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IEC 60601-1
Medical Equipment Compliance,
Certification, and Regulatory Services and Information

Medical Equipment Compliance Associates, LLC

ISO 17025 Certificates for Accredited Testing Reports,
About MECA

 

MECA was formed in 2002, to assist medical device companies with safety certification, ISO 17025 accredited compliance reports, and regulatory needs. We have grown our business and our network of associates with the leaders in their respective fields, to offer the highest level of certification and regulatory support that you will find anywhere.


MECA Team CV Link: Team Experience, Certificates, Committees, Publications

Electrical, Mechanical, Thermal Testing Lab

MECA only handles medical and laboratory equipment, so our lab is customized to expedite testing to the
IEC 60601-1 and IEC 61010-1 standards, as well as the Collaterals, Particulars, and national deviations.

Alarm System / Sound Testing Lab

MECA's ISO 3744 Hemi-Anechoic Sound Chamber allows us to test medical devices to the IEC 60601-1-8 Alarm standard.
This allows us to measure sound levels, frequency response, timing, and harmonics.

Water Ingress, Humidity, Environmental Testing Lab

MECA conducts testing to the IEC 60529 standard, for IPX1 to IPX8 water ingress ratings.
Humidity preconditioning chamber, for testing large devices, such as bariatric hospital beds.
Environmental chambers and ovens, for conditioning required by the medical and laboratory standards.

 
MECA History:

2014/08/01 - MECA becomes a full CBTL (CB Testing Laboratory), under the CB Scheme

Medical Equipment Compliance Associates, LLC can now create CB Reports (certificates issued by UL)


2012/10/23 - MECA becomes an A2LA Accredited Laboratory, under ISO 17025 (For Testing Labs)
Some countries now require A2LA or ilac Accredited labs to conduct testing, for acceptance of the test data.
(A2LA is a signatory of the ilac MRA arrangement)
With this accreditation, our data can be accepted by any country requiring this, including Brazil.


2012/05/04 - MECA becomes an Intertek Recognized Test Laboratory for the Medical Standards

Clients who are in need of the ETL Safety Mark can now use MECA to get this certification.

2009/11/04 - MECA becomes a TUV Rheinland Qualified Laboratory

Clients who are in need of the TUV Rheinland Safety Mark can now use MECA to get this certification.

2008/11/17 - MECA becomes an Associated CB Testing Laboratory (ACTL), under the CB Scheme

Medical Equipment Compliance Associates, LLC has been accepted by the IECEE as an ACTL, associated with UL.
This allows MECA to conduct testing and write reports for the CB Scheme.

2007/08/28 - MECA enters the UL Third Party Test Data Program (TPTDP)
Clients who are in need of the UL Safety Mark can now use MECA to get their UL Classification.

2002/07/16 - MECA (Medical Equipment Compliance Associates, LLC) is founded by Brian Biersach
After working for UL (Underwriters Laboratories, inc.) in the medical device section, Brian forms MECA.
This was done to assist medical device companies in complying with the required international standards.
There was a need for this assistance in the medical industry, due to the increasing complexity of the standards.
Over the following years, MECA grew from a consulting company, to a fully accredited testing laboratory.

MECA Equipment Experience List

The following is a list of equipment that we have experience evaluating to the '60601 and other medical standards.
Don't see your equipment listed here? We evaluate new types of medical equipment all of the time.
* Note, we do not handle the evaluation of wheel chairs (manual or electrical).
Due to confidentiality requirements of most clients, we can not specify manufacturer's devices specifically

