EMC requirements for IVD laboratory equipment
- Thread starter CharlieUK
- Start date
If the 60601-1 suite is pulled in, since home use, you'll likely need 60601-1-11 (home healthcare).
If you know of a predicate device, you can go to the FDA Establishment Registration & Device Listing site and find out what the relative recognized consensus standards are.
If you know of a predicate device, you can go to the FDA Establishment Registration & Device Listing site and find out what the relative recognized consensus standards are.
Is the IVD blood analyser coming into contact with or exchanging energy with a patient? I.e. Does it "have an applied part or transfer energy to or from the patient " where applied part means "part [that] in normal use comes into contact with the patient for [the device] to perform its function"?
If it is not, then I don't think it falls under the definition of "Medical electrical equipment" and so would not fall under the scope of IEC 60601. IEC 61326 allows for the use of IVD equipment in the laboratory "and other environments" and its definition of a class B equipment explicitly mentions use in a "residential" environment.
The related standard IEC 61010-1 explicitly mentions as an example "Self-test IVD equipment to be used in the home" (I don't take this as exclusively applying to "Self-test" though) and references out to IEC 61326 as the relevant EMC standard for this type of equipment (see clause 1.2.2).
If it is not, then I don't think it falls under the definition of "Medical electrical equipment" and so would not fall under the scope of IEC 60601. IEC 61326 allows for the use of IVD equipment in the laboratory "and other environments" and its definition of a class B equipment explicitly mentions use in a "residential" environment.
The related standard IEC 61010-1 explicitly mentions as an example "Self-test IVD equipment to be used in the home" (I don't take this as exclusively applying to "Self-test" though) and references out to IEC 61326 as the relevant EMC standard for this type of equipment (see clause 1.2.2).
IEC 61326-2-6 is on the FDA's consensus standards list, and would the correct standard to use but it needs to be the 2020 edition.
Similar threads
