DRAFT KENYA STANDARD  DKS 2942 : 2022 
ICS ……….  
First Edition  
  
 © KEBS 2022  
  
 
 
Flocked swabs for clin ical use —  Specification  
 
 
 
 
 
KENYA BUREAU OF STANDARDS (KEBS)  
PUBLIC REVIEW DRAFT                                        FEBRUARY,2022  DKS 2942 : 2022 
ii © KEBS 2022 – All rights reserved  
 TECHNICAL COMMITTEE REPRESENTATION  
The following organizations were represented on the Technical Committee:  
 
Alpha Medical Manufacturers Limited  
Association of Medical Engineers of Kenya (AMEK)  
Christian Health Association of Kenya (CHAK)  
Diverse Management Consultancy Ltd.  
Equra Health Kenya  
Jads Diagnostics EA Ltd.  
Kenya Accreditation Service (KENAS)  
Kenya National Chamber of Commerce and Industr y (KNCCI)  
Medtronics Kenya  
Ministry of Health  
Nairobi County — Sub county Health Services, Kamukunji  
Physicist Society of Kenya  
Kenya Bureau of Standards — Secretariat  
 
 
 
 
 
 
 
 
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, 2020 
Copyright. Users are reminded that by virtue of Section 25 of the Copyright Act, Cap. 130 of 2001 of  the Laws of Kenya, copyright subsists 
in all Kenya Standards and except as provided under Section 25 of this Act, no Kenya Standard produced by Kenya Burea u of Standards 
may be reproduced, stored in a retrieval system in any form or transmitted by any means without prior permission in writing f rom the 
Managing Director.   DRAFT KENYA S TANDARD  DKS 2942 : 2022 
ICS ……..  
First  Edition  
 
© KEBS 2022 – All rights reserved  iii 
   
 
 
 
Flocked s wabs for clinical use —  Specification  
 
 
Kenya Bureau of Standards,  Popo Ro ad, 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 2942 : 2022 
iv © KEBS 2022 – All rights reserved  
 Foreword  
This Kenya Publicly Available Specification  was prepared by the Hospital devices, tools and equipment  
Technical Committee under the guidance of the Standards Projects Committee, and it is in accordance with the 
procedures of the Kenya Bureau of Standards  
This document gives t he minimum specifications of a swabs  to be used in health care premises and public 
during the current COVID -19 pandemic or any other emergency declared by the minister concerned with Health  
at the time . It sets out minimum  requirements of what is ‘minimall y acceptable’ performance.  A swab  with lower 
specifications than this is likely to provide no protective benefit and might lead to increased harm, which would 
be unacceptable for regulators . 
This document is intended to guide m anufacturers  in the process o f meeting the k ey requirements of a swab  
and does not attempt to provide a comprehensive list of requirements as the manufacturer is expected to be 
familiar with the concepts of swabbing and manufacturing of medical  devices.  
It is expected that t hat full demonstration of compliance with ISO 18526 :2020 shall be upheld and shall be a  
require ment  for development.  
In the process of preparing  this standard, clinical acceptance of functionality,  sterility , safety and performance 
by relevant stakeholders and their consensus was sought.  
During the preparation of this standard, reference was ma de to the following documents : 
KS 2556:2018 Impregnated cotton swabs – Specification  
KS 1029, Methods for determinatio n of sterility of textile products,  
Acknowledgement is hereby made for the assi stance derived from these sources.  
 DKS 2942 : 202 2   
 
© KEBS 2022– All rights reserved   
 Flocked s wabs for medical use —  Specification  
1 Scope  
This draft Kenya S tandard  prescribes the minimum requirements , testing methods and use of flocked 
swabs  during the COVID -19 pandemic  or any other emergency declared by the minister concerned with 
Health  at the time . 
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 editio n of the referenced document (including any amendments) applies.  
ISO 11137 -1:2006Sterilization of health care products — Radiation — Part 1: Requirements for 
development, validation and routine control of a sterilization process for medical devices   
ISO 11 737-1:2006, Sterilization of medical devices — Microbiological methods — Part 1: Determination of 
a population of microorganisms on products   
ISO 11607 -1:2019, Packaging for terminally sterilized medical devices — Part 1: Requirements for 
materials, steril e barrier systems and packaging systems  
3 Terms and definitions  
For the purpose of this document, the terms and definitions given  in KS ISO 4007 and the following apply.  
3.1 
swab  
devices ready to use, composed of a flocked, foam or polyester tip (head) , plastic stick and a test tube with 
screw cap containing a room temperature stable viral transport medium, suitable for the transportation and 
preservation of Viruses, such as Influenza H1N1, Chlamydia, Mycoplasma and Ureaplasma specimens  for 
use in health  care facilities in Kenya during the COVID -19 pandemic  or any other emergency declared by 
the minister concerned with Health.  
Broadly, it can also be defined as absorbent pad or piece of material used in surgery and medicine for 
cleaning wounds, applying m edication, or taking specimens  
4 Requirements  
 4.1 General  
         4.1.1  Manufacture and distribution of flocked swabs shall be done in premises that meet the 
 requirements of KS ISO 13485.  
 
