DRAFT UGANDA STANDARD  
  DUS 2220  
First Edition  
2019 -mm-dd 
 
 
 Reference number  
DUS 2220 : 2019 
© UNBS 2019   
  
Zinc oxide surgical adhesive plaster  — Specification  
 DUS 2220 : 2019  
ii © UNBS 2019  – 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 2019   
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permission from UNBS.  
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The Executive Director  
Uganda National Bureau of Standards  
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Kampala  
Uganda  
Tel: +256 41 4 333 2 50/1/2/3  
Fax: +256 41 4 286 123  
E-mail: info@unbs.go.ug  
Web: www.unbs.go.ug  DUS 2220 :2019  
© UNBS 2019  – 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 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 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 
including 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 comme nts 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 STANDARD  DUS 2220 : 2019  
 
© UNBS 2019 – All rights reserved  1 
 Zinc oxide surgical adhesive plaster  (tape) — Specification  
1 Scope   
This Draft Uganda standard specifies the requirements, methods of test and sampling of zinc oxide surgical 
adhesive plaster . 
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 IS O 10993 , Biological evaluation of medical devices   
ISO 1833 , Textiles — Quantitative chemical analysis  — Part 5: Mixtures of viscose, cupro or modal and cotton 
fibres (method using sodium zincate) 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 browsing 
platform: available at http://www.iso.org/obp  
3.1  
surgical adhesive plaster (surgical adhesive tape)  
medical device in the form of pressure -sensitive adhesive tape used in medicine and first aid as a bandage to 
hold dressing onto a wound  
3.2 
zinc oxide surgical adhesive plaster   
surgical adhesive plaster  consist ing of a strip of fabric material or plastic coated on one side with an adhesive 
material containing zinc oxide as a mild antiseptic  
4 Requirements  
4.1 General requirements  
4.1.1 The z inc oxide surgical adhesive plaster shall be made  of a fabric coated with zinc oxide adhesive 
mass and shall not set when  unrolled . 
4.1.2 The fabric shall be plain -woven  consistin g of cotton or rayon /viscose  or combined cotton and 
rayon /viscose . The composition of rayon/viscose in the blends shall not exceed 25% when tested in 
accordance with ISO 1833 -5. 
4.1.3 The zinc oxide surgical adhesive plast er shall be free from any spinning, weaving,  or processing 
defects.  DUS 2220 : 2019  
2 © UNBS 2019  – All rights reserved  
 4.1.4 The zinc oxide surgical adhesive plaster shall be non-toxic, hypoallergenic and non -irritating when 
tested in accordance with US ISO 10993.  
4.1.5 The adhesive surface shall be free from  any foreign matter.  
4.1.6  Each roll selected for test under annex C  and D shall be conditioned for minimum period of 24hours 
at 27 °C ± 2°C and 65% ± 5% relative humidity  prior to testing and testing  shall be conducted under the same 
atmosphere. Where the testing cannot be carried out in the same atmosphere, the testing shall be 
commenced within 2minutes of withdrawal of the sample from the conditioning atmosphere.  
4.2 Specific requirements  
The z inc oxide surgical adhesive plaster shall also conform to the requirements specified in Table 1 when 
tested in accordance with the test methods prescribed therein.  
Table 1 — Specific requirements  for zinc oxide surgical adhesive plaster  
Characteris tic Requirement  Test method  
Zinc oxide content  ≥ 10% Annex A  
Weight of adhesive mass, g/m2 ≥ 115  Annex B 
Tensile strength , kgf/cm  ≥ 8 Annex C  
Adhesion property  Adhesive strength, kgf/cm ≥7  Annex D  
Adhesion to metal , gf/cm ≥ 200  Annex E  
 
5 sterility  
The sterile  zinc oxide surgical adhesive plaster shall be when tested  in accordance with annex F 
6 Packaging  
6.1 The zinc oxide surgical adhesive plaster  shall be uniformly wound on suitable spools or cores  
6.2 The wound zinc oxide  surgical adhesive plaster  shall be packaged in suitable packaging materials, 
which shall protect the product from contamination and damage during transportation, handling and storage.  
7 Labelling  
Each package shall be legibly and indelibly marked  with th e following information : 
a) Name of plaster as “  “Zinc oxide surgical adhesive plaster” manufacturer’s name;  
b) dimensions of the plaster;  
1. width in Centimetres  
2. length in metres / yards;  
c) batch (lot)  numb er; 
d) month and year of manufacture and expiry,  DUS 2220 : 2019  
© UNBS  2019  – All rights reserved  3 
 e) direction for storage  and use ; 
f) sterile or non-sterile  
g) caution : discard after use, for single use, don’t expose to direct sunlight  
h) and other information required by the regulatory body . 
8 Sampling  
Sampling shall be done in accordance with  annex G. DUS 2220 : 2019  
4 © UNBS 2019  – All rights reserved  
 Annex  A 
(normative)  
 
