Minimize the work necessary to update end medical devices to the latest standards.
By Don Baldwin, Technical Support Manager—Power at Sager Electronics.
Medical equipment safety standards are critical in ensuring patient and operator safety. The evolution from Medical 60601-1 Ed 3.1 to Ed 3.2 product safety and 60601- 1-2 from Ed 4.0 to Ed 4.1 electromagnetic compatibility (EMC) marks a significant advancement in addressing emerging risks, enhancing usability, and aligning with technological innovations.
The new standards broaden their scope to include essential performance and usability aspects. This expansion reflects a holistic approach to device safety and functionality, considering the entire user experience while ensuring that devices maintain functionality and safety under varying electromagnetic environments. The changes introduce more stringent requirements for risk management processes: manufacturers must conduct comprehensive risk assessments throughout the device lifecycle, ensuring potential hazards are identified and mitigated effectively, requiring implementation of additional risk reduction measures to mitigate EMC- related risks successfully.
Medical safety 60601-1 Ed 3.2 emphasizes usability engineering as a critical factor in device design and development, including considerations for intuitive operation, user interfaces, environmental conditions, and ergonomic factors, aiming to reduce user errors and improve overall safety. It also defines essential performance criteria more clearly: manufacturers must make certain devices consistently meet these criteria under normal conditions and foreseeable misuse scenarios, enhancing reliability and predictability in clinical settings.
EMC requirements 60601- 1-2 Ed 4.1 includes updated testing protocols to evaluate device performance under realistic electromagnetic conditions. This includes more rigorous scenarios to simulate diverse clinical environments and potential electromagnetic interference (EMI), ensuring devices remain safe and operational in practical settings, and placing greater emphasis on compatibility with external medical and non-medical equipment. Manufacturers must make sure devices can coexist with other electronic systems without causing or succumbing to interference, thereby minimizing disruptions in clinical workflows and patient care.
Specific cybersecurity provisions to safeguard medical devices against evolving cyber threats are being integrated, including requirements for secure design, data protection, and resilience against unauthorized access, protecting patient data confidentiality and device integrity.
In order to establish clearer guidelines for compliance documentation, manufacturers are required to provide comprehensive evidence of conformity with regulatory standards, facilitating smoother regulatory approval processes and maintaining transparency in device performance and safety claims.
These updated standards align more closely with relevant international standards and regulatory frameworks, promoting global harmonization of medical device safety and EMC requirements. This alignment simplifies compliance efforts for manufacturers operating in multiple markets and enhances consistency in device safety and EMC standards worldwide.
The transition from 60601- 1Ed3.1toEd3.2and 60601-1-2 Ed 4.0 to Ed 4.1 underscores the industry’s commitment to innovation and safety, fostering confidenceamong healthcare providers and patients alike in the reliability and effectiveness of medical devices in diverse clinical settings.
Sager Electronics’ suppliers are in the process or have completed updating the approvals on their medical power supplies to the latest Medical Safety 60601-1 Ed 3.2 and EMC 60601-1-2 Ed 4.1 standards. Sourcing a power supply that meets the latest safety and EMC requirements minimizes the amount of additional work necessary to update the end medical device to the latest standards.