DRAFT UGA NDA STANDARD  
  DUS 2111  
First Edition  
2018 -mm-dd 
 
 
 Reference number  
DUS 2111 :2018 
© UNBS 2018   
  
Umbilical cord clamp — Specification  
 DUS 2111 : 2018  
ii © UNBS 2018  – 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 app lication  
© UNBS 2018   
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilised in any 
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permission f rom UNBS.  
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The Executive Director  
Uganda National Bureau of Standards  
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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  WDUS 2111 :2018  
© UNBS 2018  – 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 c o-
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 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 key stakeholders 
including governmen t, 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 recom mending 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 2111 :2018  
 
© UNBS 2018  – All rights reserved  1 
 Umbilical cord clamp  — Specification  
1 Scope   
This Draft Uganda Standard specifies the requirements,  methods of test  and sampling  for umbilical cord 
clamps.  
It does not include specifications for  devices for dividing the umbilical cord after c lamp ing. 
2 Normative references   
The following ref erenced 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.   
ISO 2859 -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 , Biological evaluation of medical devices  — Part 1: Evaluation and testing within a risk 
management process  
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 add resses: — ISO Online browsing 
platform: available at http://www.iso.org/obp  
3.1  
umbilical cord  
cord arising from the navel that connects the fetus with the placenta . 
3.2  
umbilical cord clamp  
device used to constrict the umbilical cord to prevent blood l oss from a newborn when the cord is divided . The 
clamp may stay on for several days on the remaining cord attached to the baby.   
4 Material  
4.1 The umbilical cord clamp shall  be made  of medical grade polymer  material  suitable for clinical use in 
hospitals.  
4.2 The umbilical cord clamp  shall be non-slip, disposable, sterile and non -toxic.  
4.3 The finished umbilical cord  clamp  shall be present ed in several colors .  DUS 2111:2018  
2 © UNBS 2018  – All rights reserved  
 5 Requirements  
5.1 The clamp shall be sterile  when tested in accordance with Annex B  
5.2 The clamp shall provide safe security lock, with a click sound to indica te correct locking, to protect 
against accidental re -opening after clamping.  
5.3 The clamp jaws shall be grooved and serrated to hold and occlude the umbilical cord securely without 
cutting through, thereby spreading the cord evenly across 6 mm  arm and hol ds it firmly in place (see Figures 1 
to figure  8). 
 
Figure 1 : side elevational view of an umbilical  cord embodying the new des ign .Figure 2 : front elevational view  
Figure 3 : a view taken perpendicular to the top. F igure 4: Transverse cross -sectional view   
Figure 5 : a fragmentary view-showing  top of the lower member thereof. Figure 6: an enlarged fragmentary top perspective 
view of the front of the lower member thereof. Figure 7 : an enlarged fragmentary top perspective view of the front of the 
bottom membe r thereof. Figure 8 : a side elevational view thereof closed position.  
5.4 The clamp shall have a finger grip to ensure safe and easy handling.  
5.5 The clamp shall be construct ed to ensure that no breakage occurs while the clamp is in use.  DUS 2111 : 2018  
© UNBS 2018  – All rights  reserved  3 
 5.6 The clamp sha ll maintain constant closing force on the cord as it dries and shrinks  
5.7 The outer surface shall be smooth with rounded edges to prevent injury on the baby or snag on the 
newborn  clothing.  
5 Packaging  
Umbilical Cord clamps shall be packaged in individual  sterile pack that are of easy peel when opening.  
6 Labeling  
Each package of the umbilical cord  shall be indelibly and legibly marked with the following information:  
a) Manufacturer’s name/ trade name and/or trade mark;  
b) Date of manufacture;  
c) Expiry date;  
d) Prod uct name as, ‘UMBILICAL CORD CLAMP’;  
e) Batch/lot number;  
f) Country of origin;  and  
g) With wordings like ‘for single -use only’ , ‘forbidden to use if package is damaged” Inserts in case of 
secondary  packaging with direction for use.  
7 Sampling   
Sampling shall be d one in accordance with ISO 2859 -1. 
8  Biocompatibility  
The test for biocompatibility shall be carried by the manufacturer for which the certificate of conformity shall be 
provided. The umbilical cord clamp shall be non-toxic when examined  in accordance with US ISO 10993  —1. DUS 2111:2018  
4 © UNBS 2018  – All rights reserved  
 ANNEX  
(normative ) 
 
Sterility  
B.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.  
B.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                      1 000 mL  
pH after sterilization                   7.1 ± 0.2  
B.2.1 Mix the L -cystine, agar, sodium chloride, glucose, water -soluble yea st extract and pancreatic digest of 
casein with the water R and heat until solution is effected.  
B.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 s olution 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.  
B.2.3 Add the resazurin sodium  solution, mix and place the medium in suitable vessels which provi de 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, sto re at a temperature between 2 °C and 25 °C in a sterile, airtight container.  
B.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 stea m 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 medium is to be 
incubated  at 30 °C - 35 °C.  DUS 2111 : 2018  
© UNBS 2018  – All rights  reserved  5 
 B.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 medium provided that i t has been validated as described in the growth promotion test.  
B.3 Alternative thioglycollate medium  
Where prescribed, justified and authorized, the following alternative thioglycollate medium may be used. 
Prepare a mixture having the same composition a s 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 condit ions.  
B.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                      1 000 mL  
pH after sterilization                   7.3 ± 0.2  
B.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 sterilization the solution will have a pH of 
7.3 ± 0.2.  
B.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.  
The media used comply with the following tests given in E.6, carried out before or in parallel with the test on 
the product to be examined..  
B.5 Sterility  
Incubate portions of the media for 14 days. No growth of micro -organisms occurs.  
B.6 Growth Promotion Test of Aerobes, A naerobes, and Fungi  
B.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 E1.  
B.6.2 Inoculate portions of Fluid Thioglyc ollate 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 .  Inoculate 
portions of alternative thioglycollate medium with a small number (not more than 100 cfu) of Clostridium 
sporogenes. F Inoculate portions of Soybean –Casein  DUS 2111:2018  
6 © UNBS 2018  – All rights reserved  
 B.6.3 Digest Medium with a small number (not more than 100 cfu) of the f ollowing 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 days in the case of bacteria and not more 
than 5  days in the case of fungi.  
B.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 i f a clearly visible growth of the microorganisms occurs  
Table B1—. Strains of the Test Microorganisms Suitable for Use in the Growth Promotion Test  
Test Microorganisms  
Aerobic bacteria  Fungi  
Staphylococcus aureu s ATCC 6538, CIP 4.83,NCTC 10788, 
NCIMB 9518, NBRC 13276  Candida albicans   ATCC 10231, IP 48.72, 
NCPF 3179, NBRC 1594  
 DUS 2111 : 2018  
© UNBS 2018  – All rights  reserved  7 
 Bibliography  
[1] KS 2557:2018.  Umbilical cord clamp  — Specif ication.  
 DUS 2111 : 2018  
© UNBS 2018  – 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 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 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 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 2111 : 2018    
 
ICS 11.040.30  
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© UNBS 2018 – All rights reserved