Determination of z inc oxide content  
A.1 Reagents  
A.1.1  Nitric acid  
A.1.2  Dilute ammonium hydroxide (6N) 
A.1.3  pH 10 buffer  — Dissolve 68g of ammonium chloride in 200ml of water,  add 570ml of concentrated 
ammonia and dilute to one litre.  
A.1.4  Eriochrome black T  indicator  — Dissolve 0.2g of eriochrome black T and add 2g of hydroxylamine 
hydrochloride in 50 ml of methanol.  
A.1.5   Standard EDTA solution  0.01M  
A.2  Procedure  
A.2.1  Cut from the sample under test 1  g of specimen weighing taking as much care as possible to cut 
parallel to the warp and weft threads.  
A.2.2  Heat it in 10ml of nitric acid in a round bottomed flask until the plaster disintegrates  and boil  it for 10 - 
15minutes on a low flame.  
A.2.3  Cool and dilute with 10 to 15 ml of water and one or two drops of methyl red indicator. Neutralise 
using dilute ammonia solution.   
A.2.4  Add 20ml o f pH 10 buffer and 2 drops of  eriochrome black T indicator to obtain a clear visible red 
colouration in the solution.  
A.2.5  Titrate it with EDTA solution until the colour changes from red to blue.  
A.3 Calculation  
Zinc oxide (as ZnO) percent by weight = 
  
Where  
V Volume in  ml of EDTA solution used for titration  
W Weight in grams of adhesive mass  
M molarity of EDTA solution used for titration  DUS 2220 : 2019  
© UNBS  2019  – All rights reserved  5 
 Annex B  
normative  
 
Determination of w eight of adhesive mass  
B.1 Test specimen  
Cut about 1g of plaster from the sample and weigh accur ately. Take care to cut parallel to the edges of the 
plaster  
B.2 procedure  
B.2.1  Measure the area of the specimen accurately and extract with chloroform in a soxhlet extractor until 
the adhesive mas completely disintegrates. Take out the fabric, dry to rem ove residual chloroform and 
immerse in dilute acetic acid for 3hours.  
B.2.2  Remove the sample in a suitable vessel and wash 12 times with boiling water using 1000  ml for each 
washing. Pass the wash waters through 150-micron  sieve to collect any loose fibr e or yarn. Dr y the residue to 
constant weig ht at 100 °C ± 2°C and correct the weight for moisture regain.  
B.3 Calculation  
Calculate the weight of the adhesive mass in grams per square metre  
Weight of adhesive mass = 
  
Where  
W weight in grams of the sample  taken,  
w weight in grams of residual fabric corrected for moisture regain  
A Area in square metres of sample taken  DUS 2220 : 2019  
6 © UNBS 2019  – All rights reserved  
 Annex C  
(normative)  
 
Determination of t ensile strength  
C.1  Apparatus  
Tensile testing machine  
C.2  Procedure  
C.2.1  Take test sample of suff icient length to accommodate in the jaw separation of 12 cm and measure its 
width.  
C.2.2   Clamp the strip of the plaster squarely in the jaw of the tensile testing machine. Note the load at 
break.  
C.2.3  Reject the pieces breaking within 5mm of the edge of  the jaws. Repeat the test for two-test specimen 
taken from the sample roll.  
C.2.3 Determine the mean of the three determinations as the breaking strength in kilograms per centimetre 
width.  DUS 2220 : 2019  
© UNBS  2019  – All rights reserved  7 
 Annex D 
(normative)  
 
Determination of a dhesive strength  
D.1 Appar atus 
D.1.1 Tensile testing machi ne  
D.1.2 Plastic or glass plates  
D.1.3 Roller - Rubber roller which applies 850g pressure to the specimen. It shall be constructed that the 
weight of the handle is not added to the weight of the roller during use.  
 
