This oversight can be costly to the medical manufacturer in terms of product design expenses, compliance testing and certification turnaround time, and the device approval process. Medical products ...

In all its incarnations, IEC 60601-1 has played an important part in ensuring the safety of electrically operated medical devices and, therefore, in complying with medical device regulations. 1 The ...

Earlier this year the US followed the EU and Canada in moving to the3 rd edition of the IEC 60601-1 medical device standard. This change presents several challenges and adds layers of complexity for ...

KingPo KP-6061C helps laboratories evaluate medical bed dynamic loading, mattress platform impact, body-weight ...

The IEC 60601 standards series is one part of putting together a technical file or a 510(k) submission. It’s about more than electrical safety — it covers mechanical safety, labeling and risk ...

Magic Leap, the storied unicorn developing enterprise AR headsets, announced at CES 2023 that its flagship device Magic Leap 2 earned a certification that clears it for use in the operating room. The ...

The upcoming 4th Edition of the IEC 60601 1 standard represents a significant evolution in the regulatory expectations for medical electrical equipment and medical electrical systems. This ...

The IEC 60601-1standard establishes general safety requirements for all aspects of medical devices. It includes test requirements, documentation, protection from electrical hazards, protection from ...