UGANDA STANDARD  
  DUS1511 :201
4 
First Edition  
2013 -mm-dd 
 
 
 Reference number  
DUS 1511 : 2013 
© UNBS 2013   
  
Oxygen for medical use  — Specifications  
 DUS 1511 : 2014  
ii © UNBS 2014  – All rights r eserved  
 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 200 7  
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permissio n from UNBS.  
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The Executive Director  
Uganda National Bureau of Standards  
P.O. Box 6329  
Kampala  
Uganda  
Tel: 256 41 4 505 995  
Fax: 256 41 4 286 123  
E-mail: unbs@infocom.co.ug  
Web: www.unbs.go.ug  DUS 1511 : 2014  
© UNBS 2014  – All rights reserved  iii 
 Contents  Page 
Foreword  ................................ ................................ ................................ ................................ ............................  iv 
1 Scope  ................................ ................................ ................................ ................................ ......................  5 
2 Normative references  ................................ ................................ ................................ ............................  5 
3 Definitions  ................................ ................................ ................................ ................................ ..............  5 
4 Requirements  ................................ ................................ ................................ ................................ .........  5 
4.1 Description  ................................ ................................ ................................ ................................ .............  5 
4.2 Physical and chemical requirements  ................................ ................................ ................................ .. 6 
5 Packagi ng ................................ ................................ ................................ ................................ ...............  6 
6 Marking and labelling  ................................ ................................ ................................ ............................  6 
6.1 In case of oxygen cylinder  ................................ ................................ ................................ ...................  6 
6.2 In case of liquefied oxygen tank  ................................ ................................ ................................ ..........  7 
7 Sampling and criteria for conformity  ................................ ................................ ................................ .. 7 
7.1 Sampling  ................................ ................................ ................................ ................................ ................  7 
7.2  Criteria for conformity ................................ ................................ .............. Error! Bookmark not defined.  
Annex  A (normative)  Moisture  ................................ ................................ ................................ .........................  8 
A.1 Apparatus  ................................ ................................ ................................ ................................ ...............  8 
A.2 Reagents  ................................ ................................ ................................ ................................ ................  8 
A.2.1  Dry ice  ................................ ................................ ................................ ................................ .....................  8 
A.2.2  Acetone or ethanol  ................................ ................................ ................................ ................................  8 
A.3 Procedure  ................................ ................................ ................................ ................................ ...............  8 
Annex  B (normative)  Acidity and alkalinity  ................................ ................................ ................................ .. 10 
B.1 Apparatus  ................................ ................................ ................................ ................................ .............  10 
B.2 Reagents  ................................ ................................ ................................ ................................ ..............  10 
B.2 Procedure  ................................ ................................ ................................ ................................ .............  10 
Annex  C (normative)  Oxidising substance  ................................ ................................ ................................ ... 12 
C.1 Apparatus  ................................ ................................ ................................ ................................ .............  12 
C.2 Reagents, solutions and preparations  ................................ ................................ ..............................  12 
C.3 Procedure  ................................ ................................ ................................ ................................ .............  12 
Annex  C (normative)  Purity  ................................ ................................ ................................ ............................  13 
C.1 Apparatus  ................................ ................................ ................................ ................................ .............  13 
C.2 Reagents and preparation  ................................ ................................ ................................ ..................  13 
C.3 Procedure  ................................ ................................ ................................ ................................ .............  13 
Annex  D (normative)  Carbon dioxide  ................................ ................................ ................................ ............  15 
D.1 Apparatus  ................................ ................................ ................................ ................................ .............  15 
D.2 Procedure  ................................ ................................ ................................ ................................ .............  15 
Annex  E (normative)  Recommendation for storage and handing  ................................ ..............................  16 
E.1 Storing oxygen cylinders  ................................ ................................ ................................ ...................  16 
E.2 Handing of oxygen cylinders  ................................ ................................ ...Error! Bookmark not defined.  
E.3 Storing a nd filling liquid oxygen  ................................ .............................. Error! Bookmark not defined.  
 DUS 1511 : 2014  
iv © UNBS 2014  – All rights r eserved  
 Foreword  
Uganda National Bureau of Standards (UNBS) is a parastatal under the Ministry of Tourism, Trade and 
Industry established under Cap 327 , of the Laws of Uganda.  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/SPS Agreements of the W orld 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 representatives of 
consumers, trader s, academicians, manufacturers, government and other stakeholders.  
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 t he draft standards 
for approval and declaration as Uganda Standards by the National Standards Council.  
Committee membership  
 DUS 1511 : 2014 
v  
 Oxygen for medical use  — Specifications  
1 Scope  
This draft Uganda standard  specifies the requirements  and methods of sampling  and test requirements for  
oxygen for medical use only.  
2 Normative references  
The following referenced documents are indispensable for the application of this document. For dated 
references, only the edition cited applies. For undated references, the latest ed ition of the referenced 
document (including any amendments) applies.  
ISO 5145, Cylinder valve outlets for gases and gas mixtures — Selection and dimensioning  
ISO 32,  Gas cylinders for medical use — Marking for identification of content  
ISO 7225 ; Gas cylind ers — Precautionary labels  
3 Terms and d efinitions  
For the purposes of this standard, the following terms and definition  shall apply   
3.1 
medical oxygen,  
a gaseous or  liquid oxygen, having a chemical formula 0 2, intended for medical use.  
3.2 
lot 
oxygen fi lled in container of the same type and size at the same period.  
3.3 
gas for medical use  
any gas or mixture of gases intended to be administered to patients for therapeutic, diagnostic or prophylactic  
purposes, with or without pharmacological action, or to be used for surgical tools, and it covers both medicinal  
and medical gases (see ISO 5145)  
 
