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Celectronics
Compatible Electronics

FDA, ASCA, EU Medical Device Testing

Medical Device Testing Services

Compatible Electronics is your trusted partner for comprehensive medical device testing. Our FDA ASCA recognized laboratory provides electrical safety, EMC, usability, and specialized device testing to support regulatory submissions worldwide — including faster 510(k) clearance through the ASCA program.

FDA ASCA Recognized NVLAP Accredited ILAC Certified ISO/IEC 17025:2017

Comprehensive Medical Device Testing Under One Roof

From fundamental electrical safety to electromagnetic compatibility, usability engineering, alarm systems, and device-specific particular standards — Compatible Electronics offers the complete range of medical device testing services. Our engineers and NVLAP accredited facilities ensure accurate, well-documented results that satisfy FDA and international regulatory bodies.

3
FDA ASCA Recognitions
7
Semi-Anechoic Facilities
3
SoCal Locations
30+
Years Experience

Medical Device Testing Overview

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Medical Device Testing Services Overview

Complete overview of our medical device testing capabilities, covering electrical safety, EMC, usability, IVD, and specialized device standards. Learn how our FDA ASCA recognition streamlines your 510(k) submission and accelerates market clearance.

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Why Partner With Compatible Electronics?

By utilizing Compatible Electronics NVLAP accredited testing (Lab Codes: 200063-0, 200527-0, and 200528-0), FDA ASCA recognition, and ILAC certification for your medical device compliance testing, you can expect:

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Efficient overall process delivery and reporting

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Lab scheduling access to meet your testing needs and deadlines

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The most current regulations and testing protocols applied

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Technical design consulting for device development

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Rapid project commencement on short notice

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Competitive quotations

🔍 Witness your testing in person — customers are welcome to observe our testing process at any of our Southern California locations: Lake Forest (949-587-0400) · Brea (714-579-0500) · Newbury Park (805-480-4044)

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FDA ASCA Recognized Testing

Our test reports are accepted by FDA without additional review — providing a faster, more predictable path to 510(k) clearance

TL-80 | TL-81 | TL-82

FDA ASCA Recognized Laboratory

Compatible Electronics holds three FDA ASCA recognitions covering electrical safety, EMC, and IVD equipment safety. FDA accepts our test reports without additional technical review.

  • TL-80: IEC 60601-1 Electrical Safety
  • TL-81: IEC 60601-1-2 EMC Testing
  • TL-82: IEC 61010-2-101 IVD Safety
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Electrical Safety Testing

Fundamental safety testing for medical electrical equipment — leakage current, dielectric strength, applied part classification, and more

FDA ASCA TL-80

IEC 60601-1 Medical Electrical Safety Testing

General safety standard for medical electrical equipment worldwide. Covers electric shock, mechanical hazards, temperature, fire, and radiation hazards.

  • IEC 60601-1 Ed. 3.1 and 3.2
  • Leakage current & dielectric strength
  • Type B, BF, and CF applied parts
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FDA Recognized

ANSI/AAMI ES60601-1 Testing

US national adoption of IEC 60601-1, including American market deviations for 120V/60Hz power, NEMA connectors, and UL component requirements.

  • US national differences coverage
  • 120V/60Hz specific requirements
  • NEMA plug/receptacle verification
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IEC 60601-1

Medical Device Safety Testing Services

Complete safety evaluations covering electrical, mechanical, thermal, and environmental hazards to patients, operators, and the environment.

  • Insulation, leakage & dielectric testing
  • Mechanical, thermal & fire hazard testing
  • IP rating & environmental protection
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EMC Testing

Emissions and immunity testing ensuring medical devices perform safely in their electromagnetic environment

FDA ASCA TL-81

IEC 60601-1-2 Medical Device EMC Testing

Edition 4.0/4.1 collateral standard for electromagnetic compatibility in medical electrical equipment. Risk-based approach with essential performance verification.

  • Emissions & immunity per IEC 60601-1-2
  • Essential performance identification
  • Professional & home healthcare environments
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NVLAP Accredited

Medical Device EMC Testing Services

Comprehensive EMC testing capabilities covering radiated/conducted emissions, full immunity suite, wireless coexistence, and proximity field testing.

  • Radiated & conducted emissions (CISPR 11)
  • Full IEC 61000-4-X immunity suite
  • Proximity field & wireless coexistence
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IEC 61326-2-6

IEC 61326-2-6 IVD EMC Testing

Particular EMC standard for in vitro diagnostic equipment used in clinical laboratories. Supplements IEC 61326-1 with IVD-specific electromagnetic environment requirements.

  • IEC 61326-2-6 Ed. 2.0 and 3.0
  • IVD-specific emission limits
  • Laboratory EMC environment testing
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Collateral Standards Testing

Specialized requirements for usability, alarms, home healthcare, and other cross-cutting safety topics

IEC 60601-1-6

IEC 60601-1-6 Usability Testing

Usability engineering for medical electrical equipment. Identifies and mitigates use errors that could cause patient harm, integrating IEC 62366 principles.

