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AS 4031—1992

Australian Standard

Non-reusable containers for the

collection of sharp medical items
used in health care areas

First publi shed as AS 4031—1992.

Dennis Mok.
Incorporating:
Amdt 1—1996

PUBLISHED BY STANDARDS AUSTRALIA

(STANDARDS ASSOCIATION OF AUSTRALIA)
1 THE CRESCENT, HOMEBUSH, NSW 2140
ISBN 0 7262 7491 7
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AS 4031—1992 2

PREFACE

This Standard was prepared by the Standards Australia Committee on Hypodermic and Other
Equipment for General Medical Use, under the direction of the Multitechnics Standards Policy
Board.
Cognisance has been taken of BS 7320:1990, Specification for sharps containers, in the development
of this Standard.
The committee deliberated at length on the minimum penetration resistance of 12.5 N specified in
Clause 6.2. This value was arrived at having regard to BS 7320, the draft Canadian Standard and
local testing.
Reusable containers are not dealt with in this Standard, nor are ‘personal use’ (i.e. a container
holding the equivalent of ten 1 mL syringes) non-reusable ‘sharps’ containers issued in needle
exchange programs. However, such containers should at least meet the requirements for impact
resistance and resistance to penetration in this Standard.

CONTENTS
Page
1 SCOPE . . . . . . . . . . . . . . . . . . ... . . ... . . . . . . . . . . . . . . . .. . . .... . . .. .. 3
2 REFERENCED DOCUMENTS . . .. . . . .. . . . . . . . . . . . . . . . . .. . . .... . . .. .. 3
3 DEFINITIONS . . . . . . . . . . . . . ... . . ... . . . . . . . . . . . . . . . .. . . ... . . . .. . . 3
4 MATERIALS . . . . . . . . . . . . . . .. . . . .. . . . . . . . . . . . . . . . . .. . . .. .. . . .. .. 3
5 DESIGN AND CONSTRUCTION ... . . . .. . . . . . . . . . . . . . . . .. . . .... . . .. .. 3
6 PHYSICAL TESTS . . . . . . . . . . . .. . . . .. . . . . . . . . . . . . . . . .. . . .. .. . . .. .. 3
7 COLOUR . . . . . . . . . . . . . . . . . ... . . ... . . . . . . . . . . . . . . . .. . . . ... . . .. .. 3
8 MARKING . . . . . . . . . . . . . . . . ... . . ... . . . . . . . . . . . . . . . .. . . .. .. . . .. .. 4

APPENDICES

A METHOD OF TEST FOR HANDLE INTEGRITY . . . . . . . . . . . . . . .. .. . .. 5

B METHOD FOR DETERMINING IMPACT RESISTANCE . . . . . . . . . .. .. . .. 6
C METHOD FOR DETERMINING RESISTANCE TO PENETRATION . .. . . . .. 7
D METHOD FOR DETERMINING TOPPLING RESISTANCE . . . . . . . .. .. . .. 8

Dennis Mok.

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3 AS 4031—1992

STANDARDS AUSTRALIA

Australian Standard

Non-reusable containers for the collection of sharp medical items

used in health care areas

1 SCOPE This Standard sets out requirements for non-reusable containers intended for the safe
collection and transport of used sharp objects, which may be infectious, in health care areas, and
are disposed of with their contents.
2 REFERENCED DOCUMENTS The following documents are referred to in this Standard:
AS
1301 Methods of test for pulp and paper (metric units)
1301.P426s Method P426s: Thickness of single sheets of paper, paperboard and corrugated
fibreboard
1319 Safety signs for the occupational environment
1946 Hypodermic equipment — Single-use needles (sterile) for general medical use
3 DEFINITIONS For the purpose of this Standard, the definitions below apply.
3.1 Container — a receptacle intended for the collection and disposal of sharps.
3.2 Sharps— objects or devices having sharp points or protruberances or cutting edges, capable
of cutting or piercing the skin.
3.3 Health care area — an area set aside for administering health care within or outside a health
care facility.
4 MATERIALS The container should be made of material which will not produce emissions or
residues or persist in the environment in a manner unacceptable to the appropriate regulatory
authority if the container is incinerated by an approved method of incineration, or disposed of in
a landfill.
NOTE: For non-metalli c containers, heavy metals and halogenated materi als should not be used.
5 DESIGN AND CONSTRUCTION
5.1 Handle The container shall be provided either with at least one handle or a means of carrying
it without holding its body. When tested in accordance with Appendix A, the handle or other integral
carrying feature shall remain intact and there shall be no separation of the handle or the integral
carrying feature from the container.
5.2 Mouth of container The container shall have a mouth or opening for the introduction of sharp
objects. The mouth should be such that the ability to remove any contents from the container is
minimized. The mouth shall be capable of being capped with the closure device when full or ready
for disposal.
5.3 Closure device A closure device shall be provided and be permanently attached and integral

