EUROPEAN PHARMACOPOEIA 11.

0 Catgut, sterile

04/2020:90004 Diameter. Carry out the test on 5 sutures. Use a suitable

instrument capable of measuring with an accuracy of at least
0.002 mm and having a circular pressor foot 10 mm to 15 mm
in diameter. The pressor foot and the moving parts attached
to it are weighted so as to apply a total load of 100 ± 10 g to
the suture being tested. When making the measurement,
SUTURES FOR HUMAN USE : lower the pressor foot slowly to avoid crushing the suture.
INTRODUCTION Measure the diameter at intervals of 30 cm over the whole
length of the suture. For a suture less than 90 cm in length,
Sutures for human use are medical devices as defined in measure at 3 points approximately evenly spaced along the
Regulation (EU) 2017/745 and any subsequent amendments. suture. The suture is not subjected to more tension than is
Monographs can be applied to show compliance with certain necessary to keep it straight during measurement. The average
requirements therein. of the measurements carried out on the sutures being tested
and not less than two-thirds of the measurements taken on
each suture are within the limits given in the columns under A
01/2008:0317 in Table 0317.-1 for the gauge number concerned. None of
the measurements is outside the limits given in the columns
under B in Table 0317.-1 for the gauge number concerned.

Table 0317.-1. – Diameters and Breaking Loads

CATGUT, STERILE Diameter Breaking load
(millimetres) (newtons)
Chorda resorbilis sterilis Gauge
number A B C D
DEFINITION min. max. min. max.
Sterile catgut consists of sutures prepared from collagen taken 0.1 0.010 0.019 0.005 0.025 - -
from the intestinal membranes of mammals. After cleaning,
0.2 0.020 0.029 0.015 0.035 - -
the membranes are split longitudinally into strips of varying
width, which, when assembled in small numbers, according 0.3 0.030 0.039 0.025 0.045 0.20 0.05
to the diameter required, are twisted under tension, dried,
polished, selected and sterilised. The sutures may be treated 0.4 0.040 0.049 0.035 0.060 0.30 0.10
with chemical substances such as chromium salts to prolong 0.5 0.050 0.069 0.045 0.085 0.40 0.20
absorption and glycerol to make them supple, provided such
substances do not reduce tissue acceptability. 0.7 0.070 0.099 0.060 0.125 0.70 0.30
Appropriate harmonised standards may be considered when 1 0.100 0.149 0.085 0.175 1.8 0.40
assessing compliance with respect to origin and processing of
1.5 0.150 0.199 0.125 0.225 3.8 0.70
raw materials and with respect to biocompatibility.
Sterile catgut is a surgical wound-closure device. Being an 2 0.200 0.249 0.175 0.275 7.5 1.8
absorbable suture it serves to approximate tissue during the 2.5 0.250 0.299 0.225 0.325 10 3.8
healing period and is subsequently metabolised by proteolytic
activity. 3 0.300 0.349 0.275 0.375 12.5 7.5

PRODUCTION 3.5 0.350 0.399 0.325 0.450 20 10

Production complies with relevant regulations on the use of 4 0.400 0.499 0.375 0.550 27.5 12.5
animal tissues in medical devices notably concerning the risk 5 0.500 0.599 0.450 0.650 38.0 20.0
of transmission of animal spongiform encephalopathy agents.
Appropriate harmonised standards may apply with respect to 6 0.600 0.699 0.550 0.750 45.0 27.5
appropriate validated methods of sterilisation, environmental 7 0.700 0.799 0.650 0.850 60.0 38.0
control during manufacturing, labelling and packaging.
8 0.800 0.899 0.750 0.950 70.0 45.0
It is essential for the effectiveness and the performance
characteristics during use and during the functional lifetime
of catgut that the following physical properties are specified :
consistent diameter, sufficient initial strength and firm needle
Minimum breaking load. The minimum breaking load is
attachment.
determined over a simple knot formed by placing one end
The requirements outlined below have been established, taking of a suture held in the right hand over the other end held in
into account stresses which occur during normal conditions the left hand, passing one end over the suture and through
of use. These requirements can be used to demonstrate that the loop so formed (see Figure 0317.-1) and pulling the knot
individual production batches of sterile catgut are suitable for tight. Carry out the test on 5 sutures. Submit sutures of
wound closure according to usual surgical techniques. length greater than 75 cm to 2 measurements and shorter
TESTS sutures to one measurement. Determine the breaking load
using a suitable tensilometer. The apparatus has 2 clamps for
If stored in a preserving liquid, remove the sutures from the holding the suture, one of which is mobile and is driven at a
sachet and measure promptly and in succession the length, constant rate of 30 cm/min. The clamps are designed so that
diameter and breaking load. If stored in the dry state, immerse the suture being tested can be attached without any possibility
the sutures in alcohol R or a 90 per cent V/V solution of of slipping. At the beginning of the test the length of suture
2-propanol R for 24 h and proceed with the measurements as between the clamps is 12.5 cm to 20 cm and the knot is
indicated below. midway between the clamps. Set the mobile clamp in motion
Length. Measure the length without applying to the suture and note the force required to break the suture. If the suture
more tension than is necessary to keep it straight. The length breaks in a clamp or within 1 cm of it, the result is discarded
of each suture is not less than 90 per cent of the length stated and the test repeated on another suture. The average of all the
on the label and does not exceed 350 cm. results, excluding those legitimately discarded, is equal to or

