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What is IEC 60601-1 Ed 3.1 Testing?

IEC 60601 is a broadly recognized international standard, which ensures that the medical equipment tested is safe and effective to use. IEC 60601-1 Ed 3.1 is the IEC 60601-1:2005 version added up with the amendment AMD1:2012.  IEC 60601-1 Ed 3.1 is a significant edition that incorporates over twenty new requirements and sixty changes to the prevailing requirements to enhance the scope of safety, performance and risk management of the medical devices.

Why is IEC 60601-1 Ed 3.1 Testing Important?

For medical electrical system manufacturers, IEC 60601-1 Ed 3.1 embodies a major difference from its earlier edition IEC 60601-1 Ed 3.0. IEC 60601-1 Ed 3.1 has many new requirements focusing on performance, risk management procedures, and usability engineering principles. IEC 60601-1 Ed 3.1 also incorporates changes and revised requirements focusing on mechanical hazards, electrical hazards, new product labeling as well as requirements pertaining to documentation.

How Can We Help?

We are here to ensure that your medical equipment to comply with the rules and regulations of IEC 60601-1 Ed 3.1. Here are the services we offer:

  • We prepare the entire set of documents to evidently prove that the software embedded within your medical electrical system adheres to the IEC 62304 Standards. We do extensive testing of your device's software and help you prepare more than 15 to 20 documents including Software Configuration Management Plan, Software Quality Assurance Plan, Software Development Plan, Software Requirement Specification, Software Design Specification, Unit Test Case Document for each unit, Integration System Test Case Document, System Testing Document and much more

  • We also perform hardware testing and prepare all required documents pertaining to IEC 60601-1 Ed 3.1

  • We shall prepare the usability file

  • We shall also prepare the risk management file encompassing all software hazards, hardware hazards, and detailed risk analysis to prove that the device has acceptable risks and it is safe to use


As a manufacturer of a medical electrical system, if you are looking for help with your medical device testing, then do contact us immediately! We are glad to help you with IEC 60601-1 Ed 3.1 Testing!

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