KENYA STANDARD      DKS 1534 : 202 1 
ICS 97.170  
                                                                                            
 
 
 
 
 
 
 
 
  
 
 
 
 
 
               Menstrual tampons  — Specification  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   © KEBS 202 1                                                                                     Second Edition  2021  
 DKS 1534 : 2021  
 
ii  © KEBS 2021  — All rights reserved   
TECHNICAL COMMITTEE REPRESENTATION  
 
The following organizations were represented on the Technical Committee:  
 
Nursing Council of Kenya  
University of Nairobi — School of Medicine  
Kenya Industrial Rese arch and D evelopment Institute  (KIRDI)  
Kenya Medical Association  
National Environmental Management Authority  (NEMA)  
Kenya Medical Supplies Authority  
Radbone Clark  
Procter and Gamble  
KIM FAY East Africa Ltd . 
Chalange Industries  ltd  
Consumer Information Network  
The N airobi Hospital  
Nairobi Enterprises  
Pharmacy and Poison Board  
Kimberley Clark LTD  
Ministry of Health(MOH)  
Kenya Pea diatric Association(KPA)  
Mount Kenya University(MKU)  
Moi University — Department of industrial and Textile Engineering  
Ministry of  Defence –Research & Development  
Intertek kenya  
PadMad Kenya Ltd  
Marvel Five Investment ltd  
Mbagathi County Hospital  
Interconsumer Products Ltd  
Kenya Bureau of Standards — Secretariat  
 
 
 
 
 
 
 
REVISION OF KENYA STANDA RDS  
 
In order to keep abreast of progress in industry, Kenya Standards shall be regularly reviewed. Suggestions 
for improvements to published standards, addressed to the Managing Director, Kenya Bureau of Standards, 
are welcome . 
 
 
 
© Kenya Bureau of Standa rds, 2021 
 
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 K enya 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 STANDARD                  DKS 1534 : 202 1 
ICS 11.040.30  
© KEBS 2021 — All rights reserved  iii  
 
 
 
 
 
 
 
 
Menstrual tampons  — Specification  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Kenya Bure au of Standards, Popo Road, Off Mombasa Road,  
P.O. Box 54974 - 00200,  Nairobi, Kenya  
 +254 020 6948000, + 254 722202137, + 254 734600471  
 info@kebs.org  
 @KEBS_ke  
 kenya bureau of standards (kebs)  
 
 
 
 
 
 
 DKS 1534 : 2021  
 
iv  © KEBS 2021  — All rights reserved   
Foreword  
 
This Kenya Standard has been pre pared by the Technical Committee on Towels, Medical and Hygienic 
Textile Products under guidance of the Standards Projects Committee, and it is in accordance with the 
procedures of the Kenya Bureau of Standards.  
 
This Kenya Standard on menstrual tampons s pecifies materials, performance test for absorptive capacity, 
the strength of withdrawal cord, a microbial count to detect possible contamination during manufacture, 
instructions for hygienic use, and information about TSS and its warning symptoms.  
 
 
This standard has been revised in the following areas:  
 
 Test method for Staphylococcus aureus  has been updated  
 Test method for Total aerobic bacterial count  has been updated  
 Test method for Pseudonymous aeruginosa  has been updated  
 Test method for Escherichia co li has been updated  
 Test method for Absorptive  capacity has been reviewed  
 Marking has been reviewed to include date of manufacture and expiry  
 
This Second edition cancels and rep laces the First edition (KS 1534:2000)  which has been technically 
revised.  
 
 
During the preparation of this Kenya Standard reference was made to the following document:  
 AS 2869: 2008    Tampons — Menstrual.  
 
Acknowledgment is hereby made for assistance received from this source.  
 
  
© KEBS 2021  — All rights reserved    1 Menstrual Tampons  — Specification  
 
1 Scope  
 
This Kenya Standard specifies requirements for menstrual tampons .  
 
2 Normative references : 
 
The following referenced documents referred to in the text in such a way that some or all of their content 
constitutes requirements of this document. For dated referenc es, only the edition cited applies. For undated 
references, the latest edition of the referenced document (including any amendments) applies.  
KS ISO 10993 -10, Biological evaluation of medical devices  Part 10: Tests for irritation and delayed -type 
hypersens itivity  
KS ISO 4074, Natural rubber latex male condoms —Requirements and test methods   
KS ISO 7500 -1, Metallic materials — Calibration and verification of static uniaxial testing machines                                          
Part 1: Tension/compression testing machines — Calibration and verification of the force -measuring system  
KS ISO 22718,  Cosmetics -Microbiology - Detection of Staphylococcus aureus  
KS ISO 22717,  Cosmetics - Microbiology - Detection of Pseudomonas aeruginosa  
KS ISO 21150, Cosmetics -Microbiology - Detection of Escherichia coli  
ISO 8784, Microbiological examination — Part 1: Enumeration of bacteria and bacterial spores based on 
disintegration  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3 Terms and Definitions  
 DKS 1534 : 2021  
 
