ISO 9001 vs ISO 13485 for Microscopes: Which Matters?

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BK5000 Series Biological Microscope

1、US Requirements (FDA + Electrical Safety)

Research or Industrial Microscopes (Non-medical)

Most standard lab microscopes used in universities or research labs do not require FDA clearance.

But they still need basic safety compliance:

UL or ETL listing (electrical safety)

FCC compliance (electromagnetic interference)

If it plugs in, US buyers expect UL/ETL + FCC.

Clinical or Diagnostic Microscopes (Medical Use)

If the microscope is marketed for diagnosing disease, pathology, or clinical testing, it may be regulated as a medical device.

In that case, you may need:

FDA registration

510(k) clearance (for certain diagnostic systems)

Quality system compliance (21 CFR Part 820)

Medical claims = FDA involvement.

2、EU Requirements (CE Marking Is the Big One)

CE Marking (Mandatory)

To sell in the EU, the microscope must meet CE requirements under relevant directives, such as:

Low Voltage Directive (LVD) – electrical safety

EMC Directive – electromagnetic compatibility

RoHS Directive – restriction of hazardous substances

No CE mark = no legal sale in the EU.

Common International Standards Buyers Look For

Even when not legally required, serious labs and distributors often expect:

ISO 9001 (general manufacturing quality)

ISO 13485 (if medical-related)

IEC 61010-1 (laboratory electrical safety standard)

These help prove reliability and compliance.