Standard and Regulation Glossary

AAMI – The AAMI (Association for the Advancement of Medical Instrumentation) standards program consists of over 100 technical committees and working groups that produce Standards, Recommended Practices, and Technical Information Reports for medical devices. For more than 50 years, AAMI has been at the forefront in developing voluntary consensus standards, technical information reports, and other technical documents. These standards, developed through the coordination of volunteers from around the world, are used throughout the healthcare field to ensure the safe and effective production, distribution, and use of health technology. AAMI is an accredited standards development organization by the American National Standards Institute (ANSI) which signifies that the procedures we use to develop American National Standards meet ANSI’s essential requirements for openness, balance, consensus, and due process.

ANSI/AAMI PB70:2012 (ANSI/AAMI PB 70:2012) – Liquid Barrier Performance And Classification Of Protective Apparel And Drapes In Health Care Facilities. This standard establishes minimum barrier performance requirements, a classification system, and associated labelling requirements for protective apparel, surgical drapes, and drape accessories intended for use in health care facilities.

ACT is a legislation passed by the Parliament. Acts, (not including Schedules to Acts)( can only be amended by another Act of Parliament. Acts set out the broad legal/ policy principles.

AS and AS/NZS – Standards Australia develops internationally aligned Australian standards (AS) and participates in standards-related activities that deliver benefit to the nation. Standards Australia and Standards New Zealand also work together to develop joint standards (AS/NZS).

AS/NZS 4011:2014 – Single-use medical examination gloves (superseded ASNZS 4011:1997) Specification for gloves made from rubber latex or rubber solution (ISO 11193-1:2008, MOD). Specifies requirements for exam gloves use in medical examinations and diagnostic or therapeutic procedures to protect the patient and the user from cross-contamination.

AS4381:2015 – Single-use face masks for use in health care (superseded AS4381:2002) This Standard sets out requirements for single-use face masks which are used in health care where it is necessary to keep cross-contamination between the health care workers and the patient to a minimum. The masks are intended for use in surgical, medical and dental procedures.

ASTM – The American Society for Testing and Materials. ASTM develops and publishes technical standards for many different industries with the goal of enhancing performance and safety over a wide range of products, materials, systems, and services. At ASTM International, producers, users, consumers, and others from all over the world join together to develop voluntary consensus standards. Their voluntary members represent producers, users consumers, government and academia from more than 140 countries. They develop technical documents that are the basis of manufacturing, management, procurement, codes and regulations for dozens of industry sectors. ASTM standards are voluntary in that they do not mandate their use. However, government regulators often gave voluntary standards the force of law by citing them in laws, regulations and codes. ASTM standards are developed under a process that embraces the World Trade Organization Technical Barriers to Trade Agreement principles. The ASTM standards development process is open and transparent, allowing individuals and governments to participate directly, and as equals, in a global consensus decision.

ASTM F2101 -19 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus. This test method is used to measure the bacterial filtration efficiency (BFE) of medical face mask materials, employing a ratio of the upstream bacterial challenge to downstream residual concentration to determine filtration efficiency of medical face mask materials. This test method has been specifically designed for measuring bacterial filtration efficiency of medical face masks, using Staphylococcus aureus as the challenge organism. The use of S. aureus is based on its clinical relevance as a leading cause of nosocomial infections.  This test method has been designed to introduce a bacterial aerosol challenge to the test specimens at a flow rate of 28.3 L/mm. (1 ft3/min). This flow rate is within the range of normal respiration and within the limitations of the cascade impactor. Degradation by physical, chemical, and thermal stresses could negatively impact the performance of the medical face mask material. The integrity of the material can also be compromised during use by such effects as flexing and abrasion, or by wetting with contaminants such as alcohol and perspiration. Testing without these stresses could lead to a false sense of security. If these conditions are of concern, evaluate the performance of the medical face mask material for bacterial filtration efficiency following an appropriate pretreatment technique representative of the expected conditions of use. Consider preconditioning to assess the impact of storage conditions and shelf life for disposable products, and the effects of laundering and sterilization for reusable products.

ASTM D6319 Standard Specification for Nitrile Examination Gloves for Medical Application – This specification contains test procedures for evaluating the performance and safety of nitrile rubber gloves for use in conducting medical examinations and diagnosis and therapeutic procedures. The products covered by this specification include nitrile rubber gloves that fit either hand, paired gloves, and gloves by sie and packaged sterile or non-sterile or bulk nonsterile. An approved lubricant for absorbable dusting powder may be applied to the gloves. Other lubricants may also be used, provided, that their safety and efficacy have been previously established. Both the inside ad outside surfaces of the glove should be free of talc. All products should meet the required degree of sterility, freedom from holes, physical requirements before and after ageing, amount of powder on the glove, tensile strength and ultimate elongation.

ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs – The objective of this practice is to provide a uniform procedure for assessing the resistance of medical glove materials to permeation by chemotherapy drugs, and to establish a consistent reporting of the test data. This practice covers a protocol for the assessment of resistance of medical glove materials to permeation by potentially hazardous cancer chemotherapy drugs under conditions of continuous contact. An assessment is made based on the permeation (breakthrough) of nine chemotherapy drugs through the glove material over a certain period of time.

