 DEAS 1019 -2: 2019  
ICS 11.040.30  
 
© EA C 2019                                                                                                                              1st Edition 2019   
 DRAFT EAST AFRICAN STANDARD  
Surgical sutures — Specification — Part 2: Non -absorbable  
EAST AFRICAN COMMUNITY  DEAS 1019 -2: 2019  
ii © EAC 2019  – All rights reserved  
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Violators may be prosecuted . DEAS 1019 -2: 2019  
© EAC 2019  – All rights reserved  iii 
 Contents  Page 
Foreword  ................................ ................................ ................................ ................................ .............................  v 
1 Scope  ................................ ................................ ................................ ................................ ......................  1 
2 Normative references  ................................ ................................ ................................ ............................  1 
3 Terms and definitions  ................................ ................................ ................................ ...........................  1 
4 Classes of non -absorbable sutures  ................................ ................................ ................................ .... 2 
4.1 Class I  ................................ ................................ ................................ ................................ .....................  2 
4.2 Class II  ................................ ................................ ................................ ................................ ....................  2 
4.3 Class III  ................................ ................................ ................................ ................................ ...................  2 
5 Requirements  ................................ ................................ ................................ ................................ .........  2 
5.1 General requirements  ................................ ................................ ................................ ...........................  2 
5.2 Specific requirements  ................................ ................................ ................................ ...........................  2 
5.2.1  Biocompatibility  ................................ ................................ ................................ ................................ ..... 2 
5.2.2  Materials  ................................ ................................ ................................ ................................ .................  2 
5.2.3  Length  ................................ ................................ ................................ ................................ .....................  3 
5.2.4   Diameter  ................................ ................................ ................................ ................................ ................  4 
5.2.4  Tensile strength  ................................ ................................ ................................ ................................ ..... 4 
5.2.5  Needle attachment  ................................ ................................ ................................ ................................ . 5 
5.2.6  Extractable colour  ................................ ................................ ................................ ................................ . 5 
5.2.7  Sterility  ................................ ................................ ................................ ................................ ...................  6 
Annex  A (normative)  Identification of sutures  ................................ ................................ ...............................  8 
A.1 Identification of s ilk ................................ ................................ ................................ ...............................  8 
A.1.1  Method A  ................................ ................................ ................................ ................................ ................  8 
A.1.2  Method B  ................................ ................................ ................................ ................................ ................  8 
A.2 Identification of linen  ................................ ................................ ................................ ............................  8 
A.2.1  Method A  ................................ ................................ ................................ ................................ ................  8 
A.2.2  Method B  ................................ ................................ ................................ ................................ ................  8 
A.3 Identification of poly (ethylene terephthalate)  ................................ ................................ ....................  8 
A.3.1  Method A  ................................ ................................ ................................ ................................ ................  8 
A.3.2  Method B  ................................ ................................ ................................ ................................ ................  8 
A.4 Identification of polyamide -6 ................................ ................................ ................................ ................  8 
A.4.1  Method A  ................................ ................................ ................................ ................................ ................  9 
A.4.2  Method B  ................................ ................................ ................................ ................................ ................  9 
A.5 Identification of polyamide -6/6 ................................ ................................ ................................ .............  9 
A.5.1  Method A  ................................ ................................ ................................ ................................ ................  9 
A.5.2  Method B.  ................................ ................................ ................................ ................................ ...............  9 
A.5.3  Method C  ................................ ................................ ................................ ................................ ................  9 
A.5.4  Method D  ................................ ................................ ................................ ................................ ................  9 
A.6 Identification of polypropylene  ................................ ................................ ................................ ............  9 
A.6.1  Method A . ................................ ................................ ................................ ................................ ...............  9 
A.6.2  Method B  ................................ ................................ ................................ ................................ ................  9 
A.6.3  Method C  ................................ ................................ ................................ ................................ ................  9 
A.7 Identification of stainless steel  ................................ ................................ ................................ ..........  10 
A.8 Identification of poly (vinylidene difluoride)  ................................ ................................ .....................  10 
A.8.1  Method A  ................................ ................................ ................................ ................................ ..............  10 
A.8.2  Method B  ................................ ................................ ................................ ................................ ..............  10 
A.8.3  Method C  ................................ ................................ ................................ ................................ ..............  10 
Annex  B (normative)  Diameter of sutures  ................................ ................................ ................................ .... 11 
Annex  C (normative)  Tensile strength  ................................ ................................ ................................ ..........  12 DEAS 1019 -2: 2019  
iv © EAC 2019  – All rights reserved  
 Annex  D (normative)  Needle attachment ................................ ................................ ................................ ...... 13 
Annex  E (normative)  Extract able colours  ................................ ................................ ................................ .... 14 
Annex F (normative )  Sterility test  ................................ ................................ ................................ ................  15 
Bibliography  ................................ ................................ ................................ ................................ .....................  18 
 DEAS 1019 -2: 2019  
© EAC 2019  – All rights reserved  v 
 Foreword  
Development of the East African Standards 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 whe n 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 t he National 
Standards 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 
stakehold ers including government, 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 a nd incorporated before 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 therefore expected to ensure that they always have the latest versions of the standards 
they are implementing .  
The committee responsible  for this document is Technical Commi ttee EASC/TC 078, Healthcare and medical 
devices . 
Attention is draw n 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 . 
DEAS 101 9 : 2019 consists  of the following parts, under the general title Surg ical sutures — Specification : 
Part 1: Surgical sutures — Specification — Part 1: Absorbable  
Part 2: Surgical sutures — Specification — Part 2: Non Absorbable  DEAS 1019 -2: 2019  
vi © EAC 2019  – All rights reserved  
 Introduction  
Surgical sutures are used in a variety of different surgical procedures to close wo unds and aid in tissue 
healing. These sutures may be a single filament or multifilament or braided or twisted with or without a coating  
Surgical sutures are classified into two types:  
a) absorbable surgical sutures; and  
b) non-absorbable surgical sutures.  
 DRAFT EAST AFRICAN STANDARD  DEAS 1019 -2: 2019  
 
