1Medical Device Standards Order (Endotoxin Requirements for Medical Devices) 2018

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Medical Device Standards Order (Endotoxin Requirements for Medical Devices) 2018

Therapeutic Goods Act 1989

I, Elizabeth McGrath, delegate of the Minister for Health for the purposes of section 41CB of the Therapeutic Goods Act 1989 and acting under that section, HEREBY DETERMINE:

(1) that the matters specified in sections 6 and 7 of this Order constitute a medical device standard for the kinds of medical devices identified in section 5 of this Order; and

(2) that medical devices of those kinds that comply with sections 6 and 7 of this Order are to be treated as complying with Clause 7.2 of the essential principles set out in Schedule 1 to the Therapeutic Goods (Medical Devices) Regulations 2002, in relation to minimising the risks associated with endotoxin contaminants and residues in or on medical devices.

Dated this 7th day of September 2018

(Signed by)

Elizabeth McGrath

Delegate of the Minister for Health

1 Name of Order

This Order is the Medical Device Standards Order (Endotoxin Requirements for Medical Devices) 2018.

2 Commencement

This Order commences on the day after it is registered on the Federal Register of Legislation.

3 Authority

This Order is made under subsection 41CB (1) of the Therapeutic Goods Act 1989 (the Act).

4 Definitions

In this Order:

Act means the Therapeutic Goods Act 1989.

default standard has the same meaning as in the Act.

endotoxin is the high molecular weight lipopolysaccharide component of the outer cell wall of gram-negative bacteria, which is usually a fever-inducing contaminant in the manufacturing process of medical devices.

final product medical device or medical device component that has been subjected to all manufacturing processes for the ‘to be marketed’ medical device including packaging and if applicable, sterilisation.

label has the same meaning as in the Act.

manufacturer has the same meaning as in section 41BG of the Act.

medical device has the same meaning as in section 41BD of the Act.

Regulations means the Therapeutic Goods (Medical Devices) Regulations 2002, as in force from time to time.

5 Application

This Order constitutes a medical device standard for any of the following kinds of medical devices:

(a) implantable medical devices;
(b) devices in direct or indirect contact with a person’s cardiovascular system, the lymphatic system, or cerebrospinal fluid that are labelled sterile and non-pyrogenic. These include, but are not limited to:

fluid pathways of catheters and administration sets such as solution administration sets, extension sets, transfer sets, blood and blood products administration sets, intravenous catheters, extracorporeal oxygenator tubing, dialysis tubing, intramuscular drug delivery catheters, transfusion and infusion assemblies, and epidural catheters;
liquid medical devices such as dialysate; and
implantable medical devices such as heart valves, vascular grafts, and cerebral spinal fluid shunt systems;

(c) devices in direct or indirect contact with a person’s intraocular environment. These include but are not limited to:

intraocular fluids such as ophthalmic viscosurgical devices including viscoelastic surgical aids;
implantable intraocular solid devices such as intraocular lenses, implantable miniature telescope, and iris reconstruction lenses;
glaucoma devices such as aqueous shunts and intraocular pressure lowering implants;
capsular tension ring devices; and
accessories of irrigation/aspiration sleeves and tubing used in the intraocular environment; or

(d) any other devices labelled sterile and non-pyrogenic.