Figure 1 — Roller  
D.2  Procedure  
D.2.1 Clean the surface of the glass or plastic plate thoroughly with toluene. When all the solvent has 
evaporated ,Wipe the surface with a piece of clean dry tissue paper or cotton wool.  
D.2.2 Apply 2.5 cm by 5cm of one end of th e test specimen to the plastic /glass plate without stretching, 
keeping  adhesive side down to the centre of the plate  and leaving the reminder of the test specimen extending 
beyond the plate. Precautions should be taken not to entrap any air bubble between  the tape.  
D.2.3  Place the roller centrally across the test specimen and draw the roller once in each direction  at 
constant speed of about 30cm/min.  
D.2.4  Adjust the temperature of the plastic or glass plate surface and the tape to 37 °C and conduct the t est 
within two minutes.  
D.2.5 Clamp the specimen in the jaws of the tensile strength machine. The jaws are about 10cm apart at the 
beginning of the test. Start the machine. Read the load at break or maximum load in case of the peel off on 
the sealer. Disca rd the specimen breaking near the edge of the jaws. Repeat the test for four -test specimen 
taken from the sample roll.  DUS 2220 : 2019  
8 © UNBS 2019  – All rights reserved  
 D.3 Calculation  
Calculate the load require6d to cause break or pull off of the tape in terms of 9cm of width. The mean of the 
five value s obtained shall  be reported as adhesive strength . DUS 2220 : 2019  
© UNBS  2019  – All rights reserved  9 
 Annex E 
(normative)  
 
Determination of adhesion to metal  
E.1 Apparatus  
E.1.1  Tensile testing machine  
E.1.2  Stainless steel plates —Rectangular 10 x 30 cm p olished stainless steel plates. The stainless steel 
shall be have a standard abrasive satin finish(180grit) with the direction of gritting lying parallel to the longer 
side of the plate. It shall be marked boldly at intervals of 2cm along both longitudinal  edges.  
E.1.3  Roller - A steel roller of 80 ± 2mm diameter and 45 ± 1mm in width covered with rubber approximately 
6mm thick having a hardness of 80 ± 5 IRHD. The weight of the roller which applies pressure to the test 
sample shall be 205 ± 0.05kg.It shall be so constructed that the weight of the handle is not added to the 
weight of the roller during use.( see figure 1)  
E.2 Procedure  
E.2.1 Clean thoroughly the surface of the stainless steel plate with redistilled toluene using a fresh piece of 
untreated pape r tissue or cotton wool for each cleaning. When all the solvent has evaporated, wipe the 
surface with apiece of clean dry tissue paper or cotton wool taking precautions not to touch the steel plate with 
fingers  
E.2.2  Apply atleast 25 cm of test sample with out stretching, keeping adhesive side down. To the centre of 
surface of the steel plate and parallel to the longer side, leaving the reminder of the test sample extending 
beyond the steel plate sufficient to be accommodated in the testing equipment. Precau tion shall be taken that 
no air bubbles are trapped between the tape and the plate.  
Note – In the case of the tapes less than 3cm width, cut the other strips from the sample roll and apply them parallel and 
adjacent to the test sample to provide a total wi dth of 3cm for rolling purposes.  
E.2.3  Place the roller centrally across the test sample at one end of the plate and pass the roller once in 
each direction at constant speed of approximately 30cm /min, ensuring that no additional pressure of the 
weight of the roller s applied during the process.  
E.2.4  Allow the steel plate with the test sample to remain undisturbed for 10 ± 0.5 minutes at the 
temperature of 27°C ± 2°C and 65% ± 5% relative humidity.  
E.2.5  Fold the free end of the test sample at an angle of  180° and peel off 3cm from the steel plate leaving 
atleast 22 cm in contact with the steel plate.  
E.2.6 Clamp this exposed end of the plate in the lower jaw (if using a vertical pendulum or spring balance 
machine) or attach the whole plate to the moving c arriage (if the testing machine is of horizontal type).attach 
the free end of the tape to the head of the tension measuring device and disengage the pawls if any.  
E.2.7 Start the tensile machine and take readings at 2cm intervals when the tape is pulled fr om the steel 
plate, disregarding the pulling of the first 5 cm and the last 3cm.The mean of 5 readings shall give the load 
required to cause the separation of tape from the steel plate. If the specimen breaks during the test, repeat the 
test on another spe cimen cut from the same roll.  DUS 2220 : 2019  
10 © UNBS 2019  – All rights reserved  
 E3 Calculation  
Calculate the load required to cause the separation of the tape from the steel plate (or from a piece of tape 
itself as the case may be) in terms of grams per centimetre of width. The mean of five values obtaine d shall be 
reported as adhesion strength . DUS 2220 : 2019  
© UNBS  2019  – All rights reserved  11 
 Annex F  
(normative)  
 
