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Standards and conformance summary information: Personal Protective Equipment (PPE) products and hand sanitisers

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Publication Date: 
August 2020

In consultation with Australia’s Technical Infrastructure Alliance peak bodies, we help businesses design, manufacture and procure PPE and hand sanitiser by maintaining information about: 

  • Australian standards and testing methods for PPE and hand sanitiser
  • Australian laboratories with PPE and hand sanitiser testing capabilities. This includes:
    • laboratories with National Association of Testing Authorities (NATA) accreditation for relevant testing capabilities
    • ‘self-declared’ laboratories, which are labs without NATA accreditation who have advised that they can issue formal test reports in accordance with the nominated Australian Standards on behalf of their organisation for the relevant PPE and/or hand sanitiser test(s)

    Self declared laboratories may not have been independently assessed. It is recommended advice is sought from relevant regulators, customers and other stakeholders to confirm the suitability of non-accredited laboratory results for your needs.

    You can also read the Industry User Guide 8: Working with NATA Accredited Personal Protective Equipment (PPE) testing laboratories on the NATA website for information on the benefits of using NATA accredited labs.

Some PPE and hand sanitisers are subject to the Therapeutic Goods Act 1989. We recommend you seek advice about regulatory requirements specific to your product. Regulatory requirements are not part of the scope of this information and advice on such matters should be sought from the relevant authority.

PPE Product Category Australian or Joint Australian/New Zealand Standard Test Method Standards Test Method Description NATA Accredited laboratories by test method# Laboratories with self-declared testing capability (non-NATA accredited)*
Surgical Masks - Levels 1-3 and Respirators - P1, P2, P3 AS 4381:2015 ASTM F2101-14 or EN 14683:2014 Bacterial Filtration Efficiency CSIRO#  
EN14683:2014 Differential Pressure Drop CSIRO#, NMI#  
ASTMF1862/F1862M/13 or ISO 22609 Synthetic Blood Penetration CSIRO#, NMI# VicLab*
AS ISO 13485 for Manufacturing  Quality Management System    
AS/NZS 1716:2012 AS/NZS 1716 Appendix I Particle filtration efficiency   TestSafe NSW*, VicLab*
AS/NZS 1716 Appendix G Inhalation resistance   NMI*, TestSafe NSW*, VicLab*
AS/NZS 1716 Appendix G Exhalation resistance  NMI*, TestSafe NSW*, VicLab*
AS/NZS 1716 Appendix D  Facial Fit-Inward leakage   TestSafe NSW*, VicLab*
AS/NZS 1716 Appendix E5.6 Simulated Wear TestSafe NSW*, VicLab*
AS/NZS 1716 Appendix F Exhalation valve leakage if fitted   TestSafe NSW*, VicLab*
  Calibration of required reference equipment (flowmeters, pressure indicators, reference gas mixtures etc.) Contact NATA for advice on accredited laboratories for your specific need  
Protective Clothing AS 3789.6-1996 AS 2001.2.3 Determination of breaking force and extension of textile fabrics Australian Textile Mills Pty Ltd#, AWTA Product Testing# VicLab*
AS 2001.2.5 Determination of the number of threads per unit length in woven fabric Australian Textile Mills Pty Ltd#, AWTA Product Testing#  
AS 2001.2.12 Determination of width of fabrics Australian Textile Mills Pty Ltd#, AWTA Product Testing# VicLab*
AS 2001.2.13 Determination of mass per unit area and mass per unit length of fabrics Australian Textile Mills Pty Ltd#, AWTA Product Testing# VicLab*
AS 2001.2.16 Determination of water repellency of textile surfaces—Spray rating test Australian Textile Mills Pty Ltd#, AWTA Product Testing# VicLab*
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 Australian Textile Mills Pty Ltd#, AWTA Product Testing# VicLab*
AS 2001.4.8/AS 2001.4.E01/ISO 105-E01 Determination of colourfastness to water Australian Textile Mills Pty Ltd#, AWTA Product Testing# VicLab*
AS 2001.4.15 Determination of colourfastness to washing Australian Textile Mills Pty Ltd#, AWTA Product Testing#  
AS 2001.4.17 Determination of colourfastness to perspiration AWTA Product Testing# VicLab*
AS 2001.4.21 Determination of colourfastness to light using an artificial light source (mercury vapour, tungsten filament, internally phosphor-coated lamp)  Australian Textile Mills Pty Ltd#, AWTA Product Testing#,
VicLab#
 
AS 2001.5.5 Determination of dimensional change in laundering of textile fabrics and garments—Cube machine method Australian Textile Mills Pty Ltd#, AWTA Product Testing#  
AS 2001.7 Quantitative analysis of fibre mixtures Australian Textile Mills Pty Ltd#, AWTA Product Testing#  
AS 3789.6 App C Method for determination of oil repellency   AWTA Product Testing*
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   AWTA Product Testing*
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   VicLab*
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#  
EN 1811   AWTA Product Testing*, VicLab*
EN ISO 4045 VicLab#  
EN 1413   AWTA Product Testing*, VicLab*
ISO 105-EO4 Australian Textile Mills Pty Ltd#, AWTA Product Testing#  
EN 14362.1   AWTA Product Testing*, VicLab*
ISO 105-B02 AWTA Product Testing# VicLab*
Gloves AS/NZS 4179:2014  N/A Tests are detailed within the Standard Enersol Pty Limited#, VicLab#  
AS/NZS 4011.1:2014  N/A Tests are detailed within the Standard Therapeutic Goods Administration#, VicLab#  
AS/NZS 4011.2:2014  N/A Tests are detailed within the Standard VicLab#  
AS/NZS 2161.10.1:2005 Rec:2016  N/A Tests are detailed within the Standard VicLab#  
Eye and Face Protection AS/NZS 1337.1:2010      UNSW ORLAB# NMI (optical testing)*
VicLab - (only to clauses applicable as to AS 4067)*
Sterility Testing - General       Contact NATA  
Hand Sanitisers Nil EN13727 in vitro test – testing for reduction in viable counts of transient organisms in labware (e.g. test tubes), under clean conditions, compared with a control. Eurofins AMS#
Mérieux NutriSciences#
 
EN 1500 in vivo test – testing for reduction in transient organisms on human test subjects (approximately 20), with reduction to be not significantly smaller than that produced by a reference hand rub (control) with propran-2-ol 60% v/v. Eurofins AMS#
Mérieux NutriSciences#
 
In house method VL 315 based on AOAC Official Method 972.11 and 972.10 Method involves identification and quantitation of Ethanol and/or Iso-propanol in antiseptic hand rubs (sanitisers) using Gas Chromatography with duel separation columns. The method was validated to cover a range of percentages (15% - 85 % v/v, with a limit of reporting of 5% v/v). The method will be used to identify and ensure the affective concentrations of the appropriate alcohols are incorporated into the sanitiser. NMI#  
# Note: Laboratories included in this column on advice from NATA.
* Note: Laboratories are included in this column on the basis that they have provided advice in writing that they have capabilities to issue formal test reports in accordance with the nominated Australian Standards on behalf of their organisation for the relevant test shown.

Disclaimer

This publication provides reference material for general information purposes only. It does not constitute legal or other professional advice. The Australian Technical Infrastructure Alliance and our department disclaim liability, to the extent permitted by law, for any liabilities, losses, damages and costs arising from relying on the information in this publication. You should seek legal or other professional advice for your specific circumstances. Any references to third-party organisations do not constitute endorsement of those organisations or their products or services.

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