 DEAS 1070 : 2021  
ICS 11.040.30  
 
© EAC 2021                                                                                                                               1st Edition 2021   
 DRAFT EAST AFRICAN STANDARD  
Medical cotton swab — Specification  
EAST AFRICAN COMMUNITY  DEAS 1070 : 2021  
ii © EAC  2021  – All rights reserved  
 Copyright notice  
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Reproduction for sales purposes may be subject to royalty payments or a licensing agreement.  
Violators may be prosecuted . DEAS 1070 : 2021  
© EAC 2021  – All rights reserved  iii 
 Contents  Page 
Foreword  ................................ ................................ ................................ ................................ ............................  iv 
1 Scope  ................................ ................................ ................................ ................................ ......................  1 
2 Normative references  ................................ ................................ ................................ ............................  1 
3 Terms and definitions  ................................ ................................ ................................ ...........................  1 
4 Requirements  ................................ ................................ ................................ ................................ .........  2 
4.1 General requirements  ................................ ................................ ................................ ...........................  2 
4.2 Specific requirements  ................................ ................................ ................................ ...........................  2 
Annex  A (normative)  Determination of submersion time and water absorption  ................................ ........  4 
A.1 Principle  ................................ ................................ ................................ ................................ .................  4 
A.2 Apparatus  ................................ ................................ ................................ ................................ ...............  4 
A.3 Procedure  ................................ ................................ ................................ ................................ ...............  4 
A.4 Calculati on ................................ ................................ ................................ ................................ .............  5 
A.4.1  Submersion time  ................................ ................................ ................................ ................................ ... 5 
A.4.2  Water absorption  ................................ ................................ ................................ ................................ ... 5 
A.5 Report  ................................ ................................ ................................ ................................ .....................  5 
Annex  B (normative)  Determination of water soluble substances  ................................ ..............................  6 
B.1 Principle  ................................ ................................ ................................ ................................ .................  6 
B.2 Apparatus  ................................ ................................ ................................ ................................ ...............  6 
B.3 Procedure  ................................ ................................ ................................ ................................ ...............  6 
B.4 Calculation  ................................ ................................ ................................ ................................ .............  6 
B.5 Report  ................................ ................................ ................................ ................................ .....................  6 
Annex C (normative)  Determination of fluorescent brightening agents  ................................ .....................  7 
C.1 Principle  ................................ ................................ ................................ ................................ .................  7 
C.2 Apparatus  ................................ ................................ ................................ ................................ ...............  7 
C.3 Procedure  ................................ ................................ ................................ ................................ ...............  7 
C.4 Report  ................................ ................................ ................................ ................................ .....................  7 
Annex D  (normative)  Sterility test  ................................ ................................ ................................ ....................  8 
D.1 Introduction  ................................ ................................ ................................ ................................ ............  8 
D.2 Fluid thioglycollate medium  ................................ ................................ ................................ .................  8 
D.3 Alternative thioglycollate medium  ................................ ................................ ................................ ....... 9 
D.4 Soya -bean casein digest medium  ................................ ................................ ................................ ........  9 
D.5 Sterility  ................................ ................................ ................................ ................................ ...................  9 
D.6 Growth promotion test of aerobes, anaerobes, and fungi  ................................ ................................  9 
Bibliography  ................................ ................................ ................................ ................................ ......................  11 
 DEAS 1070 : 2021  
iv © EAC  2021  – All rights reserved  
 Foreword  
Development of the East African Standar ds has been necessitated by the need for harmonizing requirements 
governing quality of products and services in the East African Community. It is envisaged that through 
harmonized standardization, trade barriers that are encountered when goods and services  are exchanged 
within the Community will be removed.  
The Community has established an East African Standards Committee  (EASC)  mandated to develop and 
issue East African Standards  (EAS) . The Committee is composed of representatives of the National 
Standard s Bodies in Partner States, together with the representatives from the public and private sector 
organizations  in the community .  
East African Standards are developed through  Technical Committees that are representative of key 
stakeholders including govern ment, academia, consumer groups, private sector and other interested parties. 
Draft East African Standards are circulated to stakeholders through the National Standards Bodies in the 
Partner States. The comments received are discussed and incorporated befo re finalization of standards, in 
accordance with the Principles and procedures for development of East African Standards.  
East African Standards are subject to review, to keep pace with technological advances. Users of the East 
African Standards are there fore expected to ensure that they always have the latest versions of the standards 
they are implementing .  
The committee responsible  for this document is Technical Committee EASC /TC 078, Healthcare and Medical 
devices . 
Attention is drawn to the possibility  that some of the elements of this document may be subject of patent 
rights. EAC shall not be held responsible for identifying any or all such patent rights.  
 DRAFT EAST AFRICAN STANDARD  DEAS 1070 : 2021  
 