© EAC  2019  – All rights reserved  1 
 Surgical sutures — Specification — Part 2: Non -absorbable  
1 Scope   
This Draft East African Standard specifies the requirements, sampling and test methods for non-absorbable 
surgical sutures . 
2 Normative references   
The following documents are referred t o 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 5832 -1, Implants for surgery  — Metallic materials — Part 1: Wrought stainless steel  
ISO 10993 (all parts), Biological evaluation of medical devices  
ISO 24153 , Random sampling and randomisation procedures  
DEAS 1018 , Surgical needles — Specifica tion 
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  
3.1 
monofilament  
suture made of a single strand  
3.2  
multifilament  
suture composed of several filaments twisted or braided together  
3.3  
non-absorbable sutures  
sutures which, when introduced into a  living tissue, are not absorbed by th e tissue  
3.4 
surgical sutures  
medical devices that are used to hold body tissues together after a surgery or injury   DEAS 1019 -2: 2019  
2 © EAC 2019  – All rights reserved  
 4 Classes of non-absorbable sutures  
4.1 Class I  
These are composed of silk or synthetic fibres of mon ofilament, twisted or braided construction where the 
coating if any does not significantly affect the thickness.  
4.2 Class II  
These are composed of cotton or linen fibres or coated natural or synthetic fibres where coating significantly 
affects the thickn ess but does not contribute to the strength.  
4.3 Class III  
These are composed of monofilament or multifilament metal wire . 
5 Requirements  
5.1 General  requirements   
5.1.1 The suture shall either be monofilament or multifilament. If multifilament, the indivi dual filament may 
be combined by spinning, twisting, braiding or any combination.  
5.1.2 It shall be sterile.  
5.1.3 It may be coloured, coated or both  
5.2 Specific requirements  
5.2.1  Biocompatibility  
When tested in accordance with the relevant parts of ISO 10993, the suture shall be biocompatible if the test 
is conducted appropriately to the body contact with indicated contact duration . 
5.2.2 Materials  
The sutures shall comply with the requirements  for materials  given in Table 1 when tested in accordance wit h 
Annex A . DEAS 1019 -2: 2019  
© EAC 2019  – All rights reserved  3 
 Table 1 — Requirements for  non-absorbable suture materials.  
Material  Requirements  Test method  (Annex A)  
Silk A cross -section is more or less triangular to semi -circular, 
with rounded edges and without a lumen . A.1.1  
The fibres shall be colou red pale yellow . A.1 2  
Linen  The fibres are seen to be 12 µm to 31 µm wide and, along 
the greater part of their length, have thick walls, sometimes 
marked with fine longitudinal striations, and a narrow 
lumen. The fibres gradually narrow to a long, fine p oint. 
Sometimes there are unilateral swellings with transverse 
lines.  A.2 1  
The fibres are coloured violet -blue. A.2.2 
Polyethylene  terephthalate  
(PET)  Dissolves with difficulty  A.3.1 
The material remains intact even after immersion for 6 h . A.3.2  
Polyamide -6 No crystals appear  A.4.1  
Dissolves  A.4.2  
Polyamide -6/6 It melts and burns forming a hard globule of residue with off 
characteristic odour resembling that of celery . A.5.1  
A violet -brown colour slowly appears on the paper and 
fades slowly in  air; it disappears almost immediately on 
washing with dilute sulfuric acid R . A.5.2 
The material disintegrates in the cold and dissolves within a 
few minutes.  A.5.3  
Does not dissolve in 20 ml of a 70 % m/m solution of 
anhydrous formic acid R but disso lves in 20 ml of an 80 % 
m/m solution of anhydrous formic acid R  A.5.4 
Polypropylene  It burns with a blue flame giving off an odour of burning 
paraffin wax and of octyl alcohol.  A.6.1  
Complies when compared  with the spectrum obtained with 
polypropylene CRS  A.6.2  
The relative density of the material s hall be  0.89 g/ml to 
0.91 g/m l. A.6.3  
Stainless steel  Comply with the requirements of 4.2 Table 1 of US ISO 
5832 -1  A.7 
Poly (vinylidene difluoride)  It melts in a flame and does not burn after removal of the 
flame . 
No green colour is produced  when heated with an oxidizing 
flame.  A.8.1  
The spectrum shall show absorption maxima at the 
following wave -numbers: 838.3 ± 0.5 cm -1, 873.3 ± 1 cm -1, 
1070.0 ± 2 cm -1, 1165.0 ± 10 cm -1, 1275 ± 0.5 cm -1, 1399 
± 5 cm -1. A.8.2  
The relative density of the material is 1.71 to 1.78.  A.8.3  
 
