Which standards apply to my device?
Tell me what your device is and what it does, and see the standards that usually apply to it, with a short note on why each one is on your list.
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Your device type may also have its own product standard, such as a particular standard in the IEC 60601-2 series. The list shows the general standards, and the edition to use depends on your market, so check the harmonized standards for the EU and the FDA recognized consensus standards for the US.
Tell me about your device and your markets, and we will go over the standards, the editions and what each one means for your technical file.
This is a starting list based on your answers, not a full regulatory assessment. Your device, its claims and your markets decide the final list.
Tick everything that applies. You can change your answers at any time.
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What is your product?
What is true for your product?
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Choose what your product is, and the list will appear here.
Standards for your device
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