2  © KEBS 202 1 — All rights reserved  For the purpose s of this standard, the follow ing definitions shall apply :  
 
 
3.1 aseptic technique  
  
the exercise of special procedures for maintaining sterility of equipment, media and suchlike, or the purity of 
cultures by eliminating adventitious contamination and for protecting the operator and e nvironment  
 
 
3.2 batch  
 
quantity of tampons which, as far as practicable, consists of material or items of single type, grade, class, 
absorptive capacity and composition, and which has been manufactured under essentially the same 
conditions in a specified period of time  
 
3.3 contamination  
 
the   undesirable   transfer   of   organisms   from   one   person, material    or    environment    to    another  
 
3.4 disinfectant  
 
an agent that is used for disinfection  
 
3.5 disinfection  
 
a process intended to kill  or remove micro -organisms, but which cannot usually kill bacterial spores  
 
3.6 menstrual tampon   
 
a product made  of permissible materials (see 4 .1) that is inserted into the vagina and used to absorb 
menstrual discharge  
 
NOTE Throughout this standard, th e term “tampon” is to be taken to mean “menstrual tampon”.  
 
3.7 packaging  
 
tampons are supplied to the consumer inside several layers of packaging . These are as follows:  
 
a)  unit pack  — The pack enclosing a single tampon  and applicator, where provided.  
b)  primary pack  — The pack co ntaining one or more unit packs.  
c)  supply pack  — The pack that is supplied to the consumer. It may be the primary pack, or co ntain one 
or more primary packs.  
d)  transport pack  — The pack intended for transportation of one or  more supply packs . 
 
3.8  sterilization  
 
a process that is intended to kill or remove all types of micro -organisms; with an acceptably low probability of 
a micro -organism surviving on any article . 
 
3.9 Syngina  
 
The term is derived from ‘synthetic vagina’  
 
4  Materials  DKS 1534 : 2021  
 
© KEBS 2021  — All rights reserved  3  
4.1  Permissible materials  
 
Tampons shall be manufactured from cellulosic materials (such as cotton and viscose rayon), or synthetic 
textile polymers, either singly or in combination, provided that adequate testing does not demonstrate a 
haza rd. Polyester foam shall be not used. Carbo xymethylcellulose (CMC) shall  not added to tampons.  
 
NOTE : Although in -vitro studies have indicated that polyester foam and not CMC may be responsible for enhancing the production of 
TSST -1 toxin under certain tes t conditions, high absorbency per se has been implicated in some epidemiological studies. It was 
therefore decided to prohibit the use of polyester foam, and to prohibit the addition of CMC to tampons. This requirement is in 
recognition of the fact that, a lthough naturally occurring low background levels may be present, CMC is not added to tampons as there 
are consumer concern about this substance. Concern has also been expressed about acrylate modified rayons. Where such materia ls 
are used, evidence is req uired that no demonstrable hazard exists.  
 
4.2  Freedom from toxic and irritant effect  
 
Tampons shall not contain ingredients in sufficient concentration to cause a toxic or irritant reaction when 
used as directed.  
 
NOTE  A suitable method is given in KS ISO 10993 -10. 
 
 
4.3  Freedom from impurities  
 
No foreign matter shall be evident when the material is visually inspected.  
 
4.4  Ether soluble substances  
 
4.4.1     Requirement  
 
When the tampon material, excluding the withdrawal cord, is tested in accordanc e with KS 08 -638 Annex J 
with diet hyl ether as solvent, and two 5 g samples as described in 4.4.2, the material shall contain less than 
0.5% soluble substances.  
 
4.4.2  Test specimen  
 
Prepare the test specimen as follows:  
 
a) Avoiding contamination, tear two o r more tampons apart, removing the withdrawal cord from the 
body of the tampon. This may require the use of a cutting device as some tampons have the 
withdrawal cord sewn to the body of the tampon.  
b) Remove sufficient fibrous material to make up a pooled spe cimen of mass approximately 5g.  
 
5   Requirements  
 
5.1  Length of withdrawal cord   
 
The length of the withdrawal cord hanging free from the tampon shall be not less than 80 mm.  
 
 
5.2  Applicator  DKS 1534 : 2021  
 
4  © KEBS 202 1 — All rights reserved   
The applicator, where provided, shall be smooth and designed  to minimize risk of trauma.  
 