Sterility test  
F.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 bacteria; however, it will also detect aerobic bacteria. Soya -
bean casein digest medium is suitable for the culture of both fungi and aerobic bacteria.  
F.2 Fluid thioglycollate  medium  
L-Cystine                 0.5 g  
Agar                  0.75 g  
Sodium chloride                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 (1g/L of resazurin sodium), freshly prepared    1.0 mL  
Water R                 1000 mL  
pH after sterilisation               7.1 ± 0.2  
F.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 until solution is effected.  
F.2.2 Dissolve the sodium thioglycollate or thioglycollic acid in the solution and, if necessary, add 1 M 
sodium hydroxide so that, after sterilisation, the solution will have a pH of 7.1 ± 0.2. If filtration i s necessary, 
heat the solution again without boiling and filter while hot through moistened filter paper.  
F.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 n ot more than the upper half of the medium has undergone a colour 
change indicative of oxygen uptake at the end of the incubation period. Sterilise using a validated process. If 
the medium is stored, store at a temperature between 2 °C and 25 °C in a steril e, airtight container.  
F.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 steam until the pink colour 
disappears and cooling quickl y, 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 
incubated at 30 -35 °C.  DUS 2220 : 2019  
12 © UNBS 2019  – All rights reserved  
 F.2.5 For products containing a mercurial preservative that cannot be tested by the membrane -filtration 
method, fluid thioglycollate medium incubated at 20 -25 °C may be used instead of soya -bean casein digest 
medium provided that it has bee n validated as described in growth promotion test.  
F.3 Alternative thioglycollate medium  
Where prescribed or justified and authorised, 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 solution, sterilise as directed above. The pH after sterilisation is 7.1 ± 0.2. Heat 
in a water -bath prior to use and incubate at 30 -35 °C under anaerobi c conditions .  
F.4 Soya -bean casein 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                      1000 mL  
pH after sterilization                   7.3 ± 0.2  
F.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 sterilisation the solution will have a pH of 
7.3 ± 0.2.  
F.4.2 Filter, if necessary, to clarify, distribute into suitable vessels and sterilise 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 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 -25 °C.  
The media used comply with the following tests, carried out before or in parallel with the test on the product to 
be examined.  
F.5 Sterility  
Incubate portions  of the media for 14 days. No growth of micro -organisms occurs  DUS 2220 : 2019  
© UNBS  2019  – All rights reserved  13 
 Anne x G 
(normative)  
 
Sampling  
G.1 The number of sample  to be selected from each lot shall depend upon the size of the lot and shall be in 
accordance with table  G1 
Table G1 — sample size and criteria for conformity  
Lot size Sample size Acceptance number  
Upto 300  13 1 
300 to 500  13 1 
5001 to 1000  20 2 
1001 to 3000  32 3 
3001 to 10000  32 3 
10001 to 35000  50 5 
35001 and above  80 7 
 
G.2 The lot shall be considered  as conforming to the requirements if the number of defectives  found in the 
sample is less than or equal to the corresponding  acceptance number of defectives  as given in table G1  DUS 2220 : 2019  
14 © UNBS 2019  – All rights reserved  
 Bibliography  
[1] IS 4717 (1980): Zinc Oxide Self -adhesive Plaster  
[2] USP42 -NF37 - 4181  
 DUS 2220: 2019  
© UNBS 2019 – All rights reserved  15 
 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 Standards Act, and the Regulations made 
thereunder. This mark can be used only by those licensed under the certification mark scheme operated by 
the U ganda 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 product is an assurance that the goods comply with the 
requirements of that standard under a system of super vision, control and testing in accordance with the 
certification mark scheme of the Uganda National Bureau of Standards. UNBS marked 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 2220: 2019    
 
ICS 11.040.30  
Price based on nn pages  
© UNBS 2019 – All rights reserved