Medical Device Testing
Medical Device Testing for Electrical Safety and EMC
IEC 60601 electrical safety and EMC testing for medical electrical equipment, scoped to the device, its applied parts, and the markets that will register it.
Medical Device Testing
A medical device is tested as a device, not as a piece of electronics that happens to be used in a clinic.
Medical electrical equipment is held to IEC 60601 and its particular standards. Applied parts, essential performance, and the EMC environment of a clinical setting change the plan. A report written to a general electronics standard does not answer those questions.
ORBIS scopes the safety and EMC evidence the registration will rely on. We identify the device boundary, the applied parts, the particular standard, and the markets, then coordinate testing a certification body and a health authority will accept.
How ORBIS scopes it
What decides the file
Safety
Shock, energy, mechanical, and thermal hazards under the medical standard, including the parts that touch a patient.
EMC
Emissions and immunity in the environment the standard defines, not a generic industrial profile.
Registration is next
The test report is evidence. Medical device registration is the filing that uses it.
Questions
Before you start
We have an IEC 62368-1 report. Is that enough?
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Not for a medical electrical device. The medical standard asks different questions, and health authorities expect that file.
Does testing include the registration?
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Testing produces the evidence. Registration is a separate service, and we scope them together so the report matches the filing.
Bring the product and the markets.
We will tell you which of this work applies, which evidence you already have, and what still has to be done before the product ships.
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