MEDICAL EQUIPMENT:
- Ablation Devices (Cardiac, Lung, Prostate, Uterus, etc.)
- Alarms for Medical Equipment
- Ambulatory Electrocardiographic Monitors (Holter Monitors)
- Anaesthetic Machines
- Artificial Hearts (Externally Powered or controlled)
- Automatic Cycling Indirect Blood Pressure Monitors
- Baby Incubators
- Biopsy Devices (breast, brain, etc.)
- Blankets, Pads and Mattresses for Heating in Medical Use
- Blood Glucose Meters and Accessories
- Blood Warmers
- Breast Pumps
- Cardiac Ablation Devices
- Cardiac Defibrillators
- Cardiac Pumps
- Chairs with Heaters (Used With Patients)
- Cooling Equipment (Patient Coolers)
- CT and CAT Scanners (Computer Assisted Tomography)
- Defibrillators (Conventional, AED)
- Dental Chairs
- Dental Curing Lights
- Dental Electrosurgical Generators
- Dental Drills
- Dental Imaging Devices
- Dermatomes
- Diagnostic and Therapeutic Lasers
- Diagnostic Tables
- Diagnostic X-ray Generators
- Direct Blood Pressure Monitors
- Drills for medical use
- Electrocardiographs (ECG EKG)
- Electroencephalographs (EEG)
- Electromyographs (EMG)
- Electrosurgical (RF) Generators
- Electrosurgical Accessories (Hand pieces, Probes)
- Endoscopic Equipment and Accessories
- Exam Tables
- Extracorporeally and Internally Induced Lithotriptors
- Fluid Pumps for Medical Use
- Fluid Warmers
- Gamma Cameras (PET Systems)
- Gas Monitoring Equipment
- Harmonic Surgical Equipment
- Headwalls for Medical Use
- Hemodialysis Equipment
- High Frequency Surgical Equipment
- Hospital Beds
- Imaging Equipment
- Infant Radiant Warmers
- Infusion Pumps (volumetric, syringe, insulin)
- Light Treatment Equipment for Medical Use (LED, LASER, Lamp)
- Lithotriptors
- Lung Ventilators
- LASER Medical Devices
- Luminaires (Surgical and for Diagnosis)
- LVADs (Left Ventricular Assist Devices)
- Magnetic Resonance Imaging Equipment (MRI)
- Magnetic Resonance Imaging Coils (head, wrist, breast, etc.)
- Mammographic Stereotactic Devices
- Mammographic X-ray Equipment
- Medical Stretchers
- Medical Monitors (computer monitors for medical)
- Multiparameter Patient Monitoring Equipment (ECG, SpO2, NIBP, Direct BP, CO2, Temp, CO, etc.)
- Muscle Stimulators
- Nerve Stimulators
- Operating Tables
- Ophthalmological Equipment (Slit Lamps, etc.)
- Pacemaker Programmers
- Patient Monitors
- Patient Movement Devices
- Perfusion Equipment (Heart Bypass)
- Positron Emission Tomography (PET) Scanners
- Pulse Oximeters (SpO2)
- Pumps for Medical Use
- Recording and Analysing Electrocardiographs
- Remote Controlled Automatically Driven Gamma Ray Afterloaders
- Renal Denervation Devices
- Respiratory Gas Monitoring Equipment
- Robotic Surgical Equipment
- Stretchers
- Superconducting Quantum Interface Devices (SQUIDs)
- Telemetry Systems
- Temperature Measurement Equipment
- Thermometers for Medical Use (Conductive and Infrared)
- Transcutaneous Partial Pressure Monitors
- Treadmills for Medical Use
- Treatment Tables
- Ultrasonic Medical Diagnostic and Monitoring Equipment
- Ultrasonic Therapy Equipment
- Veterinary Medical Equipment
- Warming Equipment (Patient Warmers)
- X-Ray Equipment for Computed Tomography
- X-Ray Source Assemblies for Medical Diagnosis
- X-Ray Tube Assemblies for Medical Diagnosis

LABORATORY EQUIPMENT:
- Blood Glucose Meters and Accessories
- Cabinet X-Ray Equipment
- Centrifuges
- Control Equipment
- Heating Equipment
- IVD Equipment (In-Vitro Diagnostic)
- Mixing and Stirring Equipment
- Sterilizers
- Testing and Measuring Equipment