Therapeutic Goods Order No. 49 General standard for sutures: Schedules
These are the Schedules for TGO 49 General standard for sutures <http://www.tga.gov.au/docs/html/tgo/tgo49.htm>.
Note: If you intend to rely on any legislation referred to on this website, you should access copies of the official versions on the Attorney General's Department's ComLaw website <http://www.comlaw.gov.au> (incorporating the Federal Register of Legislative Instruments (FRLI)). Instruments are amended from time to time and may, on occasions, be replaced or new instruments made.
Schedule 1 Diameter of absorbable and non-absorbable sutures
DIAMETER (mm)
| METRIC SIZE (GAUGE NO.) |
RANGE FOR THE MEAN |
INDIVIDUAL MINIMUM |
INDIVIDUAL MAXIMUM |
| 0.01 |
0.001 - 0.009 |
- |
0.015 |
| 0.1 |
0.010 - 0.019 |
0.005 |
0.025 |
| 0.2 |
0.020 - 0.029 |
0.015 |
0.035 |
| 0.3 |
0.030 - 0.039 |
0.025 |
0.045 |
| 0.4 |
0.040 - 0.049 |
0.035 |
0.060 |
| 0.5 |
0.050 - 0.069 |
0.045 |
0.085 |
| 0.7 |
0.070 - 0.099 |
0.060 |
0.125 |
| 1 |
0.10 - 0.149 |
0.085 |
0.175 |
| 1.5 |
0.15 - 0.199 |
0.125 |
0.225 |
| 2 |
0.20 - 0.249 |
0.175 |
0.275 |
| 2.5 |
0.25 - 0.299 |
0.225 |
0.325 |
| 3 |
0.30 - 0.349 |
0.275 |
0.375 |
| 3.5 |
0.35 - 0.399 |
0.320 |
0.450 |
| 4 |
0.40 - 0.499 |
0.375 |
0.550 |
| 5 |
0.50 - 0.599 |
0.450 |
0.650 |
| 6 |
0.60 - 0.699 |
0.550 |
0.750 |
| 7 |
0.70 - 0.799 |
0.650 |
0.850 |
| 8 |
0.80 - 0.899 |
0.750 |
0.950 |
| 0.5 |
0.050 - 0.069 |
0.045 |
0.085 |
| 0.7 |
0.070 - 0.099 |
0.060 |
0.125 |
| 1 |
0.10 - 0.149 |
0.085 |
0.175 |
| 1.2 |
0.12 - 0.149 |
0.110 |
0.175 |
| 1.5 |
0.15 - 0.199 |
0.125 |
0.225 |
| 2 |
0.20 - 0.249 |
0.175 |
0.275 |
| 2.5 |
0.25 - 0.299 |
0.225 |
0.325 |
| 3 |
0.30 - 0.349 |
0.275 |
0.375 |
| 3.5 |
0.35 - 0.399 |
0.320 |
0.450 |
| 4 |
0.40 - 0.449 |
0.375 |
0.550 |
| 4.5 |
0.45 - 0.499 |
0.425 |
0.550 |
| 5 |
0.50 - 0.599 |
0.450 |
0.650 |
| 6 |
0.60 - 0.699 |
0.550 |
0.750 |
| 7 |
0.70 - 0.799 |
0.650 |
0.850 |
| 8 |
0.80 - 0.899 |
0.750 |
|
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Schedule 2 Breaking force of non-absorbable sutures
METRIC SIZE
CLASS 1 |
MEAN BREAKING FORCE USING SIMPLE KNOT (GAUGE NO.) |
| |
NEWTONS |
(kgf) |
NEWTONS |
(kgf) |
| 0.01 |
0.010 |
(0.001) |
- |
- |
| 0.1 |
0.039 |
(0.004 |
0.029 |
(0.003) |
| 0.2 |
0.137 |
(0.014) |
0.098 |
(0.010) |
| 0.3 |
0.294 |
(0.030) |
0.216 |
(0.022) |
