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 |
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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 |
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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 |
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EN ISO 4045 |
VicLab |
EN 1413 |
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ISO 105-EO4 |
AWTA Product Testing, Australian Textile Mills Pty Ltd |
EN 14362.1 |
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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 |
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UNSW ORLAB |
BSI, CertMark International, SAI Global |
Sterility Testing - General |
TGA guidelines 2006 (PDF) |
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Contact NATA |
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