North American NRTL Certification on Medical Devices
Compatible Electronics provides NRTL certification support for medical devices under ANSI/UL/CSA 60601-1 via the Data Acceptance Program — performing the construction evaluation, safety testing, and test report package submission so your device can receive the North American Certification Mark.
What Is NRTL Certification?
A Nationally Recognized Testing Laboratory (NRTL) is a private organization recognized by OSHA to test and certify products for safety compliance with national consensus standards. The NRTL mark — typically a UL, CSA, ETL, or equivalent listing mark — is required for many products sold into the United States and Canada, and is especially important for electrical medical devices placed in clinical, hospital, and home healthcare settings.
For medical electrical equipment, NRTL certification is granted under ANSI/UL/CSA 60601-1, which is the North American harmonized version of the internationally recognized IEC 60601-1 standard. Many US healthcare facilities and purchasing organizations require an NRTL mark before a device may be plugged into a facility's electrical system.
Unlike an FDA 510(k) submission — which is a regulatory clearance pathway — NRTL certification is a product safety listing. Both may be required for the same device, and Compatible Electronics is uniquely positioned to support both pathways from a single test campaign through its FDA ASCA accreditation and NRTL Data Acceptance Program partnership.
Our NRTL Certification Services
Compatible Electronics has completed its application and standards scope to partner with an NRTL Safety Agency. We are now able to offer testing, evaluation, and assistance applying the North American NRTL Certification Mark on medical devices under the Data Acceptance Program. If your device requires an NRTL mark, we provide a comprehensive turnkey service.
Construction Evaluation
- Physical and electrical review of device construction
- Component and material verification
- Insulation, creepage, and clearance analysis
- Applied part classification review
- Documentation and labeling review
Safety Testing
- ANSI/UL/CSA 60601-1 general requirements
- Dielectric strength and leakage current
- Temperature and abnormal operation tests
- Mechanical strength and stability
- Applicable clause 2xx particular requirements
EMC & Collateral Standards
Submission Package
- Complete NVLAP-accredited test reports
- Device Evaluation and Device Information Package
- Submission to the NRTL Agency for listing review
- Coordination through grant of listing permission
- Ongoing support for annual follow-up inspections
ⓘ Compatible Electronics continues to provide its standard IEC 60601-1, ANSI/AAMI ES60601-1, and IEC 60601-1-2 EMC testing for FDA 510(k) review and international markets. In many cases, a single test campaign can satisfy both NRTL listing and FDA submission requirements simultaneously.
Standards Covered Under NRTL Testing
Our NVLAP-accredited scope includes the principal IEC 60601 general requirements standard as well as numerous collateral and particular standards applicable to specific device types. The table below shows key standards relevant to medical device NRTL certification, drawn from our current accreditation scope (NVLAP Lab Code 200527-0, effective 2025-06-05 through 2026-06-30).
General Requirements — 60601-1
- ANSI/AAMI ES60601-1:2005/A2:2021 — US national standard (MOD IEC 60601-1:2005)
- IEC 60601-1, 3rd Ed. (2005) + A1 (2012) — International
- EN 60601-1:2006 + A1:2013, + A12:2014 — European
- IEC 60601-1 Ed. 6.0 / IEC 60601-1:2005/A2:2020 — Latest editions
Collateral Standards — 60601-1-x
- IEC 60601-1-2 Ed. 4.0 / 4.1 — Electromagnetic disturbances (EMC)
- IEC 60601-1-6 Ed. 3.0 / 3.1 / 3.2 — Usability engineering
- IEC 60601-1-8 Ed. 2.1 / 2.2 — Alarm systems
- IEC 60601-1-11 Ed. 2.0 / 2.1 — Home healthcare environment
Particular Requirements — 60601-2-x
- IEC 60601-2-2 — High frequency surgical equipment
- IEC 60601-2-4 — Cardiac defibrillators
- IEC 60601-2-12 — Critical care ventilators
- IEC 60601-2-24 — Infusion pumps and controllers
- IEC 60601-2-35 — Blankets, pads and mattresses for heating
FDA ASCA Recognized Standards
- ANSI AAMI ES60601-1 (FDA#19-46) — including AMD2:2021
- IEC 60601-1-2 Ed. 4.1 (FDA#19-36) — EMC
- IEC 60601-1-6 Ed. 3.1 / 3.2 (FDA#5-89, #5-132) — Usability
- IEC 60601-1-8 Ed. 2.1 / 2.2 (FDA#5-76, #5-131) — Alarms
- IEC 60601-1-11 Ed. 2.0 / 2.1 (FDA#19-14, #19-38) — Home healthcare
The NRTL Certification Process
The Data Acceptance Program allows an OSHA-recognized NRTL Agency to accept test data generated by an accredited laboratory such as Compatible Electronics. This streamlines the listing process and avoids duplicating testing at a separate facility.
