 DRAFT UGANDA STANDARD  
  DUS 2288  
First Edition  
2020-mm-dd 
 
 
 Reference number  
DUS 2288 : 2020 
© UNBS 2020   
  
Adhesive plaster  for medical use — Specification  
 DUS 2288 : 2020  
ii © UNBS 20 – 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 application  
© UNBS 2020   
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 DUS 2288 :2020  
© UNBS 2020 – All rights reserved  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 m andated 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  Agreem ent of the World Trade 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 
includi ng government, academia, 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 recommending 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 STAND ARD  DUS 2288 : 2020  
 
© UNBS 2020  – All rights reserved  1 
 Adhesive plaster  for medical use  — Specification  
1 Scope  
This Draft Uganda Standard specifies requirements, sampling and methods of test for adhesive plaster  (also 
known as adhesive tape) for medical use . 
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.  
US ISO 2 859-1, 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 evaluation of medical devices  
3 Terms and definitions   
For the purpos es 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 browsing platform: available at http://www.iso.org/obp  
Adhesive plaster  
fabric or film evenly coated on one side with a pressure -sensitive adhesive mixture.  
4 Requirements  
4.1 General requirements  
4.1.1  Adhesive plaster  shall consist of fabric and/or film evenly coated on one side with a pressure -
sensitive, adhesive mixture  
4.1.2 Adhesive plaster shall be free  any spinning, weaving or processing defects and any foreign matter.  
4.1.3  When tested in accordance  with the relevant parts of ISO 10993, adhesive plaster shall be  non-toxic, 
hypoallergenic and non -irritating . 
4.2 Specifi c req uirements  
Adhesive plaster shall conform to the requirements specified in Table 1 when tested in accordance with the 
test methods specified  therein.  DUS 2288: 2020  
2 © UNBS  2020  – All rights reserved  
 Table 1—Specific requirements of adhesive plaster  
S.No.  Characteristic  Requirement  Test method  
i Dimension s Length — ≥98.0% of that stated on the label.  Annex A  
Width  — ≥ 95% of that stated on the label  
ii Tensile strength  Tape made from fabric — ≥ 20.41 kg per 2.54 
cm of width  Annex B  
Tape made from film — ≥ 3 kg per 2.54 cm of 
width.  
iii Adhesive strength  Tape made from fabric — the average of not less 
than 10 tests is not less than 18 kg  Annex C  
 
5 Sterility  
The sterile  adhesive plaste r shall be free from any micro -organisms tested in accordance with Annex D  
6 Packaging  
Adhesive plaster shall be packaged in well-closed containers, that guarantee product safety and integrit y. 
7 Labelling  
Each container shall be legibly and indelibly marked with the following information:  
a) name and physical address of manufacturer and registered trade mark, if any;  
b) name of produ ct as “adhesive plaster for medical use ” or “adhesive tape” ; 
c) dimensions ; 
d) instructions for use;  
e) precaution, like “Don’t use if opened or damaged ”;”; 
f) lot/batch number;  
g) country of origi n; 
h) sterile or non -sterile;  if sterile, shall have a p recau tion, “for singl e use only ”; 
i) date of manufacture; and  
j) expiry date  
8 Sampling  
8.1 Sampling shall be done in accordance with US ISO 2859 -1. 
8.2 Acceptance criteria: None shall fail  DUS 2288 : 2020  
© UNBS 2020  – All rights reserved  3 
 Annex  A 
(normative)  
 
Determination of length and width  
A.1 Length  
Measur e the  length of adhes ive plaster along the centre line.  
A.2 Width  
A.2.1  Measure the width at 5 locations evenly spaced along the centre line of the tape and determine the 
average  
A.2.2  The average 5 measurements shall be not less than 95% of the labelled width  of the tape DUS 2288: 2020  
4 © UNBS  2020  – All rights reserved  
 Annex B 
(normative)  
 
