Impregnated Cotton swabs Specification...Nursing Council of Kenya Ministry of Health Government Chemist Department Coast Provincial Hospital County of Nairobi Association for the Physically

KENYA STANDARDS KS 2556: 2018

Impregnated Cotton swabs — Specification

©KEBS 2018 First Edition 2018

KS 2556: 2018

ii © KEBS 2018 — All rights reserved

TECHNICAL COMMITTEE REPRESENTATION

The following organizations were represented on the Technical Committee Nursing Council of Kenya Ministry of Health Government Chemist Department Coast Provincial Hospital County of Nairobi Association for the Physically Disabled of Kenya CHAK Kenyatta National Hospital Kenya Bureau of Standards — Secretariat

REVISION OF KENYA STANDARDS

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© Kenya Bureau of Standards, 2018

Copyright. Users are reminded that by virtue of section 25 of the Copyright Act, Cap. 12 of 2001 of the Laws of Kenya, copyright subsists in

all Kenya Standards and except as provided under section 26 of this Act, no Kenya Standard produced by Kenya Bureau of Standards may

be reproduced, stored in a retrieval system in any form or transmitted by any means without prior permission in writing from the Managing

Director.

KENYA STANDARDS KS 2556: 2018

© KEBS 2018 — All rights reserved iii

Cotton swabs — Specification

KENYA BUREAU OF STANDARDS (KEBS)

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Coast Region Lake Region North Rift Region

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KS 2556: 2018

iv © KEBS 2018 — All rights reserved

Foreword

Kenya Bureau of Standards is a national standards body (NSB). The work of preparing Kenya Standards is normally carried out through national technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. National organizations, governmental and non-governmental, in liaison with KEBS, also take part in the work.

Kenya Standards are drafted in accordance with the rules given in the KS ISO/IEC Directives, Part 2.

The main task of technical committees is to prepare National Standards. Draft Kenya Standards adopted by the technical committees are circulated to the technical committee members for balloting. Publication as a Kenya Standard requires approval by at least 2/3 of the members casting a vote.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. KEBS shall not be held responsible for identifying any or all such patent rights.

This Kenya Standard was prepared by Technical Committee KEBS/TC 136, Medical Tools, devices and Equipment.

During the preparation of this standard, reference was made to the following documents:

KN WA 2556:2014 Cotton swabs - Specification

The assistance derived from these publications is hereby acknowledged.

© KEBS 2018 — All rights reserved 1

KENYA STANDARD CD 09/SERV/2018

Impregnated Cotton swabs – Specification 1 Scope This Kenya Standard specifies minimum requirements and prescribes the methods of test for Impregnated Cotton Swabs.

2 Application This standard shall not apply to the non-woven cotton swabs.

3 Normative Reference The following standards shall be applicable to the cotton swabs. KS 32, Conditions of testing textiles KS 124-1, Methods for determination of commercial mass consignment of textile fibres and yarns, KS 210, Glossary of terms relating to fabrics made from natural fibres, KS 360, Methods for determination of pH values of aqueous extracts of textile materials, KS 1029, Methods for determination of sterility of textile products, KS 1184, Isopropyl alcohol – Specification, KS 1833, Textile – Quantitative chemical analysis of binary fibre mixtures.

4 Terms and definitions For the purpose of this standard, the following definitions and those given in KS 210 shall apply. 4.1 Swab absorbent pad or piece of material used in surgery and medicine for cleaning wounds, applying medication, or taking specimens. 5 Requirements 5.1 Materials The cotton fibres shall be well carded and bleached to a good white, free from pieces of thread and reasonably free from leaf, shell, fibre-dust and foreign matter. It may be slightly off white if it is sterilized. It shall offer appreciable resistance when pulled.

KS 2556: 2018

2 © KEBS 2018 — All rights reserved

5.2 Freedom from microorganisms The pre-injection swabs shall be sterile. 5.3 Absorbency

When tested in accordance with Annex A, the mass of water shall be 16 g for each gram of dry cotton, in the minimum.

5.4 Submersion time When tested in accordance with Annex A, the time required for complete submersion shall not be more than 10 s. 5.5 pH Value

The pH value of the aqueous extract of cotton wool shall range from 6 to 8. The pH shall be tested in accordance with KS 360.

5.6 Soluble substances When tested in accordance with Annex B, the water-soluble substances shall not constitute more than 0.5 % of the mass of cotton.

5.7 Fibre composition

The fibre composition of the cotton bud shall be 100 % cotton. This shall be tested by a microscope and also in accordance with KS 1833.

5.8 Fluorescent brightening agents Fluorescent brightening agents shall not be used in the manufacture of cotton swabs and when tested in accordance with Annex C, not more than occasional point of fluorescence shall be visible.

5.9 Isopropyl alcohol or “spirit”

Isopropyl alcohol, or “spirit” used in the manufacture of the cotton swabs shall be 70% Isopropyl alcohol or 2-Propanol 70 %v/v in 0.5ml in addition to meeting the requirements of KS 1184.

6 Packaging 6.1 Impregnated Cotton swabs shall be packaged in suitable containers which guarantee product safety and integrity.

6.2 The disposal of the used packaging material and condemned product shall be done in compliance with the EMCA 1999, and Waste Regulations 2006 on solid and liquid wastes of the Laws of Kenya.

