Electromedical design and verification.
Getting a device through IEC 60601 testing the first time, then keeping it compliant for its whole commercial life.
You are probably in one of these situations.
The later an electrical safety or EMC issue is found, the more it costs. My job is to surface it before the test lab does.
- Testing is approaching and the list of applicable standards is not settled.
- A test report has come back with electrical safety or EMC failures.
- A component is going obsolete and its replacement needs assessing.
What I actually do.
Standards strategy
General, collateral and particular standards identified, every non-applicable clause justified.
Essential performance
Defined from the risk analysis, with the acceptance criteria for EMC testing.
Design review
Insulation, creepage, leakage currents, filtering and shielding reviewed before the lab.
Verification plan
Requirements-to-tests matrix, lab selection, attendance during testing.
Test failures
Cause found, fix verified, impact on other tests assessed.
Production life
Obsolescence, supplier changes, impact of design changes.
Deliverables
| Ref. | Deliverable |
|---|---|
| D1 | Justified list of applicable standards |
| D2 | Insulation diagram and means-of-protection table |
| D3 | Verification plan and traceability matrix |
| D4 | Pre-test assessment report |
| D5 | Test failure analysis file |
Standards
| IEC 60601-1 | General requirements for basic safety and essential performance |
|---|---|
| IEC 60601-1-2 | Electromagnetic disturbances |
| IEC 60601-1-6 / IEC 62366-1 | Usability |
| IEC 60601-1-8 | Alarm systems |
| IEC 60601-1-11 | Home healthcare environment |
| IEC 60601-2 series | Particular requirements by device type |
| ISO 14971 | Risk management |
Frequently asked questions
Do you run the tests?
No: an accredited lab runs them. I prepare them, follow them and interpret the results.
Can you attend testing?
Yes, on site or remotely, to decide on a fix without waiting for the written report.
Does a change mean repeating tests?
Not always: the impact assessment separates tests to repeat from those that can be justified by analysis.
A project to move forward? Let's talk.
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