legitimately discarded,is equal to or greater than the value given in column C in Table 0317.-1and no individual result is less than that given in column D for the gauge number concerned.
Figure 0317.-1.–Simple knot
Soluble chromium compounds .Place 0.25g in a conical flask containing 1mL of water R per 10mg of catgut.Stopper the flask,allow to stand at 37±0.5°C for 24h,cool and decant the liquid.Transfer 5mL to a small test tube and add 2mL of a 10g/L solution of diphenylcarbazide R in alcohol R and 2mL of dilute sulfuric acid R .The solution is not more intensely coloured than a standard prepared at the same time using 5mL of a solution containing 2.83μg of potassium dichromate R per millilitre,2mL of dilute sulfuric acid R and 2mL of a 10g/L solution of diphenylcarbazide R in alcohol R (1ppm of Cr).N
eedle attachment .If the catgut is supplied with an eyeless needle attached that is not stated to be detachable,it complies with the test for needle attachment.Carry out the test on 5sutures.Use a suitable tensilometer,such as that described for the determination of the minimum breaking load.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.Set the mobile clamp in motion and note the force required to break the suture or to detach it from the needle.The average of the 5determinations and all individual values are not less than the respective values given in Table 0317.-2for the gauge number concerned.If not more than one individual value fails to meet the individual requirement,repeat the test on an additional 10sutures.The catgut complies with the test if none of these 10values is less than the individual value in Table 0317.-2for the gauge number concerned.
Table 0317.-2.–Minimum Strengths of Needle Attachment
Gauge number
Mean value (newtons)Individual values (newtons)0.50.500.25
0.70.800.401 1.70.801.5 2.3 1.12 4.5 2.32.5 5.6 2.83 6.8 3.43.511.0 4.5415.0 4.55
18.0
6.0
STORAGE (PACKAGING)
Sterile catgut sutures are presented in individual sachets that 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,—name of the product,
—intended use (surgical suture,absorbable).
01/2008:0324
SUTURES,STERILE NON-ABSORBABLE
Fila non resorbilia sterilia
DEFINITION
Sterile non-absorbable sutures are sutures which,when
introduced into a living organism,are not metabolised by that organism.Sterile non-absorbable sutures vary in origin,which may be animal,vegetable,metallic or synthetic.They occur as cylindrical monofilaments or as multifilament sutures consisting of elementary fibres which are assembled by twisting,cabling or braiding;they may be sheathed;they may be treated to render them non-capillary,and they may be coloured.
Appropriate harmonised standards may be considered when assessing compliance with respect to origin and processing of raw materials and with respect to biocompatibility.
Sterile non-absorbable surgical sutures serve to approximate tissue during the healing period and provide continuing wound support.
Commonly used materials include the following:Silk (Filum bombycis)
Sterile braided silk suture is obtained by braiding a number of threads,according to the diameter required,of degummed silk obtained from the cocoons of the silkworm Bombyx mori L.Linen (Filum li
ni)
Sterile linen thread consists of the pericyclic fibres of the stem of Linum usitatissimum L.The elementary fibres,2.5cm to 5cm long,are assembled in bundles 30cm to 80cm long and spun into continuous lengths of suitable diameter.Poly(ethylene terephthalate)(Filum ethyleni polyterephthalici)
Sterile poly(ethylene terephthalate)suture is obtained by drawing poly(ethylene terephthalate)through a suitable die.The suture is prepared by braiding very fine filaments in suitable numbers,depending on the gauge required.Polyamide-6(Filum polyamidicum-6)
Sterile polyamide-6suture is obtained by drawing through a suitable die a synthetic plastic material formed by the polymerisation of ε-caprolactam.It consists of smooth,cylindrical monofilaments or braided filaments,or lightly twisted sutures sheathed with the same material.Polyamide-6/6(Filum polyamidicum-6/6)
Sterile polyamide-6/6suture is obtained by drawing through a suitable die a synthetic plastic material formed by the polycondensation of hexamethylenediamine and adipic acid.It consists of smooth,cylindrical monofilaments or braided filaments,or lightly twisted sutures sheathed with the same material.
Polypropylene(Filum polypropylenicum)
Polypropylene suture is obtained by drawing polypropylene through a suitable die.It consists of smooth cylindrical mono-filaments.
