 DEAS 1069 : 2021  
ICS 11.020.00 
 
© EAC 2021                                                                                                                               1st Edition 2021   
 DRAFT EAST AFRICAN STANDARD  
Cotton ear bud  — Specification  
 
EAST AFRICAN COMMUNITY  DEAS 1069 : 2021  
ii © EAC  2021  – All rights reserved  
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Reproduction for sales purposes may be subject to royalty payments or a licensing agreement.  
Violators may be prosecuted . DEAS 1069 : 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 
4.3 Fluorescent Brightening Agents  ................................ ................................ ................................ ..........  2 
5 Packaging  ................................ ................................ ................................ ................................ ...............  3 
6 Labelling  ................................ ................................ ................................ ................................ .................  3 
7 Sampling  ................................ ................................ ................................ ................................ ................  3 
Annex  A (normative)  Determination of submersion time and w ater absorption  ................................ ........  4 
A.1 Principle  ................................ ................................ ................................ ................................ .................  4 
A2 Apparatus  ................................ ................................ ................................ ................................ ...............  4 
A3 Procedure  ................................ ................................ ................................ ................................ ...............  4 
A 4 Calculation  ................................ ................................ ................................ ................................ .............  4 
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 
Biblio graphy  ................................ ................................ ................................ ................................ ........................  8 
. DEAS 1069 : 2021  
iv © EAC  2021  – All rights reserved  
 Foreword  
Development of the East African Standards has been necessitated by the need for harmonizing requirements 
governing quality of products and services in the East African Community. It is envisaged that thro ugh 
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 Afr ican Standards  (EAS) . The Committee is composed of representatives of the National 
Standards Bodies in Partner States, together with the representatives from the public and private sector 
organizations  in the community .  
East African Standards are develope d through  Technical Committees that are representative of key 
stakeholders including government, academia, consumer groups, private sector and other interested parties. 
Draft East African Standards are circulated to stakeholders through the National Standa rds Bodies in the 
Partner States. The comments received are discussed and incorporated before finalization of standards, in 
accordance with the Principles and procedures for development of East African Standards.  
East African Standards are subject to revie w, to keep pace with technological advances. Users of the East 
African Standards are therefore expected to ensure that they always have the latest versions of the standards 
they are implementing .  
The committee responsible for this document is Technical Co mmittee EASC/TC 078, Healthcare and Medical 
devices . 
 DRAFT EAST AFRICAN STANDARD  DEAS 1069 : 2021  
 
© EAC 2021  – All rights reserved  1 
 Cotton ear bud  — Specification  
1 Scope   
This Draft East African Standard specifies requirements, sampling  and test methods for cotton ear buds . 
2 Normative references  
The following documents are referr ed to in the text in such a way that some or all of their content constitutes 
requirements of this document.  For dated references, only the edition cited applies. For undated references, 
the latest edition of the referenced document (including any amendmen ts) applies.  
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 schem es indexed by 
acceptance quality limit (AQL) for lot -by-lot inspection  
ISO 3071, Textiles — Determination of pH of aqueous extract  
ISO 10993,  Biological evaluation of medical devices  
ISO 11737 -1, Sterilization of health care products — Microbiological meth ods — Part 1: Determination of a 
population of microorganisms on products  
3 Terms and definitions   
For the purposes of this document, the following term and definition . apply.  ISO and IEC maintain 
terminological databases for use in standardization at the  following addresses:   
— ISO Online browsing platform: available at http://www.iso.org/obp  
3.1 
cotton ear bud  
small short rod with small wads of cotton wrapped around one or both ends commonly used for ear cleaning  
3.2 
wad 
a small mass or lump of cotton attached to the terminal parts of the stem of the cotton ear bud  
3.3 
submersion time  
time for wetting  a cotton ear bud  until covered completely with water”  DEAS 1069: 2021  
2 © EAC  2021  – All rights reserved  
 4 Requirements  
4.1 General requirements  
4.1.1  Cotton ear buds shall consist of a small wad of cotton wrapped around one or both ends of a short 
rod, usually made of either wood, rolled paper, or plastic.  
4.1.2  The cotton fibres shall be well carded and bleached to a good white, free from pieces of thread and 
reasonab ly 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 ear bud shall be a 100 per cent cotton. This shall be tested by a 
microscope and also in accordance with ISO  1833-11. 
4.1.4  The wad shall not detach from the stem during use.  
4.1.5  The dimensions of the stem shall be measured using a Vernier caliper , and shall be as follows:  
 length: 72 mm ±1 mm and  
 diameter: 2.0 mm ± 0.2 mm.  
4.1.6  When the product is tested fo r flexibility in accordance with Annex E, t he stem when bent to 45º shall 
not break or fracture.  
4.2 Specific requirements  
Cotton ear buds 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 ear buds  
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.   23  
 Annex A  
pH value 6 - 8 ISO 3071  
Soluble substance s, % of the mass of 
cotton, max.  0.5 Annex B  
Moisture regain, %, max   8  Annex D 
 
