 DRAFT UGANDA STANDARD  
  DUS 2235  
First Edition  
2019 -mm-dd 
 
 
 Reference number  
DUS 2235 : 2019 
© UNBS 2019   
  
Plaster of Paris bandage — Specification  
 DUS 2235: 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   
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 
permissi on from UNBS.  
Requests for permission to reproduce this document should be addressed to  
The Executive Director  
Uganda National Bureau of Standards  
P.O. Box 6329  
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 2235: 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 gove rnment, 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 /TC14, Medical devices . 
 DRAFT UGANDA STANDARD  DUS 2235: 2019  
 
© UNBS  2019  – All rights reserved  1 
 Plaster of Paris  bandage — Specification  
1 Scope   
This Draft Uganda standard specifies the requirements, methods of test and sampling of plaster of Paris 
(POP)  bandage . 
2 Normative references   
The following referenced documents referred to in the text in such a way that some or all of their conten t 
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.  
ISO 1833, Textiles — Quantitative chemical analysis  — Part 5: Mixtures of viscose, cupro or modal and cotton 
fibres (method using sodium zincate)  
US ISO 10993 (all parts), Biological evaluation of medical devices  
US ISO 24153, Random sampling and randomisation procedures  
3 Terms and definitions  
For the pur poses 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  
plaster of Paris  bandage  
cotton gauze  impregnated with calcium  sulphate hemihydrate with the aid of a medical grade binder .  
4 Fibre identification  
After freeing fabric from calcium sulphate by the method described by Annex A, the fabric shall be tested in 
accordance ISO 183 3-5. 
5 Requirements  
5.1 General requirements  
5.1.1 Plaster of Paris bandage shall have a uniform impregnation by plaster of Paris powder  
5.1.2 Plaster of Paris bandage shall be free from  spinning, weaving and processing defects  and reasonably 
free form loose powder . 
5.2 Specific requirements  
5.2.1  The Plaster of Paris bandage shall exist in different lengths and widths  (see table 1) . DUS 2235: 201 9 
2 © UNBS 2019  – All rights reserved  
 Table 1 — Some of the recommended lengths and widths of Plaster of Paris bandage  
Width ,cm  Length, m  
5.0 ± 0.2  2.70 ± 0.03  
3.00 ± 0.05  
7.5 ± 0.2  3.00 ± 0.05  
10.0 ± 0.2  3.00 ± 0.05  
15.0 ± 0.5  3.00 ± 0.05  
 
5.2.2  Plaster of Paris bandage shall conform to the requirements specified in Table 2 when tested in 
accordance with the test methods prescribed therein . 
Table 2 — Specific  requirements of Plaster of Paris  bandage  
Characteristic  Requirement  Test method  
Mass g/m2,min 340 Annex A 
Setting time , max 8 minutes  Annex B 
Cast Breaking Strength  >175 N  Annex C  
Calcium Sulphate Content %, min  85 Annex D  
 
6 Biocompatibility  
When te sted in accordance with the relevant parts of ISO 10993, the plaster of Paris bandage shall no t cause 
any harmful effect on the user . 
7 Packaging  
7.1 The POP bandage shall be wound on a suitable core to allow wetting of the inner layer of the bandage 
when immersed in water prior to application. The rolls shall be packaged in containers  to prevent moisture  
ingress , contamination , damage  during transportation, handling and storage .  
7.2 The roll may be further packed in secondary packages.  
8 Labelling  
The pac kage shall be legibly and indelibly marked with the following information:  
a) name of the product as “ Plaster of Paris  bandage” ; 
b) name and physical address of manufacturer ; 
c) dimensions of the bandage ; 
d) batch/lot number ; 
e) date of manufacture ;  
f) date of expiry; and  DUS 2235: 2019  
© UNBS  2019  – All rights  reserved  3 
 g) Quantity packed.  
9 Sampling  
Sampling shall be done in accordance with US ISO 24153  DUS 2235: 201 9 
4 © UNBS 2019  – All rights reserved  
 Annex A  
(normative)  
 