5.2.3  Length  
The length of the suture without stretching shall be not less than 95 % of the length stated on the label and 
shall not exceed 400 cm .  DEAS 1019 -2: 2019  
4 © EAC 2019  – All rights reserved  
 5.2.4  Diameter  
The diameter of sutu res shall comply with requirements given in Table 2 when determined using a suitable 
mechanical instrument capable of measuring with an accuracy of at least 0.002 mm and having a circular 
pressor foot 10 mm - 15 mm in diameter as  prescribed in Annex B.  
Table 2 — Average knot -pull limits and diameters of non -absorbable sutures  
USP Size  Metric 
size 
(gauge 
no.) Limits on 
average 
diam eter  
Mm Limits on average knot -pull (except 
where otherwise  specified)a tensile 
strength , min.   
kgf Limits on average knot -pull (except 
where otherwise  specified)a tensile 
strength  
N 
Min. Max.  Class I  Class II  Class III  Class I  Class II  Class III  
12-0 0.01 0.001  0.009  0.001a - 0.002a 0.01a - 0.02a 
11-0 0.1 0.010  0.019  0.006a 0.005a 0.02a 0.06a 0.05a 0.20a 
10-0 0.2 0.020  0.029  0.019a 0.014a 0.06a 0.194a 0.14a 0.59a 
9-0 0.3 0.030  0.039  0.043a 0.029a 0.07a 0.424a 0.28a 0.68a 
8-0 0.4 0.040  0.049 0.06 0.04 0.11 0.59 0.39 1.08 
7-0 0.5 0.050  0.069  0.11 0.06 0.16 1.08 0.59 1.57 
6-0 0.7 0.070  0.099  0.20 0.11 0.27 1.96 1.08 2.65 
5-0 1 0.10 0.149  0.40 0.23 0.54 3.92 2.26 5.30 
4-0 1.5 0.15 0.199  0.60 0.46 0.82 5.88 4.51 8.04 
3-0 2 0.20 0.249  0.96 0.66 1.36 9.41 6.47 13.3 
2-0 3 0.30 0.339  1.44 1.02 1.80 14.1 10.0 17.6 
0 3.5 0.35 0.399  2.16 1.45 3.40a 21.2 14.2 33.3a 
1 4 0.40 0.499  2.72 1.81 4.76a 26.7 17.8 46.7a 
2 5 0.50 0.599  3.52 2.54 5.90a 34.5 24.9 57.8a 
3 and 4  6 0.60 0.699  4.88 3.68 9.11a 47.8 36.1 89.3a 
5 7 0.70 0.799  6.16 - 11.4a 60.4 - 112a 
6 8 0.80 0.899  7.28 - 13.6a 71.4 - 133a 
7 9 0.90 0.999  9.04 - 15.9a 88.6 - 156a 
8 10 1.00 1.099  - - 18.2a - - 178a 
9 11 1.100  1.199  - - 20.5a - - 201a 
10 12 1.200  1.299  - - 22.8a - - 224a 
a The tensile strength of sizes smaller than metric size 0.4 is measured by straight pu ll. The tensile strength of sizes larger than metric size 3 of 
monofilament Class III (metallic). Non-absorbable  surgical suture is measured by straight pull. Silver wire meets the tensile strength values of Class I 
sutures but is tested in the same manner  as Class III sutures.  
 
