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

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.