Strategy for Success to Comply with IEC 60601-1
Ensuring compliance with IEC 60601-1 is simply a must for every medical device manufacturer. However, with revisions and updates, it’s difficult for a company to ensure they are constantly in compliance unless they have a dedicated expert on staff. Therefore, an excellent solution for this challenge is to partner with a company that is exactly that—an expert on the standard.
As medical devices continue to become more intricate and advanced, the relevant regulations and standards that ensure patient safety have evolved as well. The IEC 60601, a series of technical standards for ensuring the safety and effectiveness of medical electrical equipment, is a prime example of this. First published in 1977 by the International Electrotechnical Commission (IEC), the IEC 60601-1 has been regularly updated and restructured in an effort to ensure the continued safety and effectiveness of medical devices. These changes are often complex and require a higher level of compliance. The learning curve involved in understanding and complying with new standards often provides challenges to medical device manufacturers, which may result in costly delays to a product launch. Experienced test houses can serve as a valuable partner for guiding medical device manufacturers through the process of achieving compliance on time.
The IEC 60601-1 3rd edition is a comprehensive overhaul of the 2nd edition, which originates from 1988. The IEC published the 3rd edition of the IEC 60601-1 standard in 2005 and, subsequently, Amendment 1 in 2012. Several prominent regulatory agencies, such the United States FDA, its European counterpart, and Health Canada, have already outlined a mandatory date, which is presently in effect for the implementation of this standard. Therefore, compliance with the IEC 60601-1 3rd edition is critical for introducing a medical device to key markets in a timely manner.
In the 3rd edition, Risk Management (RM) and Essential Performance (EP) components are introduced. A manufacturer must now address and document more than 200 specific references to Risk Management. As a result of this, a greater level of collaboration is required between the manufacturer and the test house to ensure successful compliance of medical devices to IEC 60601-1. Compliance of a medical device to IEC 60601-1 3rd edition requires that a manufacturer have in place a risk management process complying with relevant requirements of ISO 14971: 2007. It is very important to note that one cannot satisfy the risk management requirements of IEC 60601-1 3rd edition by auditing the risk management processes or by achieving ISO 14971: 2007 registration.
Effective handling of risk management components, as specified by IEC 60601-1 3rd edition and ISO 14971: 2007, is important in achieving a successful certification. As Antony Young-Taylor, TÜV SÜD’s (www.tuv-sud-america.com) technical manager outlines, “A medical device manufacturer might face challenges with regard to documenting risk management. For example, a manufacturer may not be familiar with risk management techniques or have a complete understanding of the risk management requirements. Without a thorough understanding of the requirements as specified in IEC 60601-1 3rd edition, it can be difficult for a manufacturer to complete the risk management tables showing where the requirements have been met. It is important to note that these tables become an integral part of the test report.”
These challenges can often delay the certification process, requiring an inordinate amount of time during the initial phase of a testing project to correct the risk management files and tables. Partners who specialize in testing medical devices can offer specialized services that support manufacturers in implementing the IEC 60601-3rd edition, such as pre-assessments of risk management files and training on risk management techniques and principles. For example, the risk management review that TÜV SÜD offers is a premium service that will alleviate some of the manufacturer’s burdens. With this service, a TÜV SÜD test engineer can visit the manufacturer on-site or host the review in one of its laboratories. The test engineer can explain the risk management requirements and identify findings that can be fixed. As a result, the manufacturer can be confident that the certification process will go smoothly after completing a risk management review. With the risk management training sessions, an expert in the field can deliver the manufacturer the knowledge and confidence to ensure that their product will be certified without delay.
Complying with medical device standards can often be a daunting process. However, it is not a process that the manufacturer needs to embark on alone. Contacting and partnering with an experienced test house approximately two to three months before final testing and certification will help ensure that a manufacturer is able to successfully launch their products without costly and time consuming delays.
For more information, consider TÜV SÜD’s IEC 60601 3rd Edition Risk Management Workshop (http://bit.ly/mdt1308a).