5.2.4 Tensile strength  
The tensile strength of sutures shall comply with the requirements in Table 2 when tested in accordance with 
Annex C.  DEAS 1019 -2: 2019  
© EAC 2019  – All rights reserved  5 
 5.2.5 Needle attachment  
5.2.5.1 If the sutures are supplied with an eyeless needle attach ed that is not stated to be detachable, 
they shall comply with the requirements given in Table 3 when tested in accordance with in Annex D.  
Table 3 — Needle attachment for non -absorbable sutures  
Gauge number  Limits on needle attachment  
Non-absorbable 
sutu res Average, min.  
kgf Individual, min.  
kgf Average, min.  
N Individual min.  
N 
0.1 0.007  0.005  0.069  0.049  
0.2 0.014  0.010  0.137  0.098  
0.3 0.021  0.015  0.206  0.147  
0.4 0.050  0.025  0.490  0.245  
0.5 0.080  0.040  0.784  0.392  
0.7 0.17 0.08 1.67 0.784  
1 0.23 0.11 2.25 1.08 
1.5 0.45 0.23 4.41 2.25 
2 0.68 0.34 6.67 3.33 
3 1.10 0.45 10.8 4.41 
3.5 1.50 0.45 14.7 4.41 
4 1.80 0.60 17.6 5.88 
5 and larger  1.80 0.70 17.6 6.86 
 
