 DRAFT UGANDA STANDARD  
  DUS 2229 -2 
First Edition  
2020 -mm-dd 
 
 
 Reference number  
DUS 2229 -2:2020  
© UNBS 2020   
  
Surgical gauze — Specification — Part 2: Petrolatum  
 DUS 2229 -2:2020 
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 application  
© UNB S 2020  
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 DUS 2229 -2:2020  
© 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 i s 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 commen ts 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  
US 2229 consists of the following  parts, under the general title surgical  gauze — Specification :  
• ⎯ Part 1: Absorbent   
• ⎯ Part 2: Petrolatum  
 
 DRAFT UGANDA STANDARD  DUS 2229 -2:2020  
 
© UNBS 2020 – All rights reserved  1 
 Surgical gauze — Specification — Part 2: Petrolatum  
1 Scope  
This Draft Uganda standard specifies the requirements, methods of test and sampling o f petrolatum gauze  
(also known as paraffin gauze or vaseline gauze ). 
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 ref erences, only the edition cited applies. For undated 
references, the latest edition of the referenced document (including any amendments) applies.  
FDUS 2229 -1, Surgical gauze — Specification — be Part 1: Absorbent  
US ISO 2137, Petroleum products and lubric ants — Determination of cone penetration of lubricating greases 
and petrolatum  
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 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  
petrolatum gauze  
gauze saturated with white petrolatum  
4 Requirements  
4.1 General requirements  
4.1.1  Petrolatum gauze shall consist of a bsorbent gauze saturated with white petrolatum   
4.1.2  Petrolatum gauze shall be free from any foreign matter . 
4.2 Specific requirements  
4.2.1  Petrolatum gauze shall also conform to the requirements specified in Table 1 when tested in 
accordance with the test methods prescribed therein  DUS 2229 -2:2020  
2 © UNBS 2020  – All rights reserved  
 Table 1 — Specific requ irements of petrolatum gauze   
Characteristic  Requirement  Test method  
Assay , % 70 – 80 Annex A 
 
4.2.2  The conditioned absorbent gauze obtained in the assay shall meet the requirements for fibre content, 
thread count, length, width, and weight under FDUS 2 229-1. 
4.2.3  The petrolatum recovered by draining in the assay shall meet  the following requirements given in 
Table 2  
Table 2 — Requirements of petrolatum  
Characteristic  Requirement  Test method  
Consistency at 25 °C, (0.1 mm ) 60 – 300 US ISO 2137  
Sulphat ed ash, %, max  0.05 Annex B  
Polycyclic aromatic hydrocarbons  At no wavelength in the range 260 nm to 
420 nm does the absorbance of the test 
solution exceed that of the reference 
solution at 278 nm.  Annex C  
 
5 Sterility  
Petrolatum gauze shall be sterile w hen tested in accordance with Annex D 
6 Biocompatibility  
When tested in accordance with the relevant parts of ISO 10993, the petrolatum gauze shall not cause any 
harmful effect on the user.  
7 Packaging  
Each  petrolatum gauze unit  shall be  packaged individua lly that the sterility of the unit is maintained until the 
package is opened for use.  
8 Labelling  
Each package shall be legibly and indelibly marked with the following information:  
a) Name of product as “petrolatum gauze”;  or “paraffin gauze” or “Vaseline gau ze” 
b) name and physical address of manufacturer;  
c) thread count / type ; 
d) length and width;  
e) date of manufacture,  DUS 2229 -2:2020  
© UNBS 2020  – All rights reserved  3 
 f) date of expiry;  
g) batch/lot number;  
h) storage conditions;  
i) precaution “don’t use if  damage d” or ha s been opened previously ; and  
j) sterile  
9 Sampling  
Sampl ing shall be done i n accordance with US ISO 2859 -1. DUS 2229 -2:2020  
4 © UNBS 2020  – All rights reserved  
 Annex A  
(normative)  
 