Determination of mass  
A.1 Measure the area of a sample weighing about  25 g. Wash the sample thoroughly with cold  water, 
wringing the material by hand a fter each  washing, pass the washings through a sieve with  a nominal mesh 
aperture of 106 µm and return  any loose threads or fibres retained by the sieve  to the bulk material. Add 400 
ml of water to  the residual material, heat slowly and boil for 1minute.  
A.2 Cool by the addition of about 400 ml  of water, decant the liquid through a sieve with  a nominal mesh 
aperture of 106 µm and wring by hand as much water from the material as possible.  
A.3 Repeat this boiling, wash with a further five 400 ml quantities o f water. Place the washed material, 
together with any loose threads or fibres, in a beaker and cover the material with at 0.5 % solution of diastase, 
maintaining at 70°C until free from starch. Repeat the boiling, wash and dry to constant mass at 105°C.  DUS 2235: 2019  
© UNBS  2019  – All rights  reserved  5 
 Annex B 
(normative)  
 
Determination of Setting time  
B.1 Loosely roll a strip of the bandage about  5 cm wide and weighing about 20 g and immerse it for 15 
seconds in 100 ml of water at 30°C in a cylindrical vessel about 5 cm in diameter.  
B.2 Remove the sample  from water without squeezing allow to drain for 10 seconds and wind on a glass 
rod or smooth mandrel of non -absorbent material about one cm in diameter.  
B.3 After a period of 8 minutes measured from removal of sample from water, remove the glass rod or 
mandrel. The test specimen shall not crumble under the pressure of fingers.  DUS 2235: 201 9 
6 © UNBS 2019  – All rights reserved  
 Annex C 
(normative)  
 
Determination of casting breaking strength  
C.1 Apparatus  
C.1.1 Beaker One litre  
C.1.2  Cylindrical Pipe,  5 cm diameter . 
C.1.3 Waxed Paper  
C.1.4 Timer  
C.1.5 Cast  Crushing Equipment  
C.2 Procedure  
C.2.1 Immerse 5 cm × 2.7 m size bandage in a beaker of water at 27 °C ± 2 °C. After 10 seconds, remove 
the bandage and squeeze to remove the excess of water.  
C.2.2 Wrap the bandage convolutely on a 5 cm diameter cylindric al pipe which has been covered with a 
sheet of waxed paper. Laminate the successive layers, placing each layer directly on top of the preceding 
layer, and smoothen by hand.  
C.2.3 After a period of 1 hour measured from the time of immersion of the bandage in water, remove the 
cast from the pipe and crush on a cast crushing equipment. The maximum reading obtained on the scale 
during crushing is recorded as one hour cast breaking strength of the bandage.  DUS 2235: 2019  
© UNBS  2019  – All rights  reserved  7 
 Annex D 
(normative)  
 
Determination of calcium sulphate  
D 1 Reagents  
D.1.1 Hydrochloric Acid , reagent grade  
D.1.2 EDTA  (Ethylene Diamine Tetra Acetate Dihydrate Sodium Salt ) Solution, 0.1 M . 
D.1.3 Sodium Hydroxide Solution , 2N, freshly prepared . 
D.1.4 Muroxide  indicator , 5 percent ammonium perpurate mixed with  sodium chloride, reagent grade . 
D.2 Procedure  
D.2.1 Weigh 0.2 g of the material and transfer quantitatively to a dry 500ml Erlenmeyer  flask.  
D.2.2 Add about 10 ml of concentrated hydrochloric acid followed by about 100 ml of distilled water. Boil the 
flask till the POP bandage  disintegrates  for 30mins - 45min s.  
D.2.3 Cool the flask and neutralize the acid with 2 N sodium hydroxide with the help of litmus paper.  
D.2.4 Add about 10 ml excess of alkali and a pinch of muroxide indicator. Titrate with 0’1 M EDTA  solution 
to violet end point . 
C.3 Calculation  
Percent by mass Calcium sulphate  (as CaSO4 0.5H2O ) = 
  
 
Where  
V is the volume of EDTA solution needed in ml,  
M is the molarity of EDTA solution, and  
W is the  mass of the material taken.  DUS 2235: 201 9 
8 © UNBS 2019  – All rights reserved  
 Bibliography  
IS 47 38:1993,  Bandage, Plaster of Paris  
 DUS 2235: 2019  
© UNBS  2019  – All rights reserved  9 
 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 gove rned 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 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 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 Nat ional 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 2235: 2019    
 
ICS 11.040.40  
Price based on nn pages  
© UNBS 2019 – All rights reserved   
  