FEATURE POWER ELECTRONICS


LEGISLATIVE CHANGES THAT WILL IMPACT POWER SUPPLIES


Kevin Parmenter, VP applications engineering at Excelsys Technologies investigates why obtaining ISO 13485 compliance from your power supply partner is crucial if you are in the medical electronics device industry


and ISO62304 software requirements for medical systems – also makes frequent reference to ISO13485 – and dovetails into these standards to make a comprehensive overview of most of what medical device companies must meet if they are to sell globally. ISO9001 is different in many ways. Many global medical device manufactures interpret this, that they must maintain both ISO9000 (9001) AND ISO13485. One principal difference is that ISO 13485


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SO 13485 is a series of requirements that help medical device manufacturers develop a quality management system. According to the official ISO 13485 standard, these requirements “can be used by an organisation for the design and development, production, installation and servicing of medical devices, and the design, development, and provision of related services.”1 Although ISO 13485 is a stand-alone document, it is often harmonised with ISO 9001, the world’s leading quality management standard. According to ISO’s website, the revised 9001 standard is expected to be published by the end of 2015. Standards such as ISO14971 – risk management and data collection and ISO62304 the software standard for medical devices both dovetail into ISO13485 – this should be a very key point on just how important and relevant this specification is.


WHY SHOULD I CARE ABOUT ISO13485? Primarily the most important, or perhaps the highest risk regulatory item a medical device company can focus on is the power supply, it’s simply a compliance and safety and regulatory mine field if you don’t pick the right partner – the power supply contains high voltages, lots of EMI-EMC (which proper design helps meet compliance) high energy, exposure to surges and transients – which can potentially cause fires, leakage currents; in short this is a key risk item and if you don’t pick the right partner a lot can go wrong. Much of these – but not all are covered in ISO60601 (latest editions including EMC). With relation to ISO13485 for the sake of this


discussion – the power supply is a critical item for meeting global safety and compliance approvals, including ISO13485. This is important because interpretation by many medical device makers is that if they have


18 JULY-AUGUST 2016 | ELECTRONICS


to meet something it’s simply easier to push requirements onto suppliers, which by definition if suppliers meet ISO13485 it’s easier for the device maker to meet ISO13485. Manufacturers can employ ISO 13485 to meet the quality system requirements of the European directives, including European Medical Device Directive (93/42/EEC). Confusion frequently occurs when people use the abbreviated ISO 13485 to refer to both ISO 13485:2003 and EN ISO 13485: 2012. This leads some to assume that there is a 2012 version of the primary (2003) standard, which there isn’t. The third version is CAN/CSA-ISO 13485:03. Conformance to this standard is necessary in order to secure a Canadian Medical Device Licence for a Canadian class II, III or IV medical device. Health Canada considers this variant to be the equivalent to ISO 133485:2003. US medical electronics device makers have interpreted this to mean they must meet ISO13485 and ISO9000- 9001 and they require their suppliers to do so as well.


HOW DOES ISO 13485 DIFFER FROM ISO 9001? The most fundamental difference between the two standards is that ISO 13845 is tailored specifically to medical device companies, whereas any company, of any size, within any industry sector, can use ISO 9001. Additionally, ISO 9001 requires the certified company or organisation to demonstrate continual improvement. By contrast, ISO 13485 requires only that the organisation demonstrate that its quality system is effectively implemented and maintained. Again, specifications such as ISO14971 for risk analysis for medical equipment companies


Figure 1:


Medical Approvals for Excelsys Xgen Configurable Power Supplies


excludes the ISO 9001 requirements regarding customer satisfaction, focusing instead on regulatory requirements as a management responsibility. Finally, unlike ISO 9001, 13485 places great emphasis on the importance of risk. It requires device manufacturers, as well as their sub-tier suppliers and contractors, to apply risk management and risk analysis from product development through product realisation. It is not uncommon for non-medical device


companies to upgrade or migrate from 9001 to ISO 13485 (or to maintain both certifications) in order to introduce their existing products for use in medical applications. Device manufacturers that intend to market their products within the European Union will need to address compliance with the requirements of the applicable Medical Device Directive (MDD) and CE marking process. ISO 13485 is recognised as a critical aid in supporting compliance with the MDD.2 In today’s global medical device industry, it’s


no longer enough to merely comply with FDA requirements. Medical device manufacturers must address the demands of regulators from countries around the world. Achieving ISO 13485 certification is a worthy endeavour since maintaining ISO standards promotes customer, investor, and employee confidence, and builds a system that is ideal for automation and increased productivity. Requiring suppliers to adhere to these


requirements in their manufacturing and process operations is a reasonable way for medical device companies to meet their goals of obtaining and sustaining ISO13485 compliance as well as ISO9000-9001. If you are not sure – ask your power supply partner for documentation and certifications that they meet these necessary standards to save your organisation time and money.


Excelsys Technologies Ltd. www.excelsys.com T: +353 21 4354716


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