Determination of tensile strength  
B.1 Determine the tensile strength of tape, after previously unrolling and conditioning it for not less than 4 
hours in a standard at mosph ere of 65 ± 2% r elative humidity, at 21 ± 1.1° (70 ± 2°F), with a pendulum -type 
testing machine, as described under  B.2. 
B.2 Determine the tensile strength of textile fabrics, including adhesive tape, on a constant -speed or 
pendulum type of testing ma chine  of the followin g general description. The clamps for holding the specimen 
are smooth, at, parallel jaws that are not less than 25 mm in length in the dimension parallel to the direction of 
application of the load. When the width of the strip being te sted does not exceed 19 mm, the jaws of the clamp 
should be at least 25 mm wide. If the width of the strip is greater than 19 mm and not greater than 44 mm, the 
width of the jaws of the clamp should be at least 50 mm. If the width of the specimen is greate r than 44 mm, 
cut a 2 5- mm strip, and use a clamp with jaws not less than 50 mm wide. Round all edges that might have a 
cutting action on the specimen to a radius of 0.4 mm. The jaws are 76.2 mm apart at the beginning of the test, 
and they separate at the rate of 30.5 cm ± 13 mm per minute. The machine is of such capacity that when the 
break occurs, the deviation of the pendulum from the vertical is between 9° and 45°.  DUS 2288 : 2020  
© UNBS 2020  – All rights reserved  5 
 Annex C  
(normative)  
 
Determination of a dhesive strength  
C.1 Determine the adhesive streng th of tape that is ma de from fabric by cutting a strip of the Tape 2.54 cm 
wide and approximately 15 cm long, and applying 12.90 sq cm, 2.54 cm by 5.08 cm, of one end of the strip to 
a clean plastic or glass surface by means of a rubber roller under a pres sure of 850 g, passin g the roller twice 
over the Tape at a rate of 30 cm per minute.  
C.2 Adjust the temperature of the plastic or glass surface and the Tape to 37°, and conduct the test 
immediately thereafter as directed under B.2 using a pendulum -type te sting  machine, the pu ll being exerted 
parallel with the warp and the plastic or glass surface: The average of not less than 10 tests is not less than 
18 kg.  
 DUS 2288: 2020  
6 © UNBS  2020  – All rights reserved  
 Annex D  
(normative)  
 