7 Labeling and Marking

7.1 Each container shall be legibly and indelibly marked with the following information; i) Manufacturer/Importer name and registered trade mark, if any,

ii) The words, “Impregnated Cotton Swabs”,

iii) Size declaration

iv) Instructions for use

v) The words, “For external use only”,


vi) Lot/batch number,

vii) Country of Origin.

viii) Date of manufacture

ix) Expiry date

KS 2556: 2018


Annex A (Normative)

Determination of submersion time and water absorption

A.1 Principle Cotton is placed in metallic basket and allowed to sink in tub of water. The time taken to submerge completely is

noted and amount of water absorbed is measured.

A.2 Apparatus A.2.1 Cylindrical basket, weighing 0.54±0.069 g, of height 16 mm, diameter 10 mm with square openings of 15

mm to 20 mm, made of copper wire of 0.4 mm diameter.

A.2.2 Tub of water, of 10 cm – 20 cm.

A.2.3 Thermometer

A.2.4 Stop watch, 0.2 s accuracy.

A.2.5 Container

A.2.6 Weighing balance

A.3 Procedure

A.3.1 Take random specimen of 5 g of cotton wool from several containers of cotton swabs and place them

loosely in the cylindrical basket.

A.3.2 Weigh the basket using a weighing balance before placing the specimen. Weigh again after placing the

specimen.

A.3.3 Drop the basket with its contents in a horizontal position into a tub of eater, with water at about 20ºC

reaching a height of approximately 100 mm.

A.3.4 Measure by means of stop watch, the time required for the basket to sink below the surface of water in

seconds.

A.3.5 Repeat the procedure above two more times.

A.3.6 After testing the submersion time for each cotton ball, leave the submerged basket at the bottom of the

water for 3 minutes. Remove the basket with its contents from water. Leave it for 30 s in a horizontal

position above the tub so as to drain the remaining water.

A.3.7 Place the basket in a container of known weight (M1), weigh it (M2).


A.4 Calculation

A.4.1 Submersion time

Take the average of the three measurements in A.3.4 and A.3.5 as the sinking time in seconds.

A.4.2 Water absorption

Water absorbed = M2-(M1 + 0.54 + 1)

Where,

M2 = mass of container + basket + cotton wool after absorption

M1 = mass of container.

Water absorbed by each gram of cotton wool

= tonwoolmassof

bedwaterabsor

cot

=1

)54.1( 12 mm

A.5 Report

A.5.1 report the value calculated in A.4.1 as the submersion time in seconds.

A.5.2 Report the value calculated A.4.2 as the absorbency.

KS 2556: 2018


Annex B (normative)

Method for determination of water soluble substances

B.1 Principle Cotton wool is extracted in hot water and the extract is dried and then weighed.

B.2 Apparatus

B.2.1 Weighing balance

B.2.2 Graduated flask

B.2.3 Burner

B.2.4 Funnel

B.2.5 Filter paper

B.2.6 Drier, with temperature control.

B.2.7 Clock

B.3 Procedure

B.3.1 To 1 g of cotton ball from container, add 100 mL of water and boil gently for 30 minutes, adding sufficient

water to maintain the original volume.

B.3.2 Pour the extract through a funnel into another vessel, transfer the cotton to the funnel and press out the

water absorbed therein. With a glass rod, wash the cotton with two 150 portions of hot water, pressing the

cotton dry after each washing.

B.3.3 Filter the combined extracts and washings, evaporate to concentrate, transfer to the weighing bottles

and dry at 105 ºC to constant weight. Weigh the residual (M) in grams.

B.4 Calculation

Soluble substances, % = 1001

XM

= 100M %

B.5 Report

Report the value in B.4 as the percentage of water soluble substances.


Annex C

(normative)

Method for the determination of fluorescent brightening agents

C.1 Principle

A layer of cotton wool is examined under the UV light for detection of any fluorescent materials.

C.2 Apparatus C.2.1 Ultra-violet light source

C.2.2 Scale, graduated in mm.

C.3 Procedure

Examine a layer, about 5 mm in thickness, under the UV light, of wavelength 365 nm.

C.4 Report The sample may show only a slight brownish-violet fluorescence and not more than an occasional yellow

particle. It shows no intense blue fluorescence except that which may be shown by a few isolated fibres.

KS 2556: 2018


Annex D (normative)

Method for determination of moisture regain

D.1 Principle A known mass of absorbent cotton wool is dried and then the loss in mass expressed as a ratio of the dry mass.

D.2 Apparatus

D.2.1 Weighing balance

D.2.2 Drier, with temperature control.

D.3 Procedure

D.3.1 Weigh (M1) a known amount of cotton wool, dry it at a temperature of 100 ºC to 105 ºC until constant

mass (M2) is obtained as described in KS 124 Part 1.

D.4 Calculation

Moisture content = 100)(

2

21 XM

MM

D.5 Reporting Report the value calculated in D.4 as the moisture regain in per cent.


Annex E

(normative)

Determination of mass of cotton

E.1 Principle

Mass of a ball of cotton swab from a container is measured on a weighing balance.

E.2 Apparatus E.2.1 Weighing balance, accuracy 0.001 g.

E.3 Procedure E.3.1 Conditioning

Conditioning the specimen in accordance with KS 32.

E.3.2 Take the mass of the conditioned ball of cotton with a weighing balance. Take mass measurement of

four other balls. Calculate the average mass of bud from the five measurements.

E.4 Report Report the average mass of cotton balls as the mass of the cotton swab.

Documents

Impregnated Cotton swabs Specification...Nursing Council of Kenya Ministry of Health Government Chemist Department Coast Provincial Hospital County of Nairobi Association for the Physically