With the publication of IEC 60601 3rd edition, manufacturers have been scrambling to meet EU and Canadian deadlines and formally incorporate a risk management process in the quality management systems. Device electrical and mechanical safety continues to be a critical path on the road to regulatory approvals and ongoing compliance.
Q: I heard there are new regulations for batteries used in medical devices. What do I need to be aware of?
A: FDA has recently added UL 1642, the Standard for Lithium Batteries, and UL 2054, the Standard for Household and Commercial Batteries, to the list of consensus standards. Consensus standards are standards recognized by FDA for use in evaluating medical devices before they are approved for market entry. FDA’s Center for Devices and Radiological Health (CDRH) believes that conformance with recognized consensus standards can support a reasonable assurance of safety and/or effectiveness for many applicable aspects of medical devices. The use of consensus standards are also a means to streamline the premarket review process. Therefore, the use of these recognized standards along with the use of another consensus standard, ANSI/AAMI ES 60601-1, the Standard for Medical Electrical Equipment, may assist medical device manufacturers in reducing regulatory obstacles to enter the U.S. market. Read more.
Q: My company was acquired by another company and we work with different safety certification providers. They are requiring us to transfer our IEC 60601 and IEC 61010 certifications to their provider. What can we expect and how can we make this as painless as possible?
A: Any change, even if its intended to have positive results, such as efficiencies gained in consolidating vendors, can cause sleepless nights. Companies can make this process easier and faster by being prepared, especially if you want to avoid re-testing. For each product family, it’s important to have a complete copy of the NRTL certification report and/or CB Scheme report with test data. It’s important to review the report to verify if the product has changed. If it has, then document the changes. Then, verify the standards you would like covered including the editions or amendments. It’s also best practice to prepare a statement on company letterhead declaring the product is in good standing and not under any recall. Bring the certification body in early and partner with the engineer who will be managing the transfer to open lines of communication and have a clear understanding of project deadlines. The engineer can then guide you on other documentation needed. Read more.