General Notices (1) apply to all monographs and other texts 1339
Sutures, sterile non-absorbable EUROPEAN PHARMACOPOEIA 11.0

greater than the value given in column C in Table 0317.-1 and STORAGE (PACKAGING)
no individual result is less than that given in column D for Sterile catgut sutures are presented in individual sachets that
the gauge number concerned. maintain sterility and allow the withdrawal and use of the
sutures in aseptic conditions. Sterile catgut may be stored dry
or in a preserving liquid to which an antimicrobial agent but
not an antibiotic may be added.
Sutures in their individual sachets (primary packaging) are
kept in a protective cover (box) which maintains the physical
and mechanical properties until the time of use.
The application of appropriate harmonised standards for
packaging of medical devices shall be considered.
LABELLING
Reference may be made to the appropriate harmonised
standards for labelling of medical devices.
The details strictly necessary for the user to identify the
product properly are indicated on or in each sachet (primary
packaging) and on the protective cover (box) and include at
least :
– gauge number,
– length in centimetres or metres,
– if appropriate, that the needle is detachable,
Figure 0317.-1. – Simple knot – name of the product,
Soluble chromium compounds. Place 0.25 g in a conical – intended use (surgical suture, absorbable).
flask containing 1 mL of water R per 10 mg of catgut. Stopper
the flask, allow to stand at 37 ± 0.5 °C for 24 h, cool and decant 07/2018:0324
the liquid. Transfer 5 mL to a small test tube and add 2 mL of corrected 10.0
a 10 g/L solution of diphenylcarbazide R in alcohol R and 2 mL
of dilute sulfuric acid R. The solution is not more intensely
coloured than a standard prepared at the same time using 5 mL
of a solution containing 2.83 μg of potassium dichromate R per
millilitre, 2 mL of dilute sulfuric acid R and 2 mL of a 10 g/L
solution of diphenylcarbazide R in alcohol R (1 ppm of Cr). SUTURES, STERILE NON-
Needle attachment. If the catgut is supplied with an eyeless ABSORBABLE
needle attached that is not stated to be detachable, it complies
with the test for needle attachment. Carry out the test on Fila non resorbilia sterilia
5 sutures. Use a suitable tensilometer, such as that described
DEFINITION
for the determination of the minimum breaking load. Fix
the needle and suture (without knot) in the clamps of the Sterile non-absorbable sutures are sutures that, when
apparatus in such a way that the swaged part of the needle is introduced into a living organism, are not metabolised by
completely free of the clamp and in line with the direction that organism. Sterile non-absorbable sutures vary in origin,
of pull on the suture. Set the mobile clamp in motion and which may be animal, vegetable, metallic or synthetic. They
note the force required to break the suture or to detach it occur as cylindrical monofilaments or as multifilament sutures
from the needle. The average of the 5 determinations and consisting of elementary fibres that are assembled by twisting,
all individual values are not less than the respective values cabling or braiding ; they may be sheathed ; they may be
given in Table 0317.-2 for the gauge number concerned. If not treated to render them non-capillary ; they may be coloured.
more than one individual value fails to meet the individual Appropriate harmonised standards may be considered when
requirement, repeat the test on an additional 10 sutures. The assessing compliance with respect to origin and processing of
catgut complies with the test if none of these 10 values is raw materials and with respect to biocompatibility.
less than the individual value in Table 0317.-2 for the gauge Sterile non-absorbable surgical sutures serve to approximate
number concerned. tissue during the healing period and provide continuing
wound support.
Table 0317.-2. – Minimum Strengths of Needle Attachment The following materials are frequently used, as well as blends
thereof, as blends of synthetic materials are common.
Gauge number Mean value Individual values
(newtons) (newtons) Silk (Filum bombycis)
0.5 0.50 0.25 Sterile braided silk suture is obtained by braiding a number of
0.7 0.80 0.40
threads, according to the diameter required, of degummed silk
obtained from the cocoons of the silkworm Bombyx mori L.
1 1.7 0.80
Linen (Filum lini)
1.5 2.3 1.1 Sterile linen thread consists of the pericyclic fibres of the stem
2 4.5 2.3
of Linum usitatissimum L. The elementary fibres, 2.5-5 cm
long, are assembled in bundles 30-80 cm long and spun into
2.5 5.6 2.8 continuous lengths of suitable diameter.
3 6.8 3.4 Poly(ethylene terephthalate) (Filum ethyleni
polyterephthalici)
3.5 11.0 4.5
Sterile poly(ethylene terephthalate) suture is obtained by
4 15.0 4.5 drawing poly(ethylene terephthalate) through a suitable die.
5 18.0 6.0 The suture is prepared by braiding very fine filaments in
suitable numbers, depending on the gauge required.

1340 See the information section on general monographs (cover pages)