PUBLIC REVIEW DRAFT DRAFT UGANDA STANDARD  
  DUS DEAS  1019 -1 
First  Edition  
2019-mm-dd 
 
 Reference number  
DUS DEAS  1019 -1: 2019 
© UNBS 2019 
   
Surgical sutures — Specification — Part 1: Absorbable   
 
 PUBLIC REVIEW DRAFTDUS DEAS 1019-1: 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 
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 PUBLIC REVIEW DRAFTDUS DEAS 1019-1 : 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 1019-1: 2019 , Surgical sutures — Specification — Part 1: 
Absorbable , is identical with and has been reproduced from an East African Standard, DEAS 1019-1 : 2019, 
Surgical sutures — Specification — Part 1: Absorbable , 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 1019 -1: 2019  
ICS 11.040.30  
 
© EAC 2019                                                                                                                               1st Edition 2019   
 DRAFT EAST AFRICAN STANDARD  
Surgical sutures — Specification — Part 1: Absorbable  
EAST AFRICAN COMMUNITY  DEAS 1019 -1: 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 develop ment process is permitted without prior permission from EAC, 
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© East African Community  2019  — All rights reserved  
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Reproduction for sales purposes may be subject to royalty payments or a licensing agreement.  
Violators may be prosecuted . 
 DEAS 1019 -1: 2019  
© EAC 2019  – All rights reserved  iii 
 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 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 
Standards Bodies in Partner States, together with the represe ntatives 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 government, academia, consumer groups, private sector and o ther 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 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 lat est 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 su bject of patent 
rights. EAC shall not be held responsible for identifying any or all such patent rights. . 
DEAS 1019 : 2019  consists  of the following parts, under the general title Surgical sutures — Specification : 
Part 1: Surgical sutures — Specifi cation — Part 1: Absorbable  
Part 2: Surgical sutures — Specification — Part 2: Non Absorbable  DEAS 1019 -1: 2019  
iv © EAC  2019  – All rights reserved  
 Introduction  
Surgical sutures are used in a variety of different surgical procedures to close wounds and aid in tissue 
healing. These sutures may be a single fi lament 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 -1: 2019  
 