5.2.5.2 If sutures are supplied with removable needle, they shall comply with the requ irements given in 
table 4 when tested in accordance with Annex D.  
Table 4 — Removable needle attachment for non -absorbable sutures  
Gauge number  Limits on needle attachment  
Non-absorbable 
Sutures  Minimum  
kgf Maximum  
kgf Minimum  
N Maximum  
N 
1 0.028  1.59 0.274  15.6 
1.5 0.028  1.59 0.274  15.6 
2 0.028  1.59 0.274  15.6 
3 0.028  1.59 0.274  15.6 
3.5 0.028  1.59 0.274  15.6 
4 0.028  1.59 0.274  15.6 
5 0.028  1.59 0.274  15.6 
 
5.2.6 Extractable colour  
Dyed sutures shall be colour fast when tested in accordance with  Annex E.  DEAS 1019 -2: 2019  
6 © EAC 2019  – All rights reserved  
 5.2.7 Sterility  
It shall be sterile when tested in accordance with Annex F.  
6 Packaging  
6.1 The sterile sutures (dry or in fluid) shall be packed in sachets, packets or containers that maintain 
sterility until the container is opened and allows t he withdrawal and use of the suture in aseptic conditions.  
6.2 A number of sachets, packets or containers may be packaged in a box.  
7 Labelling  
7.1 The primary package of the suture shall be legibly and indelibly marked with the following information : 
a) name and physical address of manufacturer;  
b) name of the product;  
c) material of the suture;  
d) size of the suture;  
e) gauge number;  
f) structure (monofilament or multifilament);  
g) length of suture, in centimetres;  
h) sterile  (method of sterilization  shall be included ); 
i) if app ropriate, that the suture is coloured;  
j) batch number;  
k) type of needle if included , in accordance with DEAS 1018 ; 
l) number of sutures if multiple;  
m) Warnings, like “DO NOT RESTERILIZE. DISCARD OPEN UNUSED SUTURES. STORE AT ROOM 
TEMPERATURE. AVOID PROLONGED EXPOSU RE TO ELEVATED TEMPERATURES”; and  
n) date of manufacture ’  
o) date of expiry.  
7.2 If the sachets, packets or containers are packaged in boxes, the boxes shall be labelled with the 
following  
i) name and physical address of the manufacturer;  
ii) name of product;  
iii) compos ition of any packaging fluid if used;  
iv) batch number; and  DEAS 1019 -2: 2019  
© EAC 2019  – All rights reserved  7 
 v) whether sterile.  
NOTE  If the suture is packaged with a fluid, make sure that testing is done within 2 min after removing it from the 
fluid.  
8 Sampling  
Sampling shal l be done in accordance with ISO 241 53. DEAS 1019 -2: 2019  
8 © EAC 2019  – All rights reserved  
 Annex  A 
(normative)  
 