5.3  Absorptive capacity  
 
Each batch of tampons shall be classified into one of the absorbency ranges given in Table 1.  
When tested in accordance with Annex A, the classified absorbency range for a batch of tampons shall be 
the range into which at least 90 per cent of the estimated population of that batch fall.  
5.4  Pull strength  of withdrawal cord and its attachment point  
 
When tested in accordance with the method described in Annex B, the pull strength of the withdrawal cord  
and its attachment point shall be such that the mean force required to break or detach the cord shall be not 
less than 28 N. No value for an individual cord shall be less than 22.4 N.  
 
5.5  Water repellancy of withdrawal cord  
 
When tested in accordance wi th Annex C, the withdrawal cord shall not sink completely beneath the surface 
of the water.  
 
5.6  Microbiological requirements  
 
Table 1 - Microbial content  
 
SN Parameter  Requirement  Test method  
i.  Staphylococcus aureus  Not detecta ble per gram of 
sample  KS IS O 22718  
ii.  Total aerobic bacterial 
count , Max,  1.0 x 103 ISO 8784 -1 
iii.  Pseudonymous 
aeruginosa  Not detecta ble per gram of 
sample  KS ISO 22717  
iv.  Escherichia coli  Not detecta ble per gram of 
sample  KS ISO 21150  
 
 
6 Packaging  
 
 The following requirements and r ecommendations apply to the packaging of tampons : 
 
a) Each tampon shall be packed in a closed unit pack capable of maintaining product quality until 
opened by the consumer.  
 
b) The unit pack shall be packed in a primary pack, which is sufficiently robust to prot ect the tampons 
against damage during normal transport and normal storage. The primary pack shall be designed, 
overwrapped or sealed, so that tampering can be easily detected.  
 
c) The primary pack shall contain an information leaflet in accordance with Clause  8. 
 
 
 
 DKS 1534 : 2021  
 
© KEBS 2021  — All rights reserved  5 7 Marking  
 
7.1 Primary packs  
 
Primary packs shall be permanently and legibly marked with the following information:  
 
a)  the batch number of the tampons which may be immediately preceded by the words “Batch No.”,   
“Lot No.” or by words or s ymbols h aving a similar meaning;   
 
b)  the label given in Table 2  appropriate to the absorbency range of the tampons, e.g. “approximately   
11 g absorbency. Suitable for medium flow”, where the absorbency range of the tampons is 9 g to   
12 g;  
 
c)  the following wa rning in letters having height of not less than 1.0 mm, with the word "IMPORTANT"   
in capitals;   
 
IMPORTANT Tampon use has been associated with Toxic Shock Syndrome (TSS). TSS is a rare but serious disease that may 
cause death. Read and keep the enclosed i nformation . 
 
d) date of manufacture and expiry  
 
 
7.2  Supply packs   
 
Supply packs, as received by the consumer, shall be permanently and legibly marked with the following   
information, which shall be visible at the time of purchase:  
  
a)  description of the c ontents, including the number , and the label given in Table 2  appropriate to the   
 absorbency range of the tampons. Example  “10 tampons, approximately 11 g absorbency.  Suitable 
for medium flow", where the absorbency range of the tampons i s 9 g to 13  g;  
  
b) a list of the constituents of the body of the tampon;   
  
c)  the following warning in letters having a height of not less than 1.0 mm , with the word 
“IMPORTANT , CAUTION or WARNING ” in capitals.  
 
IMPORTANT Tampon use has been associated with Toxic Sho ck Syndrome (TSS). TSS is a rare but serious disease that may 
cause death. Read and keep the enclosed information .  
 
The information required by 7.2 a), b) and c) may be given on the primary pack only, and not repeated on the  
supply pack, provided that it is visible on the primary pack at the time of purchase.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Table 2-Absorbency ranges  
 DKS 1534 : 2021  
 
6  © KEBS 202 1 — All rights reserved   
SN Absorbency range, g  Label  
i.  12-16 Approximately 14 g absorbency Suitable 
for heavy flow  
ii.  9-13 Approximately 11 g absorbency Suitable 
for medium flow  
iii.  6-10 Approximately 6 g absorbency Suitable 
for light flow  
  
  
7.3  Manufacturer's details   
 
The name or trade mark of the manufacturer or supplier shall be permanently and legibly marked on the   
supply pack, and on the le aflet in the primary pack ( see Claus e 8) contained therein .  
  
7.4  Transport pack   
  
The transport pack, as received by the retailer, shall be marked with a date code or the batch numbers of the 
enclosed primary packs.  
 
