Medical PPE Frequently Asked Questions (FAQs)
What are the standards this facility tests against?
The facility conducts the three tests that are nominated by Australian Standard AS 4381:2015 for evaluation of the performance of a surgical mask:
- ISO 22609:2014 – Test method for resistance against penetration by synthetic blood (fixed volume, horizontally projected)
- EN 14683:2014 Annex B – Method for in-vitro determination of bacterial filtration efficiency (BFE)
- EN 14683:2014 Annex C – Method for determination of breathability (differential pressure)
Is this the only accredited testing facility for face masks in Australia?
At the time of writing (6 August) CSIRO has the only accredited testing facility for single use surgical face masks in Australia. Other accredited facilities exist in US, Europe and Asia. Others are expected to be established in Australia in future.
What does ‘accredited’ mean?
Australia’s National Association of Testing Authorities or NATA audited CSIRO’s laboratory and conducted rigorous technical assessments to ensure technical and quality management competency in accordance with AS ISO/IEC 17025 was satisfied for all of the test methods listed above. The laboratory’s accreditation ensures that manufacturers are able to demonstrate that their products meet the test criteria through application of CSIRO’s world-recognised reports.
How have face masks been tested in Australia up until this point?
In the past, Australian manufacturers had to make use of overseas test laboratories to gain the evidence required for TGA registration. CSIRO’s new facility means Australian manufacturers will save time and money by having the tests performed locally.
Why do we need an accredited facility?
PPE that is intended for use in a clinical setting, or that for which therapeutic claims are made, meets the definition of a medical device ((https://www.tga.gov.au/what-medical-device). These products are regulated by the Federal Government Department of Health’s Therapeutic Goods Administration (TGA) under the Therapeutic Goods Act 1989. Any product that makes a therapeutic claim must be included on the Australian Register of Therapeutic Goods (ARTG) before it can be supplied. Medical devices are regulated according to classification (Class I, Class Is or Class II etc). The TGA provide an online tool to determine the device class (https://www.tga.gov.au/sme-assist/what-classification-my-medical-device). All classes of devices must comply with the Essential Principles (https://www.tga.gov.au/manufacture-medical-devices-quality-management) and demonstrate required levels of conformity in terms of safety, performance, benefits and risks to ensure that they are fit for purpose.
Do we expect other countries to be able to use the facility?
Yes, CSIRO is able to offer testing of both locally and internationally-produced products.
What’s the difference between home-made and store-bought masks?
It depends on the mask. Masks that are labelled as ‘single-use surgical’, P2 and N95 and listed as a medical device on the Australian Register of Therapeutic Goods should offer significant protection against the spread of aerosolised particles. Purchased masks that are not labelled as such and are made from single or multiple layers of cloth may decrease the spread of aerosolised particles within the community, similar to a home-made mask.
How do single-use surgical face masks work?
A surgical face mask protects others from the wearer’s bodily fluids that are present in coughs, sneezes, or generated through simple talking and breathing. These actions send out small droplets of bodily fluids that may contain pathogens. Surgical masks are made from material that is fine enough to filter out small particles. To be effective they are ‘single-use’ and you must wear them according to the manufacturers’ instructions. It’s important not to touch the mask until you remove it.
What kinds of fabrics do commercial manufacturers use for making surgical face masks?
Manufacturers do not typically use conventional textile fabrics in medical masks. Mask materials need to deliver adequate filtration of biological particles, such as bacteria, in order to be effective and provide appropriate protection.
What is the latest information in Australia on face mask wearing during COVID-19?
The latest information on face mask wearing can be found on the Australian Government’s Department of Health website or your State’s Department of Health website.
How long does a single-use mask work for?
The best advice is the follow the manufacturer’s recommendations.
Do I wear my single-use face mask with the coloured or white side out?
Follow manufacturers’ recommendations, but in general most masks are designed to be worn with the white side against your face and the coloured side facing outwards.
Can you re-use a single use face mask?
No. You must dispose of a single-use face mask after use.