Identification of sutures  
A.1 Identification of silk  
A.1.1  Method A  
Dissect the end of a suture, using a needle or fine tweezers, to isolate a few individual fibres. The fibres are 
sometimes marked with very fine longitudinal stri ations parallel to the axis of the suture. Examine under a 
microscope . 
A.1.2  Method B  
Impregnate isolated fibres with iodinated potassium iodide solution R .  
A.2 Identification of linen  
A.2.1  Method A  
Dissect the end of a suture, using a needle or fine tw eezers, to isolate a few individual fibres. Examine under 
a microscope.  
A.2.2  Method B  
Impregnate isolated fibres with iodinated zinc chloride solution R.  
A.3 Identification of poly (ethyleneterephthalate)  
It is practically insoluble in most of the usual  organic solvents, but is attacked by strong alkaline solutions. It is 
incompatible with phenols.  
A.3.1  Method A  
Heat 50 mg in 50 ml of dimethylformamide R.  
A.3.2  Method B  
To about 50 mg add 10 ml of hydrochloric acid R1.  
A.4 Identification of polyamide -6  
It is practically insoluble in the usual organic solvents; it is not attacked by dilute alkaline solutions (for 
example a 100 g/l solution of sodium hydroxide R) but is attacked by dilute mineral acids (for example a 20 g/l 
solution of sulfuric acid R), by hot glacial acetic acid R and by a 70 % m/m solution of anhydrous formic acid 
R.  DEAS 1019 -2: 2019  
© EAC 2019  – All rights reserved  9 
 A.4.1  Method A  
Heat about 50 mg with 0.5 mL of hydrochloric acid R1 in a sealed glass tube at 110 °C for 18 h and allow to 
stand for 6 h.  
A.4.2  Method B  
Dissolve 50 mg in  20 mL of a 70 % m/m solution of anhydrous formic acid R.  
A.5 Identification of polyamide -6/6  
It is practically insoluble in the usual organic solvents; it is not attacked by dilute alkaline solutions (for 
example a 100 g/l solution of sodium hydroxide R)  but is attacked by dilute mineral acids (for example a 20 g/l 
solution of sulfuric acid R), by hot glacial acetic acid R and by an 80 per cent m/m solution of anhydrous 
formic acid R.  
A.5.1  Method A  
In contact with a flame  
A.5.2  Method B.  
Place about 50 mg in an ignition tube held vertically and heat gently until thick fumes are evolved. When the 
fumes fill the tube, withdraw it from the flame and insert a strip of nitrobenzaldehyde paper R.  
A.5.3  Method C  
To about 50 mg add 10 ml of hydrochloric acid R1 .  
A.5.4  Method D  
Dissolve 50 mg of sample in 20 ml of a 70 % m/m solution of anhydrous formic acid R and also in 20 ml of an 
80 % m/m solution of anhydrous formic acid R.  
A.6 Identification of polypropylene  
Polypropylene is soluble in decahydronaphthalen e, 1-chloronaphthalene and trichloroethylene. It is not soluble 
in alcohol, in ether and in cyclohexanone.   
A.6.1  Method A.  
It softens at temperatures between 160 °C and 170 °C.  
A.6.2  Method B  
To 0.25 g add 10 ml of toluene R  and boil under a reflux conde nser for about 15 min. Place a few drops of the 
solution on a disc of sodium chloride R  slide and evaporate the solvent in an oven at 80 °C. Examine by 
infrared absorption spectrophoto metry.  
A.6.3  Method C  
To 2 g add 100 m l of water R  and boil under a refl ux condenser for 2 h. Allow to cool. Determine  the relative 
density of the material using a hydrostatic balance.  DEAS 1019 -2: 2019  
10 © EAC 2019  – All rights reserved  
 A.7 Identification of stainless steel   
Stainless steel sutures shall be identified in accordance with ISO 5832 -1.  
A.8 Identification of poly ( vinylidene difluoride)   
It is soluble in warm dimethylformamide. It is insoluble in ethanol, hot and cold isopropyl alcohol, ethyl acetate, 
tetrachlorethylene .  
A.8.1  Method A  
A.8.1.1  Melts the strand between 170 °C and 180 °C.  
A.8.1.2  Place a small piece of suture on an annealed copper wire or sheet. Heat in an oxidizing flame.  
A.8.2  Method B  
Dissolve 0.25 g of the suture in 10 m l of dimethylformamide R  and boil under a reflux condenser for about 15 
min. Place a few drops of the solution on a sodium chlor ide R  slide and evaporate the solvent in an oven at 80 
°C (1 h). Examine by infrare d absorption spectrophotometry.  
A.8.3  Method C  
To 2 g of suture add 100 ml of water R and boil under a reflux condenser for 2 h. Allow to cool. Determine the 
relative densit y DEAS 1019 -2: 2019  
© EAC 2019  – All rights reserved  11 
 Annex  B 
(normative)  
 