Determination of s terility  
D.1 Introduction  
The test for sterility is carrie d out  under aseptic c onditions. In order to achieve such conditions, the test 
environment has to be adapted to the way in which the sterility test is performed. The precautions taken to 
avoid contamination are such that they do not affect any microorganism s tha t are to be reve aled in the test. 
The working conditions in which the tests are performed are monitored regularly by appropriate sampling of 
the working area and by carrying out appropriate controls. The following culture media have been found to be 
suitab le for the test for sterility. Fluid thioglycollate medium is primarily intended for the culture of anaerobic 
bacteria; however, it will also detect aerobic bacteria. Soya -bean casein digest medium is suitable for the 
culture of both fungi and aerobic  bacteria.  
D.2 Cultu re media and incubation temperatures  
Media for the test may be prepared as described below or equivalent commercial media may be used 
provided that they comply with the requirements of the Growth Promotion Test of Aerobes, Anaerobes, a nd 
Fungi. The followi ng culture media have been found to be suitable for the test for sterility. Fluid Thioglycollate 
Medium is primarily intended for the culture of anaerobic bacteria. However, it will also detect aerobic bacteria. 
Soybean –Casein Digest M edium  is suitable for  the culture of both fungi and aerobic bacteria.  
D.2.1  Fluid Thioglycollate Medium  
L-Cystine                     0.5 g  
Sodium Chloride                    2.5 g  
Dextrose Monohydrate/Anhydrous                5.5/5.0 g  
Agar                      0.75 g 
Yeast Extra ct (water -soluble)                 5.0 g  
Pancreatic Digest of Casein                 15.0 g  
Sodium Thioglycollate                   0.5 g  
or Thioglycolic Acid                   0.3 m l 
Resazurin Sodium Solution (1 in 1000), freshly prepared           1.0 m l 
Purified Water                     1000 
mL 
pH after sterilization                   7.1±0.2.  
D.2.2.1  Mix the L -cystine, agar, sodium chloride, glucose, water -soluble yeast extract and pancreatic 
digest of casein with the water R and heat unt il solution is effect ed.  DUS 2288 : 2020  
© UNBS 2020  – All rights reserved  7 
 D.2.2.2  Dissolve the sodium thioglycollate or thioglycollic acid in the solution and, if necessary, add 1 M 
sodium hydroxide so that, after sterilization, the solution will have a pH of 7.1 ± 0.2. If filtration is necessary, 
heat the s olution again wi thout boiling and filter while hot through moistened filter paper.  
D.2.2.3  Add the resazurin sodium solution, mix and place the medium in suitable vessels which provide a 
ratio of surface to depth of medium such that not more than the  uppe r half of the me dium 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, store at a temperature between 2 °C and 25 °C in a sterile, airtight cont ainer .  
D.2.2.4  If mo re 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 steam until the pink colour 
disappears and cooling quickly, taking care to prevent the introd uction 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 
incubated at 30 °C -35 °C.  
D.2.2.5  For products containing a mercurial prese rvative that cannot b e 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 it has been validated as described in growth promotion test.  
D.2.2  Alterna tive thioglycoll ate medium  
Where prescribed, justified and authorized, the following alternative thioglycollate medium may be used. 
Prepare a mixture having the same composition as that of the fluid thioglycollate medium, but omitting the 
agar and the  resazurin sodium sol ution, 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.  
D.2.3  Soya -bean casein digest medium  
Pancreatic Digest of Casein                 17.0 g  
Papaic Digest of Soybean Meal                 3.0 g  
Sodium Chloride                    5.0 g  
Dibasic Potassium Phosphate                 2.5 g  
Dextrose Monohydrate/Anhydrous                2.5/2.3 g  
Puried Water                     1000 m l 
pH af ter sterilizatio n                  7.3±0.2.  
D.2.3.1  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 solution will have a pH of 
7.3 ± 0.2.  
D.2.3.2  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, unless it is 
intended for immediate us e. Do  not use the med ium for a longer storage period than has been validated. 
Soya -bean casein digest medium is to be incubated at 20 °C -25 °C.  
D.2.3.3  The media used shall comply with the following tests given in D.4, carried out before or in parallel 
with the test on the p roduct to be examined.  
D.3 Sterility  
Incubate portions of the media for 14 days. No growth of micro -organisms occurs.  DUS 2288: 2020  
8 © UNBS  2020  – All rights reserved  
 D.4 Growth promotion test of aerobes, anaerobes, and fungi  
D.4.1  Test each lot of ready -prepared medium and each b atch of medium prepar ed either from dehydrated 
medium or from ingredients. Suitable strains of microorganisms are indicated in Table D1.  
D.4.2  Inoculate portions of Fluid Thioglycollate Medium with a small number (not more than 100 cfu) of the 
following m icroo rganisms, 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 thioglycollate medium with a small number (no t mor e than 100 cfu) of Clostridium 
sporogenes.F Inoculate portions of Soybean –Casein.  
D.4.3  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 following species of micro organism, Asperg illus 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.  
D.4.4  Seed lot culture maintenance techniques (seed -lot systems) are  used  so that the via ble 
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 D.1 —Strains of the test microorg anism s suitable for u se 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 6633, CIP 52.62, 
NCIMB 8054, NBRC 3134   
Pseudomonas aerugin osa1 ATCC 9027, 
NCIMB 8626, CIP 82.118, NBRC 13275  Candida albicans  ATCC 
10231, IP 48.72, NCPF 3179, 
NBRC 1594  Clostridium sporogenes2 ATCC 
19404, CIP 79.3, NCTC 532 or 
ATCC 11437, NBRC 14293  
1An alternative microorganism is Kocuria r hizop hila (Micrococcu s luteus) ATCC 9341.  
2An alternative to Clostridium sporogenes, when a nonspore -forming microorganism is desired, is Bacteroides vulgatus (ATCC 8482)  
 DUS 2288 : 2020  
© UNBS 2020  – All rights reserved  9 
 Bibliography  
[1] USP42 -NF37 - 4181  
[2] USP41 -NF36 - 3934  
[3] USP40 -NF35 - 6329  
 DUS 2288: 2020  
© UNBS 2020  – All rights reserved  11 
 Certification marking  
Products that conform to Uganda s tanda rds 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 Standards Act, and the Regulations made 
thereund er. This mark can be used only b y tho se 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 this mark on a product or in relation to a produc t is an assurance that the goods  comp ly 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 of Standards. UNBS marked products are 
continua lly checked by UNBS for conformi ty to that standard.  
Further particulars of the terms and conditions of licensing may be obtained from the Director, Uganda 
National Bureau of Standards.  
 
  DUS 2288: 2020  
 
ICS 11.040. 30 
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