  • Formative & summative evaluation
  • Representative user testing
  • Use-related risk analysis
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IEC 60601-1-8

IEC 60601-1-8 Alarm Systems Testing

Requirements for alarm systems in medical electrical equipment. Ensures alarm signals are perceptible, understandable, and appropriately prioritized.

  • High / medium / low priority alarm testing
  • Audible & visual signal verification
  • Distributed alarm system evaluation
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IEC 60601-1-11

IEC 60601-1-11 Home Healthcare Testing

Additional requirements for medical equipment intended for home use by patients and non-professional caregivers in uncontrolled environments.

  • Non-professional operator safety
  • Home environment stress testing
  • Lay-user instructions review
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IVD & Laboratory Equipment Testing

Safety and EMC testing for in vitro diagnostic and laboratory instruments — with FDA ASCA recognition

FDA ASCA TL-82

IEC 61010-2-101 IVD Equipment Safety Testing

Safety requirements for in vitro diagnostic equipment examining specimens derived from the human body. FDA ASCA recognized for streamlined 510(k) review.

  • Clinical & hematology analyzers
  • Molecular diagnostic equipment
  • Point-of-care and IVD systems
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IEC 61010-1

IEC 61010-1 Laboratory Equipment Safety Testing

General safety standard for electrical equipment used in measurement, control, and laboratory applications — the base standard for the IEC 61010 series.

  • IEC 61010-1 Ed. 3.0 and 3.1
  • UL 61010-1 / CSA C22.2 coverage
  • Electric shock, fire & chemical hazards
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Particular Device Standards (IEC 60601-2 Series)

Device-specific safety testing for surgical equipment, defibrillators, ventilators, infusion pumps, and more

IEC 60601-2-2

IEC 60601-2-2 High Frequency Surgical Equipment

Particular requirements for high frequency surgical equipment used for cutting, coagulation, and electrosurgical procedures.

  • IEC 60601-2-2 Ed. 5.0 and 6.0
  • Electrosurgical energy delivery safety
  • FDA 510(k) & CE marking support
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IEC 60601-2-4

IEC 60601-2-4 Cardiac Defibrillator Testing

Particular safety requirements for cardiac defibrillators — AEDs and manual defibrillators — delivering high-energy pulses to the patient's heart.

  • IEC 60601-2-4 Ed. 2.0 and 3.0
  • AED & manual defibrillator testing
  • Life-critical device regulatory support
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IEC 60601-2-12

IEC 60601-2-12 Critical Care Ventilator Testing

Particular requirements for critical care ventilators in healthcare facilities — life-supporting equipment where failure could result in patient harm.

  • IEC 60601-2-12 / ISO 80601-2-12
  • Life-supporting essential performance
  • EUA & 510(k) submission support
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IEC 60601-2-24

IEC 60601-2-24 Infusion Pump & Controller Testing

Safety requirements for infusion pumps and controllers delivering fluids and medications. Addresses over-infusion, under-infusion, and air embolism hazards.

  • IEC 60601-2-24 Ed. 1.0 and 2.0
  • Accurate fluid delivery verification
  • Alarm system integration testing
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IEC 60601-2-35

IEC 60601-2-35 Medical Heating Device Testing

Safety requirements for electrically heated blankets, pads, and mattresses used for patient warming — temperature control and burn prevention.

  • IEC 60601-2-35 Ed. 1.0 and 2.0
  • Temperature control verification
  • Patient warming safety requirements
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Why Choose Compatible Electronics for Medical Device Testing?

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FDA ASCA Recognized (TL-80, TL-81, TL-82)

Test reports accepted by FDA without additional review — faster, more predictable 510(k) clearance.

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NVLAP Accredited & ILAC Certified

Lab Codes 200063-0, 200527-0, and 200528-0. ISO/IEC 17025:2017 accredited with ILAC-MRA recognition for global acceptance.

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7 Semi-Anechoic Facilities

Seven facilities across Southern California to accommodate your testing schedule on short notice — customers welcome to witness testing in person.

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Complete Testing Capabilities

Safety, EMC, usability, alarms, IVD, and particular standards — all under one roof.

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EMC Pre-Compliance Testing

Diagnostic scans to identify problem frequencies and their locations in a repeatable procedure before formal compliance testing.

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Risk Management & Technical Consulting

ISO 14971 risk management integration, essential performance documentation, and technical design consulting for device development.

All Medical Device Testing Services

🏛️ FDA ASCA

⚡ Electrical Safety

📡 EMC Testing

📋 Collateral Standards

🔬 IVD & Laboratory

🩺 Particular Standards

Ready to Get Your Medical Device Tested?

Contact our medical device testing experts today for a quote or to discuss your regulatory requirements.

📋 Request Test Quote 📞 Call 949-587-0400

Also reach us at: Brea 714-579-0500 · Newbury Park 805-480-4044

www.celectronics.com

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