Summary information on standards and conformance for PPE Products

The Australian Technical Infrastructure Alliance (ATIA) remains committed to working alongside businesses, government, emergency services and the broader community through this challenging time in responding to COVID-19.
 
The ATIA provides a single point of access to the combined capability, expertise and resources of the four core bodies responsible for Australia’s standards and conformance:

• Standards Australia
• National Measurement Institute (NMI)
• National Association of Testing Authorities (NATA)
• Joint Accreditation System of Australia and New Zealand (JAS-ANZ)

To further assist the design, manufacture and procurement of medical Personal Protective Equipment (PPE), the following provides information on potentially relevant Australian Standards^® and corresponding test methods, as well as information on accredited Australian laboratories and certifiers.
 
This document has been prepared in consultation with the ATIA as at 3 November 2020. Standards Australia encourages interested parties to contact the relevant ATIA lead for more information or with any additional relevant details that should be included. Given the rapidly changing landscape presented by the pandemic, we are aware that industry needs are evolving, and we will aim to continue to adapt this information to cater for emerging needs.
 
Some PPE meets the definition of a medical device. Manufacturers, suppliers and sponsors of medical devices must meet regulatory obligations including under the Therapeutic Goods Act 1989 (Cth), before medical devices can be legally supplied in or exported from Australia. It is recommended that stakeholders review the information available on the Therapeutic Goods Administration’s website: www.tga.gov.au to determine what regulatory obligations apply to their specific product.

NATA has also published industry user guides that can be found on their website.
 
Contacts
For information about non-NATA accredited laboratory services, please see https://www.industry.gov.au/data-and-publications/standards-and-conformance-summary-information-personal-protective-equipment-ppe-products-and-hand-sanitisers
 
Please contact Standards Australia's Stakeholder Engagement Team for queries about the standards and conformance information by email: sem@standards.org.au
 
Disclaimer
This document is intended to provide general summary information only, may not be comprehensive and does not cater for specific circumstances. Users should obtain and rely on professional or technical advice on the standards, test methods and test laboratories to be used on a case by case basis. Any reference to any third-party organisations do not constitute an endorsement by Standards Australia of those organisations or their products or services. 