© EAC 2021  – All rights reserved  1 
 Medical cotton swabs — Specification  
1 Scope   
This Draft East African Standard specifies require ments, sampling  and test methods for medical cotton swabs . 
This standard does not apply to  flocked swabs for clinical use.  
2 Normative references  
The following documents are referred to in the text in such a way that some or all of their content constitute s 
requirements 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.  
EAS 104, Alcoholic beverages — Method of sampling and test  
ISO 1833 -11, Textiles — Quantitative chemical analysis  — Part 11: Mixtures of certain cellulose fibres with 
certain other fibres (method using sulfuric acid)  
ISO 2859 -1, Sampling procedures for inspection by attributes — Part 1: Sampling schemes indexed by 
acceptance quality limit (AQL) for lot -by-lot inspection  
ISO 3071, Textiles — Determination of pH of aqueous extract  
3 Terms and definitions   
For the purposes of this document, the following terms and definitions apply.  ISO and IEC maintain 
terminological dat abases for use in standardization at the following addresses:  — ISO Online browsing 
platform: available at http://www.iso.org/obp  
3.1 
swab 
absorbent pad or piece of material used in surgery and medicine for cleaning w ounds, applying medication, or 
taking specimens  
3.2 
submersion time  
time for wetting a medical cotton swab  until covered completely with water”  
 DEAS 1070:  2021  
2 © EAC  2021  – All rights reserved  
 4 Requirements  
4.1 General requirements  
4.1.1  Cotton swabs may consist of one or two small wads of cotton  wrapped around one or both ends of a 
short rod made of wood, rolled paper or plastic . 
4.1.2  The cotton fibres shall be well card ed 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.  
4.1.3  The fibre composition of the cotton swab shall be 100 % cotton. This sh all be tested by a microscope 
and in accordance with ISO 1833 -11. 
4.2 Specific requirements  
Cotton swabs shall comply with  the requirements given  in Table 1 when tested in accordance with the test 
methods specified  therein.  
Table 1 — Specific requirements for cotton swabs  
Characteristic  Requirement  Test method  
Submersion time  (complete submersion), s, max.  10 Annex A  
Absorbency (mass of water for each gram of dry cotton), g, min.  16 Annex A  
pH value 6 - 8  ISO 3071  
Soluble substance s, % of the mass of c otton, max.  0.5 Annex B  
 
4.3 Fluorescent brightening agents  
Fluorescent brightening agents shall not be used in the manufacture of cotton swabs. When tested in 
accordance with Annex C,  not more than occasional point of fluorescence shall be visible.  
4.4 Freedom from microorganisms  
Cotton swabs shall be sterile when tested in accordance with Annex D.  
4.5 Isopropyl alcohol  
Isopropyl alcohol  used in the manufacture of the cotton swabs shall be 70 % isopropyl alcohol or 2 -propanol 
when tested in accordance wi th EAS 104.  
5 Packaging  
Cotton swabs shall be packaged in suitable containers which guarantee product safety, sterility and integrity.  
6 Labelling  
Each package shall be legibly and indelibly labelled in English and/or any other official language (French, 
Kiswahili, etc) used in the importing East African Partner State with the following information:  
a) name and physical address of manufacturer and registered trademark, if any;  DEAS 1069: 2021  
© EAC 2021  – All rights reserved  3 
 b) name of product as “Cotton swabs”;  
c) size declaration  in SI units ; 
d) instructions for u se; 
e) precaution, “For external use only”;  
f) lot/batch number;  
g) country of origin;  
h)  declaration of sterility, “Sterile ”; 
i) date of manufacture; and  
j) expiry date.  
k) precautions.   
7 Sampling  
Sampling shall be done in accordance with ISO 2859 -1 and the acceptance crite ria shall be no defects.  
 DEAS 1070:  2021  
4 © EAC  2021  – All rights reserved  
 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 a bsorbed is measured.  
A.2 Apparatus  
A.2.1  Cylindrical basket , weighing 0.54  g ± 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 , 10 cm - 20 cm.  
A.2.3  Thermometer  
A.2.4 Stopwatch , 0.2 s accuracy.  
A.2.5  Container  
A.2.6  Weighing balance  
A.3 Procedure  
A.3.1  Take a random sample  of five grams  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 water, with water at about 20  ºC 
reaching a height of approximately 100 mm.  
A.3.4  Measur e by means of stopwatch, 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 three  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) and  weigh it ( M2). DEAS 1069: 2021  
© EAC 2021  – All rights reserved  5 
 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  
A.4.2.1  The water absorbed, expressed as grams, shall be calculated as follows:  
 