Dennis Mok.
with the container when in use.
5.4 Capacity indicator (fill line) There shall be a capacity indicator embossed or marked on the
outside wall of the container, to represent the maximum volume to which the container may be
filled.
The container shall be designed in a manner which will allow the level of its contents to be readily
determined prior to capping.
6 PHYSICAL TESTS
6.1 Impact resistance When tested in accordance with Appendix B the container shall not rupture,
nor shall it split at its joining seams, nor shall there be any leakage of fluid through the walls or
around the closure device.
6.2 Resistance to penetration When tested in accordance with Appendix C, the force required to
penetrate any sample shall be not less than 12.5 N.
6.3 Stability The container shall be constructed in a manner that will render it stable when pushed
or pulled and, when tested in accordance with Appendix D, it shall not fall over.
NOTE: This requir ement does not apply to containers intended to be carri ed on the person.
7 COLOUR Except for containers intended for the collection of cytotoxic and radioactive wastes,
the colour of the container shall be predominantly yellow.
The colour of the container intended for the collection of cytotoxic wastes should be predominantly
purple. The colour of the container intended for the collection of radioactive wastes should be
predominantly red.

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AS 4031—1992 4

8 MARKING The container shall be clearly, legibly and durably marked with the following
information:
(a) Manufacturer’s name or trademark.
(b) The bio-hazard symbol specified in AS 1319, or where appropriate, radioactive and any existing
or recognized cytotoxic symbols.
(c) Adequate description of contents, e.g. ‘sharps’, ‘infectious wastes’.
(d) The words ‘do not overfill’ or words to that effect.
(e) Capacity indicator.
(f) Assembly instructions, where appropriate.
(g) Where appropriate, warning regarding the storage of the container in wet areas.
(h) Words indicating that after the container is full, it shall not be emptied and re-used.
(i) Batch number, linked to records of manufacture.
NOTE: Manufacturers making a statement of compli ance wit h this Austr alian Standard on a product, packaging, or
promotional materi al related to that product are advised to ensure that such compli ance is capable of being verif ied.

Dennis Mok.

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5 AS 4031—1992

APPENDIX A
METHOD OF TEST FOR HANDLE INTEGRITY
(Normative)

A1 SCOPE This Appendix sets out the procedure for determining the integrity of the handle, or
other integral carrying feature, of the container.
A2 PRINCIPLE The container is filled with a suitable material to a specified mass, and suspended
by a single handle, or other integral carrying feature, for a known time, before it is examined for
handle integrity.
A3 APPARATUS The following apparatus is required:
(a) Dense material, density greater than 1000 kg/m 3 at 20°C, e.g. sand, lead shot.
(b) S-shaped hook, made from 12 mm steel bar, or a rigid support or other apparatus capable of
suspending the container at the intended carrying point. The hook size is adjusted to suit the
handle of the container.
(c) Stop watch.
A4 PROCEDURE The procedure, which shall be carried out at a temperature of 23 ±2°C and
50 ±5% relative humidity, shall be as follows:
(a) With the exception of containers made from fibreboard material, which shall be conditioned at
23 ±2°C and 50 ±5% relative humidity for at least 24 h prior to carrying out Steps (b), (c) and
(d) below, condition the container at 23 ±2°C and 50 ±5% relative humidity for at least 2 h
prior to carrying out Steps (b), (c) and (d) below.
(b) Fill the container with the dense material such that the mass of the contents, expressed in
kilograms, is numerically equal to 100% of the volume of the container at the capacity indicator
expressed in litres, as stated by the manufacturer.
(c) Suspend the container by each and every handle with the S-shaped hook or other rigid support
(see A3(b)), for 30 min.
(d) Remove the S-shaped hook or other rigid support and examine the handle or integral carrying
feature for integrity and for any evidence of separation from the container.
A5 REPORT The report shall include the following:
(a) Whether any handle or integral carrying feature has remained intact and has not separated from
the container.
(b) A reference to this test method, i.e. AS 4031, Appendix A.

