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Therapeutic Goods Order No. 49

General standard for sutures

Published in the Commonwealth of Australia Gazette, 15 February 1995

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COMMONWEALTH OF AUSTRALIA

Therapeutic Goods Act 1989

THERAPEUTIC GOODS ORDER NO. 49

General Standard for Sutures

I, DERRICK ROY BEECH, delegate of the Minister for Family Services for the purposes of the exercise of the Minister's powers under Section 10 of the Therapeutic Goods Act 1989, acting under that section:

  1. revoke, on and from 25 July 1995, Therapeutic Goods Order No. 15, "Standard for Stainless Steel Sutures" made on the twenty-fourth of July 1984;
  2. revoke, on and from 25 July 1995, Therapeutic Goods Order No.16, "Standard for Absorbable Sutures" made on the twenty-fourth day of July 1984; and
  3. revoke, on and from 25 July 1995, Therapeutic Goods Order No. 17, "Standard for Non-absorbable Sutures" made on the twenty-fourth day of July 1984.
  4. determine that with respect to quality, the standard for sutures shall be the standard (including Appendices A, B, C, D, E, F, G, and Schedules 1, 2, 3, 4, 5, 6, 7, 8 and 9) specified in this Order.

1 Application

This Order applies to all absorbable and non-absorbable monofilament and multifilament sutures, including those made from stainless steel, which are intended for therapeutic use in humans and animals.

2 Interpretation

In this Order -

'absorbable suture' means a uniform strand, consisting of the intestinal membranes of mammals or synthetic material which is absorbable by the body tissues, that may consist of a single filament or fibre, or of a thread prepared by spinning, twisting or braiding single filaments or fibres, that may be intended to be sterile or non-sterile and that may be coated;

'acetone-' means acetone that is specified in the British Pharmacopoeia;

'alcohol' means ethanol or isopropyl alcohol that is specified in the British Pharmacopoeia;

'antimicrobial agent' means a substance, other than alcohol, which has been added to the storage solution to prevent the growth of micro-organisms;

'batch number or serial number', in relation to a suture means characteristic markings:

  1. given by a manufacturer to a particular device or to all devices in a batch for the purposes of uniquely identifying that device or batch and which enables that device or batch to be traced through any or all critical stages of its manufacture and supply; and
  2. which may be immediately preceded by the words "Batch", "Batch Number", "Lot", "Lot Number", "Lot No." or "Lot Code", "Serial Number", "Serial No." or by having a similar meaning, or by the symbol "B", "(B)", or "0", "SN", "S/N", or "FABR".

The date of manufacture may be used as the "batch number" or "serial number" if clearly identifiable as a date;

'calcium chloride' means calcium chloride reagent that is specified in the British Pharmacopoeia;

'chromic catgut sutures' consist of strands prepared from collagen derived from healthy mammals which are processed by physical or chemical means so as to provide greater resistance to resorption in living mammalian tissues;

'Class I sutures' consist of sutures composed of silk or synthetic fibres of monofilament, twisted or braided construction;

'Class II sutures' consist of sutures composed of cotton, linen fibres or coated natural or synthetic fibres where the coating forms a casing of significant thickness which does not contribute appreciably to the strength of the suture, other than braided sutures which have been treated for capillarity;

'diphenylcarbazide' means an almost white powder containing 1,5-diphenylcarbazide C13Hl2N4O analytical grade reagent meeting the following specification -

Insoluble matter
Sulphated ash

'formic acid' means formic acid reagent that is specified in the British Pharmacopoeia;

'5M hydrochloric acid' means 5M hydrochloric acid reagent that is specified in the British Pharmacopoeia;

'iodinated zinc chloride solution' means zinc chloride solution, iodinated reagent that is specified in the British Pharmacopoeia;

'methyl orange' means methyl orange reagent that is specified in the British Pharmacopoeia;

'phosphoric acid' means phosphoric acid that is specified in the British Pharmacopoeia;

'potassium dichromate' means potassium dichromate reagent that is specified in the British Pharmacopoeia;

'potassium permanganate' means potassium permanganate reagent that is specified in the British Pharmacopoeia;