 4.1.2  Sterile Swabs shall be classified as “Medical Devices “in  accordance with Pharmacy and Poiso ns 
 Board  Directive, with Ministry of Health  Directive and subsequent amendments.  
 4.1.3  Swabs shall be  sterile and ready -for-use systems intended for clinical samples drawing, transport and  
 maintenance for cultural test and shall be  suitable for short contact with the human body including surgical 
 wounds.   
© KEBS 2022 – All rights reserved  iii 
  4.1.4 Test Tubes shall be  classified as IVD and intended only for the preservation of samples.  
4.1.5  Appearance  
The outer surface of the  swab shaft shall be smooth and free from bends, cravices, sharpness, while the head 
shall be free from foreign matter, blurring or contamination.  
 
4.2   Steril ity 
4.2.1 Swabs shall be sterile . The sterility  shall be validated periodically  and verified by external audit.   
4.2.2 A SAL (Sterility Assurance Level) of 1 x 10-6 shall be gu aranteed.  
Note. A Device is defined as “sterile” when it’s possible to assure or certify, on statistical basis, that the probability that it 
results non sterile is equal or lower than a chance of 1 in 1.000.000.   
4.2.3 Sterility shall be validated and constantly monitored in accordance with KS ISO 11137 and KS ISO 11737.   
4.2.4 The packaging of sterile devices shall be regularly validated and constantly monitored in order to 
guarantee the microbiological status for the indicated validity period of the integral packaging (KS ISO 11607).  
 
4.3 Pyrogenicity  
Swabs shall be Apyrogenic  or non -Pyrogenic, where absence, or presence within detection limits, of endotoxins 
by Gram -negative bacteria shall be granted.  
Note. For Devices declared as Apyrogenic a bacterial endotoxin limit 20EU/piece (EU=Endotoxin Unit) on integral packaging 
is granted. Endotoxins presence is determined by LAL tests (sensitivity 0.03 EU/ml).   
 
4.4 Quality  
4.4.1  Mechanical strength and flexibility of the shaft  
Swabs handle shall be flexible and mechanically strong to accord comfort to the patient during use.  
4.4.2  The applicator shaft of the swab s hall be  mounted on the tube plug to serves as an optimal grip for an 
efficient handling.  
4.4.3 The applicator shaft shall either  be plastic or aluminium.  
4.4.3.1 Plastic shaft : made of polystyrene, very flexible but easily breakable as needed, with atoxic  tip.  
Note.  This is p articularly suitable for mouth, throat, vagina, urogenital apparatus, skin, wounds and surgical wounds.  
 4.4.3.2 Aluminum shaft : shall have atoxic shaft, with tip,  ideal for arduous or delicate sampling. The narrow 
dimension of the swabs shaft (only 0.9 mm), high flexibility and strength, small fiber tip, make it particularly 
suitable for urogenital, urethral, ocular, nasopharyngeal and paediatric uses.  
4.4.4  Medium and t est tube  
The medium shall meet the following requirements  
a) Medium is contained in a cylindrical test tube, in transparent, unbreakable medical polypropylene (PP), 
to preserve sample and user’s safety.  
b) There shall be pressure cap made of polyethylene (HDPE) with specific colour according to medium 
type.  
c) The medium shall be p re-labelled on test tube to allow a correct sample identification. Item code, lot 
number and expiry date printed on each label for a full traceability.  
d)  The liquid transport medium shall be put inside a sponge, at the bottom of the squeezable test tube, 
in order to allow direct inoculation of the sample.  
 
Note. The addition of antibiotic substances avoids the proliferation of bacteria or fungi. The foam 
sponge with transport medium allows the survival of virus such as Papiloma, Pseudorrabia, Influenza 
aviar (H7N1), Influenza A (H1N1) o H1N1/09 pandemic, Suid herp esvirus  
  
iv © KEBS 2022 – All rights reserved  
  
  
Figure 1 (a) Pictorial presentation of sampler  
   
Figure 1  (b). Schematic dimensions of flocked swab  
 
5 Dimension.  
Test tube shall measur e 12 x 155 mm . The dimensions of the swab will be as shown in figure 1.  
 
 
 
© KEBS 2022 – All rights reserved  v 
  6 Separation strength of swab  from shaft  
When a 5N sta tic axial tension is applied  between the shaft and the swab, for 10 seconds, it shall pass 
test. 
 
7 Labelling and packaging  
The following information shall be indelibly and legibly put on the package;  
a) Name and physical address of t he manufacturer  
b) Trade name, if any  
c) the name of  the product e.g. “Swabs ” 
d) The word  “Sterile ” 
e) The phrase “Single Use Only”  
f) Instruction for use   
Note 1: Manufacturers must provide these instructions, if applicable, to each end user facility (e.g., each hospital) that 
receives the authorized face shield  
g) Batch Number  
h) Date of manufacture and expiry date