PUBLIC REVIEW DRAFT DRAFT UGANDA STANDARD  
  DUS DEAS  1018  
First  Edition  
2019-mm-dd 
 
 Reference number  
DUS DEAS  1018 : 2019 
© UNBS 2019 
   
Surgical suture needles — Specification  
 
 PUBLIC REVIEW DRAFTDUS DEAS 1018: 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 
permission from UNBS. 
Requests for permission to reproduce this document should be addressed to 
The Executive Director 
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Uganda 
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 PUBLIC REVIEW DRAFTDUS DEAS 1018: 2019 
© UNBS  2019 - All rights reserved                iii National 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 representatives of 
consumers, traders, 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 the draft standards 
for approval and declaration as Uganda Standards by the National Standards Council.  
This Draft Uganda Standard, DUS DEAS 1018: 2019 , Surgical suture needles — Specification , is identical with 
and has been reproduced from an East African Standard, DEAS 1018 : 2019, Surgical suture needles — 
Specification , and is being proposed for adoption as a Uganda Standard. 
The committee responsible for this document is Technical Committee UNBS/TC 14, Medical devices ’. 
Wherever the words, “ East African Standard " appear, they should be replaced by "Uganda Standard." 
 
  DEAS 1018 : 2019  
ICS 11.040.30  
 
© EAC 2019                                                                                                                               1st Edition 2019   
 DRAFT EAST AFRICAN STANDARD  
Surgical suture needles — Specification  
EAST AFRICAN COMMUNITY  
 
 
 
 
 
   
   DEAS 1018 : 2019  
ii © EAC  2019  – All rights reserved  
 Copyright notice  
This EAC document is copyright -protected by EAC. While the reproduction of this document by 
participants in the EAC standards development process is permitted without prior permission from EAC, 
neither this document nor any extract from it may be reproduced, stored or transmitted in any form for 
any other purpose without prior written permission from EAC.  
Requests for permission to reproduce  this document for the purpose of selling it should be addressed 
as shown below or to EAC’s member body in the country of the requester:  
© East African Community  2019  — All rights reserved  
East African Community   
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       Web: www.eac -quality.net  
Reproduction for sales purposes may be subject to royalty payments or a licensing agreement.  
Violators may be prosecuted .  DEAS 1018 : 2019  
© EAC 2019  – All rights reserved  iii 
 Foreword  
Development of the East African Standar ds has been necessitated by the need for harmonizing requirements 
governing quality of products and services in the East African Community. It is envisaged that through 
harmonized standardization, trade barriers that are encountered when goods and services  are exchanged 
within the Community will be removed.  
The Community has established an East African Standards Committee  (EASC)  mandated to develop and 
issue East African Standards  (EAS) . The Committee is composed of representatives of the National 
Standard s Bodies in Partner States, together with the representatives from the public and private sector 
organizations  in the community .  
East African Standards are developed through  Technical Committees that are representative of key 
stakeholders including govern ment, academia, consumer groups, private sector and other interested parties. 
Draft East African Standards are circulated to stakeholders through the National Standards Bodies in the 
Partner States. The comments received are discussed and incorporated befo re finalization of standards, in 
accordance with the Principles and procedures for development of East African Standards.  
East African Standards are subject to review, to keep pace with technological advances. Users of the East 
African Standards are there fore expected to ensure that they always have the latest versions of the standards 
they are implementing .  
The committee responsible  for this document is Technical Committee EASC /TC 078, Healthcare and medical 
devices . 
Attention is drawn to the possibility  that some of the elements of this document may be subject of patent 
rights. EAC shall not be held responsible for identifying any or all such patent rights.  
 DRAFT EAST AFRICAN STANDARD  DEAS 1018 : 2019  
 