3.4 
body  
cylindrical part of a gas cylinder  
4 Requirements  
4.1 General requirements  
Oxygen in gaseous  form shall be odourless,  colourless. In case of liquid  form shall be odourless, light 
blue colour . DUS 1511 : 2014  
vi © UNBS 2014  – All rights r eserved  
 4.2 Physical and chemical requirements  
Oxygen shall be as specified in Table 1.  
 
Table 1 Physical and chemical requirements  
Item Characteristics  Requirements  Analysis  
Reference clause  
1 Moisture, mg/dm3,max  0.12 Annex A  
2 Acidity or alkalinity  Shall pass the test  Annex  B 
3 Oxidising substance*  Shall pass the test  Annex  C 
4 Purity by volume, min.  99.5 Annex  D 
5 Carbondioxide, mm3dm3, max.  300 Annex  E 
4 Carbonmonoxide, mm3dm3,max.  5 Annex  F 
NOTE * In case the process  is air -liquefaction and use adsorption technique by  alumino silicate or activated alumina as 
carbon dioxide and moisture  remover, acidity or alkalinity and oxidizing substance tests are not required.  
5 Packaging  
5.1 Conta iners for oxygen shall be clean, f ree from pollutants and contaminants and shall be use for 
oxygen only.  
5.2 Containers in the form of cylinder shall be in accordance with ISO 5145 .  
5.3 The oxygen cylinder shall be white on its neck and shoulder  in accordance with ISO 32  
5.4 Provide the w rapping material for oxygen cylinder connectors to protect dust  from entering and to sort 
the used cylinders out of the unused. Provide name  and trademark of filler on the wrapping material.  
6 Marking and labelling  
Either on each container or the attached label shall at least bear number, letter  or mark indicating legibly  and 
clearly the following information:  
6.1 In case of oxygen cylinder  
a) The term  "oxygen" together with its chemical formula "0 2" written on the  container body in white letters 
of the size n ot smaller than 1/8 of the  cylinder diameter.  
b) Name of manufacturer or factory or registered trade mark and packer  or distributor with address.  
c) Lot identification  
d) Volume in dm3 at pressure 0.1 Mpa and filling pressure in Mpa at the  temperature of 27 ±20C DUS 1511 : 2014  
© UNBS 2014  – All rights reserved  vii 
 e) Warning statement or mark against the use of lubricating substance on  connection and 
recommendation for storage and the method for safety  handing by user. 
6.2 In case of liquefied oxygen tank  
a) The name "MEDICAL OXYGEN" and its chemical formula "O 2" in black  letters. 
b) Warning statement or mark for example "No smoking" "No ignition"  "Stay away from flammable 
substance".  
7 Sampling and criteria for conformity  
Sampling and acceptance shall be in accordance with the following sampling  plan or its technically equivale nt. 
7.1 Sampling  
7.1.1  In case of cylinder, a number of container(s) shall be taken at  random in accordance with the plan 
given in Table 2 for conformity  tests on requirements, containers and packaging, and marking and  labelling.  
Table 2 Sampling plan  
Lot size container  Sample size  container  
1to30  
31to60  
60andabove  1 
2 
3 
 
7.1.2  In case of tank, sample shall be taken in liquid form from the storage  tank and transferred into a Dewar 
flask or other equivalent vessels in  an amount not less than 2 dm3 for requ irement inspection.  
 
