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HEALTHCARE EMC for Medical implants


Jonathan Newell looks at the complex landscape of electrical safety standards in healthcare and the work of one US laboratory that performs EMC and electrical safety testing for medical implants.


❱ ❱ Electrically active devices that are surgically implanted in patients need to undergo EMC testing to ensure they’re not susceptible to interference


T


he healthcare industry is in a constant state of innovation at all levels. New treatments, medicines and technology emerge almost daily. Whilst


few make the headlines, the majority provide a continuous positive trend in the comfort, well-being and safety of patients.


COMPLEX STANDARDS LANDSCAPE To prevent potentially catastrophic mistakes, mishaps and misjudgements from plaguing the industry and adversely affecting its main aims, healthcare is very highly regulated and all aspects of new technology that affect it come under detailed scrutiny, including the electrical safety of medical devices. The regulatory standards landscape is complex, involving international and country specific standards as well as those imposed by Government bodies such as the US Food and Drug Administration (FDA). Generally applicable international


standards relating to electrical safety of medical devices include ISO 14708- 1, ISO 14791 (for implantable devices) and ISO 60601-n, the latter covering more than 50 different types of electro- medical devices.


INDEPENDENT TESTING With such complexity, device suppliers use the expertise of laboratory service providers such as Emergo, Eurofins and Intertek, which has recently been accredited by the American Association


for Laboratory Accreditation (A2LA) at its Boxborough, Massachusetts laboratory to test active implantable medical devices (AIMDs) to ISO 14708-1 and EN 45502-1 standards. With this accreditation, Intertek becomes the first independent laboratory in North America accredited for electrical safety and electromagnetic compatibility (EMC) testing for both implantable and non-implantable medical devices.


ACTIVE IMPLANTABLE DEVICES Active implantable medical devices rely on a source of power other than what is provided by the body or gravity, and are intended to be surgically or medically inserted into the body and remain there after the procedure. As one of the highest risk categories of medical devices, they are subject to rigorous regulatory standards by the FDA and other authorities around the world. To reduce risk and ensure quality, medical device manufacturers choose to work with third-party laboratories to illustrate compliance with these electrical safety, EMC and wireless standards. Most active implantable devices


consist of both the product inserted into the body and non-implantable supporting equipment, both of which require testing and evaluation to medical


regulatory standards, including IEC 60601-1- 2 3rd Edition for non- implantable devices and components. With the new accreditations, Intertek now offers fully-accredited electrical safety, EMC and wireless device testing and evaluation


services for both implantable and non- implantable products, with one all- encompassing report to be submitted to the FDA or other notified bodies. This in turn can help reduce costs and allow customers to get products to market faster. Sunny Rai, Senior Vice President


at Intertek, commented: “At Intertek, our focus has always been to provide innovative Assurance, Testing, Inspection and Certification services to our customers to help them bring their products to market quickly, efficiently and safely. We are delighted to offer the medical device industry the evaluation they need for active implantable devices in one location with a team of highly proficient experts who are familiar with the necessary requirements for this growing medical field.” Intertek has spent over half a century working alongside medical device manufacturers and so understands the technology and the regulatory requirements that these products must meet, including those for mobile health applications and software.


EMC Testing Vol 1 No. 2 /// 19


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