Monofilament and multifilament stainless steel(Filum aciei irrubiginibilis monofilamentum/multifilamentum)
Sterile stainless steel sutures have a chemical composition as specified in ISO5832-1-Metallic Materials for surgical implants -Part1:Specification for wrought stainless steel and comply with ISO10334-Implants for surgery-Malleable wires for use as sutures and other surgical applications.
Stainless steel sutures consist of smooth,cylindrical monofilaments or twisted filaments or braided filaments.
Poly(vinylidene difluoride)(PVDF)(Filum poly(vinylideni difluoridum))
Sterile PVDF suture is obtained by drawing through a suitable die a synthetic plastic material which is formed by polymerisation of1,1-difluorethylene.It consists of smooth cylindrical monofilaments.
IDENTIFICATION
Non-absorbable sutures may be identified by chemical tests. Materials from natural origin may also be identified by microscopic examination of the morphology of these fibres.For synthetic materials,identification by infrared spectrophotometry (2.2.24)or by differential scanning calorimetry may be applied. Identification of silk
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 striations parallel to
the axis of the suture.Examined under a microscope,a
cross-section is more or less triangular to semi-circular,with rounded edges and without a lumen.
B.Impregnate isolated fibres with iodinated potassium iodide
solution R.The fibres are coloured pale yellow. Identification of linen
A.Dissect the end of a suture,using a needle or fine tweezers,to
isolate a few individual fibres.Examined under a microscope, the fibres are seen to be12μm to31μm 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 point.Sometimes there are unilateral swellings with transverse lines.
B.Impregnate isolated fibres with iodinated zinc chloride
solution R.The fibres are coloured violet-blue. 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.50mg dissolves with difficulty when heated in50mL of
dimethylformamide R.
B.To about50mg add10mL of hydrochloric acid R1.The
material remains intact even after immersion for6h. Identification of polyamide-6
It is practically insoluble in the usual organic solvents;it is not attacked by dilute alkaline solutions(for example a100g/L solution of sodium hydroxide R)but is attacked by dilute mineral acids(for example a20g/L solution of sulfuric acid R), by hot glacial acetic acid R and by a70per cent m/m solution of anhydrous formic acid R.
A.Heat about50mg with0.5mL of hydrochloric acid R1in a
sealed glass tube at110°C for18h and allow to stand for 6h.No crystals appear.国际会计
B.50mg dissolves in20mL of a70per cent m/m solution of
anhydrous formic acid R.
Identification of polyamide-6/6
It is practically insoluble in the usual organic solvents;it is not attacked by dilute alkaline solutions(for example a100g/L solution of sodium hydroxide R)but is attacked by dilute mineral acids(for example a20g/L solution of sulfuric acid R), by hot glacial acetic acid R and by an80per cent m/m solution of anhydrous formic acid R.
A.In contact with a flame it melts and burns,forming a hard
globule of residue and gives off a characteristic odour
resembling that of celery.
B.Place about50mg 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 violet-brown colour slowly appears on the paper and fades slowly in air;it disappears almost immediately on washing with dilute sulfuric acid R.
C.To about50mg add10mL of hydrochloride acid R1.The
material disintegrates in the cold and dissolves within a few minutes.
D.50mg does not dissolve in20mL of a70per cent m/m
solution of anhydrous formic acid R but dissolves in20mL of an80per cent m/m solution of anhydrous formic acid R. Identification of polypropylene
Polypropylene is soluble in decahydronaphthalene,
1-chloronaphthalene and trichloroethylene.It is not soluble in alcohol,in ether and in cyclohexanone.
A.It softens at temperatures between160°C and170°C.
It burns with a blue flame giving off an odour of burning
paraffin wax and of octyl alcohol.
B.To0.25g add10mL of toluene R and boil under a reflux
condenser for about15min.Place a few drops of the solution on a disc of sodium chloride R slide and evaporate the
solvent in an oven at80°C.Examine by infrared absorption spectrophotometry(2.2.24),comparing with the spectrum obtained with polypropylene CRS.
C.To2g add100mL of water R and boil under a reflux
condenser for2h.Allow to cool.The relative density(2.2.5) of the material is0.89g/mL to0.91g/mL,deter
mined using
a hydrostatic balance.
