F.2.3 Suitable balance, capable of measurement in grams to two decimal places
F.3 Reagents
F.3.1 Distilled water at 20 °C ± 2 °C.
F.4 Procedure
F.4.1 Condition the sample according to Annex A.
F.4.2 Fill the beaker with water to a depth of 100 mm at about 20ºC
F.4.3 Fold a piece of gauze in sixteen folds weighing about 1g .For narrow ribbon gauze, fold as many
times as is necessary to obtain a length no greater than 80 mm.
F.4.4 Drop lightly upon the liquid surface, into a container of test liquid, starting the stop-watch when the
specimen enters the liquid.
F.4.5 Record the time taken for the specimen to sink completely below the surface of the liquid.
F.4.6 Repeat F.4.3 to F.4.5 with the four other test specimens.
F.4.7 Determine the temperature of the test liquid.
12
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prEN 14079-1:2006 (E)
F.5 Test report
The report shall include at least the following information:
a) type and batch number of gauze;
b) dimensions of the test specimens;
c) test method used and any deviations from the standard method;
d) the calculated average and individual liquid absorbency times;
e) identification of person carrying out the test.
NOTE For routine in-house testing the signature of the person carrying out the test can be omitted
13
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prEN 14079-1:2006 (E)
Annex G
(normative)
Test method for the determination of liquid absorptive capacity
G.1 Principle
This test method evaluates the liquid absorptive capacity of gauzes, that is the mass of liquid absorbed per
unit mass of the gauze, expressed as a percentage, after either a standard immersion time or after the time
needed to completely wet the gauze and after drainage has occurred. The draining time is quite short, which
is practical and especially important when very volatile liquids are used.
G.2 Equipment
G.2.1 Wire gauze made from stainless steel, of size at least 120 mm x 120 mm nominal size of opening
according to ISO 565:1990, with a metal frame.
G.2.2 Dish with test liquid, to accommodate the wire gauze with the test specimen attached.
G.2.3 Weighing glass with cover.
G.2.4 Stopwatch.
G.2.5 Clips, for holding test specimen on the wire gauze.
G.2.6 Suitable balance, capable of measurement in grams to two decimal places
G.2.7 Forceps
G.3 Reagents
G.3.1 Distilled water at 20 °C ± 2 °C.
G.4 Procedure
G.4.1 Condition the sample according to Annex A.
G.4.2 Either:
cut five test specimens of size 100 mm ± 1 mm x 100 mm ± 1 mm. If an individual piece of gauze weighs
less than 1 g, make up the test specimen from two or more layers until the total mass is at least 1 g; or
if the gauze is of insufficient width to allow test specimens of 100 mm width to be taken, cut test
specimens of the maximum width possible and of mass as given in G.4.2.a.
14
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prEN 14079-1:2006 (E)
G.4.3 After conditioning, weigh each test specimen to an accuracy of 0,01 g placing each specimen in a
weighing glass with cover.
G.4.4 Place a test specimen on the stainless steel gauze fastening it at the corners and edges with clips.
G.4.5 Place the wire gauze with test specimen 20 mm below the surface of the test liquid contained in a
suitable dish. Introduce the wire gauze and test specimen obliquely in order to avoid trapping air bubbles.
G.4.6 After 60 s remove wire gauze and test specimen from the test liquid.
G.4.7 Leaving one clip in a corner, remove all others.
G.4.8 Hang the wire gauze and test specimen freely to drain vertically for 120 s ± 3 s.
G.4.9 Using forceps, take Take the test specimen off the wire gauze and place it in a weighing glass.
Determine the mass of the specimen.
G.4.10 Repeat G.4.4 to G.4.9 for the four other test specimens.
G.5 Calculation of results
Calculate the liquid absorptive capacity (WA) as a percentage from the expression:
(M −M )
n k
W = ×100%
A
M
k
where
M is the original mass of the test specimen;
k
M is the mass of the test specimen at the end of the test.
n
G.6 Test report
The test report shall include at least the following information:
a) type and batch number of gauze;
b) test method used and any deviations from the standard method;
c) average and individual liquid absorptive capacity;
d) identification of person carrying out the test.
NOTE For routine in-house testing the signature of the person carrying out the test can be omitted
15
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prEN 14079-1:2006 (E)
Annex H
(normative)
Test method for determination of opacity of x-ray component
H.1 Principle
This test method determines the opacity of the x-ray component in gauze.
H.2 Equipment
H.2.1 30 mm thickness of 99 % pure aluminium of commerce.
H.2.2 Non-screen x-ray film
H.2.3 Sheet of lead, not less than 2 mm thick, or an equivalent thickness of lead rubber sheet.
H.2.4 10 mm thickness of aluminium.
H.3 Procedure
Place the specimen being examined or a representative specimen of the X-ray-detectable component under
the 30-mm thickness of 99% pure aluminium of commerce, in the centre of the X-ray film positioned on the
sheet of lead, masking any parts of the film not covered by the specimen with 2 mm of lead, to prevent
scattered radiation from affecting the film. Irradiate the specimen and the aluminium simultaneously with X-
rays at 70 kV peak, using an exposure sufficient to give a logarithmic photographic density of about 1,0
through a 10 mm thickness of aluminium.
H.4 Test report
The test report shall include at least the following information:
a) type and batch number of gauze;
b) type of x-ray component;
c) whether or not the specimen image is clearly visible as a lighter area against a darker background when
the developed radiograph is examined by transmitted light;
d) identification of person carrying out the test.
NOTE For routine in-house testing the signature of the person carrying out the test can be omitted
16
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prEN 14079-1:2006 (E)
Annex I
(normative)
Test method for determination of fibre identification
I.1 Principle
These test methods determine the fibre identification of gauzes.
I.2 Equipment
I.2.1 Microscope.
I.2.2 Incubator, capable of heating to 40 ºC.
I.2.3 Suitable balance, capable of measurement in grams to three decimal places
I.3 Absorbent cotton gauze and absorbent cotton ribbon gauze
I.3.1 Reagents
I.3.1.1 Zinc chloride solution, iodinated - Dissolve 20,0 g ± 0,5 g of zinc chloride and 6,5 ± 0,1 g of potassium
iodide in 10,5 ml ± 0,1 ml of water. Add 0,5 ± 0,05 g of iodine and shake for 15 min. Filter if necessary. Store
protected from light.
I.3.1.2 Zinc chloride-formic acid solution - Dissolve 20 g ± 0,5 g of zinc chloride in 80 g ± 1 g of an 85 % m/V
solution of anhydrous formic acid
I.3.2 Procedure
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.
I.3.2.1 IDENT A
Examined under a microscope, the cotton fibre shall be flat, ribbon-
...