Guidance on Medical device standards order No. 3
Medical device standards for medical devices required to be sterile
Medical Device Standards Order No. 3 - Medical Devices Required to be Sterile (MDSO 3) <http://www.tga.gov.au/devices/mdso3.htm> specifies relevant medical device standards relevant to medical devices that are required to be sterile, whether the device is to be sterilised by the manufacturer prior to release or to be supplied in a non-sterile state but packaged in such a way that it can be sterilised at a later stage following supply.
This Order determines medical device standards by reference to published standards in three areas: qualification of a device as "sterile", packaging, and validation of sterilisation processes. It is essential, as determined by the Order, that all three aspects are applied in combination for the final level of sterility to be achieved.
The requirements for devices that are to be supplied "sterile" are set out in Schedule 1 of the Order and the requirements for devices which are intended for sterilisation following supply are set out in Schedule 2 of the Order.
The validation of steam sterilisation procedures requires compliance with ISO 11134: 1994 or EN 554: 1994 and microbiological validation in accordance with AS EN 556.1-2002.
Background
The Act provides for the establishment and maintenance of a national system of controls relating to the quality, safety and efficacy of therapeutic goods that are used in Australia or exported from Australia.
Section 41CB of the Act provides the Minister, or the Minister's delegate, with the power to determine medical device standards and to also determine that medical devices that comply with these standards are to be treated as complying with specified parts of the essential principles.
The essential principles set out the requirements relating to the safety and performance characteristics of medical devices that must be complied with before a device can be imported, supplied or exported. Compliance with applicable medical device standards is not required, but it is one way to establish compliance with the essential principles. If a manufacturer chooses to apply a medical device standard, and this is applied correctly, the device is presumed to comply with the parts of the essential principles set out in the Order (section 41BH of the Act).