Identification of stainless steel
Stainless steel sutures are identified by confirming that the composition is in accordance with ISO5832Part1. 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.The strand melts between170°C and180°C.It melts in a
flame and does not burn after removal of the flame.Place a small piece of suture on an annealed copper wire or sheet.
Heat in an oxidising flame.No green colour is produced. B.Dissolve0.25g of the suture in10mL of
dimethylformamide R and boil under a reflux
condenser for about15min.Place a few drops of the solution on a sodium chloride R slide and evaporate the solvent in an oven at80°C(1h).Examine by infrared absorption
spectrophotometry(2.2.24).The spectrum shows absorption maxima at the following wave-numbers:838.3±0.5cm−1, 873.3±1cm−1,1070.0±2cm−1,1165.0±10cm−1,
1275±0.5cm−1,1399±5cm−1.
C.To2g of suture add100mL of water R and boil under a
reflux condenser for2h.Allow to cool.The relative density
(2.2.5)of the material is1.71to1.78.
PRODUCTION
The appropriate harmonised standards may apply with respect to appropriate validated methods of sterilisation,environmental control during manufacturing,labelling and packaging.
It is essential for the effectiveness and the performance characteristics during use and during the functional lifetime
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of these sutures that the following physical properties are specified:consistent diameter,sufficient initial strength and firm needle attachment.
The requirements below have been established,taking into account stresses which occur during normal conditions of use.These requirements can be used to demonstrate that individual production batches of these sutures are suitable for wound closure in accordance with usual surgical techniques.
TESTS Remove the sutures from the sachet and measure promptly
and in succession the length,diameter and minimum load.
If linen is tested the sutures are conditioned as follows:if stored in the dry state,expose to an atmosp
here with a relative humidity of 65±5per cent at 20±2°C for 4h immediately before measuring the diameter and for the determination of minimum breaking load immerse in water R at room
temperature for 30min immediately before carrying out the test.Length .Measure the length without applying more tension than is necessary to keep them straight.The length of the suture is not less than 95per cent of the length stated on the label and does not exceed 400cm.Diameter .Unless otherwise prescribed,measure the diameter
by the following method using 5sutures.Use a suitable
mechanical instrument capable of measuring with an accuracy of at least 0.002mm and having a circular pressor foot 10-15mm in diameter.The pressor foot and the moving parts attached to it are weighted so as to apply a total load of 100±10g to the
suture being tested.When making the measurements,lower
the pressor foot slowly to avoid crushing the suture.Measure
the diameter at intervals of 30cm over the whole length of
the suture.For a suture less than 90cm in length,measure at
3points approximately evenly spaced along the suture.During the measurement submit monofilament sutures to a tension
the minimum breaking load shown in column C of Table 0324.-1appropriate to the gauge number and type of material concerned or 10N whichever is less.Stainless steel sutures do not require tension to be applied during the measurement of diameter.For multifilament sutures of gauge number above 1.5make 2measurements at each point,the second measurement being
made after rotating the suture through 90°.The diameter of
that point is the average of the 2measurements.The average 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 column under A in Table 0324.-1for the gauge number concerned.None of the measurements are outside the limits given in the columns under B in Table 0324.-1for the gauge number concerned.Minimum breaking load .Unless otherwise prescribed,
determine the minimum breaking load by the following method
using sutures in the condition in which they are presented.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 0324.-1)and pulling the knot tight.For stainless steel sutures gauges 3.5and above,the minimum breaking load is determined on a straight pull.Carry out the test on 5sutures.Submit sutures of length greater than 75cm to 2measurements and shorter
sutures to 1measurement.Determine the breaking load using a suitable tensilometer.The apparatus has 2clamps for holding the suture,1of which is mobile and is driven at a constant rate of 30cm/min.The clamps are designed so that the suture being tested can be attached without any possibility of slipping.At the beginning of the test the length of suture between the
clamps is 12.5cm to 20cm and the knot is midway between 0.050.0050.0090.0030.012--0.01-0.10.0100.0190.0050.025--0.03-0.150.0150.0190.0120.025--0.060.010.20.0200.0290.0150.035--0.1-0.30.0300.0390.0250.045--0.350.060.40.0400.0490.0350.060--0.600.15 1.10.50.0500.0690.0450.085-- 1.00.35 1.60.0700.0990.0600.125 1.00.3 1.50.60 2.70.1000.1490.0850.175 2.50.6 3.0 1.0 5.3 4.00.1500.1990.1250.225 5.0 1.0 5.0 1.58.0 6.020.2000.2490.1750.2758.0 2.59.0 3.013.310.02.50.2500.2990.2250.3259.0 5.013.0 5.015.511.630.3000.3490.2750.37511.08.015.09.017.713.33.50.3500.3990.3250.45015.09.022.013.033.425.040.4000.4990.3750.55018,011.027.015.046.735.050.5000.5990.4500.65026.015.035.022.057.943.460.6000.6990,.5500.75037.018.050.027.089.467.070.7000.7990.6500.85050.026.062.035.0111.883.980.8000.8990.7500.95065.0
37.0
73.0
50.0
133.4100.190.9000.9990.850 1.050156.0117.010
1.000
1.099
0.950
1.150
178.5
133.9
独览梅花扫
腊雪within1cm of it,the result is discarded and the test repeated on another suture.The average of all the results,excluding those legitimately discarded,is equal to or greater than the value given in column C in Table0324.-1and no value is less than that given in column D for the gauge number and typeof material
concerned.