Assay  
A.1 Procedure  
A.1.1 Weigh not less than 20 units of petrolatum  gauze, place them in a heated glass funnel, maintaining 
the temperature at approximately 75° C, and allow the petro latum to melt and drain from the funnel. Draining 
may be facilitated by pressing the  gauze  with a glass rod or porcelain spatula   
A.1.2  Wash the  gauze  on the funnel with successive portions of warm methyl chloroform until it is free from 
petrolatum, allow the residual methyl chloroform to evaporate spontaneously, condition the  gauze  in a 
standard atmosphere of 65 %± 2% relative humidity at 21 °C± 1.1° C for not less than 4 hours, and weigh.  
A.2 Calculation  
The assay  expressed  as percent, shall be calculated  by the formula below : 
 
where  
W1 is the weight in grams of petrolatum gauze  
W2 is the weight in grams of the gauze  
 DUS 2229 -2:2020  
© UNBS 2020  – All rights reserved  5 
 Annex B  
(normative)  
 
Determination of sulphated ash  
B.1 Procedure  
B.1.1  Ignite a suitable crucible (for example, silica, platinum, porcel ain or quartz) at 600 °C ± 50 °C for 30 
min, allow to cool in a desiccator over silica gel or other suitable  desiccant and weigh.  
B.1.2  Place the 2 g of the substance to be examined in the crucible and weigh.  
B.1.3  Moisten the substance to be examined w ith a small amount of sulfuric acid R  (usually 1 mL) and heat 
gently at as low a temperature as practicable until the sample is thoroughly charred.  
B.1.4  After cooling, moisten the residue with a small amount of sulfuric acid R  (usually 1 mL), heat gently  
until white fumes are no longer evolved and ignite at 600 ± 50 °C until the residue is completely incinerated. 
Ensure that flames are not produced at any time during the procedure.  
B.1.5  Allow the crucible to cool in a desiccator over silica gel or other  suitable desiccant, weigh it again and 
calculate the percentage of residue. If the amount of the residue so obtained exceeds the prescribed limit, 
repeat the moistening with sulfuric acid R  and ignition, as previously, for 30 min periods until  2 consecut ive 
weighings do not differ by more than 0.5 mg or until the percentage of residue complies with the prescribed 
limit.   
B.2 Calculation  
The Loss on drying , expressed as percent by mass, shall be calculated by the formula below.  
 
Where  
W1 is the weight in  grams of a crucible  
W2 is the weight in grams of sample and crucible before drying  
W3 is the weight in grams of sample and crucible after drying  DUS 2229 -2:2020  
6 © UNBS 2020  – All rights reserved  
 Annex C 
(normative)  
 
Polycyclic aromatic hydrocarbons  
C.1 Procedure  
C.1.1 Use reagents for ultraviolet spectro photometry.  
C.1.2   Dissolve 1.0 g in 50 mL of hexane  R which has been previously shaken twice with 10 mL of dimethyl 
sulfoxide R  and t ransfer the solution to a 125 mL separating funne l with unlubricated ground -glass  parts 
(stopper, stopcock , add 20 mL of d imethyl su lfoxide R and shake vigorously for  1 min and allow to stand until 
2 clear layers are formed.  
C.1.3 Transfer the lower layer to  a second separating funnel. Repeat the extraction with a further 20 mL of 
dimethyl sulfoxide R , shake vigorously the c ombined lower layers wi th 20 mL of hexane R for 1 min and a llow 
to stand until 2 clear layers are formed.  
C.1.4 Separate the lower layer  and dilute to 50.0 mL with dimethyl sulfoxide R. Measure the absorbance 
(2.2.25)  over the range 260 nm to 420 nm usi ng a path length of 4 cm and as  compensation liquid the clear 
lower layer obtained by vigorously shaking 10 mL of  dimethyl sulfoxide R with 25 mL of hexane R for 1 min. 
Prepare a reference  solution in dimethyl sulfoxide R containing 6.0 mg of naphthalen e R per litre and  
measure the absorbance of the solution at the maximum at 278 nm using a path  length of 4 cm and dimethyl 
sulfoxide R as compensation liquid.  
C.2 Result  
At no wavelength in the range 260 nm to 420 nm does the absorbance of the test solu tion exceed that of the 
reference solution at 278 nm.  DUS 2229 -2:2020  
© UNBS 2020  – All rights reserved  7 
 Annex  D 
(normative)  
 
