F2 Labs
F2 Labs is a product compliance and certification testing lab with over 30 years of experience. They specialize in EMC, EMI, and electrical safety testing for medical devices, ensuring products meet global regulatory standards.
With over 30 years of experience, F2 Labs is a trusted partner in comprehensive product compliance and certification testing. They specialize in ensuring medical devices meet global regulatory requirements, including FCC, FDA, ISED, CE, UL, and CSA standards. F2 Labs offers expert testing services for IEC 60601-1 and IEC 60601-1-2, covering electrical safety, electromagnetic compatibility (EMC), and electromagnetic interference (EMI). Their services ensure products operate as intended in their intended environment and do not interfere with other devices, crucial for patient safety and market access. Beyond testing, F2 Labs provides expert consulting to guide clients through the entire product certification process. They are equipped to test a wide range of electrical products, from battery chargers to medical electrical equipment and wireless devices, providing reliable results with precision and efficiency. Clients praise their responsiveness, thoroughness, and ability to guide them through complex certification processes.
About
**Who they are**
F2 Labs is a product compliance and certification testing lab with over 30 years of experience, specializing in EMC, EMI, and electrical safety testing for medical devices.
**Expertise & scope**
* Offers a full range of product compliance testing services, including CE Mark, FCC, ISED Canada, IEC, UL, and CSA NRTL certifications.
* Specializes in IEC 60601-1 and IEC 60601-1-2 testing for medical electrical equipment, covering basic safety, essential performance, electromagnetic disturbances, and risk management according to ISO 14971.
* Provides testing for collateral standards such as IEC 60601-1-11 (home healthcare), IEC 60601-1-6 (usability), and IEC 60601-1-8 (alarms).
* Conducts Electromagnetic Compatibility (EMC) and Electromagnetic Interference (EMI) testing, evaluating RF emissions and immunity to ensure products operate as intended and do not interfere with other devices.
* Offers specialized medical device EMC testing to meet FDA, IEC 60601, and international regulatory standards, covering emissions, immunity (conducted, radiated, ESD), and pre-compliance scans.
* Performs on-site testing and offers consulting and educational services.
**Reputation / proof points**
* Accredited by A2LA.
* Over 30 years of experience in EMC and Safety evaluations.
F2 Labs is a product compliance and certification testing lab with over 30 years of experience, specializing in EMC, EMI, and electrical safety testing for medical devices.
**Expertise & scope**
* Offers a full range of product compliance testing services, including CE Mark, FCC, ISED Canada, IEC, UL, and CSA NRTL certifications.
* Specializes in IEC 60601-1 and IEC 60601-1-2 testing for medical electrical equipment, covering basic safety, essential performance, electromagnetic disturbances, and risk management according to ISO 14971.
* Provides testing for collateral standards such as IEC 60601-1-11 (home healthcare), IEC 60601-1-6 (usability), and IEC 60601-1-8 (alarms).
* Conducts Electromagnetic Compatibility (EMC) and Electromagnetic Interference (EMI) testing, evaluating RF emissions and immunity to ensure products operate as intended and do not interfere with other devices.
* Offers specialized medical device EMC testing to meet FDA, IEC 60601, and international regulatory standards, covering emissions, immunity (conducted, radiated, ESD), and pre-compliance scans.
* Performs on-site testing and offers consulting and educational services.
**Reputation / proof points**
* Accredited by A2LA.
* Over 30 years of experience in EMC and Safety evaluations.
Additional information
F2 Labs assists manufacturers in navigating the complexities of product compliance, particularly for medical devices. They emphasize the importance of understanding the latest standard revisions, such as the 4th edition of IEC 60601-1-2, which introduced significant technical and documentation changes. The lab can help determine the correct version of a standard to use and offers services to address common EM emitters not covered under IEC 60601-1-2, including those related to 5G cellular, WPT, X-Ray, and Electro-Surgical devices. Their approach includes pre-compliance scans to identify design issues early, saving time and costs, and ensuring devices meet global regulatory requirements for market access.
Key Highlights
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Over 30 years of experience in product compliance and certification testing.
Source
“F2 Labs is an accredited regulatory testing laboratory with more than 30 years of experience performing EMC and Safety evaluations on an extensive range of products.”
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A2LA accredited laboratory for product compliance testing.
Source
“We are an A2LA accredited lab that is fully equipped to test and approve products and equipment for a wide variety of organizational and governmental certifications.”
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Specializes in IEC 60601-1 and IEC 60601-1-2 testing for medical electrical equipment.
Source
“Guarantee the electrical safety and performance of medical devices with F2 Labs’ IEC 60601‑1 testing.”
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Offers comprehensive EMC/EMI testing, including emissions and immunity.
Source
“Ensure your products meet global electromagnetic compatibility (EMC) and interference (EMI) standards with expert compliance testing from F2 Labs.”
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Provides testing for various collateral standards within the IEC 60601 family.
Source
“In addition to IEC 60601-1, which is the general Safety standard for Medical Devices, we can also assist you with the part 2 product-specific standards: IEC 60601-1-11 for home healthcare equipment; IEC 60601-1-6 for usability; IEC 60601-1-8 for alarms;”
Certifications & Trust Signals
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A2LA Accredited Lab
Source
“We are an A2LA accredited lab that is fully equipped to test and approve products and equipment for a wide variety of organizational and governmental certifications.”
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Over 30 years of experience in EMC and Safety evaluations.
Source
“F2 Labs is an accredited regulatory testing laboratory with more than 30 years of experience performing EMC and Safety evaluations on an extensive range of products.”
Buyer Snapshot
Best for
- Medical device manufacturers requiring IEC 60601-1 and IEC 60601-1-2 compliance testing.
- Companies needing EMC/EMI testing for product market entry.
- Manufacturers seeking assistance with global regulatory certifications.
How engagement typically works
- Direct testing services.
- On-site testing options available.
- Consulting and educational support.
Typical deliverables
- EMC/EMI test reports.
- Electrical safety test reports.
- Compliance certification support.
- Pre-compliance scan reports.
Good to know
- Best when manufacturers need to ensure their medical devices meet stringent safety and electromagnetic compatibility standards.
HQ:
Location Testing, US
Languages:
English
Timezones:
EST
Status:
listed
Services & Capabilities
Electrical Safety + EMC Testing (IEC 60601)
Standards Supported:
IEC 60601-1, IEC 60601-1-2, IEC 60601-1-2 Ed. 4, IEC 60601-1-11
Test Coverage:
Both
Nrtl Relationships:
UL, CSA
Max Eut Size:
Custom
Max Eut Size Custom:
Medical electrical equipment and wireless devices
Chamber Type:
Anechoic
Pre Scan Debug Support:
Yes
On Site Testing Option:
Yes
Wireless Add On Capability:
Yes
Test Types Offered:
Conducted emissions, Radiated emissions, ESD immunity, EFT immunity, Surge immunity, RF immunity
wireless_rf_testing
Additional medical_device_emc_testing Details
Standards Supported
IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-1-6, IEC 60601-1-8, CE Mark, FCC, ISED Canada, UL, CSA
Test Coverage
Both
Nrtl Relationships
UL, CSA
Chamber Type
Anechoic
Test Types Offered
EMC testing, EMI testing, Electrical safety testing, Emissions testing, Immunity testing (conducted, radiated, ESD), Pre-compliance scans
Pricing Model
Custom