4.3 Fluorescent Brightening Agents  
Fluorescent brightening agents shall not be used in the manufacture of cotton ear bud and  when tested in 
accordance wit h Annex C,  not more than occasional point of fluorescence shall be visible.  
4.4 Microbiological requirements  
The microbial contamination in the cotton ear bud shall n ot more than 100 cfu/g , when tested in accordance 
with ISO 11737 -1. DEAS 1069: 2021  
© EAC 2021  – All rights reserved  3 
 5 Biocompatibility  
When tested in accordance with the relevant parts of ISO 10993, cotton ear buds shall be non -toxic, 
hypoallergenic, non - sensation and non -irritating.  
6 Packaging  
The cotton ear buds shall be pack aged in suitable containers  which guarantee product safety and integrity . 
7 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 o f manufacturer;  
b. name of product as “cotton ear bud”  
c. number of buds per unit package  
d. instructions for use and disposal;  
e. date of manufacture;   
f. country of origin ; 
g. batch/lot number  
h. storage conditions;   
i. expiry date   
j. precautions.   
8 Sampling  
Sampling shall be do ne in accordance with ISO 2859 -1. 
 DEAS 1069: 2021  
4 © EAC  2021  – All rights reserved  
 Annex  A 
(normative)  
 
Determination of submersion time and water absorption  
A.1 Principle  
Cotton is placed in a metallic basket and allowed to sink in a tub of water. The time taken to  submerge 
completely is noted and amou nt of water absorbed is measured.  
A2 Apparatus  
A 2.1  Cylindrical basket, weighing 2.7 + 0.3 g, of height 80 mm, diameter 50 mm with square  Openings of 
15 mm to 20 mm, made of copper wire of 0.4 mm diameter.  
A2.2  Tub of water, of 10 cm – 20 cm . 
A2.3  Thermom eter 
A2.4  Stop watch, 0.2 seconds accuracy  
A2.5  Container  
A2.6  Weighing balance  
A3 Procedure  
A3.1  Take random specimen of 5 g of cotton wool from several stems of ear buds in the laboratory  sample. 
Place it loosely in the cylindrical basket  
A3.2  Weigh the  basket using a weighing balance  before placing the specimen. Weigh again  after placing 
the specimen.  
A3.3  Drop the basket with its contents in a horizontal position into a tub of water , with water at  about 20oC 
reaching a height of approximately 100 mm  
A3.4 Measure by means of stop watch, the time required for the basket to sink below the  surface of water 
in seconds  
A3.5  Repeat the procedure above for two more specimens  
A3.6  After testing the submersion time for each specimen, 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 seconds in a 
horizontal position above the tub so as to drain the remaining water.  
A3.7  Place the basket in a container  of known weight (M 1), weigh it M 2). 
A 4 Calculation  
A4.1  Submersion time  DEAS 1069: 2021  
© EAC 2021  – All rights reserved  5 
 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 c alculated in A.4.1 as the submersion time in seconds.  
A.5.2  Report the value calculated A.4.2 as the absorbency.  DEAS 1069: 2021  
6 © EAC  2021  – All rights reserved  
 Annex  B 
(normative)  
 
Determination of water soluble substances  
B.1 Principle  
Cotton wool is e xtracted 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 co tton ball from 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 absorb ed 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 c onstant weight. 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 fluorescent 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 fluor escence except that which may be shown by a few isolated fibres.  DEAS 1069: 2021  
8 © EAC  2021  – All rights reserved  
 Annex D 
(normative)  
 
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 (M 1) a known amount of cotton wool, dry it at a temperature of 100 ˚C to 105 ˚C until constant 
mass is obtained.  
D.3.2 Weigh (M 2) again. This is the dry mass.  
D.4 Calculation  
 
 
D.5 Report  
Report the value calculated as the moisture regain in per cent  DEAS 1069: 2021  
© EAC 2021  – All rights reserved  9 
 Annex D 
(normative)  
 
Determination of flexibility  
E.1 Apparatus  
Mandrel, a triangular shaped object with an angle of 450 having two sides equal  
E.2 Procedure  
E.2.1  Position the earbud to touch the ends of the mandrel as shown in Figure 1  and leave in place for 1  
min or 2 min . 
 
 
Figure 1 — 90 and 45 degree mandrel for testing flexibility  
E.2.2  Remove the earbud and asse ss any cracks or breakage.  
E.3 Report  
Report as follows:  DEAS 1069: 2021  
10 © EAC  2021  – All rights reserved  
  0 for no breakage ; and  
 1 for breakage.  
 DEAS 1069: 2021  
© EAC 2021  – All rights reserved  11 
 Bibliography  
KS 2245:2010, Specification for co tton ear buds  
 DEAS 1069: 2021    
 
© EAC 2021  – All rights reserved  
  
  