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03 Dec

Button batteries to receive new guidance

Leaders from the consumer, services and product industry came together at Standards Australia recently to agree on the development of a button battery standard.

This decision follows an increase of concerned communities as the use of button batteries continues to rise in Australia. Known for being in children’s toys, button batteries can now be found in a much wider range of consumer products and are also sold as a standalone product.

“The outcome of this forum of members of the public, industry bodies and regulators including the Australian Consumer and Competition Commission (ACCC), confirmed concerns around button batteries and the need to provide further guidance to address button batteries issues in a measured approach,” said Head of Stakeholder Engagement Daniel Chidgey.

“While there are some standards that reference these batteries, there is not yet any holistic guidelines for products with button batteries,” said Mr Chidgey.

“Button batteries can be found in a range of items including thermometers, remote controls, children’s toys and novelty items,” said Ms Barbara Geens, Chair of the Industry Working Group on Button Batteries Safety. “The goal of this proposed standard is to create a unified approach for safer use and distribution of these batteries which is an essential step in protecting consumers.”

“This is an example of Standards Australia proactively working with industry, government and the public to provide the right standards solutions to equip the consumer products, services and safety sector. We look forward to continuing to work with industry and the Australian community in developing this pivotal guidance,” concluded Mr. Chidgey.

Read more at: Standards Australia

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13 Mar

Button battery safety failures. CHOICE test labs find plenty of safety risks in everyday household items.

Industry ignores voluntary guidelines


  • 10 out 17 common household products failed our button battery safety test.
  • Despite two deaths and many injuries to children, product makers are largely ignoring the voluntary button battery safety code.

Button batteries are everywhere these days, powering everything from medical devices to musical birthday cards.

But there’s a price to pay for the convenience: button batteries have long been a potentially lethal threat to young children, who ingest them at an alarming rate.

Read more here.

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21 Sep
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12 Feb

The ACMA requires the supplier to sign a Declaration of Conformity (DoC) before labelling the product with the RCM

The final step to product compliance involves labelling the product:

Steps to compliance
1. Identify the applicable labelling notice
2. Identify the applicable technical standards (prescribed in the relevant labelling notice) and the testing requirements
3. Demonstrate product compliance
4. Complete a Declaration of Conformity (DoC) and maintain compliance records
5. Register as a ‘responsible supplier’
6. Label the product
The ACMA regulatory arrangements require a supplier to apply a compliance label to a product before the product is supplied to the Australian market.

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31 Aug

Medical Device Regulatory Practices – An International Perspective, by Val Theisz

This book is intended to serve as a reference for professionals in the medical device industry, in particular those seeking to learn from practical examples and case studies. Medical devices, like pharmaceuticals, are highly regulated and the bar is raised constantly as patients and consumers expect the best quality healthcare and safe and effective medical technologies. Obtaining marketing authorization is the first major hurdle that med techs need to overcome in their pursuit of commercial success.
Most books on regulatory affairs present regulations in each jurisdiction separately: European Union, USA, Australia, Canada, and Japan. This book proposes practical solutions for a coherent, one-size-fits-all (or most) set of systems and processes in compliance with regulations in all key markets, throughout the life cycle of a medical device. It also contains key information about international harmonization efforts and recent regulatory trends in emerging markets; important terminology needed to understand the regulators’ language; and examples, case studies, and practical recommendations that bridge the gap between regulatory theory and practice.

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