Dennis Mok.

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AS 4031—1992 6

APPENDIX B
METHOD FOR DETERMINING IMPACT RESISTANCE
(Normative)

B1 SCOPE This Appendix sets out the method for determining the impact resistance of the container.
B2 PRINCIPLE The container is filled with a known quantity of plastics beads and surfactant solution,
the closure device fitted, and the container dropped onto a surface from a known height and in a pre-
determined orientation, and examined for integrity and leakage of fluid.
B3 APPARATUS AND MATERIALS The following are required:
(a) Plastics beads, approximately 3 mm in diameter.
(b) Impact surface, horizontal and flat, and massive enough to be immovable and rigid enough to be non-
deformable under the test conditions. The impact surface is —
(i) flat, so that no two points on its surface differ in level by more than 2 mm;
(ii) rigid, so that it will not be deformed by more than 0.1 mm when an area of 100 mm 2 is loaded
statically with a 10 kg weight anywhere on the surface; and
(iii) sufficiently large to ensure that the sharps container falls entirely upon the surface.
The impact surface has a mass at least 10 times that of the heaviest container to be tested.
NOTE:A concrete floor at least 150 mm thick is suitable provided that it complies with the above requirements.
(c) Suspension device, capable of holding the container at a designated height and orientation from the
impact surface prior to release so that the container can be dropped on its base, top, sides, corners
(if rectangular) or rims (if cylindrical).
(d) Weighing scale, capable of reading to within ±10 g.
(e) Surfactant solution*, 0.1% V/V.
B4 PROCEDURE The procedure shall be as follows:
(a) With the exception of containers made from fibreboard material, which shall be conditioned at
23 ±2°C and 50 ±5% relative humidity for at least 24 h prior to carrying out Steps (b) to (f) at the
same temperature and humidity, condition the container at 23 ±2°C and 50 ±5% relative humidity
for at least 2 h prior to carrying out Steps (b) to (f) at the same temperature and humidity.
(b) Fill the sharps container with a volume of the surfactant solution, previously maintained at 23 ±2°C,
equal to 6% of the volume of the container at the capacity indicator, or 60 mL, whichever is the
lesser, and add the plastics beads so that the total mass of the contents, expressed in kilograms, is
numerically equivalent to 40% of the volume of the container at the capacity indicator as indicated
by the manufacturer. Fit the closure device and close or lock it as if the sharps container is ready for
disposal.
(c) Using the suspension device, orientate the container so that it will fall onto the impact surface on its
bottom, and so that the height of the container, as measured by the distance between the lowest point
of the container and the nearest point on the impact surface, is 1.00 ±0.02 m.
(d) Release the sharps container within a maximum angle of 5° between the impacting base and the
impact surface, allowing it to freefall without any obstruction or restriction of its movement after it

Dennis Mok.
has struck the impact surface.
NOTE: This maximum angle does not apply when containers are dropped on their corners or rims.
(e) Leave the container where it has fallen for 1 h and then examine it for integrity, e.g. rupture and
splitting at the joining seams, and evidence of leakage, i.e. wetting of the outer surface of the
container or wetting of the impact surface, and leakage of fluid around the closure device.
(f) Repeat Steps (a) to (e), using a new container each time, under the following conditions:
(i) For a rectangular container, orientate the container to fall on its top, on two adjacent side walls,
on a corner at the top, and on a corner at the base.
(ii) For a cylindrical container, orientate the container to fall on its top, on one side, and on its top
and bottom rims.
B5 REPORT The report shall include the following:
(a) Any rupture of the containers or splitting at their joining seams in any of the dropped orientations.
(b) Any evidence of leakage of fluid through the walls, seams or joins (in a two-part container) and
around the closure devices of the containers, if the integrity of the containers has been maintained,
in any of the dropped orientations.
(c) A reference to this test method, i.e. AS 4031, Appendix B.

* DECON-90 surfactant solution available from May and Baker is suitable.

