DRAFT UGANDA STA NDARD  
  DUS 2287  
First Edition  
2020 -mm-dd 
 
 
 Reference number  
DUS 2287 : 2020 
© UNBS 2020   
  
Alcohol swab s — Specification  
 DUS 2287 : 2020  
ii © UNBS 2020  – All rights reserved  
 Compliance with this standard does not, of itself confer immunity from legal obligations  
A Uganda Standard does not purport to include all necessary provisions of a contract. Users are 
responsible for its correct applicatio n 
© UNBS 2020   
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilised in any 
form or by any means, electronic or mechanical, including photocopying and microfilm, without prior written 
permission from UNB S. 
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Uganda National Bureau of Standards  
P.O. Box 6329  
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Uganda  
Tel: +256 41 4 333 2 50/1/2/3  
Fax: +256 41 4 286 123  
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 DUS 2287 : 2020  
© UNBS 2020  – All rights r eserved  iii 
 Foreword  
Uganda National Bureau of Standards (UNBS) is a parastatal under the Ministry of Trade , Industry and 
Cooperatives established under Cap 327 , of the Laws of Uganda , as amended .  UNBS is mandated to co -
ordinate the elaboration of standards and is  
(a) a member of International Organisation for Standardisation (ISO) and  
(b) a contact point for the WHO/FAO Codex Alimentarius Commission on Food Standards, and  
(c) the National Enquiry Point on TBT  Agreement  of the World T rade Organisation (WTO).  
The work of preparing Uganda Standards is carried out through Technical Committees. A Technical 
Committee is established to deliberate on standards in a given field or area and consists of key stakeholders 
including government, aca demia, consumer groups, private sector and other interested parties.  
Draft Uganda Standards adopted by the Technical Committee are widely circulated to stakeholders and the 
general public for comments. The committee reviews the comments before recommendin g the draft standards 
for approval and declaration as Uganda Standards by the National Standards Council.  
The committee responsible for this document is Technical Committee UNBS /TC 14, Medical devices  
 DRAFT UGANDA STANDARD  DUS 2287 : 2020  
 
© UNBS 2020  – All rights reserved  1 
 Alcohol swab s — Specification  
1 Scope   
This Draft Uga nda Standard specifies  requirements, sampling  and methods of test  for alcohol swab s (also 
known as alcohol prep pad  or alcohol pad or alcohol disinfection wipe ). 
2 Normative references   
The following referenced documents referred to in the text in such a w ay 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.  
US 1692,  Determi nation of bactericidal efficacy of disinfectants/sanitizers  
US ISO 2859 -1, Sampling procedures for inspection by attributes —Part 1: Sampling schemes indexed by  
acceptance quality limit (AQL) for lot -by-lot inspection  
US ISO 10993 (all parts), Biological e valuation of medical devices  
3 Terms and definitions   
For the purposes of this document, the following terms and definitions apply. ISO and IEC maintain 
terminological databases for use in standardization at the following addresses: — ISO Online b rowsing 
platform: available at http://www.iso.org/obp  
alcohol swab  
soft absorbent pad saturated with alcohol  
4 Requirements  
4.1 General requirements  
4.1.1  Alcohol swab  shall consist of soft absorbent pad saturated with alcohol.  Isopropyl alcohol is the 
commonly us ed alcohol Soft absorbent pad may include linen, cotton and any other suitable material  
4.1.2  Alcohol swab shall be free from any foreign matter . 
4.1.3  Alcohol swab  shall be sterile  when tested in accordance with Annex A . 
4.2 Specific requirements  
Alcohol swab shall also conform to the requirements specified in Table 1when tested  in accordance with the 
test methods prescribed therein . DUS 2287:  2020  
2 © UNBS 2020  – All rights reserved  
 Table 1 — Specific requirements of alcohol swab  
S.No  Characteristic  Requirement  Test method  
i Alcohol  content,  %, v/v, 70 - 80 US EAS  104 
ii Efficacy  To pass test   US 1692  
 
