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In the context of COVID-19, there is an increasing interest in understanding the PPE regulations. To meet the growing interest, TGA the Australian Regulatory Authority has issued a guidance, which covers an overview of how PPEs are regulated, information for PPE manufactures and the PPE standards.
Overview of PPE Regulation: As per the item 2A of Schedule 1 of the Therapeutic Goods (Excluded Goods) Determination 2018, articles that are non-sterile PPE or safety apparel other than articles specified in item 1 of Schedule 1 to the Therapeutic Goods (Medical Devices - Specified Articles) Instrument 2020, are not declared as therapeutic goods. Item 1 of Schedule 1 to the Therapeutic Goods (Medical Devices - Specified Articles) Instrument 2020, specifies the following items to be medical devices: articles that are non-sterile PPE or safety apparel (including but not limited to aprons, face masks, gloves, goggles, gowns and visors) intended by the person under whose name the articles are or are to be supplied, to be used for the prevention of the transmission of disease between persons, including, where that intention may be ascertained from the articles being represented as suitable for use in surgery, or clinical, medical or other health services. These products are therefore regulated by the TGA as medical devices under the Therapeutic Goods Act 1989 and will need to be included in the ARTG before they can be supplied. PPE that meets the definition of a medical device will generally be regulated as either:
- a Class I medical device
- a Class Is (sterile) medical device
- a Class IIa medical device
Manufacturing PPE: While manufacturing PPE that makes therapeutic claims or is intended for use in a clinical setting, it should meet the definition of a medical device and align with the Regulatory requirements under:
- The Therapeutic Goods Act 1989
- The Therapeutic Goods (Medical Devices) Regulations 2002
- The Therapeutic Goods Regulations 1990
Manufacturers of all medical devices (including IVD medical devices) manufactured and/or supplied in Australia should ensure that they have appropriate conformity assessment procedures in place for the device and appropriate documentation demonstrating compliance of the device with the Essential Principles.
PPE Standards: While choosing the applicable standards for each device, the manufacturer must consider the following:
- the intended purpose of the device
- the environment in which it is likely to be used
- users of the device
- generally acknowledged state-of-the-art
Surgical Masks and Respirators
- ISO 22609:2004 Clothing for protection against infectious agents - Medical face masks
- AS/NZS 4381:2015 Single-use face masks for use in health care
- ASTM F2100 - 19 Standard specification for performance of materials used in medical face masks
- AS ISO 16900.3 2015 Respiratory protective devices
- AS NZS 1716:2012 Respiratory protective devices
- EN 149:2001 + A1 Respiratory protective devices
- GB 2626-2006 Respiratory protective equipment
- EN 14683:2019 Medical face masks
- AS NZS 1715:2009 Selection, use and maintenance of respiratory protective equipment
Surgical Gowns
- ANSI/AAMI PB70:2003, Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
- ASTM F2407 - Testing for surgical gowns
- I.S. EN 13795:2011 Surgical drapes, gowns and clean air suits
- ASTM 1670 Test method for resistance of materials used in protective clothing to penetration by synthetic blood
- ASTM 1671 Resistance of materials used in protective clothing to penetration by blood-borne pathogens
- ISO 22610 Surgical drapes, gowns and clean air suits
- ISO 22612 Clothing for protection against infectious agents
Surgical Gloves
- ISO 10282:2014 Single-use sterile rubber surgical gloves
- AS/NZS 4179:1997 (ISO 10282:1994) Australian/New Zealand Standard® Single-use sterile surgical rubber gloves
- BS ISO 10282:2014 Single-use sterile rubber surgical gloves
- ASTM International (ASTM) standard D3577-Rubber Surgical Gloves, D3578-Rubber Examination Gloves, D5250-Poly(vinyl chloride) Gloves for Medical Application or ASTM D3578 standard or equivalent standard for natural rubber latex
- AS NZS 4011 Single-use medical examination gloves
PPE manufacturers willing to enter the Australian market must adhere to the aforementioned TGA standards. To ensure compliance and to understand the guidance completely, opt for a proven Regulatory expert. Stay informed. Stay compliant.
