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 ...

IEC 60601 is no longer a standard of absolutes. The third edition allows, and in some instances requires, safety features and test requirements to be modified on the basis of risk management. By ...

CUI Devices has announced a line of medical buzzers compliant with IEC 60601-1-8 alarm signal requirements. There are four CPIM-4410-80x buzzers, with a letter replacing the ‘x’ depending on function: ...

CUI Devices’ Audio Group has announced a new line of medical buzzers compliant with the alarm signal requirements of IEC 60601-1-8. The CPIM family is a range of piezo audio indicator buzzers capable ...

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 ...

CUI Devices’ Audio Group has released a new line of medical buzzers that comply with the alarm signal requirements of IEC 60601-1-8. The CPIM family is a range of piezo audio indicator buzzers that ...

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 ...