What Are The Regulatory EMC Testing Requirements For Medical Devices?
Medical devices are heavily regulated as failure could have negative consequences ranging from injury to fatality. If a medical device is coupled with a wireless functionality it requires even more extensive knowledge of the regulatory compliances required to ensure that products are safe, fit for purpose, and what impact it can have on other electric or wireless devices in close proximity to its use.
EMC testing, therefore, becomes a critical part of any medical device testing program although it forms a small part of overall approval. EMC testing takes into account the impact on the environment as well as electromagnetic risk identification, analyses, and controls set in place to mitigate threats posed by other electrical equipment in the area.
EMC Testing And Risk Management For Medical Devices
When it comes to medical devices, risk management lies at the very heart of EMC testing. Manufacturers are required to perform assessments based on standard requirements in conjunction with any risks that may be identified. In addition, manufacturers are required by the TGA to consider the implications of being exposed to any known RF devices that may be used in medical facilities like hospitals and clinics.
Testing that specifically addresses threats from RFID (Radio Frequency Identification Readers) assesses specific modulations across a range of frequency bands on which these products operate.
Making use of our experience in conventional EMC testing, Compliance Engineering has developed a range of EMC testing services to assist manufacturers in preparing and testing against the required standards and ensuring that these types of risks are mitigated in medical devices.
Accredited Medical Device EMC Testing
Our Compliance Engineering laboratories are accredited to NATA Medical Safety standards. In Australia, all devices that come under the jurisdiction of the TGA must be tested to the base standard of IEC 60601-1 and to IEC 6060-1-2.
In addition, there may be a device standard that needs to be looked into when considering safety requirements. We also have the ability to investigate on-site interference issues associated with electronic medical equipment such as MRI and Ultrasound.
Who Is Responsible For The Regulation Of Medical Devices In Australia?
The TGA (Therapeutic Goods Administration) is in charge of regulating medical devices and other healthcare products in Australia. As some medical devices may pose a greater risk compared to others the TGA classifies and regulates these devices based on specific levels of risk.
Any manufacturer in Australia that wants to supply a medical device to the Australian market must apply to have the device included in the ARTG (Australian Register of Therapeutic Goods) the publicly available and searchable register of the TGA.
Compliance With Australian Regulatory Requirements Is Compulsory
Australia has some of the most stringent regulatory requirements for medical devices in the world. The TGA makes the final decision after an appropriate level of review has been followed and never automatically includes a device in the register, based solely on overseas approval.
Before and after a medical device has been registered the TGA has the power to compel sponsor companies to provide further information regarding the device. Based on this information the TGA has the power to either allow or refuse the supply of a new device onto the Australian market or can terminate the supply of an existing device already on the market.
How Can Compliance Engineering Help Get Approval For Your Medical Device?
Our test laboratories are capable of handling any EMC testing project from small to large. Our accredited testing reports will allow you to access local as well as many global markets.
Compliance Engineering can assist you with compliance testing for the following:
EMC testing can help save time and money before submitting a device for compliance by finding out beforehand whether it is safe and fit for purpose, whether it will interfere with other electronic devices in its vicinity, and what precautions should be taken before using the device near other sensitive equipment operating on low levels of current flow.
An EMC test can determine how your device will react when in use and how far away it should be from other equipment to prevent interference problems.
Compliance Engineering offers accredited testing services for a broad range of products in particular compliance with EMC regulations in Australia. We provide the highest standard of environmental testing that measures the performance of specific products under particular environmental conditions.
Please call us today at Compliance Engineering on + 61 3 9763 3079 or leave an enquiry.