Replacing End of Life (EOL) Components - What triggers retesting to IEC 60601-1
- Thread starter freelui
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Do you mean EOL?
Roland chung
Trusted Information Resource
No. It is not necessary to retest to 60601-1 and 60601-2-2. In many cases, replacement is actually one part of the repair. If required, all of the ME equipments after repair MUST also be retested.
However, it does make sense to test according IEC 62353 (Recurrent test and test after repair of ME equipment)
However, it does make sense to test according IEC 62353 (Recurrent test and test after repair of ME equipment)
If replacing with identical parts (maker, type number) then re-testing is not justified. A mini "production" test is normally done after service to make sure everything is re-assembled OK.
If the parts are different but expected to be equivalent, then it depends on your confidence of equivalence.
For example, two apparently similar capacitors (same ratings) can have very different high frequency response which can affect function, performance and EMC. However, many other parts can be changed with high confidence.
For each changed part, someone needs to make an engineering decision if the change could affect compliance, and if an impact is reasonably possible, make some tests to prove otherwise. These could range from simple bench test on a single PCB, or full compliance test on the whole equipment.
Most regulations are OK with changing parts without reporting to the regulator, as long as internal design change control is effective. Health Canada requires an annual report of changes but probably doesn't check the detail.
For NRTL, change of a part related to basic safety should be reported even if expected to be equivalent, unless the agency has specifically allowed "any" certified part with equivalent ratings. For performance and EMC is up to the certification agency if they include in the scope. Most only expect changes related to basic safety to be reported.
If the parts are different but expected to be equivalent, then it depends on your confidence of equivalence.
For example, two apparently similar capacitors (same ratings) can have very different high frequency response which can affect function, performance and EMC. However, many other parts can be changed with high confidence.
For each changed part, someone needs to make an engineering decision if the change could affect compliance, and if an impact is reasonably possible, make some tests to prove otherwise. These could range from simple bench test on a single PCB, or full compliance test on the whole equipment.
Most regulations are OK with changing parts without reporting to the regulator, as long as internal design change control is effective. Health Canada requires an annual report of changes but probably doesn't check the detail.
For NRTL, change of a part related to basic safety should be reported even if expected to be equivalent, unless the agency has specifically allowed "any" certified part with equivalent ratings. For performance and EMC is up to the certification agency if they include in the scope. Most only expect changes related to basic safety to be reported.
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