IEC 60601-1 is the global standard for the safety and essential performance of medical electrical devices.
Compliance is mandatory for market access, covering everything from electrical and radiation safety to durability under repeated reprocessing. Meeting IEC 60601-1 ensures patient and operator safety and also protects credibility and regulatory approval.
Frequently Asked Questions
What is IEC 60601-1 Testing and Certification?
IEC 60601-1 is the general standard for the IEC 60601 series of standards, and dictates the electrical safety and performane requirements that all medical electrical devices must meet before being allowed onto the market. Testing and certification are essential to proving that a medical electrical device meets these requirements.
What does IEC 60601-1 test cover?
The scope of IEC 60601-1 is massive, covering a broad range of tests from basic electrical safety and flammability, to radiation safety. Not all of these tests are relevant to every device, however, and for many devices justification can be made that some tests are not required to be compliant with the standard. In addition, the IEC 60601-2 series of particular standards further amend the requirements of the general standard for a huge variety of device categories.
Does IEC 60601-1 require reprocessing testing?
Yes, your device will go through reprocessing according to the device’s instructions for use as part of compliance testing. In addition, IEC 60601-1 states that manufacturers must have considered the impact of multiple cleanings and disinfections. Test Labs can support this with our extensive expertise in reprocessing validation.
Do I need to consider any other standards in the IEC 60601 series?
The other standards in the IEC 60601 series are required for full compliance. 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 practically 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.
What documentation is required before testing for compliance to the IEC?
A comprehensive risk management file and instruction manual are both required before testing for compliance to the IEC 60601 series of standards, as they dicate which tests are applicable to the device and how they should be carried out.