8 Information leaflet  
 
A leaflet containing the following information s hall be enclosed in each primary pack:  
 
a) detailed instructions for use including the need for hygiene and care in insertion;  
b) information about Toxic Shock Syndrome;  
the wording of the information on TSS shall be acceptable to the relevant regulatory authori ty in the 
country of supply.  
NOTE : an example of wording that was regarded as suitable for inclusion on the  leaflet at the  time this standard w as 
published is given in Annex D . 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 DKS 1534 : 2021  
 
© KEBS 2021  — All rights reserved  7 Annex A  
(normative)  
 
Method for measuring  absorptive cap acity  
A.1 Scope  
This annex sets out a method for measuring the absorptive capacity of a tampon under counter pressure.  
 
A.2  Principle  
 
The principal is to simulate the vaginal environmental in the laboratory by applying standard pressure to a 
tampon insid e a flexible membrane (a certain type of condom) and then introducing defined amounts of fluid 
until the tampon leaks. The tampon weight is taken before and after the tests to calculate the weight of fluid 
absorbed.  
 
A.3 Apparatus  
 
The following apparatus is required : 
 
a) Standard laboratory equipment  
b) Syngina apparatus - the Syngina apparatus set -up is illustrated in Figure A.1. This is designed to 
provide constant hydrostatic pressure of 180 ±10 mm  
i. Syngina chamber , details of which are provided in Figure A2.  
ii. Infusion pump, set to deliver 50±2mL/h  
iii. Thermostatic bath, with external circuit, set up to 27±1ºC.  
c) Straight unlubricated condoms having a tensile strength between 17 MPa and 30 MPa measured in 
accordance with KS ISO 4074  Annex I.  
NOTES:  
To install and replac e condom : 
i. Open and unravel a condom  
ii. Mark the condom at 20 mm and 160 mm length from the open end (see Figure A3).  
iii. Insert the condom through the chamber with the aid of a rod so that the 16 0 mm mark rests on the edge of the 
smaller opening of the chamber (s ee figure A2).  
iv. Cut the tip of the condom and secure with a rubber band, such that the 160 mm mark remains on the edge of the 
small opening of the chamber.  
v. Draw the condom through the large chamber  opening so that the 20 mm mark rests on the opening’s edge (see 
Figure A2) and secure with a rubber band.  
vi. Replace condoms if they leak, after every tenth test or daily, whichever applies first.  
  
A.4 Materials and Reagents  
 
The following materials and reagents are required:  
 
a) Distilled or de -ionized water . 
b) Sodium c hloride  (analytical reagent grade).  
c) Colour agent.  
NOTE: Acid  fuchsin, Fisher F97 Certified Biological Stain, Colour Index No. 42685; Fisher Scientific Company or Frucherot 
dye, E 144 or Ponceau Cochenillerot E 124  or FD&C Red#40, have been found to be effe ctive. 
d) Sodium chloride solution: Dissolve 10 g sodium chloride in 1 L distilled or de -ionized water.  DKS 1534 : 2021  
 
8  © KEBS 202 1 — All rights reserved  e) Syngina fluid: dissolve 0.5 g colour agent in 1 L sodium chloride solution.  
NOTE:  
Syngina fluid should be regularly replaced to avoid microbiological conta mination.  
Syngina fluid should be stored and used at room temperature  
 
A.5 Sample Size  
 
NOTE: An example of how to determine the sample size is given in Appendix F.  
Use the following procedure to determine the process capability and sample size:  
a) Determine  the process capability . 
b) Based on the process capability, determine a sample size that estimates the proportion of tampons 
with absorbencies within the defined limits of 90% confidence and 5%  error. In cases where the 
determined process capability approxim ates 1, resulting in an excessively small required sample 
size (below 10), a minimum sample size of 10 tampons shall be adopted . 
c) Use the sample size calculated above to test the hypothesis that atleast 90%  of the tampons from 
this sample size have absorben cies within the specified limit with 90% confidence.  
 
A.6 Preparation of Test Specimens  
 
Preparation  of the test specimens shall be as follows:  
 
a) Select the required number of tampons at random from one homogeneous batch for use in this 
procedure. Should a test be invalid in accordance with paragraph A8, draw the necessary 
additional tampons from the same batch at random to complete the required number of valid 
tests.  
b) Remove the test specimen (tampon) from its wrapping and applicator, if app licable.  
c) Unwrap the test specimen (tampon) immediately before testing.  
 