PPE Product Category	Therapeutic Goods Administration Guidance	Australian or Joint Australian/New Zealand Standard	Test Method Standards	Test Method Description	NATA Accredited Labs and Alternatives by Test Method	JAS-ANZ accredited Certification Bodies
Surgical Masks - Levels 1-3 and Respirators - P1, P2, P3	The TGA has published guidance to manufacturers and consumers of medical PPE on their website	AS 4381:2015	ASTM F2101-14 or EN 14683:2014	Bacterial Filtration Efficiency	See this industry.gov.au page for information regarding non-NATA accredited laboratory services	CertMark
			EN14683:2014	Differential Pressure Drop	CSIRO, NMI
			ASTMF1862/F1862M/13 or ISO 22609	Synthetic Blood Penetration	CSIRO, NMI
			AS ISO 13485 for Manufacturing	Quality Management System	N/A
		AS/NZS 1716:2012	AS/NZS 1716 Appendix I	Particle filtration efficiency	See this industry.gov.au page for information regarding non-NATA accredited laboratory services	SAI Global, BSI, Global-Mark, CertMark
			AS/NZS 1716 Appendix G	Inhalation resistance
			AS/NZS 1716 Appendix G	Exhalation resistance
			AS/NZS 1716 Appendix D	Facial Fit-Inward leakage
			AS/NZS 1716 Appendix E5.6	Simulated Wear
			AS/NZS 1716 Appendix F	Exhalation valve leakage if fitted
				Calibration of required reference equipment (flowmeters, pressure indicators, reference gas mixtures etc.)	Contact NATA
Protective Clothing	The TGA has published guidance to manufacturers and consumers of medical PPE on their website	AS 3789.6-1996	AS 2001.2.3	Determination of breaking force and extension of textile fabrics	AWTA Product Testing, Australian Textile Mills Pty Ltd	Currently no accredited bodies
			AS 2001.2.5	Determination of the number of threads per unit length in woven fabric	AWTA Product Testing, Australian Textile Mills Pty Ltd
			AS 2001.2.12	Determination of width of fabrics	AWTA Product Testing, Australian Textile Mills Pty Ltd
			AS 2001.2.13	Determination of mass per unit area and mass per unit length of fabrics	AWTA Product Testing, Australian Textile Mills Pty Ltd
			AS 2001.2.16	Determination of water repellency of textile surfaces—Spray rating test	AWTA Product Testing, Australian Textile Mills Pty Ltd
			AS 2001.3.6	Determination of cuprammonium fluidity of cotton and cellulosic man-made fibres	AWTA Product Testing
			AS 2001.4.3	Determination of colourfastness to rubbing	AWTA Product Testing, Australian Textile Mills Pty Ltd
			AS 2001.4.8/AS 2001.4.E01/ISO 105-E01	Determination of colourfastness to water	AWTA Product Testing, Australian Textile Mills Pty Ltd
			AS 2001.4.15	Determination of colourfastness to washing	AWTA Product Testing, Australian Textile Mills Pty Ltd
			AS 2001.4.17	Determination of colourfastness to perspiration	AWTA Product Testing
			AS 2001.4.21	Determination of colourfastness to light using an artificial light source (mercury vapour, tungsten filament, internally phosphor-coated lamp)	VicLab, AWTA Product Testing, Australian Textile Mills Pty Ltd
			AS 2001.5.5	Determination of dimensional change in laundering of textile fabrics and garments—Cube machine method	AWTA Product Testing, Australian Textile Mills Pty Ltd
			AS 2001.7	Quantitative analysis of fibre mixtures	AWTA Product Testing, Australian Textile Mills Pty Ltd
			AS 3789.6 App C	Method for determination of oil repellency
			AS 3789.6 App D	Method for determination of pilling and fuzzing	AWTA Product Testing
			BS 4032	Method of test for the determination of certain water- or alkali-soluble additives in cellulosic or synthetic fibres, yarns and fabrics or yarns and fabrics made from blends of such fibres	See this industry.gov.au page for information regarding non-NATA accredited laboratory services
			ISO 7211.3	Determination of crimp of yarn in fabric	AWTA Product Testing
		AS 3789.2–1991	N/A	Refers to AS 3789.6	N/A	N/A
		AS/NZS ISO 6529:2006	ASTM F1862, ISO 22609	Synthetic Blood Penetration	See this industry.gov.au page for information regarding non-NATA accredited laboratory services	Currently no accredited bodies
		AS/NZS 4501.1:2008	N/A	Currently no testing referenced in this Standard	N/A	N/A
		AS/NZS 4501.2:2006 (identical adoption of EN 340-2004)	EN 420	For type testing and licensing the entire standard must be tested and adhered to	VicLab	BSI
			EN 1811
			EN ISO 4045		VicLab
			EN 1413
			ISO 105-EO4		AWTA Product Testing, Australian Textile Mills Pty Ltd
			EN 14362.1
			ISO 105-B02		AWTA Product Testing
Gloves	The TGA has published guidance to manufacturers and consumers of medical PPE on their website	AS/NZS 4179:2014	N/A	Tests are detailed within the Standard	VicLab, Enersol Pty Limited	BSI
		AS/NZS 4011.1:2014	N/A	Tests are detailed within the Standard	VicLab, Therapeutic Goods Administration	BSI
		AS/NZS 4011.2:2014	N/A	Tests are detailed within the Standard	VicLab	BSI
		AS/NZS 2161.10.1:2005 Rec:2016	N/A	Tests are detailed within the Standard	VicLab	Currently no accredited bodies
Eye and Face Protection	The TGA has published guidance to manufacturers and consumers of medical PPE on their website	AS/NZS 1337.1:2010			UNSW ORLAB	BSI, CertMark International, SAI Global
Sterility Testing - General	TGA guidelines 2006 (PDF)				Contact NATA

Last update: 3 November 2020