Accreditations

F2 Labs holds multiple accreditations and recognitions in order to best serve our customers. We have three testing laboratories in the United States: in Damascus, Maryland, Middlefield, Ohio, and Indianapolis, Indiana. Our labs are A2LA accredited, ASCA accredited, FCC accredited, and Innovation, Science and Economic Development Canada (ISED) accredited. In addition to these accreditations, F2 Labs is a member of the International Trade Council.

To learn more about each of our accreditations keep reading below.


A2LA Accredited Testing Lab

F2 Labs is an independent testing lab that is internationally accredited by A2LA, which is an ILAC signatory, to ISO/IEC 17025 standards.



0793.01


0793.02

ILAC – International Laboratory Accreditation Cooperation is an organization that counts as its members’ laboratory accreditation bodies representing over 70 economies and regional organizations. In many economies, there is an accreditation body recognized by the government to carry out the assessment and verification against international standards of testing, calibration, inspection, and certification activities in both the private and public sectors. The ILAC MRA allows you to make use of a global network of testing and calibration laboratories that have been accredited to provide accurate and reliable results. The MRA supports international trade by promoting international confidence and acceptance of accredited laboratory data. Technical barriers to trade, such as the retesting of products each time they enter a new economy would be reduced.

For more information on the ILAC MRA:
Click Here


ASCA Accredited Testing Lab

F2 Labs is an ASCA-accredited testing laboratory that performs testing in accordance with the specifications of ISO/IEC 17025 and ASCA program specifications. We believe this program will help not only increase product safety for the end-user but also shorten the time it takes for FDA approval of your product.

 

ASCA ID # Lab ASCA Category State Current Scope
TL-21 F2 Labs – Maryland Basic Safety and essential performance Maryland/ United States
  • Scope F2 Labs MD

    ANSI/AAMI ES60601-1 – Medical electrical equipment-Part 1: General requirements for basic safety and essential performance

    ANSI/AAMI HA60601-1-11 – MEDICAL ELECTRICAL EQUIPMENT – Part 1-11: General Requirements For Basic Safety And Essential Performance – Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment

    IEC 60601-1-10 – Medical electrical equipment — Part 1-10: General requirements for basic safety and essential performance — Collateral standard: Requirements for the development of physiologic closed-loop controllers

    IEC 60601-1-11 – Medical electrical equipment — Part 1-11: General requirements for basic safety and essential performance — Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

    IEC 60601-1-12 – Medical Electrical Equipment — Part 1-12: General requirements for basic safety and essential performance — Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the emergency medical services environment

    IEC 60601-1-6 – Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability

    IEC 60601-1-8 – Medical electrical equipment — Part 1-8: General requirements for basic safety and essential performance — Collateral standard: General requirements, tests, and guidance for alarm systems in medical electrical equipment and medical electrical systems

    IEC 60601-2-10 – Medical electrical equipment – Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators

    IEC 60601-2-18 – Medical electrical equipment – Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment

    IEC 60601-2-19 – Medical electrical equipment – Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators

    IEC 60601-2-2 – Medical electrical equipment – Part 2-2: Particular requirements for the basic safety and essential performance of high-frequency surgical equipment and high-frequency surgical accessories

    IEC 60601-2-20 – Medical electrical equipment – Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators

    IEC 60601-2-21 – Medical electrical equipment – Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers

    IEC 60601-2-22 – Medical electrical equipment – Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment

    IEC 60601-2-25 – Medical electrical equipment – Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs

    IEC 60601-2-27 – Medical electrical equipment – Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment

    IEC 60601-2-47 – Medical electrical equipment – Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems

    IEC 60601-2-52 – Medical electrical equipment – Part 2-52: Particular requirements for the basic safety and essential performance of medical beds

    IEC 60601-2-57 – Medical electrical equipment – Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use

    IEC 60601-2-6 – Medical electrical equipment – Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment

    IEC 61010-1 – Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 1: General requirements

    IEC 80601-2-35 – Medical electrical equipment — Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads, or mattresses and intended for heating in medical use

    IEC 80601-2-59 – Medical electrical equipment — Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening

    IEC 80601-2-60 – Medical electrical equipment — Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment

    ISO 80601-2-56 – Medical electrical equipment — Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement

    ISO 80601-2-69 – Medical electrical equipment — Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment

    ISO 80601-2-74 – Medical electrical equipment — Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment

TL- 22 F2 Labs – Ohio Basic Safety and essential performance Ohio/ United States
  • Scope F2 Labs OH

    IEC 60601-1-2 – Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests

    IEC 60601-2-1 Only including section(s) 201.17/202 – Medical electrical equipment – Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV

    IEC 60601-2-10 Only including section(s) 201.17/202 – Medical electrical equipment – Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators

    IEC 60601-2-11 Only including section(s) 201.17/202 – Medical electrical equipment – Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment

    IEC 60601-2-16 Only including section(s) 201.17/202 – Medical electrical equipment – Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration, and haemofiltration equipment

    IEC 60601-2-18 Only including section(s) 201.17/202 – Medical electrical equipment – Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment

    IEC 60601-2-19 – Medical electrical equipment – Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators

    IEC 60601-2-2 Only including section(s) 201.17/202 – Medical electrical equipment – Part 2-2: Particular requirements for the basic safety and essential performance of high-frequency surgical equipment and high-frequency surgical accessories

    IEC 60601-2-20 Only including section(s) 201.17/202 – Medical electrical equipment – Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators

    IEC 60601-2-21 – Medical electrical equipment – Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers

    IEC 60601-2-22 Only including section(s) 201.17/202 –Medical electrical equipment – Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic, and diagnostic laser equipment