© EAC 2019  – All right s reserved  1 
 Surgical sutures — Specification — Part 1: Absorbable  
1 Scope   
This Draft East African Standard specifies the requirements, sampling and test methods for absorbable 
surgical sutures.  
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.  
ISO 10993 (all parts), Biological evaluation of medical devices  
ISO 24153 — Random sampling and randomisation procedures   
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 addr esses:  
— ISO Online browsing platform: available at http://www.iso.org/obp  
3.1 
absorbable sutures  
sutures capable of being absorbed by living animal tissues  during the healing process  
3.2  
monofilament  
suture  made of a single strand  
3.3  
multifilament  
suture composed of several filaments twisted or braided together  
3.4 
surgical sutures  
medical devices that are used to hold /appose  body tissues together after a surgery or injury  
4 Types  
Absorbable sutures  shall include the following types:  
a) natural absorbable sutures, prepared from collagen derived from healthy mammals. Natural 
absorbable sutures are categorized into two:  DEAS 1019 -1: 2019  
2 © EAC 2019  – All rights reserved  
 • plain; and  
• chromic gut;  
b) synthetic absorbable sutures, prepared from a synthetic polymer, polymers o r copolymers which, 
when introduced into a living organism, are absorbed by that organism and cause no undue tissue 
irritation. They consist of completely polymerized material.  
5 Requirements  
5.1 General requirements  
5.1.1 The suture shall either be monofi lament or multifilament. If multifilament, the individual filament may be 
combined by spinning, twisting, braiding or any combination.  
5.1.2 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 Length  
The length  of the suture without stretching shall be  not less than 95 % of the leng th stated on the label  and 
shall not  exceed 400 cm . 
5.2.3 Diameter  
5.2.3.1 Collagen suture  
When determined in accordance with  Annex A, the average diameter, and not fewer than 20, of the 30 
measurements on the 10 -strand sample s hall be  within the limits on  the average diameter prescribed in  Table  
1. None of the individual measurements s hall be  less than the midpoint of the range for the next smaller size 
or more than the midpoint of the range for the next larger size.  
5.2.3.2 Synthetic suture  
When determine d in accordance with Annex A,  the average diameter of the strands being measured s hall be  
within the tolerances prescribed in  Table 2 . None of the ob served measurements s hall be  less than the 
midpoint of the range for the next smaller size or more than the midpoint of the range for the next larger size.  DEAS 1019 -1: 2019  
© EAC 2019  – All rights reserved  3 
 Table 1 — Diameter and tensile strength of natural (collagen) sutures  
USP size  Gauge 
number 
(Metric  
size)  Limits on average 
diameter  
Mm Knot pull tensile strength , 
min. 
kgf Knot pull tensile strength , 
min. 
N 
Minimum  Maximum  Limit on 
average  Limit on 
individual 
strand  Limit on 
average  Limit on 
individual 
strand  
9-0 0.4 0.040  0.049  - - - - 
8-0 0.5 0.050 0.069  0.045  0.025  0.44 0.24 
7-0 0.7 0.070  0.099  0.07 0.055  0.69 0.54 
6-0 1 0.10 0.149  0.18 0.10 1.76 0.98 
5-0 1.5 0.15 0.199  0.38 0.20 3.73 1.96 
4-0 2 0.20 0.249  0.77 0.40 7.55 3.92 
3-0 3 0.30 0.339  1.25 0.68 12.2 6.67 
2-0 3.5 0.35 0.399  2.00 1.04 19.6 10.2 
0 4 0.40 0.499  2.77 1.45 27.2 14.2 
1 5 0.50 0.599  3.80 1.95 37.3 19.1 
2 6 0.60 0.699  4.51 2.40 44.2 25.5 
3 7 0.70 0.799  5.90 2.99 57.8 29.3 
4 8 0.80 0.899  7.00 3.49 68.6 34.2 
Table 2 — Diameter and tensile strength of synthetic suture s 
USP size,  
Min. Gauge 
number 
(Metric size)  Limits on average diameter  
Mm Knot -pull tensile (except 
where  strength otherwise 
specified)* Limit on 
average , min.  
kgf Knot -pull tensile 
strength (except where 
otherwise specified)   
N Minimum  Maximum  
12-0 0.01 0.001  0.009  - - 
11-0 0.1 0.010  0.019  - - 
10-0 0.2 0.020  0.029 * 0.025  0.24*  
9-0 0.3 0.030  0.039  0.050*  0.49*  
8-0 0.4 0.040  0.049  0.07 0.69 
7-0 0.5 0.050  0.069  0.14 1.37 
6-0 0.7 0.070  0.099  0.25 2.45 
5-0 1 0.10 0.149  0.68 6.67 
4-0 1.5 0.15 0.199  0.95 9.32 
3-0 2 0.20 0.249  1.77 17.4 
2-0 3 0.30 0.339  2.68 26.3 
0 3.5 0.35 0.399  3.90 38.2 
1 4 0.40 0.499  5.08 49.8 
2 5 0.50 0.599  6.35 62.3 
3 and 4  6 0.60 0.699  7.29 71.5 DEAS 1019 -1: 2019  
4 © EAC 2019  – All rights reserved  
 5 7 0.70 0.799  - - 
 
