Standards Development

Australian Standards are published documents setting out specifications and procedures designed to ensure products, services and systems are safe, reliable and consistently perform in the way they were intended. They establish a common language that defines quality and safety criteria and are used by manufacturers and regulators to achieve consistent outcomes.

The Australian Dental Industry Association (ADIA) is the primary reference point for Standards Australia in seeking advice and guidance from dental product manufacturers regarding development of product technical standards. This is primarily facilitated by the nomination by ADIA nominating representatives, of member businesses to serve on Standards Australia technical committees.

As the peak business association representing manufacturers and suppliers of dental products, ADIA nominates representatives to the following Standards Australia committees:

CS-099 — Sports Mouthguards

This committee reviews the acceptability for Australia of International Standards addressing the performance safety and specification requirements for sports mouthguards in addition to relevant clinical and laboratory test methods for these products.

HE-004 — Dentistry

This committee reviews the acceptability for Australia of International Standards addressing the performance safety and specification requirements of dental products as well as clinically relevant laboratory test methods for dental products.

HE-008 — Diagnostic Ionizing Imaging Equipment

This committee develops Australian Standards (AS3200.2) for dento-maxillofacial x-ray equipment (including computed tomography) that sets out safety requirements associated with equipment design and use.

HE-013 — Surgical Apparel

This committee develops Australian Standards (AS4381, AS/NZS4011.1, AS/NZS4011.2 and AS/NZS4179) that set out design, performance and test requirements for single-use face masks, single-use examination gloves and single-use surgical gloves used in healthcare.

HE-023 — Processing Of Medical & Surgical Instruments

This Committee develops Australian Standards and is represented on several International Standards Organisation (ISO) Committees, including ISO TC 198 “Sterilization of health care products”

AS 2773:2019 - Ultrasonic cleaners for health service organisations
AS 5330:2019 - Drying cabinets for reusable medical devices
AS 5369:2023 - Reprocessing of reusable medical devices and other devices in health and non-health related facilities
AS/ISO/TS 11137-(series):2020 - Sterilization of health care products - Radiation - Parts 1 through 4

HE-030 — Biological and Clinical Evaluation of Medical Device

This committee reviews the acceptability for Australia of International Standards addressing the approach to biological and clinical evaluation of medical and dental materials and devices, together with standardisation of biological test methods applicable to those materials and devices as well as good clinical practice principles to clinical investigations in humans of those devices.

ME-003 — Sterilising Equipment

This committee reviews the acceptability for Australia of International Standard addressing the design, performance and maintenance requirements for machines in healthcare facilities that wash, disinfect or sterilise equipment.

ADIA provides members the opportunity to review draft Australian Standards and make submissions to ensure they reflect the needs and interests of dental product manufacturers, suppliers and consumers.

Further Information

If you have an interest in ADIA's work at a parliamentary and departmental level to secure the policy reforms that support businesses in the dental industry, subscribe to the ADIA database for regular updates. Alternatively, you can contact the Association via email or by telephone on 1300 943 094.

This information is available for your use under a Creative Commons Attribution 3.0 Australia licence, with the exception of the ADIA logo, other images and where otherwise stated.