1
Pre-Test Review
We review your device specifications, intended use, applied parts classification, and applicable particular standards to define the full test plan before scheduling begins.
2
Construction Evaluation
Engineers perform a detailed physical and electrical construction evaluation, reviewing insulation, component ratings, labeling, and compliance with clauses that require engineering judgment.
3
Safety & EMC Testing
All required safety measurements are performed at our Lake Forest/Silverado, Brea, or Newbury Park facilities. IEC 60601-1-2 EMC testing and applicable collateral standards testing are conducted concurrently to minimize project time.
4
Test Report Package
We compile the complete Device Evaluation, Device Information Package, and NVLAP-accredited test reports for submission to the NRTL Agency under the Data Acceptance Program.
5
NRTL Agency Review
The NRTL Agency reviews the submitted package. Upon approval, permission is granted to apply the North American Certification/Canadian Mark to the medical device.
6
Ongoing Compliance
NRTL listings require periodic follow-up inspections. We maintain documentation to support your listing through manufacturing changes and annual facility audits.
NRTL Listing and FDA 510(k): A Combined Approach
Many medical device manufacturers need to satisfy both the FDA's premarket submission requirements and NRTL listing requirements. Compatible Electronics is one of the few labs in North America accredited under the FDA Accreditation Scheme for Conformity Assessment (ASCA) and simultaneously capable of supporting the NRTL Data Acceptance Program. This means a single test engagement at Compatible Electronics can generate data that supports both pathways.
Under the FDA ASCA program, test reports from Compatible Electronics for recognized standards such as ANSI/AAMI ES60601-1 (FDA#19-46) and IEC 60601-1-2 Ed. 4.1 (FDA#19-36) may accompany 510(k) and De Novo submissions in lieu of full data review. Combined with our NRTL Data Acceptance Program capability, manufacturers can significantly reduce time to market and total testing cost.
🔎 Our test data is also recognized internationally through ILAC-MRA, enabling acceptance in over 100 countries. A single Compatible Electronics test campaign can simultaneously support NRTL listing, FDA ASCA submission, IEC 60601-1 for CE marking in Europe, and multiple additional market authorizations.
Why Compatible Electronics for NRTL Medical Device Certification?
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FDA ASCA Accredited — Medical device test data accepted for FDA 510(k) and De Novo submissions
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NVLAP Accredited — ISO/IEC 17025:2017 accredited lab, NVLAP Lab Code 200527-0, with full scope of accreditation
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ILAC-MRA Recognized — ILAC-MRA accreditation enables global acceptance of test data in 100+ countries
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Fast Scheduling — most projects are scheduled within days; concurrent safety and EMC testing minimizes total calendar time
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Data Acceptance Program — our test packages are accepted directly by the NRTL Agency, avoiding duplicate testing at a separate listing lab
Related Medical Device & Certification Services
NRTL certification draws on a broad foundation of safety and EMC testing capabilities. Below are the most relevant related services and resources.
Ready to Get Your Device NRTL Listed?
Contact Compatible Electronics to discuss your NRTL certification project. We'll identify the applicable standards, outline the testing scope, and provide a quote.
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