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Essential Performance Specification (IEC 60601, Medical Device)

29,00 €

This downloadable Essential performance specification (EPS) template will help you identify the essential performance of your device.

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Note: Safety for electrical medical devices templates are included in the blended course.

Description

Why it is useful

The IEC 60601 standards apply to all medical electrical equipment and medical electrical systems placed on the market regardless of classification.
Having a clearly identified essential performance specification helps you manage the safety requirements of the standards.
Also, it is a necessary input to perform the tests required by the standards.
The template works well together with the other templates made available on MedicalDeviceHQ.com.

How to use it

1. You may use this essential performance specification template in your quality management system after adapting it to your needs and after removal of the informative text.
2. Use the template as an inspiration while authoring your own.
3. Use the template as a benchmark to check your own existing procedures and templates.
In this template, instructions and/or explanations are included using blue italic texts such as these. Instructions and explanations should be removed before review of the document.
All texts that are not blue are example texts that can and should be edited by you.
Texts that most certainly should be replaced or updated are identified by the { and } characters. They should be removed and the example text customised to work with the current project.

Support

If you have questions about the content of the template, you may ask questions in the support forum. The support forum is accessible on this link when you are logged into your Medical Device HQ account.

Need safety for electrical medical device training and a course certificate?

If you should want to learn more about using the template or safety for electric medical devices in general, it is covered in our online Introduction to Safety for Electrical Medical Devices and IEC 60601 course and our public Safety for Electrical Medical Devices and IEC 60601 blended course. Our blended courses combine a self-paced online course first followed by a live virtual classroom session.

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Would you like to learn more about risk management or design control?

Take a look at our online Risk Management course on ISO 14971:2019 and online Design Control for Medical Devices course. These courses are taken by both competent authorities, notified bodies and medical device manufacturers and distributors.

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