 
                                         
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 DKS 1534 : 2021  
 
© KEBS 2021  — All rights reserved  9  
 
 
    
 
 
 
 
 
FIGURE A.1 SYNGINA APPARATUS SET UP  
 
 
 
 
 
 
 
 DKS 1534 : 2021  
 
10  © KEBS 202 1 — All rights reserved   
 
 
                                   FIGURE A.2 DETAILS OF SYNGINA  
 
 
 
 
 
 DKS 1534 : 2021  
 
© KEBS 2021  — All rights reserved  11  
 
 
 
FIGURE A.3 PREPARATION OF CONDOM  
 
 
 
A.7 Procedure  
 
 The procedure shall be as follows:  
a) Weigh the specimen (tampon) to be tested (including the withdrawal cord) to the nearest 0.01 gram, 
and record the weight  
b) With the Syngina chamber empty place the tampon wi thin the condom so that the centre of the 
tampon is at the centre of the chamber and the withdrawal cord is positioned towards the bottom of 
the chamber (see Figure A.1)  
c) Insert the infusion needle (cannula) through the optional septum cap so that it contac ts the top end 
of the tampon  
d) Fill the outer part of the chamber with water and adjust the flow such that water trickles over the 
head and back to the water bath. The liquid must not rise into the atmospheric vent  
e) Examine the position of the tampon and, if necessary, drain, re -centre and repeat steps (c)  and (d)  
f) Pump the Syngina fluid into the chamber  
g) The ‘end point’ is defined by the first drop of liquid that exits the apparatus. Terminate, the test by 
stopping the fluid flow. The test shall be discarded if  fluid is detected in the folds of the condom 
before the tampon is saturated  DKS 1534 : 2021  
 
12  © KEBS 202 1 — All rights reserved  h) Drain the water from the chamber, remove the tampon and weigh it immediately to the nearest 0.01 
gram, and record the wet weight  
i) After the tampon has been weighed carefully remove  any residual fluid (using a non -fibre shedding 
absorbent laboratory wipe ) from the inside of each condom in preparation of the next test.  
NOTE: If the test stand comprises more than one chamber, use tampons with the same absorbency, for parallel testing  
 
A.8 Invalid Test  
 
A test shall be considered invalid in the following instances:  
a) Failure to maintain hydrostatic pressure of 180±10 mm.  
b) Tampon expands longitudinally forcing the top of the condom open.  
A new condom shall be inserted in the Syngina in every  such case and the determination is repeated  
 
A.9 Test Repot  
 
 The test report shall contain the following information:  
a) The highest and lowest absorptive capacity results in grams of water per tampon.  
b) The number of tampons tested.  
c) The absorbency range, as given in Table 1, into which 90% of the estimated population fall.  
d) Reference to this test method, i.e. Appendix A of KS 1534  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 DKS 1534 : 2021  
 
© KEBS 2021  — All rights reserved  13                                            Annex  B 
 
 (normative)  
 
Method for testing the strength of  the withdrawal cord and its attachment to the 
tampon  
 
B.1 Scope  
  
This annex sets out a method for determining the strength of the withdrawal cord and its attachment to the 
tampon in both wet and dry conditions.  
 
B.2 Principle  
Tampon is supported in a hol der leaving the withdrawal cord free. The holder containing the tampon is rigidly 
supported while an increasing force is applied to the withdrawal cord until either the cord breaks or it is 
detached from the body of the tampon.  
Figure B.1 gives a diagramma tic sketch of the arrangement.  
  
B.3  Apparatus  
 
a) Tensile testing machine complying with the following:  
 
i) the machine shall comply with requirements of machines as specified in  KS ISO 7500 -1 except that 
the error in measurement of length shall not exce ed 1.0 mm;  
 
ii)  the machine shall provide means for indicating the force applied to the test specimen clearly and 
continuously on a dial scale or chart. It shall also provide means for indicating the force required to 
break or detach the cord;  
 
iii)  the capacity of the machine or the range selected shall be such that the force required to break the 
test specimen shall be not less than 10% of the machine capacity;  
 
iv)  the machine shall be capable of extending the specimen at a constant rate of 200 ± 25 m m/min;  
 
v) the force measuring mechanism of the machine shall allow little or no movement of the fixed jaws in 
the direction of the applied force;  
vi)  the fixed and moving jaws of the machine shall be in same plane, parallel to one another and at 
right angles  to the direction of application of the force;  
vii) the jaws of the machine shall be so constructed so as not  to damage the test specimen.  
 
NOTE   Suitable packaging materials or embedding techniques may be used whenever necessary to prevent test specimens slipping 
in the jaws.  
 
b) Two holders (see Figure B.2 having internal diameters of 26 ± 1 mm and 29  ± 1 mm, respectively . 
 
NOTE      The example of a holder shown in Figure B.2 will introduce a small error as the applied force will be slightly offset. This 
error is typically <1 %. The flat plate of that holder  has been offset to allow easy insertion of the tampon.  
 
c) A wire 200 mm long with the end bent to form a hook as shown in Figure B 3. If optional slotted 
holders are used, wire is not required.  
d) Time r, capable of measuring 5 min accurately.  
 
