 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  
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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  
  
  