IEC 60601-1 Pre-Compliance Evaluation for medical electrical devices
In order to comply with MDR requirements, medical electrical device (ME device) manufacturers must send their products to a certification test house and meet the many requirements laid out in IEC 60601-1. This is a costly and challenging process – it is exceedingly rare for a device to pass the requirements first time – often taking years of work and tens of thousands of pounds in costs.
At Test Labs, we offer an IEC 60601-1 pre-compliance evaluation service to help manufacturers avoid expensive repeat testing with a certification test house. Before you submit your device for compliance testing, Test Labs will perform a review of the associated documentation of a device (such as the risk file, markings, instructions for use (IFU), etc.), test the device for compatibility with the IFU using repeated cleaning, disinfection, and sterilisation cycles, and perform basic electrical, mechanical and temperature safety tests.
We can also perform optional tests, including an engineering file review (to IEC 60601-1-6 & IEC 62366), software life-cycle process review (to IEC 62304 & clause 14 of IEC 60601), and assess medical equipment used in the home healthcare environment according to the requirements of IEC 60601-1-11.
For manufacturers that also produce non-electrical medical devices, Test Labs also provides a reusable medical device reprocessing validation service.
Frequently Asked Questions
What is Pre-Compliance IEC 60601-1 Testing?
Pre-compliance IEC 60601-1 Testing is a service for manufacturers looking to submit their devices for full compliance to the IEC 60601 series of standards. It focuses on common points of non-compliance in both testing and documentation to reduce the risk of re-testing with a certification body.
Do I need to consider any other standards in the IEC 60601 series?
While not always required for pre-compliance testing, the other standards in the series will be required when it comes to full compiance. The collateral standards (IEC 60601-1-##) provide guidance and additional testing requirements that some devices will need to follow: IEC 60601-1-2 is the EMC testing standard and is necessary for pratically all devices. The particular standards (60601-2-##) are for specific types of device (infusion pumps, or infant incubators, for example). These add, amend, or delete required clauses from IEC 60601-1, the general standard, to ensure the requirements are relevant to the device.
Do I need to provide multiple samples for pre-compliance testing?
Yes. Some of the pre-compliance tests, such as the dielectric strength test, can be destructive, so additional samples are needed to avoid delays in testing.
How is pre-compliance different from full IEC 60601-1 testing?
Pre-compliance is intended to uncover potential points of non-compliance before a device starts the full compliance process, highlighting issues to avoid retesting with a certified body. Pre-compliance focuses on clauses in the IEC 60601-1 standard that frequently lead to non-compliance.
When should pre-compliance testing be done?
Pre-compliance can be useful at the prototyping stages to discover design challenges that need to be overcome, as well as at the end stages of development to ensure that there are no nasty surprises waiting to be uncovered during full compliance. In either case, it is ultimately a service to help avoid costly retests with a certification body.