Sterility test  
D.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 cult ure 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 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  
Thiog lycollic acid                   0.3 mL 
Resazurin sodium solution (1  g/L of resazurin sodium), freshly prepared       1.0 m L 
Water R                     1 000 m L 
pH after sterilization                  7.1 ± 0.2  
D.2.1 Mix the L -cystine, agar, sodium chloride, g lucose, water -soluble 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, af ter sterilization, the solution will have 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.  
D.2.3 Add the resazurin sodium solution, mix and place the medium in suita ble vessels which provide a ratio 
of surface 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, store at a temperature between 2 °C and 25 °C in a sterile, airtight container.  
D.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 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 medi um is to be 
incubated at 30  °C - 35 °C.  DUS 2229 -2:2020  
8 © UNBS 2020  – All rights reserved  
 D.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 m edium provided that it has been validated as described in growth promotion test.  
D.3 Alternative thioglycollate medium  
Where prescribed, justified and authorized, the following alternative thioglycollate medium may be used. 
Prepare a mixture having the sa me composition as that of the fluid thioglycollate 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.  
D.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 m onohydrate/anhydrous               2.5 g/2.3 g  
Water R                     1 000 m L 
pH after sterilization                  7.3 ± 0.2  
D.4.1 Dissolve the solids in water R , warming slightly to effect solution. Cool the solution to room 
temperature. Add 1 M sod ium hydroxide , if necessary, so that after sterilization the solution will have a pH of 
7.3 ± 0.2.  
D.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, 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 °C - 25 °C .  
D.4.3 The media used shall compl y with the following tests  given in D.6, carried out before or in parallel with 
the test on the product to be examined.   
D.5 Sterility  
Incubate portions of the media for 14 d ays. No growth of micro -organisms occurs.  
D.6 Growth promotion test of aerobes, an aerobes, and  fungi  
D.6.1 Test each lot of ready -prepared medium and each batch of medium prepared either from dehydrated 
medium or from ingredients. Suitable strains of microorganisms are indicated in Table D1. 
D.6.2 Inoculate portions of Fluid Thioglycoll ate 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 
microorganism , Clostridium sporogenes , Pseudomonas aeruginosa , and Staphylococcus aureus . Inocul ate 
portions of alternative thioglycollate medium with a small number (not more than 100 cfu) of Clostridium 
sporogenes.F  Inoculate portions of Soybean –Casein . DUS 2229 -2:2020  
© UNBS 2020  – All rights reserved  9 
 D.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 following species of microorganism , Aspergillus brasiliensis , 
Bacillus subtilis , and Candida albicans . Incubate for not more than 3 d ays in the case of bacteria and not more 
than 5 d ays in the case of fun gi.  
D.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 gro wth of the microorganisms occurs . 
Table D.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,NCTC 10788, NCIMB 951 8, NBRC 
13276  
Bacillus subtilis ATCC 6633, 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 5 32 or  
ATCC 11437, NBRC 14293  
 DUS 2229 -2:2020  
10 © UNBS 2020  – All rights reserved  
 Bibliography  
[1] British Pharmacopeia 2015  
[2] USP43 -NF38 - 2092  
[3] USP42 -NF37 - 2045  
[4] USP41 -NF36 - 1929  
[4 DUS 2229 -2:2020  
© UNBS 2020 – All rights reserved  11 
 Certification marking  
Products that conform to Uganda standards may be marked with Uganda National Bureau of Sta ndards 
(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 oper ated 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 sy stem of supervision, 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 an d conditions of licensing may be obtained from the Director, Uganda 
National Bureau of Standards.  
 
 DUS 2229 -2:2020    
 
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