 DUS 1511 : 2014  
viii © UNBS 2014  – All rights r eserved  
 Annex  A 
(normative)  
 
Moisture  
A.1 Apparatus  
The apparatus shall be as shown in figure 1.  
A.2 Reagents  
A.2.1  Dry ice  
A.2.2  Acetone or ethanol  
A.3 Procedure  
a) Pass the sample gas through the inlet tube at a rate of approximately 1  to 5 dm3min. Add acetone or 
ethanol approximately half of the height  into the cylindrical vessel.  
b) Gradually add small pieces of dry ice and stir well until water vapour is  formed on the external surface 
of the cylindrical vessel A at the end of  the inlet tube. Im mediately read the temperature.  
c) Repeat the test by allowing the temperature to go up until all water  vapour disappears. Then repeat 
(b) until constant  temperature is obtained. Provided that the temperature measured is  not higher than 
- 400C, the sample is deemed to have moisture  content not exceeding 0.12 mg/dm3  
 
Fig 1 Apparatus for analysis of moisture content  
 
A. is a thin -walled cylindrical vessel made of metal, for example copper coated  with chromium, with 
approximately 4 mm. diameter and 7.5 to 12.7 cm. high, the external surface being polished and not 
causing any difference in  temperature at the internal and external surfaces.  DUS 1511 : 2014  
© UNBS 2014  – All rights reserved  ix 
 B. is a glass or transparent vessel with a lid.  
C. is an inlet tube, made of copper with an orifice of 6 mm. End of tube is  
D. approximate ly 2.5 mm. above the bottom of the vessel.  
E. is an outlet tube, made of copper with an orifice of 6 mm. The other end  
F. connected to gas volume meter.  
G. is a thermometer capable of r eading a temperature below - 400C. DUS 1511 : 2014  
x © UNBS 2014  – All rights r eserved  
 Annex  B 
(normative)  
 
Acidity and alkalinity  
B.1 Apparatus  
a) Three glass cylinders of 30 mm internal diameter and approximately  180 mm in height with stoppered. 
The second cylinder shall be  provided with a rubber stopper, fitted with an inlet tube having an  orifice 
of 0.5 mm in internal diameter with l ength almost reaching the  bottom of glass cylinder, and an outlet 
tube connected to gas volume  meter.  
b) Gas volume meter  
B.2 Reagents  
a) Hydrochloric acid solution, 0.01 mol/dm3  
b) Meth yl red indicator solution, 0.5 by weight. Dissolve 0.5 g of methyl  red in 100 c m^f distilled water.  
B.2 Procedure  
Transfer 1 cm3 of methyl red indicator solution into 350 cm3 of distilled water  and heat to boiling for 5 min. 
Then transfer the warm solution into three  glass cylinders, 100 cm3 each. The first cylinder - Drop 0.1 cm3 of  
hydrochloric acid solution. The second and the third cylinders - Drop 0.2  cm3 of hydrochloric acid solution. 
Stopper the first and the third cylinders  and pass 2 dtr^of the sample gas through the second cylinder within 
30 min. Compare the colour in the thr ee cylinders by placing them on white  surface. Unstopper and view the 
colour from top of the cylinder. Samples  shall be deemed to comply with the specification if colour of solution 
in the  second cylinder is not more yellow than in the first cylinder or pi nk intensity  in the second cylinder is not 
more than in the third cylinder.  DUS 1511 : 2014  
© UNBS 2014  – All rights reserved  xi 
  
 
Fig 2 Apparatus for analysis of acidity  
 
 
 
 
 
 
 
 
 DUS 1511 : 2014  
xii © UNBS 2014  – All rights r eserved  
 Annex  C 
(normative)  
 