 DKS 1534 : 2021  
 
14  © KEBS 202 1 — All rights reserved   
 
  
 
 Figure B.1 — Typical set -up for  withdrawal cord attachment test  
 
 
 
e) Beaker of 1 L capacity.  
 
f)  Pair of tongs.  
 
g) Distilled or deionized water  
 DKS 1534 : 2021  
 
© KEBS 2021  — All rights reserved  15 B.4 Test specimen s 
There sha ll be 20 unopened tampons at random from one batch. Should a test be invalid in accordance with 
Clause B.6, the necessary additional test specimens shall be drawn to complete 20 valid tests. Out of the 20 
tampons, 10 shall be used for testing in the dry st ate and 10 for testing in the wet state.  
 
B.5  Procedure  
B.5.1   Dry state  
The procedure shall be as follows:  
a)         condition the wrapped tampons for not less than 12 h at 20  ± 2°C and 65 ± 5% relative humidity;  
b) unwrap a tampon, remove the applicato r where provided, and extend the withdrawal cord away from 
the body of the tampon;  
c)  using the hook, which is inserted through the hole in the base of the holder, pull the withdrawal cord 
through the hole so that the tampon is held within the 26 mm inter nal diameter holder with cord free 
(see Figures B.2 and B.3.  Alternatively, if the slotted holder is used, the tampon can be threaded 
into the holder without using the wire hook;  
d) place the flange on the holder into the upper jaw of the tensile testing machine. The base of the 
holder shall be at least 60 mm above the top of the lower jaw;  
e)  extend the cord so that there are no kinks in it and clamp the lower end in the lower jaw (see Figure 
B.1);  
f)  set the machine to give a constant rate of extension  of 200 ±  25 mm/min;  
 
g)  set the machine in motion and record the force required to either break the cord or detach it from the 
body of the tampon;  
h) repeat steps b) to g) a further nine times;  
i) calculate the mean force.  
 
B.5.2   Wet state  
 
The procedu re shall be as follows:  
a) unwrap a tampon, remove the applicator, where provided, and place the tampon in the 1 000 mL 
beaker in an excess of the water;  
 
b)  leave the tampon in the water for at least 5 min;  
 
c)  remove the tampon with the tong and gently  squeeze to remove excess water;  
 
d)  place the tampon in the 29 mm internal diameter holder, inserting the withdrawal cord through the 
hole in the base.  
e) follow steps d) to i) as specified in B.5.1  
B.6  Invalid test  
B.6.1   A test shall be considered inv alid if the cord breaks at the point where it enters the lower grips.  
 
B.6.2   A new tampon is inserted into the holder in each such case and the procedure is repeated.  
 DKS 1534 : 2021  
 
16  © KEBS 202 1 — All rights reserved  B.7  Test report  
 
The report shall contain the following information:  
 
a)  For the  dry state:  
 
i)  the results of each of the 10 individual tests; and  
ii) the mean force of the 10 tests.  
b)  For the  wet state:  
i)   the result of each of the 10 individual tests; and  
 
ii) the mean force of the 10 tests.  
 
c) Reference to this test method , i.e. Ann ex B of KS 1534  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 DKS 1534 : 2021  
 
© KEBS 2021  — All rights reserved  17 
 
 
 
 DKS 1534 : 2021  
 
18  © KEBS 202 1 — All rights reserved   
 
 
Figure B.3 —  Threading cord through tampon holder  FRONT 
VIEW  SIDE 
VIEW  DKS 1534 : 2021  
 
© KEBS 2021  — All rights reserved  19 Annex   C  
(normative)  
 
Method for determining the water repellency  of the withdrawal cord  
 
C.1 Scope  
 
This annex se ts out a method for determining water repellency  properties of the withdrawal cord.  
 
C.2  Principle  
 
A section of the withdrawal cord is placed on the surface of water in a beaker. If the repellency of the cord is 
such that it does not sink in a prescribe d time, the cord is determined to have satisfactory water repellency.  
 
C.3  Apparatus  
 
C.3.1  The following apparatus shall be required:  
 
a) five beakers, each of 500 mL minimum capacity, almost filled with tap water;  
 
b)   blade or pair of scissors;  
 
c) tweezers;  
 
d) timer, capable of recording time to 5 h;  
 
e)  ruler.  
 
C.4  Test Specimens  
 
Select five unopened tampons at random from one batch.  
 
C.5  Procedure  
 
C.5.1  The procedure shall be as follows:  
 
a) condition the wrapped tampons for at least 12 h at 20  ± 2°C and 65 ± 5% relative humidity;  
b)       unwrap a tampon, remove the applicator where provided, and, using tweezers, extend the withdrawal 
cord away from the body of the tampon;  
c)  using the ruler and scissors or blade, cut a section of the cord ap proximately 75 mm long;  
d)  repeat steps b) and c) for each of the other four tampons;  
e) again, using tweezers, lightly drop the section of cord taken from each tampon on to the surface of 
water in a separate beaker;  
f) start the timer;  
g)  after 5 h, ex amine the beakers to see if the five cord samples are floating on the water surface or 
have sunk completely beneath the surface.  
 