EN (ISO) 374 is Protective gloves against dangerous chemicals and micro-organisms – consists of the following standards:

  • EN 374-2:2014 – Determination of resistance to penetration. Chemicals can penetrate through holes and other defects in the glove material. To secure a glove to be approved as a chemical protection glove the glove shall not leak water or air when tested according to penetration.
  • EN 374-4:2013– The glove material might be negatively affected by chemical contact. Degradation shall be determined according to each chemical. The degradation result, in percentage (%), shall be reported in the user instruction.
  • EN 16523-1:2015 Determination of material resistance to permeation by chemicals. Permeation by liquid chemical under conditions of continuous contact. The chemicals break through the glove material at a molecular level. The breakthrough time is here evaluated and the glove must withstand a breakthrough time of at least:
    • Type A – 30 minutes (level 2) against minimum 6 test chemicals
    • Type B – 30 minutes (level 2) against minimum 3 test chemicals
    • Type C – 10 minutes (level 1) against minimum 1 test chemical

EN 455-1:2000 – This standard specifies requirements and gives the test method for medical gloves for single use in order to determine freedom from holes.

EN 455;2: 2009 – This standard specifies requirements and gives test methods for physical properties of single-use medical gloves in order to ensure that there provide and maintain in use an adequate level of protection from cross-contamination for both patient and user.

EN 455-4:2009 Shelf life determination – this test ascertains requirements for shelf life for medical gloves for single use. Also ascertains the requirements for labelling and the disclosure of information relevant tot he test methods used.

FDA – The scope of the U.S. Food & Drug Administration regulatory authority is very broad. They regulate a vast range of industries and products including food, drug \, biologics, medical devices, cosmetic, veterinary products, advertising, alcohol, meat & poultry, pesticides, water and etc. In short, FDA is similar to TGA in some ways where they regulate the medical devices being sold into the US market.

HACCP stands for Hazard Analysis Critical Control Point. HACCP is a risk management methodology used by the food and related industries for the control of food safety hazards to acceptable risk levels. HACCP international’s Certification Mark is confirmation, from an independent 3rd party product certifier, as to a non-food product’s ability to support the integrity and safety of food as demanded by industry expectations, legislation and GFSI (Global Food Safety Initiative) endorsed standards.

ISO (The international organization for standardization) is a worldwide federation of national standards bodies. It is an independent, non-governmental international organization with a membership of 162 national standards bodies. Through its member, it brings together experts to share knowledge and develop voluntary, consensus-based, market-relevant International Standards that support innovation and provide solutions to global challenges. It also provides specifications for products, services and systems, to ensure quality, safety and efficiency.

ISO 11193-1 Single-use medical examination gloves – Part 1: Specification for gloves made from rubber latex or rubber solution – specifies requirements for packaged sterile, or bulked non-sterile, rubber gloves intended for use in medical examinations and diagnostic or therapeutic procedures to protect the patient and the user from cross-contamination. It also covers rubber gloves intended for use In handling contaminated medical materials and gloves with the smooth surface over all or part of the glove.

NFPA 1999 The National Fore Protection Association (NFPA) is a global not-for-profit organization, established in 1896, devoted to eliminating death, injury, property and economic loss due to fire, electrical and related hazards. This standard specifies the minimum documentation, design, performance, testing and certification requirements for new single-use and new multiple-use emergency medical protective clothing, including garments, gloves, footwear, and face protection devices, used by fire and emergency services personnel during emergency medical operations. ( The standard primarily being more recognised in USA)

Regulations, Rules, Codes etc. are commonly known as ‘subsidiary legislation’ and require publishing in the Government Gazette to become legal. These are the guidelines that dictate how the provisions of the Act are applied. They may also contain pro format official forms ha are required under the Act/ Regulations and schedules to Acts can only be amended by a notice published in the Government Gazette. Generally, if it’s the legal/statement of Law that you want, then it is the Act that is required. If it is an implementation detail, then the Regulation is required.

TGA – Therapeutic Goods Administration is part of the Australian Government Department of Health, and is responsible for regulating therapeutic goods including prescription medicines, vaccines, sunscreens, vitamins and minerals, medical devices, blood and blood products.

What are the differences between the Australian Standards and Mandatory Standards?

There are two key differences between voluntary standards and mandatory standards:

  1. It is legal to supply products in Australia that do not meet Australian standards:
  2. While Australian (voluntary) Standards may address a range of issues that are not safety-related, mandatory safety standards should

Often, but not always, the requirements of a mandatory standard are based on an existing voluntary standard. It is illegal to claim that a product meets either voluntary or mandatory standards when it does not.

What are Voluntary standards

  • voluntary standards are developed by Standards Australia or other standards-making body through a process of technical committee assessment, discussion and drafting.
  • Suppliers may choose to meet some, all or none of the requirements of voluntary standards.
  • Depending on how current they are, voluntary standards are likely to represent industry best practice with the safe design, supply and use of those products captured by the definitions in the standard.

What are mandatory standards

  • Mandatory standards are developed by the ACCC through a process of internal assessment, discussion and drafting in conjunction with public and industry consultation. (None of the mandatory standards applies to any of the Mun’s products)
  • Suppliers are legally bound to comply with all the requirements of mandatory standards
  • Mandatory standards establish a minimum set of safety requirements which all products captured by the definitions in the standard must meet to be legally supplied in Australia.

In summary….

Australian standards are NOT mandatory.

On their own, Standards have no legal status and no requirement for compliance by manufacturers, consumers or the public, hence the term ‘voluntary Standard’. Australian (AS) or joint Australian/New Zealand (AS/NZS) Standards are often called up in State and Commonwealth legislation. When this happens, these Standards become mandatory and can be subject to the scrutiny of the courts.