Figure0324.-1.–Simple knot
Needle attachment.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.Carry out the test on
5sutures.Use a suitable tensilometer,such as that described for the determination of the minimum breaking load.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.Set the mobile clamp in motion and note the force required to break the suture or to de
tach it from the needle. The average of the5determinations and all individual values are not less than the respective values given in Table0324.-2for the gauge number concerned.If not more than1individual value fails to meet the individual requirement,repeat the test on an additional10sutures.The attachment complies with the test if none of these10values is less than the individual value in Table0324.-2for the gauge number concerned.
Table0324.-2.–Minimum strengths of needle attachment
Gauge number Mean value
(newtons)Individual value (newtons)
0.40.500.25
0.50.800.40
0.7 1.70.80
1 2.3 1.1
1.5 4.5
2.3
2 6.8 3.4
2.59.0 4.5
311.0 4.5
3.515.0
4.5
418.0 6.0
518.07.0
625.012.5
725.012.5
850.025
950.025
1075.037.5 Extractable colour.Sutures that are dyed and intended to remain so during use comply with the test for extractable colour. Place0.25g of the suture to be examined in a conical flask,add 25.0mL of water R and cover the mouth of the flask with a short-stemmed funnel.Boil for15min,cool and adjust to the original volume with water R.Depending on the colour of the suture,prepare the appropriate reference solution as described in Table0324.-3using the primary colour solutions(2.2.2). The test solution is not more intensely coloured than the appropriate reference solution.
Table0324.-3.–Colour reference solutions Colour of
strand
Composition of reference solution
(parts by volume)
Red
primary
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solution
Yellow
primary
solution
Blue
primary
solution
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条例实施细则
Water R Yellow-brown0.2 1.28.6 Pink-red 1.0--9.0 Green-blue-- 2.08.0 Violet 1.6-8.4-Monomer and oligomers.Polyamide-6suture additionally complies with the following test for monomer and oligomers.In a continuous-extraction apparatus,treat1.00g with30mL of methanol R at a rate of at least3extractions per hour for7h. Evaporate the extract to dryness,dry the residue at110°C for 10min,allow to cool in a desiccator and weigh.The residue weighs not more than20mg(2per cent).
STORAGE(PACKAGING)
Sterile non-absorbable sutures are presented in a suitable sachet that maintains sterility and allows the withdrawal and use of a suture in aseptic conditions.They may be stored dry or in a preserving liquid to which an antimicrobial agent but no antibiotic may be added.
Sterile non-absorbable sutures are intended to be used only on the occasion when the sachet is first opened.
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 in addition. LABELLING
Reference may be made to the appropriate harmonised standards for the 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,
—name of the product,
—intended use(surgical suture,non-absorbable),
—if appropriate,that the suture is coloured,
—if appropriate,the structure(braided,monofilament, sheathed).
01/2008:0667 SUTURES,STERILE SYNTHETIC
ABSORBABLE BRAIDED
Fila resorbilia synthetica torta sterilia DEFINITION
Sterile synthetic absorbable braided sutures consist of sutures prepared from a synthetic polymer,polymers or copolymers which,when introduced into a living organism,are absorbed by that organism and cause no undue tissue irritation.They consist of completely polymerised material.They occur as
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