5.3 Minimum breaking load (tensile strength)  
5.3.1 Colla gen suture  
When determine on not fewer t han 10 strands of suture as prescribed in Annex B, the tensile strength, 
determined as the minimum strength for each individual strand tested, and calculated as the average strength 
from any one lot, shall be as give n in Table 1 . If not more than one strand fails to meet the limit on individual 
strands, repeat the test with not fewer than 20 additional strands: t he requirements of the test are met if none 
of the additional strands falls below the limit on individual strands, and if the average strength of all the strands 
tested does not fall below the stated limit in  Table 1 . 
5.3.2 Synthetic suture  
When determined on not fewer than 10 strands of suture in accordance with Annex B,  the minimum tensile 
strength of each size of synthetic suture, calculated as the average strength from any one lot, shall be as 
given  in Table 2 . 
5.4 Needle attachment  
5.4.1 If the sutures are supplied with an eyeless needle atta ched that is not stated to be detachable, they 
shall comply with the  requirements given in Table 3 when  tested for needle attachment  as prescribed in annex 
C. 
5.4.2 If sutures are supplied with removable needle, they shall comply with the requirements give n in Table 
4 when tested in accordance with Annex C.  
Table 3 — Needle attachment for absorbable suture s 
Gauge number  Limits on needle attachment , min.  
Natural  (collagen) 
absorbable suture  Synthetic 
absorbable 
sutures  Average  
kgf Individual  
Kgf Average  
N Individual  
N 
- 0.1 0.007  0.005  0.069  0.049  
- 0.2 0.014  0.010  0.137  0.098  
0.4 0.3 0.021  0.015  0.206  0.147  
0.5 0.4 0.050  0.025  0.490  0.245  
0.7 0.5 0.080  0.040  0.784  0.392  
1 0.7 0.17 0.08 1.67 0.784  
1.5 1 0.23 0.11 2.25 1.08 
2 1.5 0.45 0.23 4.41 2.25 
3 2 0.68 0.34 6.67 3.33 
3.5 3 1.10 0.45 10.8 4.41 
4 3.5 1.50 0.45 14.7 4.41 
5 4 1.80 0.60 17.6 5.88 
6 and larger  5 and larger  1.80 0.70 17.6 6.86 DEAS 1019 -1: 2019  
© EAC 2019  – All rights reserved  5 
 Table 4 — Removable needle attachment for absorbable sutures  
Gauge number  Limits on needle attachment  
Natural (collagen) 
absorbable suture  Synthetic absorbable 
sutures  Minimum  
Kgf Maximum  
kgf Minimum  
N Maximum  
N 
1.5 1 0.028  1.59 0.274  15.6 
2 1.5 0.028  1.59 0.274  15.6 
3 2 0.028  1.59 0.274  15.6 
3.5 3 0.028  1.59 0.274  15.6 
4 3.5 0.028  1.59 0.274  15.6 
5 4 0.028  1.59 0.274  15.6 
6 5 0.028  1.59 0.274  15.6 
 
5.5 Extractable colour  
Dyed sutures shall be colour fast when tested in accordance with Annex D.  
5.6 Sterility  
It shall be sterile when tested in accordance with Annex E.  
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 the 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) size of the suture  (gauge number);  
d) material and comp osition,  
e) type of suture (absorbable);  
f) structure (monofilament, or multifilament);  
g) length of suture, in centimetres;  
h) if appropriate, that the suture is coloured;  
i) batch number;  DEAS 1019 -1: 2019  
6 © EAC 2019  – All rights reserved  
 j) absorption time;  
k) sterile;  
l) kind of needle if included;  
m) warnings, like “DO NOT RE -STERILIZE. DISCARD OPEN UNUSED SUTURES. STORE AT ROOM 
TEMPERATURE. AVOID PROLONGED EXPOSURE TO ELEVATED TEMPERATURES”; and  
n) date of manufacture and  
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) type of suture (absorbable);  
iv) structure (monofilament or multifilament);  
v) composition of any packaging fluid, if used;  
vi) batch number; and  
vii) sterile  
NOTE  If the suture is pack aged with a fluid, make sure that testing is done within 2 min after removing it from the 
fluid.  
8 Sampling  
Sampling sha ll be done in accordance with  ISO 24153.  DEAS 1019 -1: 2019  
© EAC 2019  – All rights reserved  7 
 Annex  A 
(normative)  
 