C.6 Test report  
 
 The test report shall contain the following information:  
a) whether or not any of the samples sank completel y beneath the water surface;  
 
b)      reference to this test method according to this Annex C.  DKS 1534 : 2021  
 
20  © KEBS 202 1 — All rights reserved  Annex   D  
(informative)  
 
Example of information on TSS for inclusion in information leaflet  
 
D.1  Scope  
This annex provides an example of the minimum information t o be included in the information leaflet, and 
advice to manufacturers regarding the provision of extra information.  
D.2  Content of leaflet  
 
The leaflet should contain information about:  
 
a)  toxic shock syndrome (TSS);  
 
b)  precautions for hygiene and co mfort when using tampons;  
 
c)  instructions for correct use of the product.  
 
An example of wording in Clause D .2 a) a nd b) above is given in Clause D .3 below. The leaflet should 
includ ed all of the points in Clause D .3, plus any other information which the  manufacturer thinks is relevant.  
An example h as not been included in Clause D .2 c), as the instructions are likely to vary from product 
product and, for many products, are provided by line drawings as well as words.  
 
The expression and organization of th e information in the leaflet should be determined by the manufacturer 
with reference  to the requirements of Clause D .4. 
 
D.3  Example of wording  
                                   CAUTION — TOXIC SHOCK SYNDROME (TSS)  
 What is TSS?  
 
Toxic shock syndrome (T SS) is a rare but serious illness that may cause death. It is caused by a toxin (a 
kind of biological poison) which is  produced by a type of bacteria (Staphylococcus aureus). These bacteria 
are found in the nose of about one third of the population. They m ay also be found on the skin, and 
occasionally in the vagina, without causing harm.  
 
 Who is  at risk?  
TSS can occur in both males and females of any age but is more common in the young women who use 
tampons during their period.  
 Symptoms  of TSS?  
The early symptoms of TSS may begin suddenly and are similar to the "flue". Remember, early recognition 
of these symptoms is very important.  
 
-  FEELING VERY ILL, HEADACHE, MUSCULAR PAINS  
-  HIGH FEVER AND CHILLS. USUALLY 39°C (102°F) OR HIGHER  
-  VOMITING, DIARRHOE A, OR BOTH  
- FAINTING, DIZZINESS, WEAKNESS, OR CONFUSION  
- SUNBURN — LIKE RASH  
 DKS 1534 : 2021  
 
© KEBS 2021  — All rights reserved  21 What must I do if I think I have TSS?  
 
If, during your period or shortly after, you have any of the above symptoms, REMOVE YOUR TAMPON AND 
SEE A DOCTOR IMMEDIATELY. Remember it is  very important to tell the doctor that you have been using 
tampons.  
 
If you have ever had TSS you should not use tampons until you have discussed the matter with a doctor. 
You may not have developed resistance to the toxin and could get TSS again.  
 
 How d oes TSS occur?  
 
If the toxin is produced in the vagina or a wound, and absorbed from there into the bloodstream, a person 
who is not resistant to the toxin may become ill.  Most people develop resistance to the toxin (that is the 
illness is so rare) and in these people there is no harmful effect.  
 
The symptoms of TSS may develop rapidly. Early recognition and treatment of these symptoms can usually 
prevent serious illness.  
 
Do tampons cause  TSS?  
 
The simple answer is no. Tampons do not carry the bacteria whi ch cause TSS. However, tampon use has 
been associated with an increased risk of TSS. Although TSS can occur with the use of tampons of any 
absorbency, the risk increases with the use of tampons of higher absorbency.  
 
 
Where can I get more  information about  TSS?  
More information is available, free of charge, from the Toxic Shock Syndrome I formation service a web -
based service at www.toxicshock.org.au  
 
Precautions on tampon use  
 
-One should use the lowest absorben cy tampon for comfort and level of blood flow. Use only one tampon at 
a time.  
 
- Wash hands before unwrapping and inserting a tampon, and again afterwards.  
 
- Unwrap a fresh, clean tampon just before use – do not handle it more than necessary or place it o n any 
surface.  
 
- Do not inset a tampon if it hurts to do so.  
 
- Removal of the tampon should be easy; if the tampon is dry and difficult to remove, the absorbency is too 
high or the tampon has not been in place long enough. Tampons should be changed as of ten as necessary 
but should not be left longer than 8 hours.  
- Remove the used tampon before inserting the next one and do not forget to remove the last tampon used 
at the end of your period.  
 
  -Only use a tampon when menstruating.  
 
 - Ask a doctor if it is okay to use tampons if recently given birth, had a caesarean section, a miscarriage, an 
abortion or any operation on the reproductive system.  
 
