What is IEC 60601-1?
First published in 1977 by the International Electrotechnical Commission, IEC 60601-1 General requirements for basic safety and essential performance is the general standard of the 60601 series and gives requirements that must be met throughout the rest of the series. “General” here is a little misleading: the standard is enormous.
IEC 60601-1 is used both by technicians out in the field, manufacturers hoping to receive certification for a medical electrical device (ME device), and the test & certification houses who test ME devices for compliance to the standard.
What’s in the IEC 60601-1 standard?
For technicians, the IEC 60601-1 Evaluation standard is mostly used for comprehensive electrical safety testing to verify that equipment is safe for both operators and patients alike. For manufacturers the standard covers even more aspects of a device, from safety aspects beyond electrical safety, such as its ability to withstand high temperatures and its shielding from various forms of radiation to regulatory requirements like the correct markings that should be displayed.
The standard is split into 17 sections, beginning with the general requirements for the device (including risk control measures) and the general requirements for performing the various tests in the standard. Further sections go into more detail regarding the classification, identification, markings, and documentation. The majority of the remaining sections (and the bulk of the standard) include detailed instructions for the various tests and requirements that ME devices need to meet during those tests.
The end of the standard is made up of nearly 200 pages of annexes, figures, and tables, which provide detailed examples of testing circuits, test apparatus, as well as the exact limits for every test that a ME device needs to conform to.
Conforming to the IEC 60601-1 standard
The reason the standard is important to manufacturers is that their devices need to conform to it in order for the devices to meet the requirements of Medical Devices Regulations such as MDR in the EU. In order for them to prove that this is the case, the device shall be subject to compliance assessment which is normally conducted by third-party test houses to the applicable requirements of the IEC 60601 series.
Performance requirements of multiple reprocessing cycles
Once all the testing was concluded and validated, for both the cleaning and sterilisation processes, the MD were then tested on multiple cycles to assess that repeated reprocessing would not affect the intended use or the safety of ME Equipment .
An example of reprocessing the dental ME Equipment applied part 50 times for cleaning and 50 times for sterilisation. After the 50 reprocessing cycles the intended use was assessed and compared to a brand new unprocessed MD. If it could be demonstrated that there was no difference in performance between the processed and unprocessed MD this would indicate the suitability of multiple reprocessing cycles and therefore full validation of the customer IFU.
Following successful validation of the IFU with BS EN ISO 17665-1:2006 and BS EN ISO 15883-5:2021 and with multiple cycles (50 in total) the IFU for the dental MD can be considered to be in compliance with ISO 17664-1:2021, fulfilling one of the requirements of the MDR.
Preparing for compliance
To help manufacturers avoid the unnecessary cost of repeatedly sending their device to a test house, Test Labs offers an IEC 60601-1 pre-compliance evaluation service. This service aims to help manufacturers identify and address potential non-compliances before sending their device to a certification test house, saving them money, time, and stress.
The service includes the following:
- Documentation review. We review the design and technical documentation for your ME device, including the risk management file, medical equipment identification, and markings.
- Critical component and insulation review. We verify that all critical components of your ME device have been identified, then verify that these components have been certified appropriately. We review the electrical insulation of your device and create an insulation diagram.
- Laboratory testing. We perform a selection of laboratory tests according to IEC 60601-1, including verifying the functionality and safety of the equipment after performing cleaning, disinfection, and sterilization.
- Once reviews and testing are complete, we send a report detailing our findings (including any potential non-compliances), laboratory test results, and a test plan identifying the applicable tests that will be conducted during compliance testing.
For more information, please visit our IEC 60601-1 pre-compliance evaluation service page.