| 0.4 |
0.49 |
(0.05) |
0.294 |
(0.03) |
| 0.5 |
0.98 |
(0.10) |
0.490 |
(0.05) |
| 0.7 |
1.86 |
(0.19) |
0.98 |
(0.10) |
| 1 |
3.72 |
(0.38) |
2.16 |
(0.22) |
| 1.5 |
5.68 |
(0.58) |
4.31 |
(0.44) |
| 2 |
8.43 |
(0.86) |
6.27 |
(0.64) |
| 2.5 |
10.29 |
(1.05) |
8.04 |
(0.82) |
| 3 |
12.15 |
(1.24) |
9.02 |
(0.92) |
| 3.5 |
19.21 |
(1.96) |
12.25 |
(1.25) |
| 4 |
24.70 |
(2.52) |
15.78 |
(1.61) |
| 5 |
32.54 |
(3.32) |
22.93 |
(2.34) |
| 6 |
45.08 |
(4.6) |
34.10 |
(3.48) |
| 7 |
54.19 |
(5.53) |
39.59 |
(4.04) |
| 8 |
68.60 |
(7.00) |
47.24 |
(4.82) |
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Schedule 3 Breaking force of catgut sutures
| METRIC SIZE (GAUGE NO.) |
MEAN BREAKING FORCE USING SURGEONS KNOT NEWTONS |
(KGF) |
| 0.3 |
0.225 |
(0.023) |
| 0.4 |
0.333 |
(0.034) |
| 0.5 |
0.441 |
(0.045) |
| 0.7 |
0.588 |
(0.06) |
| 1 |
1.67 |
(0.17) |
| 1.5 |
3.43 |
(0.35) |
| 2 |
7.35 |
(0.75) |
| 2.5 |
8.82 |
(0.90) |
| 3 |
11.27 |
(1.15) |
| 3.5 |
17.64 |
(1.80) |
| 4 |
25.19 |
(2.57) |
| 5 |
35.28 |
(3.60) |
| 6 |
41.45 |
(4.23) |
| 7 |
55.08 |
(5.62) |
| 8 |
65.86 |
(6.72) |
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Schedule 4 Breaking force of synthetic absorbable sutures
| METRIC SIZE (GAUGE NO.) |
MEAN BREAKING FORCE USING SIMPLE KNOT NEWTONS |
(kgf) |
| 0.3 |
0.441 |
(0.045) |
| 0.4 |
0.588 |
(0.06) |
| 0.5 |
1.27 |
(0.13) |
| 0.7 |
2.25 |
(0.23) |
| 1 |
6.47 |
(0.66) |
| 1.5 |
8.33 |
(0.85) |
| 2 |
15.39 |
(1.57) |
| 3 |
24.30 |
(2.48) |
| 3.5 |
36.26 |
(3.70) |
| 4 |
47.04 |
(4.80) |
| 5 |
59.49 |
(6.07) |
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Schedule 5 Straight pull force of stainless steel sutures
MEAN BREAKING FORCE ON STRAIGHT PULL
| METRIC SIZE (GAUGE NO.) |
NEWTONS |
(kgf) |
| 0.5 |
1.57 |
0.16 |
| 0.7 |
2.65 |
0.27 |
| 1.0 |
5.29 |
0.54 |
| 1.2 |
6.66 |
0.68 |
| 1.5 |
8.04 |
0.82 |
| 2 |
13.30 |
1.36 |
| 2.5 |
15.5 |
1.58 |
| 3 |
17.6 |
1.80 |
| 3.5 |
33.3 |
3.40 |
| 4 |
46.7 |
4.76 |
| 4.5 |
52.2 |
5.33 |
| 5 |
57.8 |
5.90 |
| 6 |
89.3 |
9.11 |
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Schedule 6 Strength of needle attachment for non-absorbable sutures including those composed of stainless steel
MINIMUM BREAKING FORCE
| METRIC SIZE (GAUGE NO.) |
MEAN NEWTONS |
INDIVIDUAL (kgf) |
NEWTONS |
(kgf) |
| 0.4 |
0.392 |
(0.04) |
0.196 |
(0.020) |
| 0.5 |
0.686 |
(0.070) |