where  
M2 is the mass , in grams,  of container , basket and cotton wool after absorption ; 
M1 is the mass, in grams,  of container.  
A.4.2.2  Water absorbed by each gram of cotton wool, expressed as grams, shall be calculated as follows:  
 
A.5 Report  
A.5.1  Report the value calculated i n A.4.1 as the submersion time in seconds.  
A.5.2  Report the value calculated A.4.2 as the absorbency.  DEAS 1070:  2021  
6 © EAC  2021  – All rights reserved  
 Annex  B 
(normative)  
 
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 one gram of cotton ball f rom container, add 100 mL of water and boil gently for 30 min, 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 wei ght. Weigh the residual ( M) in grams.  
B.4 Calculation  
Soluble substances, expressed as percent, shall be calculated as follows:  
 
B.5 Report  
Report the value in B.4 as the percentage of water soluble substances . 
 DEAS 1069: 2021  
© EAC 2021  – All rights reserved  7 
 Annex C  
(normative)  
 
Determination of fluor escent brightening agents  
C.1 Principle  
A layer of cotton wool is examined under the ultraviolet (UV) light for detection of any fluorescent materials.  
C.2 Apparatus  
C.2.1  Ultraviolet (UV) light source  
C.2.2  Scale , graduated in millimetres  
C.3 Procedure  
Examine a layer, about five millimetres 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 e xcept that which may be shown by a few isolated fibres.  DEAS 1070:  2021  
8 © EAC  2021  – All rights reserved  
 Annex D  
(normative)  
 
