Answers to Critical Questions

How will the third edition of IEC/EN 60601-1 and 62336 affect your products?

IEC/EN 60601-1 has been a crucial tool for demonstrating the safety of electrically operated medical devices and their compliance with regulatory requirements around the world. This critical standard has been revised! The new edition includes requirements: to apply Risk Management to each design, to identify and address safety related to Essential Performance and to perform a usability analysis according to IEC/EN 62336 (harmonized to the MDD) to identify what constitutes reasonably foreseeable misuse. The new standard can also provide far greater flexibility in meeting requirements, but it will be critical for designers and engineers to fully understand the requirements.

Contact Strategic Device Compliance Services and your organization can benefit from the same training provided by the authors of the standard or take advantage of our Compliance Upgrade Package!

Download A FREE Sample of Our IEC 60601-1, 3rd Edition Compliance Management Tool!

Is your Risk Management process compliant with ISO 14971?

Many manufacturers are aware of the new ISO 14971 which has also been adopted by Europe as a harmonized standard that has replace EN 1441 (Risk Analysis). A recent informal survey of European Notified Bodies indicated that roughly 90% of the manufacturers they serve claim to have 14971 compliant processes. However, the Notified Bodies also estimate that only 10-15% of those processes actually do comply. Our consultants participation in the development of 14971 gives us the ability to help you fully meet the requirements with a cost-efficient risk management process.

Also, see our articles: "Establishing Overall Risk for Medical Devices" and "The Use and Misuse of FMEA in Risk Analysis" to learn about two of the most commonly misunderstood requirements of the Risk Management Standard.

What constitutes Essential Performance and how will it impact your product Designs? Traditionally, Medical Device Safety Standards have limited their scope to "basic safety". Basic safety addresses hazards associated with electric shock, mechanical movement and strength, high temperatures, etc. The IEC/EN 60601-1 series of standards (and most device safety standards) have been revised to include aspects of medical device performance that can impact safety (Essential Performance). The current edition of the medical device EMC standard (IEC/EN 60601-1-2) already requires that these characteristics be identified and demonstrate immunity to EMC. The ISO 14971 Risk Management standard also requires that Essential Performance be addressed. Over the next few years virtually all device safety standards will incorporate requirements that address Essential Performance as well as basic safety. Strategic Device Compliance Services can guide your organization in addressing Essential Performance in a cost effective way.

What are the impacts to old and new designs of the new Electromagnetic Compatibility (EMC) standard?

In 2000, the IEC and CENELEC published a new edition of IEC/EN 60601-1-2. The standard significantly expanded the requirements of the 1993 Edition applicable to:

Require the inclusion of detailed information about each devices emission of and immunity to electromagnetic energy.
Offer new options regarding emissions testing of some systems components.
Restrict the emissions of types of electromagnetic energy not addressed in the 1993 Edition of the standard.
Require that manufacturers identify those aspects of their device's performance which constitute Essential Performance.

Strategic Device Compliance Services can help your organization achieve compliance with IEC/EN 60601-1-2 and the amendment currently being developed quickly. For a detailed analysis of the new standard, see our article in Compliance Engineering Magazine: "Medical Devices: Diagnosing the New EMC Standard".

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