Medical Device and Laboratory Equipment Safety Standards

Testing and Documenting Compliance

Medical Electrical Equipment Standards

IEC 60601-1 with national differences: e.g. US (AAMI ES), Europe (EN), Canada (CSA), etc.

Medical Electrical Equipment Electromagnetic Disturbances

IEC 60601-1-2 with national differences: e.g. US (AAMI ES), Europe (EN), Canada (CSA), etc.

Laboratory Equipment Standards

IEC 61010-1 with national differences: e.g. US (UL), Europe (EN), Canada (CSA), etc.

Services Offered

Where are you in your Product Development Lifecycle?

Services Overview Computer Computer Computer Computer Computer

1. Feasibility Studies

2. Design & Development

3. Design Freeze

4. Formal Testing & Compliance Review

5. Production Release & Post-Production

MECA Device Experience

Learn more about some of the devices that MECA has evaluated to the IEC 60601-1 and IEC 61010-1 series of standards.

Equipment Experience
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