Diameter of sutures  
B.1 Lay the strand across the center of the anvil and presser foot and gently lower the foot until its entire 
weight rests upon the suture Measure non -absorbable s utures whether packaged in dry form or in fluid 
immediately after removal from the container without drying or conditioning.  
B.2 Measure the diameter of the suture at three points corresponding roughly to one -fourth, one half and 
three fourths of its lengt h (see Table 2)  
B.3 In case of braided sutures of size larger than 3 -0 (metric size) make two measurements at each end 
point at right angles to each other and use the average as observed diameter at that point.  
B.4 In case of multifilament sutures, attach a portion of the designated section of the strand in affixed clamp 
in such a way that the strand lies across the centre of anvil. While holding the strand in the same plane as the 
surface of the anvil, place under tension by suitable means such as by passi ng the free end of the strand 
around a cylinder or pulley and attaching to the free end a weight of about one half of the knot pull limit . DEAS 1019 -2: 2019  
12 © EAC 2019  – All rights reserved  
 Annex  C 
(normative)  
 
Tensile strength  
C.1 Introduction  
The minimum breaking load is determined over a simple knot formed by placing one  end of a suture held in 
the right hand over the other end held in the left hand, passing one end over the suture and through the loop 
so formed (see Figure C.1) and pulling the knot tigh t.  
 
Figure C.1 — Simple knot  
C.2 Procedure  
C.2.1  Determine the tensile strength of a surgical suture on a motor -driven tensile strength testing machine 
having suitable clamps for holding the specimen firmly and using either the principle of constant rate  of load 
on specimen or the principle of constant rate of elongation of specimen, as described below.  
C.2.2  Gauge length is defined as the interior distance between the two clamps. For gauge lengths of 125 
mm to 200 mm, the mobile clamp is driven at a con stant rate of elongation of 30 cm/min ± 5 cm/min. For 
gauge lengths of less than 125 mm, the rate of elongation per minute is adjusted to equal two times the gauge 
length per minute. For example, a 5 -cm gauge length has a rate of elongation of 10 cm/min.  
C.2.3 Determine the tensile strength of the suture, whether packaged in dry form or in fluid, promptly after 
removal from the container, without prior drying or conditioning.  
C.2.4  Attach one end of the suture to the clamp at the load end of the machine, p ass the other end through 
the opposite clamp, applying sufficient tension so that the specimen is taut between the clamps, and engage 
the second clamp. Perform as many breaks as are specified in the individual monograph. If the break occurs 
at the clamp, d iscard the reading on the specimen.  DEAS 1019 -2: 2019  
© EAC 2019  – All rights reserved  13 
 Annex  D 
(normative)  
 
Needle attachment  
D.1 If the sutures are supplied with an eyeless needle attached that is not stated to be detachable, they 
comply with the test for needle attachment shown in Table 3 and for removable needle attachment, they shall 
comply with the table 4.  
D.2 Carry out the test on five sutures. Use a suitable tensilometer, such as that described for the 
determination of the minimum breaking load.  
D.3 Fix the needle and suture (without knot) in the clamps of the apparatus in such a way that the swaged 
part of the needle is completely free of the clamp and in line with the direction of pull on the suture.  
D.4 Set the mobile clamp in motion and note the  force required to break the suture or to detach it from the 
needle.  
D.5 The average of the five determinations and all individual values are not less than the respective values 
given in Table 3 and Table 4 for the gauge number concerned.  
D.6 If not more than one individual value fails to meet the individual requirement, repeat the test on an 
additional 10 sutures. The attachment complies with the test if none of these 10 values is less than the 
individual value in Table 3 and Table 4 for the gauge number concerned  DEAS 1019 -2: 2019  
14 © EAC 2019  – All rights reserved  
 Annex  E 
(normative)  
 
Extractable colours  
E.1 Place 0.25 g of the suture to be examined in a conical flask, add 25.0 ml of water R and cover the 
mouth of the flask with a short -stemmed funnel.  
E.2 Boil for 15 min, cool and adjust to the original volume with water R.  
E.3 Depending on the colour of the suture, prepare the appropriate reference solution as described in Table 
E.1 using the primary colour solutions. The test solution shall not be more i ntensely coloured than the 
appropriate reference solution.  
Table E.1 – Colour referencing solution  
Colour of strand  Composition of reference solution (parts by volume)  
Red primary solution  
 Yellow primary solution  
 Blue primary solution  Water Ra 
Yellow - brown  0.2 1.2 - 8.6 
Pink- red  1.0 - - 9.0 
Green -blue - - 2.0 8.0 
Violet  1.6 - 8.4 - 
a R implies water, Reagent grade or distilled water  DEAS 1019 -2: 2019  
© EAC 2019  – All rights reserved  15 
 Annex F  
(normative )  
 