'simple knot' means a knot formed by passing the end of a suture held in the one hand over that held in the other hand then drawing the free end through the loop and pulling it taut;

'sodium azide' means a white powder containing not less than 99 per cent sodium azide, NaN3, when assayed iodimetrically, and meeting the following specification -

Water insoluble matter
Loss on drying
Lead
Free alkali (NaOH)

'stainless steel' means fully-softened stainless steel, the composition of which conforms with British Standard 4106-1967;

'stainless steel suture' means a uniform suture of stainless steel wire, which is circular in cross section, that consists of a single monofilament wire, or of a thread prepared by twisting or braiding monofilament wires and may be intended to be sterile or non-sterile;

'sterile surgical catgut' consists of sterile strands prepared from collagen derived from healthy mammals;

'strong ammonia solution' means strong ammonia solution that is specified in the British Pharmacopoeia;

'sulphuric acid' means sulphuric acid reagent that is specified in the British Pharmacopoeia;

'surgeon's knot' means a square knot in which the free end is first passed twice through the loop, and pulled taut, then passed once through a second loop and the ends drawn taut so that a single knot is superimposed on a compound knot, the initial loop for the knot being formed by one turn of the suture around flexible rubber tubing of 6.5 mm inside diameter and 1.6 mm wall thickness;

'suture' means a uniform strand of natural or synthetic material which resists absorption by the body tissues, that may consist of a single filament or fibre, or of a thread prepared by spinning, twisting or braiding single filaments or fibres, that may be intended to be sterile or non-sterile and may be coated;

'synthetic absorbable sutures' consist of sutures composed of coated or uncoated synthetic fibres which are absorbable by body tissues;

'xylene' means xylene reagent that is specified in the British Pharmacopoeia.

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3 Length

When measured in accordance with the test for length of suture specified in Appendix A, the sutures shall comply with the standard for length:

  1. where the suture is not intended to be sterile, if the length of the suture is greater than 90% of the length stated; or
  2. where the suture is intended to be sterile, if the total length of any individual suture in each container does not exceed 350 cm, and the length of each suture is greater than:
    1. Non-absorbable sutures : 95% of the length stated; and
    2. Absorbable sutures : 90% of the length stated; or
  3. where the suture is solely intended to be used for veterinary use the length of the suture is greater than 90% of the length stated.

4 Diameter

When determined in accordance with the test for diameter of suture, specified in Appendix B.2, the sutures shall comply with the standard for diameter, if:

  1. the mean of the diameters of the sutures in the sample is within the limits specified in Schedule 1;
  2. none of the individual diameters is less than the minimum value specified in Schedule 1;
  3. none of the individual diameters is greater than the maximum value specified in Schedule 1; and
  4. not less than two-thirds of the diameters recorded on each suture are within the limits for mean diameter specified in Schedule 1.

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5 Knot Pull Breaking Force

(This clause applies to absorbable and non-absorbable sutures excluding those made of monofilament and multifilament stainless steel wire.)

5.1 When determined in accordance with the test for knot pull breaking force specified in Appendix C.2, the sutures shall comply with the standard for knot pull breaking force:

  1. where the suture is non-absorbable and is intended to be sterile, if the mean value for knot pull breaking force is not less than the mean value given in Schedule 2; except that if the knot pull breaking force of not more than one suture is found to be less than 70% of the mean value specified in Schedule 2, then the sutures shall comply with the standard if the knot pull breaking force of each of an additional 20 sutures is not less than 70% of the specified mean value; or
  2. where the suture is non-absorbable and not intended to be sterile, if the mean value for knot pull breaking force shall be not less than 125% of the mean value given in Schedule 2; except that if the knot pull breaking force of not more than one suture is found to be less than 87.5% of the mean value specified in Schedule 2, then the sutures shall comply with the standard if the knot pull breaking force of each of an additional 20 sutures is not less than 87.5% of the specified mean value; or
  3. where the suture is made of catgut, if the mean value for the knot pull breaking force is not less than the value given in Schedule 3; except that if the knot pull breaking force of not more than one suture is less than 50% of the mean value specified in Schedule 3, then the sutures shall comply with the standard if the knot pull breaking force of each of an additional 20 sutures is not less than 50% of the specified value; or
  4. where the suture is a synthetic absorbable suture, if the value for the knot pull breaking force is not less than the mean value given in Schedule 4; except that if the knot pull breaking force of not more than one suture is less than 70% of the mean value specified in Schedule 4, then the sutures shall comply with the standard if the knot pull breaking force of each of an additional 20 sutures is not less than 70% of the specified value.

