KENYA STANDARD DKS 1534: 2021

KENYA STANDARD DKS 1534: 2021

ICS 97.170

Menstrual tampons — Specification

© KEBS 2021 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 Research and Development 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 Nairobi Hospital Nairobi Enterprises Pharmacy and Poison Board Kimberley Clark LTD Ministry of Health(MOH) Kenya Peadiatric 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 STANDARDS 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 Standards, 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 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.

https://www.kenyapaediatric.org/




KENYA STANDARD DKS 1534: 2021

ICS 11.040.30

© KEBS 2021— All rights reserved iii

Menstrual tampons — Specification

Kenya Bureau of Standards, Popo Road, Off Mombasa Road, P.O. Box 54974 - 00200, Nairobi, Kenya

+254 020 6948000, + 254 722202137, + 254 734600471

[email protected]

@KEBS_ke

kenya bureau of standards (kebs)

DKS 1534: 2021

iv © KEBS 2021 — All rights reserved

Foreword This Kenya Standard has been prepared 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 specifies 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 coli 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 replaces 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 references, 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

hypersensitivity

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

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2 © KEBS 2021 — All rights reserved

For the purposes of this standard, the following 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 environment

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, the 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 containing one or more unit packs.

c) supply pack — The pack that is supplied to the consumer. It may be the primary pack, or contain 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

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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

hazard. Polyester foam shall be not used. Carboxymethylcellulose (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 test 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, although 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 materials are used, evidence is required 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 accordance with KS 08-638 Annex J

with diethyl ether as solvent, and two 5g 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 or 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 specimen 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

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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 with 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 detectable per gram of sample

KS ISO 22718

ii. Total aerobic bacterial count, Max,

1.0 x 103 ISO 8784-1

iii. Pseudonymous aeruginosa

Not detectable per gram of sample

KS ISO 22717

iv. Escherichia coli Not detectable per gram of sample

KS ISO 21150

6 Packaging

The following requirements and recommendations 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 protect 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.

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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 symbols having 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 warning 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 information. 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 contents, 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 is 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 Shock 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

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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 leaflet in the primary pack (see Clause 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 shall 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 authority 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 was

published is given in Annex D.

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Annex A (normative)

Method for measuring absorptive capacity 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 inside 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 replace 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 160 mm mark rests on the edge of the

smaller opening of the chamber (see 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 chloride (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 effective.

d) Sodium chloride solution: Dissolve 10 g sodium chloride in 1 L distilled or de-ionized water.

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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 contamination.

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 approximates 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 absorbencies 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 applicable.

c) Unwrap the test specimen (tampon) immediately before testing.

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FIGURE A.1 SYNGINA APPARATUS SET UP

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FIGURE A.2 DETAILS OF SYNGINA

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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 within 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 contacts 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

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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

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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 holder 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 diagrammatic 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 exceed 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 mm/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) Timer, capable of measuring 5 min accurately.

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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

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B.4 Test specimens

There shall 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 state 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 applicator 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 internal 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 procedure 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 invalid 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.

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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. Annex B of KS 1534

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Figure B.3 — Threading cord through tampon holder

FRONT VIEW

SIDE VIEW

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Annex C (normative)

Method for determining the water repellency of the withdrawal cord

C.1 Scope This annex sets 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 prescribed 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 approximately 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, examine 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 completely beneath the water surface;

b) reference to this test method according to this Annex C.

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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 to 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 comfort when using tampons; c) instructions for correct use of the product. An example of wording in Clause D.2 a) and b) above is given in Clause D.3 below. The leaflet should included all of the points in Clause D.3, plus any other information which the manufacturer thinks is relevant. An example has 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 the 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 (TSS) 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 may 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, DIARRHOEA, OR BOTH

- FAINTING, DIZZINESS, WEAKNESS, OR CONFUSION

- SUNBURN — LIKE RASH

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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 does 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 which 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 absorbency 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 on 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 often 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.

http://www.toxicshock.org.au/

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D.4 Advice to manufacturers

a) The simple style and language used in the above example have been chosen in order 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 consideration 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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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 sampling 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 limits 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 randomly sampled and tested.

The capability of a process may vary, and it will therefore require periodic redetermination.

DKS 1534: 2021


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’)

DKS 1534: 2021


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 limits) 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.

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KENYA STANDARD DKS 1534: 2021