© EAC 2019  – All rights reserved  1 
 Surgical suture needles — Specification  
1 Scope  
This Draft East African  Standard specifie s the r equirements , sampling and test methods for surgical suture 
needles . 
2 Normative references  
The following documents are 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 A751 -01, Standard Test Methods, Practices, and Terminology for Chemical Analysis of Steel Products   
ASTM F1089 -02, Standard Test Method for Corrosion of Surgical Instruments   
ASTM F1840 -10, Standard Terminology for Surgical Suture Needles   
ISO 6507 -1, Metallic materials —Vicker hardness test — Part 1: Test method   
ISO 24153 , Random sampling and randomisation procedur es 
ISO 13402, Surgical and dental hand instruments — Determination of resistance against autoclaving, 
corrosion and thermal exposure   
ASTM F3014 – 14, Standard Test Method for Penetration Testing of Needles Used in Surgical Sutures   
ASTM F1874 - 98, Standa rd Test Method for Bend Testing of Needles Used in Surgical Sutures   
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 follo wing addresses:  
— ISO Online browsing platform: available at http://www.iso.org/obp  
33.1  
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. Some 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).  DEAS 1018 : 2019  
2 © EAC  2019  – All rights reserved  
 3.3  
strand  
fibre/suture used to hol d body tissues together after a surgery or injury  
3.4  
surgical suture needle  
surgical needle 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 suture needles  
Surgical suture needles that have a hole at the suture side of the needle. Eyed suture needles are categorized 
into closed eye or French (split/spring) eye.  
4.2 Swaged or eyeless needles  
Surgical suture  needles that have a suture crimped within the needle. The suture strand is permanently 
attached needle by the manufacturer.  
5 Requirements  
5.1 General requirements  
5.1.1  The surface of the suture needle shall be smooth and free from dents.  
5.1.2  The s uture needles shall be free from grinding marks, polishing dirt or the other material which could 
necessitate cleaning 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 nee dle shall be clean and properly formed and shall be smooth from inside 
and outside.  
5.2 Chemical composition  
When tested in accordance with ASTM A751 -01, the suture needles shall be made of stainless steel wires of 
either of the composition  given in Tabl e 1 or Table 2 .  DEAS 1018 : 2019  
© EAC 2019  – All rights reserved  3 
 Table 1 — Chemical composition for surgical suture needles  
Element  Percentage  
% 
Carbon  0.30 – 0.40 
Manganese  1.00 max.  
Phosphorous  0.045 max.  
Sulphur  0.045 max.  
Silicon  1.00 max.  
Chromium  12.00 – 14.00  
Nickel  1.00 max.  
 
Table 2 — Chemical composition for surgical suture needles  
Element  Percentage  
% 
Carbon  0.60 – 0.75 
Manganese  1.00 max.  
Phosphorous  0.040 max.  
Sulphur  0.030 max.  
Silicon  1.00 max.  
Chromium  16.00 – 18.00  
Nickel  0.75 max.  
 
5.3 Quality requirements  
5.3.1  Hardne ss  
When te sted in accordance with  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 requirements for corrosion resistance given i n F1089 -02 
when t ested in in accordance with  ISO 13402.  
5.3.3  Bend test  
The surgical suture needles shall be tested in accordance with ASTM F1874 - 98.The straight suture needle 
shall deem to have failed as being too hard, if it breaks 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  
The penetration test of surgical needles shall be done in accordance with ASTM F3014 – 14. The piercing 
resistance shall be less than 25 g.  DEAS 1018 : 2019  
4 © EAC  2019  – All rights reserved  
 This test is applicable to  all needles, except blunt point needle s. 
6 Packaging  
The surgical suture needle shall packed in suitable packets or containers that protects the needle from 
contamination and deterioration.  
7 Labelling  
The packa ge shall be legibly and indelibly marked with the following information:  
a) manufacturer'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) warning/ 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 ISO 24153. (Acceptance criteria - 
none shall fail). DEAS 1018 : 2019  
© EAC 2019  – All rights reserved  5 
 Annex  A 
(normative)  
 
Sizes shapes and dimensions  
A.1 Schematic of a surgical suture needle  
 
 
Figure A.1 ——Schematic of a surgical needle  DEAS 1018 : 2019  
6 © EAC  2019  – All rights reserved  
 A.2 Curvatures  
 
Figure A.2 — Typical curvatures  DEAS 1018 : 2019  
© EAC 2019  – All rights reserved  7 
 A.3 Point configura tions  
 
Figure A.3 — Typical point configur ations  
A.4 Attachment end of surgical suture needles  
 
 
Figure A.4 — Needle eye  DEAS 1018 : 2019  
8 © EAC  2019  – All rights reserved  
 Bibliography  
[1] IS 1501:2002 , Method for Vickers hardness test for metallic materials (Third Revision ).  
[2] IS 7531 (1990): Surgical Instruments — Corrosion Resistance of Sta inless Steel Surgical Instruments 
— Methods of Tests.   
[3] IS 9165 (Part 1): 1992, Surgical instruments — Needles, suture Part 1 — Specification .  
[4] ISO 6507 -2:2018, Metallic materials — Vickers hardness test — Part 2: Verification and calibration of 
testing machines . 
 DEAS 1018 :2019    
 
© EAC 2019  – All rights reserved