5 Biocompatibility  
When tested in accordance with the relevant parts of ISO 10993, the alcohol swabs  shall not cause any 
harmful effect to the skin 
6 Packaging  
6.1 Each  alcohol swab shall be individually  wrapped  in suitable containers, which guarantee product safety, 
sterility,  and integrity until the container is opened.  
6.2 Individually wrapped alcohol swabs  shall be packaged in s econdary packages.  
7 Labelling  
Each package  shall be l egibly and indelibly  marked with the following information : 
a) name and physical address of manufacturer;  
b) name of the product;  “alcohol swabs ” or “ alcohol prep pad s” or “alcohol pads“or  “alcohol disinfection 
wipes”; 
c) instructions for use;  
d) swab size in mm  
e) % alcohol content;  
f) preca ution, “for external use only” “for single use”;  and “don’t use when package is damaged”,  
g) lot/batch number;  
h) country of origin;  
i) date of manufacture; and  
j) expiry date  
8 Sampling  
Sampling shall be done in accordance with US ISO 2859 -1. Acce ptance criteria: None shall fail  DUS 2287 : 2020  
© UNBS 2020  – All rights reserved  3 
 Annex  A 
(normative)  
 
sterility test  
A.1 Introduction  
The following culture media have been found to be suitable for the test for sterility. Fluid thioglycollate medium 
is primarily intended for the culture of anaerobic bact eria; however, it wi ll also detect aerobic bacteria. Soya 
bean  casein digest medium is suitable for the culture of both fungi and aerobic bacteria.  
A.2 Fluid thioglycollate medium  
L-Cystine                   0.5 g  
Agar                    0.75 g  
Sodium chl oride                  2.5 g  
Glucose monohydrate/anhydrous              5.5 g/5.0 g  
Yeast extract (water -soluble)               5.0 g  
Pancreatic digest of casein               15.0 g  
Sodium thioglycollate or                0.5 g  
Thioglycollic acid                  0.3 mL  
Resazurin sodium solution (1 g/L of resazurin sodium), freshly prepared  1.0 mL  
Water R                    1 000 mL  
pH after sterilization                 7.1 ± 0.2  
A.2.1 Mix the L -cystine, agar, sodium chloride, glucose, water -solubl e yeast extract and pancreatic digest of 
casein with the water R and heat until solution is effected. D.2.2  Dissolve the sodium thioglycollate or 
thioglycollic acid in the solution and, if necessary, add 1 M sodium hydroxide so that, after sterilization, t he 
solution will hav e a pH of 7.1 ± 0.2. If filtration is necessary, heat the solution again without boiling and filter 
while hot through moistened filter paper.  
A.2.3 Add the resazurin sodium solution, mix and place the medium in suitable vessels which p rovide a ratio 
of su rface to depth of medium such that not more than the upper half of the medium has undergone a colour 
change indicative of oxygen uptake at the end of the incubation period. Sterilize using a validated process. If 
the medium is stored, s tore at a temperatur e between 2 °C and 25 °C in a sterile, airtight container.  
A.2.4 If more than the upper one -third of the medium has acquired a pink colour, the medium may be 
restored once by heating the containers in a water -bath or in free -flowing st eam until the pink c olour 
disappears and cooling quickly, taking care to prevent the introduction of non -sterile air into the container. Do 
not use the medium for a longer storage period than has been validated. Fluid thioglycollate medium is to be 
incubat ed at 30 °C -35 °C.  DUS 2287:  2020  
4 © UNBS 2020  – All rights reserved  
 A.2.5 For products containing a mercurial preservative that cannot be tested by the membrane -filtration 
method, fluid thioglycollate medium incubated at 20 °C -25 °C may be used instead of soya -bean casein 
digest medium provided that i t has been validated  as described in growth promotion test.  
A.3 Alternative thioglycollate medium  
Where prescribed, justified and authorized, the following alternative thioglycollate medium may be used. 
Prepare a mixture having the same composition as tha t of the fluid thiog lycollate medium, but omitting the 
agar and the resazurin sodium solution, sterilize as directed above. The pH after sterilization is 7.1 ± 0.2. Heat 
in a water -bath prior to use and incubate at 30 °C -35 °C under anaerobic conditions.  
A.4 Soya -bean casei n digest medium  
Pancreatic digest of casein             17.0 g  
Papaic digest of soya -bean meal           3.0 g  
 Sodium chloride               5.0 g  