Diameter of sutures  
A.1 Introduction  
The gauge for determining the diame ter of the suture is of the dead -weight type, mechanical or electrical, and 
equipped with a direct -reading dial, a digital readout, or a printed readout. Use a gauge graduated to 0.002 
mm or smaller. The anvil of the gauge is about 50 mm in diameter, and t he presser foot is 12.70  mm ± 0.02 
mm in diameter. The presser foot and moving parts connected therewith are weighted so as to apply a total 
load of 210  g ± 3 g to the specimen. The presser foot and anvil surfaces are plane to within 0.005 mm and 
parallel to each other to within 0.005 mm . For measuring the diameter of metric size 0.4 and smaller, remove 
the additional weight from the presser foot so that the total load on the suture does not exceed 60 g.  
A.2 Procedure  
A.2.1  Natural (collagen) absorbable sut ures  
A.2.1.1  Carry out the test on 10 sutures . Determine the diameter immediately after removal from the 
container or packet and without stretching.  
A.2.1.2  Lay the strand across the centre of the anvil and the pressor foot, and gently lower the foot unti l 
its entire weight rests upon the suture  
A.2.1.3  Lower the pressor foot slowly to avoid crushing the suture. Measure the diameter at three points 
along the suture strand at intervals of 30 cm over the whole length of the suture.  
A.2.1.4  For a suture less  than 90 cm in length, measure at three points approximately evenly spaced 
along the suture.  The suture is not subjected to more tension than is necessary to keep it straight during 
measurement.  
A.2.2  Synthetic absorbable sutures  
A.2.2.1 Lay the strand acr oss the center of the anvil and presser foot, and gently lower the foot until its 
entire weight rests upon the suture.  
A.2.2.2 Measure the diameter of the suture at three points corresponding roughly to one -fourth, one -half, 
and three -fourths of its lengt h. In the case of braided suture of sizes larger than 3 -0 (metric size 2), make two 
measurements at each point at right angles to each other, and use the average as the observed diameter at 
that point.  
A.2.2.3 In measuring multifilament, attach a portion o f the designated section of the strand in a fixed clamp in 
such a way that the strand lies across the center of the anvil. While holding the strand in the same plane as 
the surface of the anvil, place the strand under tension by suitable means, taking care  not to permit the strand, 
if twisted, to untwist. Measure the diameter at the designated points on the strand, and calculate the average 
diameter . DEAS 1019 -1: 2019  
8 © EAC 2019  – All rights reserved  
 Annex  B 
(normative)  
 
Minimum breaking load  
B.1 Introductio n 
Carry out the test on five sutures. 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 B.1) and pulling the knot tight.  
 
Figure B.1 — Simple knot  
B.2 Collagen absorbable sutures  
Refer to Table 1 for breaking load.  
B.3 Synthetic absorbable sutures  
Refer to Table 2  for breaking load . 
B.4 Procedure  
B.4.1  Determine the tensi le 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 o f specimen, as described below.  
B.4.2  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 constant 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. 
B.4.3  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.  
B.4.4  Attach one end of the suture to the clamp at the load end of the machine, pass the other end through 
the opposite clamp, applying sufficient tens ion 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, discard the reading on the specimen.  
 DEAS 1019 -1: 2019  
© EAC 2019  – All rights reserved  9 
 Annex  C 
(normative)  
 
Needle attachment  
C.1 If the sutures are supplied with an eyeless needle attached that is not stated to be detachable, they 
shall comply with the requirements given  in Table 3 for needle attachment  and for removable ne edle 
attachment, they shall comply with the Table 4 . 
C.2 Carry out the test on five sutures. Use a suitable tensilometer, such as that described for the 
determination of the minimum breaking load.  
C.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.  
C.4 Set the mobile clamp in motion and note the force required to break the suture or to detach it fro m the 
needle.  
C.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.  
C.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 -1: 2019  
10 © EAC 2019  – All rights reserved  
 Annex  D 
(normative)  
 