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7 AS 4031—1992

APPENDIX C
METHOD FOR DETERMINING RESISTANCE TO PENETRATION
(Normative)

C1 SCOPE This Appendix sets out the method for determining the resistance of the container to
penetration by a ‘sharp’.
C2 PRINCIPLE Samples of the material from different parts of the container are taken and the
minimum force required for penetration, using a hypodermic needle, is determined.
C3 APPARATUS The following apparatus is required:
(a) Tensometer, having a load cell capable of measuring the force applied to a needle penetrating
a sample with means to record the force necessary just to penetrate the under surface of the
sample after the needle is pressed into the top surface. The machine permits only vertical
displacement of the needle support, and is configured to plot the force versus displacement
profile of the needle penetrating the sample, on a graph.
(b) Sample support, 40 mm × 40 mm × 12 mm, with a 6 mm diameter hole in the centre of the
largest face.
(c) Needle holder, designed to hold a hypodermic needle, such that the needle points vertically
downwards towards the sample support.
(d) Portable jigsaw.
(e) Vernier calliper, ball micrometer or micrometer as specified in AS 1301.P426s, as appropriate.
(f) Hypodermic needle, 0.80 mm in nominal external diameter and 25 mm in length, and complying
with AS 1946.
C4 TEST SAMPLE The test sample shall be prepared as follows:
(a) Using the portable jigsaw, cut five strips, approximately 25 mm wide, from the base, sidewall,
closure device, top and corner of the container.
(b) Cut a 25 mm × 25 mm test sample from each strip, and, with the exception of test samples
made of fibreboard material, which shall be conditioned at 23 ±2°C and 50 ±5% relative
humidity for at least 24 h prior to testing, condition the test samples at a temperature of
23 ±2°C and a relative humidity of 50 ±5% for a minimum of 2 h, prior to testing.
C5 PROCEDURE The procedure, which shall be carried out at a temperature of 23 ±2°C and
50 ±5% relative humidity, shall be as follows:
(a) Attach the needle holder with the hypodermic needle to the load cell of the tensometer.
(b) Place a test sample on the sample support with the inside surface facing upwards, and locate
it centrally on the table of the tensometer.
NOTE: Care should be taken to avoid distorti ng the sample by attempti ng to fl atten any curves.
(c) Lower the needle towards the sample at a rate of 100 mm/min and at an angle of 90 ±5°,
allowing the needle to pass through the sample, with the tensometer plotting the force

Dennis Mok.
displacement profile of the needle penetrating through the sample.
(d) Measure the thickness of the sample that has been penetrated, using either the vernier calliper
ball micrometer or micrometer as specified in AS 1301.P426s, as appropriate.
(e) Plot the sample thickness on the force displacement profile and determine the penetration force
by reference to the graph.
(f) Repeat Steps (b) to (e) with the remainder of the test samples.
C6 REPORT The report shall include the following information:
(a) The force required to just penetrate the under surface of each sample.
(b) A reference to this test method, i.e. AS 4031, Appendix C.

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AS 4031—1992 8

APPENDIX D
METHOD FOR DETERMINING TOPPLING RESISTANCE
(Normative)

D1 SCOPE This Appendix sets out the method for determining the toppling resistance of a
container.

D2 PRINCIPLE A filled container is placed on a plane having a non-slip surface which is

inclined at 15° to the horizontal, and observed as to whether it remains standing or topples.

D3 APPARATUS A plane, either preset at an angle of 15 ±1° to the horizontal or capable of

being raised to, and maintained at that angle, is required. The plane shall have a surface such, that
when it is inclined, the container does not slide on it. Covering the plane with Grade ‘O‘ sand or
emery paper has been found to achieve the necessary degree of roughness. Figure D1 illustrates a
typical test set-up.

D4 SAMPLE One representative container shall be tested.

D5 PROCEDURE The procedure shall be as follows:

(a) Fill the container to its nominal capacity with the sharp items it is designed to contain or with
a substance of similar bulk density and seal it in the designed manner.
(b) Carefully place the container on the plane, so that its short axis is parallel to the line of tilt (see
Figure D1). If a variable-angle plane is used, it shall be in a horizontal attitude when the
container is placed on it, and the angle of inclination shall then be increased at a rate not
exceeding 1°/s.
(c) Note whether the container remains standing or topples.

D6 REPORT The report shall include the following information:

(a) Full details of the container tested.
(b) A statement as to whether the container remained standing or toppled.
(c) A reference to this test method, i.e. AS 4031, Appendix D.

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(a) Top view

(b) Side view

FIGU RE D1 TYPICA L TES T SET-UP

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