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 21 September 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 Currently no accredited bodies (& no certifications)
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. 
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
 
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: 21 September 2020