Extractable colours  
D.1 Prepare the matching solution that corresponds to the extractable colour of the suture by combing the 
colorimetric solutions in the proportions indicated in Table D .1 and adding water, if necessary to make 10.0 
parts.  
D.2 Place 0.25 g o f suture in a conical flask containing 1.0 ml of water for each 10 mg of the sample. Close 
the flask, and allow it to stand at 37  ° ± 0.5° for 24 h.  
D.3 Cool, decant the water from the suture, and compare it with the matching solution ; any colour present is 
not more intense than that of the appropriate matching solution . 
Table D.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 -1: 2019  
© EAC 2019  – All rights reserved  11 
 Annex E  
(normative)  
 
Sterility test  
E.1 Introduction  
The following culture media have been found to be s uitable 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 aerobi c bacteria.  
E.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  
E.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.  
E.2.2  Dissolve the sodiu m thioglycollate 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 through moistened filter paper.  
E.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 chan ge indicative 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.  
E.2.4  If more than the upper one -third of th e 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 th e 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.  DEAS 1019 -1: 2019  
12 © EAC 2019  – All rights reserved  
 E.2.5  For products containing a mercurial preservative that cannot be tested by the membrane -filtratio n 
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 the growth promotion test.  
E.3 Alternative thioglycollate medium  
Where prescribed, justified and authorized, 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 after sterilization is 7.1 ± 0.2. Heat 
in a water -bath prior to use and incubate at 30 °C - 35 °C under anaerobic conditions.  
E.4 Soya -bean casein digest medium  
Pancreatic digest of casein                  17.0 g  
Papaic digest of soya -bean m eal               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  
E.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.  
E.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.  
E.5 Sterility  
Incubate portions of the media for 14 days. No growth of micro -organisms occurs.  
E.6 Growth Promotion Test of Aerobes, Anaerobes, and Fungi  
E.6.1  Test each lot of ready -prepared medium and each batch of medium prepared either from dehydrated 
medium or from ingredi ents.   Suitable strains of microorganisms are indicated in Table E1.  
E.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 fo llowing 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 -1: 2019  
© EAC 2019  – All rights reserved  13 
 E.6.3  Digest 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: Aspergillus brasiliensis, 
Bacillus subtilis, and Can dida albicans. Incubate for not more than 3 days in the case of bacteria and not more 
than 5 days in the case of fungi.  
E.6.4  Seed lot culture maintenance techniques (seed -lot systems) are used so that the viable 
microorganisms used for inoculation are no t 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 E1 —. Strains of the Test Microorganisms Suitable for Use in the Growth Promotion Test  
Test Microorga nisms  
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 -1: 2019  
14 © EAC 2019  – All rights reserved  
 Bibliography  
[1] British Pharmacopoeia , 2017  
[2] ISO 11135:2014, Sterilization of heal th care products — Ethylene oxide  
[3] ISO 11137 -1:2006, Sterilization of health care products -- Radiation -- Part 1: Requirements for 
development, validation and routine control of a sterilization process for medical devices   
[4] ISO 11137 -2:2013, Sterili zation of health care products -- Radiation -- Part 2: Establishing the 
sterilization dose  
[5] ISO 11137 -3:2017, Sterilization of health care products -- Radiation -- Part 3: Guidance on dosimetric 
aspects of development, validation and routine control  
[6] ISO 17665 -1:2006, Sterilization of health care products -- Moist heat -- Part 1: Requirements for the 
development, validation and routine control of a sterilization process for medical devices  
[7] ISO/TS 17665 -2:2009, Sterilization of health care products  -- Moist heat -- Part 2: Guidance on the 
application of ISO 17665 -1 
[8] ISO 11138 -3:2017, Sterilization of health care products -- Biological indicators -- Part 3: Biological 
indicators for moist heat sterilization processes  
[9] US Pharmacopoeia 40, 201 9 
[10] US 1958 -1:2019, Surgical sutures — Specification — Part 1: Absorbable  
 DEAS 1019 -1: 2019    
 
© EAC 2019 – All rights reserved