Dipotassium hydrogen phosphate           2.5 g  
Glucose monohydrate/anhydrous           2.5 g/2.3 g  
Water R                 1 000 mL  
pH after sterilization              7.3 ± 0.2  
A.4.1 Dissolve the solids in water R, warming slightly to effect solution. Cool the solution to room 
temperature. Add 1 M sodium hydroxide, if necessary, so that after  sterilization the s olution will have a pH of 
7.3 ± 0.2.  
A.4.2 Filter, if necessary, to clarify, distribute into suitable vessels and sterilize using a validated process. 
Store at a temperature between 2 °C and 25 °C in a sterile well -closed container, un less it is intended for 
immediate use. Do not use the medium for a longer storage period than has been validated. Soya -bean 
casein digest medium is to be incubated at 20 °C -25 °C.  
A.4.3 The media used shall comply with the following tests given in D.6, c arried out before or  in parallel with 
the test on the product to be examined.  
D.5 Sterility  
Incubate portions of the media for 14 days. No growth of micro -organisms occurs.  
A.6 Growth promotion test of aerobes, anaerobes, and fungi  
A.6.1 Test each lot o f ready -prepared med ium and each batch of medium prepared either from dehydrated 
medium or from ingredients. Suitable strains of microorganisms are indicated in Table D1.  
A.6.2 Inoculate portions of Fluid Thioglycollate Medium with a small number (not mor e than 100 cfu) of t he 
following microorganisms, using a separate portion of medium for each of the following species of 
microorganism, Clostridium sporogenes , Pseudomonas aeruginosa , and Staphylococcus aureus . Inoculate 
portions of alternative thioglycoll ate medium with a sm all number (not more than 100 cfu) of Clostridium 
sporogenes. F Inoculate portions of Soybean –Casein.  DUS 2287 : 2020  
© UNBS 2020  – All rights reserved  5 
 A.6.3 Digest medium with a small number (not more than 100 cfu) of the following microorganisms, using a 
separate portion of medium for  each of the followi ng species of microorganism, Aspergillus brasiliensis, 
Bacillus subtilis , and Candida albicans . Incubate for not more than 3 days in the case of bacteria and not more 
than 5 days in the case of fungi.  
A.6.4 Seed lot culture maintenance  techniques (seed -lot systems) are used so that the viable 
microorganisms used for inoculation are not more than five passages removed from the original master seed 
lot. The media are suitable if a clearly visible growth of the microorganisms occurs.  
Table  A.1 —Strains of the  test microorganisms suitable for use in the growth promotion test  
Test microorganisms  
Aerobic bacteria  Fungi Anaerobic bacterium  
Staphylococcus aureus  ATCC 6538, 
CIP 4.83, NCTC10788, NCIMB 9518, 
NBRC 13276  
Bacillus subtilis  ATCC 663 3, CIP 
52.62, NCIMB 8054, NBRC 3134 
Pseudomonas aeruginosa  ATCC 
9027, NCIMB 8626, CIP 82.118, 
NBRC 13275  Candida albicans  ATCC 10231, IP 
48.72, NCPF 3179, NBRC 1594  Clostridium sporogenes  ATCC 19404, 
CIP 79.3, NCTC 532 or ATCC 11437, 
NBRC 14293  
 DUS 2287:  2020  
6 © UNBS 2020  – All rights reserved  
 Bibliogra phy 
[1] Dulong, C., Brett, K., & Argáez, C. (2020). Skin Preparation for Injections: A Review of Clinical 
Effectiveness, Cost -Effectiveness and Guidelines . 
[2] KS 2556: 2018, Impregnated Cotton swabs —Specification   
[3] US EAS 789: 2013, Instant hand saniti zers — Specification  
 DUS 2287 : 2020  
© UNBS 2020  – All rights reserved  7 
 Certification marking  
Products that conform to Uganda standards may be marked with Uganda National Bureau of Standards 
(UNBS) Certification Mark shown in the figure below.  
The use of the UNBS Certification Mark is governed by the St andards Act, and the  Regulations made 
thereunder. This mark can be used only by those licensed under the certification mark scheme operated by 
the Uganda National Bureau of Standards and in conjunction with the relevant Uganda Standard. The 
presence of thi s mark on a product or in relation to a product is an assurance that the goods comply with the 
requirements of that standard under a system of supervision, control and testing in accordance with the 
certification mark scheme of the Uganda National Bureau o f Standards. UNBS ma rked products are 
continually checked by UNBS for conformity to that standard.  
Further particulars of the terms and conditions of licensing may be obtained from the Director, Uganda 
National Bureau of Standards.  
 
 DUS 2287 : 2020    
 
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