    IEC 60601-2-23 Only including section(s) 201.17/202 – Medical electrical equipment – Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment

    IEC 60601-2-25 – Medical electrical equipment – Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs

    IEC 60601-2-27 – Medical electrical equipment – Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment

    IEC 60601-2-28 Only including section(s) 201.17/202 – Medical electrical equipment – Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis

    IEC 60601-2-29 Only including section(s) 201.17/202 – Medical electrical equipment – Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators

    IEC 60601-2-31 Only including section(s) 201.17/202 – Medical electrical equipment — Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with an internal power source

    IEC 60601-2-33 Only including section(s) 201.17/202 – Medical electrical equipment – Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis

    IEC 60601-2-34 Only including section(s) 201.17/202 – Medical electrical equipment – Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment

    IEC 60601-2-36 Only including section(s) 201.17/202 – Medical electrical equipment – Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy

    IEC 60601-2-37 Only including section(s) 201.17/202 – Medical electrical equipment – Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment

    IEC 60601-2-43 Only including section(s) 201.17/202 – Medical electrical equipment – Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures

    IEC 60601-2-44 Only including section(s) 201.17/202 – Medical electrical equipment – Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography

    IEC 60601-2-45 Only including section(s) 201.17/202 – Medical electrical equipment – Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices

    IEC 60601-2-47 – Medical electrical equipment – Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems

    IEC 60601-2-5 Only including section(s) 201.17/202 – Medical electrical equipment – Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment

    IEC 60601-2-50 Only including section(s) 201.17/202 – Medical electrical equipment – Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment

    IEC 60601-2-52 Only including section(s) 201.17/202 – Medical electrical equipment — Part 2-52: Particular requirements for the basic safety and essential performance of medical beds

    IEC 60601-2-54 Only including section(s) 201.17/202 – Medical electrical equipment – Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy

    IEC 60601-2-57 Only including section(s) 201.17/202 – Medical electrical equipment – Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use

    IEC 60601-2-6 Only including section(s) 201.17/202 – Medical electrical equipment – Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment

    IEC 60601-2-64 Only including section(s) 201.17/202 – Medical electrical equipment – Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment

    IEC 80601-2-59 Only including section(s) 201.17/202 – Medical electrical equipment – Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening

    IEC 80601-2-60 Only including section(s) 201.17/202 – Medical electrical equipment — Part 2-60: Particular requirements for basic safety and essential performance of dental equipment

    ISO 80601-2-12 Only including section(s) 201.17/202 – Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators

    ISO 80601-2-55 Only including section(s) 201.17/202 – Medical electrical equipment — Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors

    ISO 80601-2-56 Only including section(s) 201.17/202 – Medical electrical equipment — Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement

    ISO 80601-2-61 Only including section(s) 201.17/202 – Medical electrical equipment — Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment.

    ISO 80601-2-69 Only including section(s) 201.17/202 – Medical electrical equipment — Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment

    ISO 80601-2-70 Only including section(s) 201.17/202 – Medical electrical equipment — Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment.

    ISO 80601-2-80 Only Section(s) 201.17/202 – Medical electrical equipment — Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency

What is ASCA?

The FDA launched ASCA with the intention to support its public health mission by increasing confidence in test results provided by testing laboratories. F2 Labs was among the first to become ASCA-accredited. Becoming accredited comes with standards a laboratory must follow past the initial application process, including periodic audits. This helps ensure confidence with the FDA that we are following the proper procedures and can help get your product through the FDA 510K process quicker.

 

According to the FDA, this program will help enhance confidence in medical device testing, promote consistency and predictability in the premarket review process, encourage effective use of FDA resources, and support international harmonization. The increased confidence in testing may be particularly helpful for premarket submissions that rely on Declarations of Conformity to FDA-recognized consensus standards using test results from ASCA-accredited testing laboratories.

 

For more information on ASCA-accredited labs click here.


FCC Accredited Testing Lab

F2 Labs – OH is accredited by the FCC for testing. In the table below, you will find the extent of our scope compiled by the FCC’s Office of Engineering and Technology.

 

Office of Engineering and Technology (OET) Accredited Test Firm Scope List

 

Scope FCC Rule Parts Recognized Since
Unintentional Radiators FCC Part 15, Subpart B 07-06-2017
Industrial, Scientific, and Medical Equipment FCC Part 18 07-06-2017
Intentional Radiators FCC Part 15 Subpart C 07-06-2017
U-NII without DFS Intentional Radiators FCC Part 15, Subpart E 01-09-2020

 

For more information about F2 Labs FCC scope of accreditation, click here.


ISED Accredited Testing Lab

F2 Labs – OH is accredited by ISED Canada (Innovation, Science and Economic Development Canada) as a wireless device testing lab. Wireless Device Testing laboratories are recognized by ISED Canada in order to test to Canadian radio equipment requirements.

 

Organization CAB identifier Scope / Recognition Date

(yyyy-mm-dd)

F2 LABS16740 Peters Road,
Middlefield, OH 44062, United StatesCompany Number: 4730B
US0193 RSS-102 (RF Exp.) (2019-02-20)

 

RSS-GEN (2019-02-20)

 

RSS-119 (2019-07-30)

 

RSS-210 (2019-02-20)

 

RSS-247 (no DFS) (2019-02-20)

 

IMPORTANT NOTICE

F2 Labs does NOT test, certify, or provide any services related to respiratory masks or protective gloves. Any certificates or documents indicating otherwise are fraudulent; please notify us at legal@f2labs.com if you become aware of or obtain any such certificate or document.

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