Sterility test  
D.1 Introduction  
The following culture media have been found to be suitable for the test for sterility. Fluid thioglycollate medium 
is primarily intended for the c ulture of anaerobic bacteria; however, it will also detect aerobic bacteria. 
Soyabean casein digest medium is suitable for the culture of both fungi and aerobic bacteria.  
D.2 Fluid thioglycollate medium  
L-Cystine                   0.5 g  
Agar                    0.75 g  
Sodium chloride                  2.5 g  
Glucose monohydrate/anhydrous              5.5 g/5.0 g  
Yeast extract (water -soluble)               5.0 g  
Pancreatic digest of casein                15.0 g  
Sodium thioglycollate or                0.5 g  
Thioglycollic acid                  0.3 mL  
Resazurin sodium solution (1 g/L of resazurin sodium), freshly prepared      1.0 mL  
Water R                    1 000 mL  
pH after sterilization                 7.1 ± 0.2   
D.2.1  Mix the L -cystine, agar, sodium chloride,  glucose, water -soluble yeast extract and pancreatic digest of 
casein with the water R and heat until solution is effected.  
D.2.2  Dissolve the sodium thioglycollate or thioglycollic acid in the solution and, if necessary, add 1 M 
sodium hydroxide so that,  after sterilization, the solution will have a pH of 7.1 ± 0.2. If filtration is necessary, 
heat the solution again without boiling and filter while hot through moistened filter paper.  
D.2.3  Add the resazurin sodium solution, mix and place the medium in s uitable vessels which provide a ratio 
of surface to depth of medium such that not more than the upper half of the medium has undergone a colour 
change indicative of oxygen uptake at the end of the incubation period. Sterilize using a validated process. If 
the medium is stored, store at a temperature between 2 °C and 25 °C in a sterile, airtight container.   
D.2.4  If more than the upper one -third of the medium has acquired a pink colour, the medium may be 
restored once by heating the containers in a water -bath or in free -flowing steam until the pink colour 
disappears and cooling quickly, taking care to prevent the introduction of non -sterile air into the container. Do 
not use the medium for a longer storage period than has been validated. Fluid thioglycollate  medium is to be 
incubated at 30 °C - 35 °C.  DEAS 1069: 2021  
© EAC 2021  – All rights reserved  9 
 D.2.5  For products containing a mercurial preservative that cannot be tested by the membrane -filtration 
method, fluid thioglycollate medium incubated at 20 °C - 25 °C may be used instead of soya -bean casein 
digest medium provided that it has been validated as described in growth promotion test.  
D.3 Alternative thioglycollate medium  
Where prescribed, justified and authorized, the following alternative thioglycollate medium may be used. 
Prepare a mixture having t he same composition as that of the fluid thioglycollate medium, but omitting the 
agar and the resazurin sodium solution, sterilize as directed above. The pH after sterilization is 7.1 ± 0.2. Heat 
in a water -bath prior to use and incubate at 30 °C - 35 °C u nder anaerobic conditions.  
D.4 Soya -bean casein digest medium  
Pancreatic digest of casein                                                                            17.0 g  
Papaic digest of soya -bean meal                                                                    3.0 g  
Sodium chloride                                                                                              5.0 g  
Dipotassium hydrogen phosphate                                                                  2.5 g  
Glucose mono hydrate/anhydrous                                                                  2.5 g/2.3 g  
Water R                                                                                                         1 000 mL  
pH after sterilization                                                                                       7.3 ± 0.2  
D.4.1  Dissolve the solids in water R, warming slightly to effect solution. Cool the solution to room 
temperature. Add 1 M sodium hydroxide, if necessary, so that after steril ization the solution will have a pH of 
7.3 ± 0.2.  
D.4.2  Filter, if necessary, to clarify, distribute into suitable vessels and sterilize using a validated process. 
Store at a temperature between 2 °C and 25 °C in a sterile well -closed container, unless it  is intended for 
immediate use. Do not use the medium for a longer storage period than has been validated. Soya -bean 
casein digest medium is to be incubated at 20 °C - 25 °C.  
D.4.3  The media used shall comply with the following tests given in D.6, carried out before or in parallel with 
the test on the product to be examined.  
D.5 Sterility  
Incubate portions of the media for 14 d. No growth of micro -organisms occurs.  
D.6 Growth promotion test of aerobes, anaerobes, and fungi  
D.6.1  Test each lot of ready -prepared medium and each batch of medium prepared either from dehydrated 
medium or from ingredients. Suitable strains of microorganisms are indicated in Table D.1.  DEAS 1070:  2021  
10 © EAC  2021  – All rights reserved  
 Table D.1 — Strains of the test microorganisms suitable for use in the growth promotion test   
Test microorganisms  
Aerobic bacteria  Fungi  Anaerobic bacterium  
Staphylococcus aureus  ATCC 6538, 
CIP 4.83, NCTC 10788, NCIMB 9518, 
NBRC 13276  
Bacillus subtilis  ATCC 6633, CIP 
52.62, NCIMB 8054, NBRC 3134  
Pseudomonas aeruginosa  ATCC 
9027, NCIMB 8626, CI P 82.118, 
NBRC 13275  Candida albicans  ATCC 10231, IP 
48.72, NCPF 3179, NBRC 1594  Clostridium sporogenes  ATCC 19404, 
CIP 79.3, NCTC 532 or ATCC 11437, 
NBRC 14293  
 
D.6.2  Inoculate portions of fluid t hioglycollate  medium with a small number (not more than 10 0 cfu) of 
Clostridium sporogenes, Pseudomonas aeruginosa , and Staphylococcus aureus , using a separate portion of 
medium for each of the species of microorganism. Inoculate portions of alternative thioglycollate medium with 
a small number (not more than 100  cfu) of Clostridium sporogenes .F Inoculate portions of soybean –casein.  
D.6.3  Digest medium with a small number (not more than 100 cfu) of Aspergillus brasiliensis , Bacillus 
subtilis , and Candida albicans , using a separate portion of medium for each of the species of  microorganism. 
Incubate for not more than three days in the case of bacteria and not more than five days in the case of fungi.  
D.6.4  Seed lot culture maintenance techniques (seed -lot systems) are used so that the viable 
microorganisms used for inoculation are not more than five passages removed from the original master seed 
lot. The media are suitable if a clearly visible growth of the microorganisms occurs.  DEAS 1069: 2021  
© EAC 2021  – All rights reserved  11 
 Bibliography  
[1] KS 2556: 2018, Impregnated cotton swabs — Specification   
[2] US 2276: 2021 , Medical cotton swabs — Specification  
 DEAS 1070 : 2021    
 
© EAC 2021  – All rights reserved  
  
  