0.294 |
(0.030) |
| 0.7 |
1.57 |
(0.16) |
0.686 |
(0.070) |
| 1 & 1.2 |
2.16 |
(0.22) |
0.98 |
(0.10) |
| 1.5 |
4.21 |
(0.43) |
2.17 |
(0.22) |
| 2 |
6.47 |
(0.66) |
3.14 |
(0.32) |
| 2.5 |
8.13 |
(0.83) |
3.72 |
(0.38) |
| 3 |
9.80 |
(1.00) |
4.21 |
(0.43) |
| 3.5 |
11.76 |
(1.20) |
4.21 |
(0.43) |
| 4 & 4.5 |
15.68 |
(1.60) |
5.68 |
(0.58) |
| 5+ |
15.68 |
(1.60) |
6.66 |
(0.68) |
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Schedule 7 Strength of needle attachment for catgut sutures minimum breaking force
| METRIC SIZE (GAUGE NO.) |
MEAN NEWTONS |
INDIVIDUAL (kgf) |
NEWTONS |
(kgf) |
| 0.4 |
0.392 |
(0.040) |
0.196 |
0.020 |
| 0.5 |
0.392 |
(0.040) |
0.196 |
0.020 |
| 0.7 |
0.686 |
(0.070) |
0.294 |
0.030 |
| 1 |
1.57 |
(0.16) |
0.686 |
0.07 |
| 1.5 |
2.16 |
(0.22) |
0.98 |
0.10 |
| 2 |
4.21 |
(0.43) |
2.17 |
0.22 |
| 2.5 |
5.39 |
(0.55) |
2.65 |
0.27 |
| 3 |
6.47 |
(0.66) |
3.14 |
0.32 |
| 3.5 |
9.80 |
(1.00) |
4.21 |
0.43 |
| 4 |
11.76 |
(1.20) |
4.21 |
0.43 |
| 5 + |
15.68 |
(1.60) |
5.88 |
0.60 |
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Schedule 8 Strength of needle attachment for synthetic absorbable sutures other than for those manufactured using catgut
MINIMUM BREAKING FORCE
| METRIC SIZE (GAUGE NO.) |
MEAN NEWTONS |
INDIVIDUAL (kgf) |
NEWTONS |
(kgf) |
| 0.4 |
0.392 |
(0.040) |
0.196 |
(0.020) |
| 0.5 |
0.686 |
(0.070) |
0.294 |
(0.030) |
| 0.7 |
1.57 |
(0.16) |
0.686 |
(0.070) |
| 1 |
2.16 |
(0.22) |
0.98 |
(0.10) |
| 1.5 |
4.21 |
(0.43) |
2.17 |
(0.22) |
| 2 |
6.47 |
(0.66) |
3.14 |
(0.32) |
| 2.5 |
8.13 |
(0.83) |
3.72 |
(0.38) |
| 3 |
9.80 |
(1.00) |
4.21 |
(0.43) |
| 3.5 |
11.76 |
(1.20) |
4.21 |
(0.43) |
| 4 |
15.68 |
(1.60) |
5.68 |
(0.58) |
| 5 + |
15.68 |
(1.60) |
6.66 |
(0.68) |
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Schedule 9 Solubility of suture materials
| Suture |
Formic Acid |
H3PO4 |
5M HC1 |
H2SO4 |
Xylene |
Formic Acid/CaC12 |
| Polyester |
insoluble |
insoluble |
insoluble |
soluble |
insoluble |
insoluble |
| Polypropylene |
insoluble |
insoluble |
insoluble |
insoluble |
soluble |
insoluble |
| Linen |
insoluble |
soluble |
insoluble |
soluble |
insoluble |
insoluble |
| Nylon |
soluble |
soluble |
soluble |
soluble |
insoluble |
soluble |
| Silk |
insoluble |
soluble |
insoluble |
soluble |
insoluble |
soluble |
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