MiCOM Labs tests medical electrical equipment to IEC 60601-1-2, the International Electrotechnical Commission (IEC) standard for electromagnetic compatibility (EMC). Our lab performs this testing under American Association for Laboratory Accreditation (A2LA) Certificate #2381.01. When your device includes a radio, our certification body team certifies the radio under the same project.
Patient monitors send readings over Wi-Fi or Bluetooth while clinicians carry phones and two-way radios nearby. We perform the proximity field immunity test at the standard's 30 cm separation distance, with levels up to 28 volts per meter (V/m) at frequencies up to 5,785 MHz.
Remote diagnostic equipment depends on a cellular or Wi-Fi link to reach your clinicians. We test that radio link against each target market's radio rules and confirm your device keeps essential performance through IEC 60601-1-2 immunity tests.
Many imaging accessories connect to host systems through signal cables. Edition 4.1 of IEC 60601-1-2 requires conducted immunity tests on signal cables longer than 1 m, down from 3 m in Edition 4.0. We test each qualifying cable port on your accessory.
IEC 60601-1-2 sets immunity levels based on the environment in which your device operates.
| Use Environment | Example Locations | Radiated RF Immunity (80 MHz to 2.7 GHz) |
|---|---|---|
| Professional Healthcare Facility | Hospitals and clinics | 3 V/m |
| Home Healthcare | Homes and public spaces | 10 V/m |
| Special Environment | Military installations and industrial zones | Set by your risk analysis |
Your radio design determines how much radio work your project needs beyond EMC.
IEC 60601-1-2 emissions and immunity
Accredited EMC report for your regulatory submission
IEC 60601-1-2 on the host device plus radio checks on the finished product
The module’s FCC grant covers the module only, so the host device still needs evaluation
IEC 60601-1-2 plus full RF testing
Direct certification in five markets
MiCOM Labs guides IEC 60601-1-2 projects from risk-based planning through testing and certification record management.
We build the test plan around your device’s essential performance and ISO 14971 risk management criteria.
MiTest® automates test runs and gives your team access to live status and reports.
MiCMS® manages certification workflows, while MiPassport® stores your compliance records after certification.
We build the test plan around your device’s essential performance and ISO 14971 risk management criteria.
MiTest® automates test runs and gives your team access to live status and reports.
MiCMS® manages certification workflows, while MiPassport® stores your compliance records after certification.
MiCOM Labs combines decades of experience with accredited testing and broad certification authority.
| Category | Proof Point |
|---|---|
| Experience | Operating since 2001 |
| Accreditation | ISO/IEC 17025 scope includes IEC 60601-1-2, valid through November 30, 2027 |
| Certification Authority | 5 certification body designations |
| Additional Market Reach | Testing support for 9 additional APEC economies under the TEL MRA Phase I |
| RF Range | Testing up to 220 GHz |
| Locations | 3 offices, headquartered in Pleasanton, California |
The U.S. Food and Drug Administration (FDA) recognized Edition 4.1 on December 21, 2020, under recognition number 19-36. Edition 4.1 adds immunity testing for proximity magnetic fields. Devices tested only to Edition 4.0 may need limited retesting for the new requirements.
The FDA and your Medical Device Regulation (MDR) Notified Body make those decisions. MiCOM Labs supplies the accredited IEC 60601-1-2 test report your submission cites. For wireless devices sold in the EU, we assess the radio as a RED Notified Body.
MiCOM Labs lists these typical phase lengths:
MiCOM Labs has stayed under the same family ownership since its founding. The engineers who tested your device the first time support every recertification cycle.
Send us your device specifications and target markets. A MiCOM Labs engineer scopes your EMC and radio testing in one plan.
Contact MiCOM Labs to Scope Your IEC 60601-1-2 Testing