Sterility test  
F1 Introduction  
The following culture media have been found to be suitable f or 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 bacteri a. 
F.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  
Pancrea tic 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  
F.2.1  Mix the L -cystine, agar, sodium chloride, glucose, water -soluble yeast extract and pancreatic digest of 
casein with the water R and heat until solution is effected.  
F.2.2  Dissolve the sodium thiogly collate or thioglycollic acid in the solution and, if necessary, add 1 M 
sodium hydroxide so that, after 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 throu gh moistened filter paper.  
F.2.3  Add the resazurin sodium solution, mix and place the medium in suitable 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 indica tive 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.  
F.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 contain er. 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.  DEAS 1019 -2: 2019  
16 © EAC 2019  – All rights reserved  
 F.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 it has been validated as described in growth promotion test.  
F.3 Alternative thioglycollate medium  
Where prescribed, justified and a uthorized, the following alternative thioglycollate medium may be used. 
Prepare a mixture having the same composition as that of the fluid thioglycollate medium, but omitting the 
agar and the resazurin sodium solution, sterilize as directed above. The pH a fter sterilization is 7.1 ± 0.2. Heat 
in a water -bath prior to use and incubate at 30 °C - 35 °C under anaerobic conditions.  
F.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  
F.4.1 Dissolve the solids in wate r 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.  
F.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 F.6, carried out before or in parallel with the test on 
the product to be examined.   
F.5 Sterility  
Incubate portions of the media for 14 day s. No growth of micro -organisms occurs.   
F.6 Growth Promotion Test of Aerobes, Anaerobes, and Fungi  
F.6.1  Test each lot of ready -prepared medium and each batch of medium prepared either from dehydrate d 
medium or from ingredients. Suitable strains of microo rganisms are indicated in Table F 1. 
F.6.2  Inoculate portions of Fluid Thioglycollate 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. FInoculate 
portions of alternative thioglycollate medium with a small number (not more than 100 cfu) of Clostridium 
sporogenes.F Inoculate portions of Soybean –Casein  DEAS 1019 -2: 2019  
© EAC 2019  – All rights reserved  17 
 F.6.3  Digest M edium 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 mo re than 3 days in the case of bacteria and not more 
than 5 days in the case of fungi.  
F.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 growth of the microorganisms occurs  
Table F1  —. Strains of the Test Microorganisms Suitable for Use in the Growth Promotion Test  
Test microorganisms  
Aerobic bacteria  Fungi  
Staphylococcus aureus  ATCC 6538, CIP 4.83,NCTC 10788, 
NCIMB 9518, NBRC 13276  Candida albicans   ATCC 10231, IP 48.72, 
NCPF 3179, NBRC 1594  DEAS 1019 -2: 2019  
18 © EAC 2019  – All rights reserved  
 Bibliography  
[1] British Pharmacopoeia, 2017,  published by The Stationery Office on behalf of the Medicines and 
Healthc are Products Regulatory Agency  
[2] ISO 11135 (both parts), Sterilization of health care products — Ethylene oxide  
[3] ISO 11137 (all parts), Sterilization of health care products — Radiation  
[4] ISO 17665 (all parts), Sterilization of health care products — Moist heat  
[5] US Pharmacopoeia  40 
[6] US 1958 -2:2019, Surgical sutures — Specification — Part 2: Non — absorbable  
 DEAS 1019 -2: 2019    
 
© EAC 2019 – All rights reserved  
  
  