6 Straight Pull Breaking Force

This clause applies only to monofilament and multifilament stainless steel sutures.

6.1 When determined in accordance with the test for straight pull breaking force and elongation specified in Appendix D.2, the sutures shall comply with the standard for straight pull breaking force if the mean value for straight pull breaking force is not less than the mean value given in Schedule 5, and no value for an individual suture is less than 80% of the mean value given in Schedule 5.

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7 Elongation

This clause applies only to monofilament and multifilament stainless steel sutures.

7.1 For both monofilament and multifilament stainless steel sutures, the sutures shall comply with the standard for elongation if the elongation of each suture is not less than 25% when measured in accordance with the test for straight pull breaking force and elongation specified in Appendix D.2.

8 Strength of Needle Attachment

8.1 When determined in accordance with the test for strength of needle attachment specified in Appendix E, the suture shall comply with the standard for strength of needle attachment:

  1. where the sutures are made of non-absorbable material including monofilament or mulitfilament stainless steel, the sutures shall comply with the standard for strength of needle attachment if neither the average value nor any of the individual values of the force required to break the needle attachment is less than the value given in Schedule 6 except that if not more than one of the individual forces is less than the specified value, then the sutures shall comply with the standard if none of the values from
    1. an additional four sutures in the case of monofilament or multifilament stainless steel wire, or
    2. an additional 10 sutures in the case of other non-absorbable material,
    is less than the specified value; or
  2. where the suture is made of catgut, if neither the mean value nor any of the individual values of the force required to break the needle attachment are less than the values given in Schedule 7 except that if not more than one of the individual forces is less than the specified value, the sutures shall comply with the standard if none of the values from an additional 10 sutures is less than the specified value; or
  3. where the suture is a synthetic absorbable suture, if neither the mean value nor any of the individual values of the force required to break the needle attachment is less than the values given in Schedule 8 except that if not more than one of the individual forces is less than the specified value, the sutures shall comply with the standard if none of the values from an additional 10 sutures is less than the specified value.

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9 Identity

This requirement does not apply to monofilament or braided multifilament stainless steel sutures.

9.1 When the relevant test for identification of composition of sutures, as specified in Appendices F 1-6, is carried out, the sutures shall pass the test.

10 Colouring Agents

This requirement does not apply to monofilament and braided multifilament stainless steel sutures.

10.1 The sutures may be pigmented or dyed with a suitable non-toxic, non-irritant colouring agent to give a uniform colour which is fast in alcohol, in the fluid in which the suture is packed and in boiling water. The colouring agent shall be a chemical approved by the Therapeutic Goods Administration for this purpose.

11 Content of Soluble Chromium

11.1 When the suture is fabricated from chromicised catgut and is tested in accordance with the test for content of soluble chromium specified in Appendices G 1-3, the suture shall comply with the standard for content of soluble chromium if the content of chromium does not exceed a concentration of 100 micrograms per gram of the suture.

12 Sterility

12.1 If the sutures are intended to be supplied in a sterile condition, then when tested for sterility in accordance with Therapeutic Goods Order Number 11 "Standard for Sterile Therapeutic Goods", the sutures shall comply with the criteria in that document.

Note: Good manufacturing practice will generally ensure that sutures are manufactured sterile. Manufacturers should ensure that their quality control procedures are such that their sutures are capable of complying with the requirements of TGO No. 11. However, where a dispute may arise, TGO 11 will be the reference method of test.

13 Labelling

13.1 Sutures are required to comply with the labelling requirements of the Order made under the Therapeutic Goods Act 1989, which specifies the minimum labelling requirements for therapeutic devices.

Dated this 25th day of January 1995

Derrick Roy Beech
Delegate of the Minister for Family Services

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