DRAFT UGANDA STANDARD  
  DUS 1959 
First  Edition  
2018 -mm-dd 
 
 
 Reference number  
DUS 1959 : 2018 
© UNBS 2018   
  
Surgical suture needles  — Specification  
 DUS 1959 : 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 application  
© UNBS 2018   
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 
permissio n from 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  DUS 1959 : 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 t o 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 govern ment, 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 re commending 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 1959 : 2018  
 
© UNBS  2018  – All rights reserved  1 
 Surgical suture needles  — Specification  
1 Scope   
This Draft Uganda standard specifies the requirements , sampling and test methods  for surgical suture 
needles.  
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.  
ASTM A 751 – 01, Standard Test Methods, Practices, a nd Terminology for Chemical Analysis of Steel 
Products  
ASTM F1840 – 10, Standard Terminology for Surgical Suture N eedles  
ASTM F1089 – 02, Standard  Test Method for Corrosion of Surgical Instruments  
US ISO 6507 -1, Metallic materials —Vicker hardness test — Part 1: Test method  
DUS 1961 , Standard Test Method for Penetration Testing of Needles Used in Surgical Sutures  
DUS 1962 , Standard Test Method for Bend Testing of Needles Used in Surgical Sutures   
WDUS ISO 13402, Surgical and dental hand instruments — Determination of resistance against autoclaving, 
corrosion and thermal exposure  
 
3 Terms and definitions  
For the purposes of this document, the terms and definitions given in F1840 – 10 and the following 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 
attachment area  
portion of the needle where the attachment of the suture takes place. For example, eyed, drilled and channel 
(See annex A) . 
3.2 
curvature  
shape of the needle viewed in profile. So me common shapes include, but are not limited to: straight, 1⁄2 curve 
or “ski,” 1⁄8 circle, 1⁄4 circle, 3⁄8 circle, 1⁄2 circle, 5⁄8 circle, and compound curvature. (See annex A)  
3.3 
Strand  
fibre/suture used to hold body tissues together after a surgery or injury  DUS 1959 : 2018  
2 © UNBS 2018  – All rights reserved  
 3.4  
surgical suture needle  
surgical needles necessary for the placement of sutures in tissues.  
3.5 
Swage  
any attachment method that uses mechanical force to crimp the end of the needle and firmly hold the suture in 
place  
4 Types  
4.1 Eyed su ture needle s 
Surgical suture needle s that have  a hole at the suture side of the needle . Eyed  suture needles are categorised 
into closed eye or French  (split/ spring) eye . 
4.2 Swaged or eyeless needle s 
Surgical sutur e needles that have a suture crimped within the needle. The suture strand is permanently 
attached needle by the manufacturer.  
5 Requirements  
5.1 Chemical composition  
When tested in accordance with ASTM A 751 – 01, the suture needles shall be made of sta inless steel wires 
of either of the following  Composition;  
Table 1 — Chemical composition for surgical suture needles  
Element  Percentage  
Carbon   0.30 - 0.40 
Manganese  1.00 Max  
Phosphorus  0.045 Max  
Sulphur  0.045 Max  
Silicon  l.00 Max  
Chromium  12.00 - 14.00  
Nickel  1.00 Max  
 DUS 1959 : 2018  
© UNBS 2018  – All rights reserved  3 
         OR 
Table 2 — Chemical composition for surgical suture needles  
Element  Percentage  
Carbon  0.60 - 0.75 
Manganese  I.00 Max  
Phosphorus  0.040 Max  
Sulphur  0.030 Max  
Silicon  l.00 Max  
Chromium  16.00 - 18.00  
Molybdenum  0.75 Max  
 
5.2 General requirements  
5.1.1 The surface of the suture needle shall be smooth and shall be free from dents.  
5.1.2 The suture needles shall be free from grinding marks, polishing dirt or the  other material which could 
necessitate clean ing prior to sterilization.  
5.1.3 The point of the needle shall be sharp except where otherwise specified.  
5.1.4 The eye (swage) of the needle shall  be clean and properly formed and shall be smooth from inside 
and outside.  
5.3 Quality requirements  
5.3.1 Hardness  
When tested in accordance with US ISO 6507 -1, the hardness of the surgical suture needle shall be 525 HV 
to 625 HV (Vicker hardness ) 
5.3.2 Corrosion resistant  
The surgical suture needle shall comply with the req uirements  for corrosion  resistance given in F1089 -02 
when tested in in accordance with WDUS ISO 13402.  
5.3.3 Bend test   
The surgical suture needles shall be tested in accordance with WDUS 1962 .The straight suture needle shall 
deem to have failed as being too hard, if it break s before the initial bend of 90 ° is achieved. There shall not be 
any permanent set in the curved suture needles  after the test.  
5.3.4 Penetration  test (for all Needles, except blunt point needle ) 
The penetration test of surgical needles shall be done in accordance with DUS 1961 . The piercing resistance 
shall be less than 25 g.  DUS 1959 : 2018  
4 © UNBS 2018  – All rights reserved  
 6 Packaging  
The surgical suture needle s hall packed in suitable packets or containers  that protects the needle from 
contamination and deterioration . 
7 Labelling  
The package shall be legibly and indelibly marked with the following information : 
a) manufact urer's name and physical address ; 
b) product name;  
c) batch number;  
d) shape of the needle ;  
e) needle  length ; 
f) Curvature  
g) Point Configurations  
h) type of eye (either eyed or eyeless);  
i) quantity of sutures needles;  
j) warnin g/ precautions ; 
k) instruction for use; and  
l) month and year of manufacture and expiry  
8 Sampling  
Random samples of the product for test shall be drawn in accordance with US ISO 24153 .Acceptance criteria 
none  shall fail.  
 DUS 1959 : 2018  
© UNBS 2018  – All rights reserved  5 
 Annex  A  
(informative )  
 
Sizes shapes and dimensions  
A.1 Schematic of a surg ical suture needle  
 
Figure A1 ——Schematic of a Surgical Needle  DUS 1959 : 2018  
6 © UNBS 2018  – All rights reserved  
 A.2 Curvatures  
 
Figure A.2 — Typical Curvatures  DUS 1959 : 2018  
© UNBS 2018  – All rights reserved  7 
 A.3 Point Configurations  
 
Figure A.3 — Typical  point configurations  DUS 1959 : 2018  
8 © UNBS 2018  – All rights reserved  
 A.4 Attachment end of surgical suture needles  
 
Figure  4 — Needle eye  DUS 1959 : 2018  
© UNBS 2018  – All rights reserved  9 
 Bibliography  
[1] ASTM F18 40 — 10:2016, Standard Terminology for Surgical Suture Needles  
[2] Is 1501:2002, method for Vickers hardness test for metallic materials (Third Revision)  
[3] IS 7531 (1990): Surgical Instruments — Corrosion Resistance of Stainless Steel Surgical Instrument s 
— Methods of Tests  
[4] IS 9165 (Part 1): 1992, Surgical instruments — needles, suture Part 1 — Specification  
[5] ISO 6507 -2:2018, Metallic materials — Vickers hardness test — Part 2: Verification and calibration of 
testing machines  
 DUS 1959 : 2018  
 
© UNBS  2018  – All rights reserved  11 
 Certification markin g 
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 
there under. 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 pro duct 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 
conti nually 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 1959 : 2018    
 
ICS 11.040.30  
Price based on nn pages  
© UNBS 2018 – All rights reserved