- MET is the first NRTL licensed by OSHA for medical equipment.
- MET-certified medical products have been universally accepted by medical equipment buyers.
- MET performs inspections of high-end medical equipment (e.g. MRI and CT scanners) in hospitals throughout North America.
- MET is nationally accepted by regulatory agencies: OSHA in the United States and SCC in Canada.
MET Laboratories certifies or tests medical electrical equipment for:
- Product safety compliance in the United States and Canada
- EMC compliance
- FDA Guidance Documents and consensus standards necessary for FDA clearance, including IEC 60601, AAMI and ASTM standards.
- Electrical wheelchairs to the ANSI/RESNA/FDA and European EN 12184 requirements
Product Safety Certification
MET-certified medical products have been universally accepted in the US and Canada. MET tests and certifies to:
- UL 60601-1
- AAMI ES60601-1
- CSA C22.2 No. 601.1
- RESNA WC-1:2009
- ISO 7176-9
For international safety certification requirements, MET tests and certifies to:
- EN 60601-1
- EN 60601-2-XX
- IEC 60601-1
- IEC 60601-2-XX
The 60601 series of standards consists of 60601-1 and 60601-2-XX. The Part 1 applies to all medical products while the Part 2 addresses specific requirements for a particular type of medical device. There are over 40 Part 2s. The –XX is a number from 1 to 40+, representing the applicable Part 2.
Medical EMC testing performed by MET is typically to EN/IEC 60601-1-2 for most devices. Additions and/or deviations to the requirements of 60601-1-2, as published in the appropriate EN/IEC 60601-2-XX for particular devices, may also be applicable.
- ANSI ISO 14708-3 – Implants for surgery – Active implantable medical devices – Part 3: Implantable neurostimulators
“I thank you for your hospitality and usual excellent service during my visit for surge immunity testing of our MC-6A Electrosurgery Unit, 220 Volt version, last Thursday. It was a very pleasant experience and you can count on me to recommend MET Labs to others at every opportunity I have.
We will again be requiring testing services fairly soon for a couple of new projects that we intend to develop and manufacture. With the very good relationship that we have with you, at MET Labs, we won’t even be tempted to look elsewhere.
Again, thank you for – unlike your business competition – making safety testing a nearly painless process.”
Dennis Karol, Production Supervisor & QMS Implementer
Macan Manufacturing Company
MET is a National Certification Body (NCB) and a Certification Body Testing Laboratory (CBTL) under the international certification body scheme, or CB scheme, for Medical Electrical products. Our test reports and certificates are recognized by over 50 countries.
MET works closely with a Notified Body to assist clients with the requirements of the Medical Device Directive 93/42/ECC. We have the expertise necessary to speed your product into the European market in a timely manner.
As an independent, third-party testing laboratory, MET puts its substantial skills and resources to work in the performance and comparative testing of your medical device. MET provides:
- Full range of performance testing including functionality, energy efficiency, durability, reliability, and more
- Full range of performance tests to many FDA Guidance Documents, AAMI and ANSI standards
- Special tests to establish and/or validate claims on new medical devices
- Unique testing facilities for many special medical devices including: electro-surgical devices, ultrasound equipment, electric wheelchairs and many more
- Litigation support testing, expert witness
Additional advantages to using MET Laboratories:
- 24 hour start for critical projects
- Real-time on-line project tracking
- Extensive knowledge of FDA requirements and procedures
- Less than one hour drive from FDA headquarters, for conducting face-to-face meetings and helping to expedite a clearance
MET’s thorough knowledge of industry performance and national safety standards, combined with extensive global testing and certification resources, allows you to get your product on the market in a timely and cost-effective way.
Product: Phoenix Arm Monitor
Standard: UL 60601-1 & C22.2 No.601-1 Medical Electrical Equipment, Part 1
Sold at: Costco, CVS, Target, Best Buy, Brookstone
Some of MET’s other Medical Device Testing customers:
“I would like to thank everyone for accommodating the testing of our product and working tirelessly to meet a very tight schedule. We are very happy with the work. Please pass our sincere appreciation to all of your associates who worked tirelessly to help us meet the tight timeframe.”
Virginia Njagi, Project Lead, EE
Dilon Technologies, Inc.