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This article will go over the process of writing test plans and protocols for medical devices in line with the IEC 60601 standard. These documents are essential in order to demonstrate that your medical device meets the established requirements.
In the video below, you will learn the difference between a test plan and a protocol, as well as show how to identify applicable test cases in a systematic way.
You can think of a test plan as a general outline. It tells you the requirements, strategy, and process for performance of any given test. It also serves as documentation of evidence and tells you how to manage test failures.
A test plan typically describes responsibilities, necessary test facilities, and usually tells you if the tests will be performed internally or at an external lab.
A test protocol describes the test at a more detailed and specific level. It can be considered a collection of test cases, where individual test cases are used to verify an established set of requirements.
Each test case typically contains a purpose, prerequisites for testing, test method, and acceptance criteria along with the individual steps necessary to execute the protocol.
The collateral standard for electromagnetic compatibility is the only IEC 60601 standard with an explicit requirement for the manufacturer to prepare a test plan. However, regulators expect you to prepare test plans and protocols as part of your technical documentation.
Put simply, this is the smartest way to ensure that you understand and can define the technical requirements applicable to your design.
Once you have the test results, they are documented in test reports. The best practice at this stage is to write a summary report in order to show that you have executed the entire test plan. The life cycle of this process can be seen in the image below.
To help with this process, it is recommended that you consult the IEC TR 62354. Not only does the standard assist you in identifying applicable test cases. It also includes relevant input to the test plan, such as types of tests, state of the test sample, the sequence of tests, and general testing conditions.
The IEC TR 62354 also includes a fairly detailed description for each test case on test equipment, safety precautions, sample preparation, test conditions, test setup, and test procedure. These descriptions are an excellent starting point for a detailed protocol, specific to your medical device.
Make sure that all the test cases identified as applicable to your medical device are captured in your risk analysis in order to define requirements, test plans, and protocols.
Now, you should know how to identify applicable test cases in a systematic way. By writing up test plans and protocols, you close the loop on effective identification and management of requirements. This means that you should be well prepared to design a medical device that meets the requirements and passes type testing.
It is worth noting that if you outsource the development process, you should still keep control of the requirements. You can do this by maintaining control of test plans, test protocols, and reports. This is typically the most effective way of making sure that the device complies with the standards.
If you want to know more about the 60601 standard and safety for electrical devices, take a look at our online course Introduction to Safety for Medical Devices and IEC 60601. This comprehensive course has in-depth information and quizzes to test your knowledge and understanding. At the end of the course you will also receive a course certificate, which many auditors will be looking for.
Our online courses are frequently taken by competent authorities, notified bodies and medical device manufacturers and distributors.
Claus Rømer Andersen is an accomplished trainer, consultant and facilitator in the medical device industry. With a background in electrical engineering, he has worked with regulatory navigation, approval management, device testing throughout his whole career.
He is recognized as having a pragmatic and solution oriented approach to helping development teams focus on relevant issues throughout the entire product life-cycle.
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