Oxidising substance  
C.1 Apparatus  
Two glass cylinders, the same as the first and the second cylinders in  clause B.2 
C.2 Reagents, solutions and preparations  
C.2.1  Glacial acetic acid, a density of 1.049 g/cm3 
C.2.2  Potassium iodide -starch solution  
Dissolve 0.75 g of potassium iodide in 100 cm3 of distilled water. Boil  and add all starch solution (dissolve 0.5  
g of starch in 35 cm3 of  distilled water), then agitate and continue to boil for a few minutes, and  allow to 
cool.Test for solution activity by adding 0.05 cm3 glacial acetic acid and  0.25 cm3  0.5 m mol/ dm3 iodine into 
15 cm3 of the solution. The solutio n colour  shall be changed into blue.  
C.3 Procedure  
Add into both cylinders the 50 cm3 of the freshly prepared potassium iodide  -starch solution and the 0.2 cm3 
of glacial acetic acid. Pass 5 dm3 of sample  gas through the second cylinder. Provided the inten sity of the 
solution in the  second cylinder is the same as that of the first, the sample is deemed to  passed the test. The 
test shall be carried out at place not being exposed to  direct light.  DUS 1511 : 2014  
© UNBS 2014  – All rights reserved  xiii 
 Annex  D 
(normative ) 
 
Purity  
D.1 Apparatus  
It shall be as shown  in see Figure 3.  
D.2 Reagents and preparation  
Ammonium chloride -ammonium hydroxide solution  
Dissolve 550 g of ammonium chloride in 1 250 cm3 of water and add  750 cm3 of concentrated ammonium 
solution, a density of 0.88 g/ cm3.  
D.3 Procedure  
D.3.1 Assemble  the apparatus (see Figure 3) with tube ends connection. Put  a suitable amount of 
ammonium chloride -ammonium hydroxide  solution into the absorption pipette and the levelling bottle.  
D.3.2 Exhause the air in the burette, the absorption pipette and stopcock C, then allow the sample gas into 
the absorption pipette until a volume of  100 cm3 is obtained.  
D.3.3 Drive the gas back and forth between the burette and the absorption  pipette until constant volume of 
gas in the burette is obtained.  
D.3.3 The lost volume  of gas in the burette is the purity of the sample gas in  percentage by volume.  
NOTE  1 Newly prepared ammonium chloride -ammonium hydroxide solution shall be a few times subjected to trial 
oxygen analysis prior to  the actual analysis. The solution can be us ed several times unless  poor oxygen absorption and 
formation of sediment is presented.  
NOTE  2 The absorption pipette should be always filled with copper.  
 
 DUS 1511 : 2014  
xiv © UNBS 2014  – All rights r eserved  
  
Figure 3.  Apparatus for analysis of purity  
A. is a burette of 100 cm3 capacity, and scales from 99 cm 3 to 100 cm3 having  scale readable to 0.1 
cm3 
B. is an absorption pipette fully containing copper wire spirals, bars or  fragments inside.  
C. is three -way capillary stopcock with an orifice of 1 mm. internal diameter.  
D. is levelling bottle of 175 cm3 capacity.  
E. A rubber hose of approximately 750 mm long connected to the burette A  and levelling bottle D  DUS 1511 : 2014  
© UNBS 2014  – All rights reserved  xv 
 Annex  E 
(normative)  
 
Carbon dioxide  
E.1 Apparatus  
E.1.1 Carbon dioxide detector tube  
E.1.2 Gas volume meter  
E.2 Procedure  
Pass 1 dm3 of sample gas through the carbon d ioxide detector tube,  connected to the gas volume meter, at 
the speed specified on each  individual type. Read the obtained value from the detector tube.  DUS 1511 : 2014  
xvi © UNBS 2014  – All rights r eserved  
 Annex  F 
(normative)  
 
Carbon monoxide  
F.1 Apparatus  
F.1.1 Carbon monoxide detector tube  
F.1.2 Gas volume  meter  
F.2 Procedure  
Pass 1 dm3 of sample gas through the carbon monoxide detector tube,  connected to the gas volume meter, 
at the speed specified on each  individual type. Read the obtained value from the detector tube.  DUS 1511 : 2014  
© UNBS 2014  – All rights reserved  xvii 
 Bibliography  
TIS 540 -2545 (2002), Th ai Industrial Standard for medical use  DUS 1511 : 2014  
xviii © UNBS 2014  – All rights r eserved  
 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 go verned 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 N ational 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 1511 : 2014    
 
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