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22  © KEBS 202 1 — All rights reserved  D.4 Advice to manufacturers  
a) The simple style and language used in the above example have been chosen in orde r to maximize 
the likelihood that younger women, and women for whom English is a second language, will be able 
to understand it. Care should be taken that the whole leaflet is written in plain language  
b) manufactures are encouraged to give careful considerat ion to the design and layout of their labels 
and information to ensure that they are as effective as possible. It is also recommended that 
manufacturers test the understandability and effectiveness of their leaflet and adjust the wording, 
design or layout accordingly  
c) reference should be made to the relevant regulatory authorities to ensure that the content of the 
leaflet complies with national requirements  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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© KEBS 2021  — All rights reserved  23  
Annex   E  
(informative)  
                              EXAMPLE OF SAMPLE  SIZE CALCULATION  
E1 SCOPE  
This annex sets out an example of the calculation procedure referred to in annex A.  
E2 STATICTICAL SAMPLING  
Statistical sampling is a procedure which enables decisions to be made about the quality of batches 
of items after inspecting or testing only a portion of those items. This procedure will only be valid if 
the sampling plan has been determined on a statistical basis and the following requirements are met:  
a) the sample must be drawn randomly from a population of a product of known history. The history 
must enable verification that the product was made from known materials by essentially the same 
processes and under essentially the same system of control . 
b) for each different situation, a suitable sampling plan is defined. A samplin g plan for one 
manufacturer of given capability and product throughout may not be relevant  to another 
manufacturer producing the same items.  
            In order for statistical sampling to be meaningful to the consumer, the manufacturer or supplier needs    
to demonstrate how the above conditions have been satisfied.  
E3 DETERMINATION OF PROCESS CAPABILITY  
Determine  the process capability as follows:  
a) let the proportion of individual tampons be absorbencies that lie within the specified absorbency 
limits be denoted by p (the population proportion), where  
P=X/N                                                                                                                                         ...E3(1) 
Where X represents the number of tampons within the lim its and N represents the sample size  
b) estimate the capability process, that is, estimate for each process the proportion of individual 
tampons absorbencies that lie within the specified absorbency limits over an extended period of 
time. This estimate is denoted by p’ (the estimate of p), where  
  p’=x/n 
          =total number of tampons within the limits over time/total number of tampons tested over time ...  E3(2) 
NOTE: in order to determine the capability of a process, more than 500 tampons should be ran domly sampled and tested.  
The capability of a process may vary, and it will therefore require periodic redetermination.  
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24  © KEBS 202 1 — All rights reserved  E4 DETERMINATION OF SAMPLE SIZE  
The acceptance error percentage margin in order to estimate the proportion of tampons 
absorbencies is 5%. If the term 1.645 x SE(p’) is taken as the 5% error, then  
               1.645 x SE(p’) =0.05 
       therefore,  
             SE(p’) =0.05/1.645  
                        =0.0304  
as  
       SE(p’) =√p’(1-p)/n                                                                                                          …E4 
Then  
      0.0304  =√ p’(1-p)/n 
              n= (1/0.0304)2 x p’(1-p’) 
                =1083 x p’(1-p’) 
Therefore, the required sample size can be calculated by n = 1083 x p’(1-p’). in cases where the 
determined process capability (as described in paragraph F3) approximates one, the sample size 
calculation above is not applicable as it provides for an infidelity small sample size. In such  cases 
use a minimum sample size of 10.  
NOTE: The standard error [ SE(P’ )] and confidence interval [ (p)] for p’ are given by:  
               SE(P’)  = √p’(1-p’)/n 
              p = p’± 1.645 x SE(P’)  
 
 
 
 
 
 
 
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© KEBS 2021  — All rights reserved  25  
E5 DETERMINATION OF ABSORBENCY RANGE  
Determine the absorbency range as follows:  
a) From the sample size calculated in paragraph F4, estimate O, the proportion of tampon absorbencies that 
lie within the limits specified.  
b) Test the hypothesis that  
  Null hypothesis (Ho): O = 0.9 
                     Vs 
     Alternative hypothesis ( Hα): O ˂ 0.9 
     i.e. that the population proportion (the true proportion absorbencies that lie between the specified li mits) is 
at least 0.9.  
c) As O is approximately normally distributed with a mean of Ô and a variance equal to Ô. (1- Ô)/n, 
            Calculate the z statistic, z = Ô-O/SE( Ô)                                                               …E5 
                           Where SE(Ô)= √ Ô (1- Ô)/n 
d)  if z˂ -1.282, the tampon batch does not meet the specified claims for absorbency.  
e) If z > - 1.282, the tampon batch does  meet the specified claims for absorbency.