MET Laboratories certifies electro-medical devices 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.

MET is the first NRTL licensed by OSHA for medical equipment!

the MET Mark is recognized throughout the United States and Canada		OSHA covers all workplaces which include all hospitals, clinics, therapy centers, and other similar facilities. MET certified medical products have been universally accepted in the US and Canada. MET performs inspections of high-end medical equipment (e.g. MRI and CAT scanners) in hospitals throughout the US. MET is nationally accepted by OSHA for the United States and the SCC for Canada.
MET has been testing and certifying medical devices for over 40 years. MET's long list of clientele include companies such as:
Becton Dickinson Stryker Howmedica Toshiba		HK Surgical, Inc. GE Medical Phillips

Product Safety Certification

MET certified medical products have been universally accepted in the US
and Canada. MET performs inspections of high-end medical equipment (e.g. MRI and CAT scanners) in hospitals throughout the US.

For North American safety certification requirements, MET tests and certifies to:

• UL 60601-1
• CSA C22.2 No. 601.1

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 consist 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 to cover the uniqueness of medical products. The –XX is a number from 1 to 40+, representing the applicable Part 2.
TOP

EMC

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.

CB Scheme

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 tests reports and certificates are recognized by nearly 30 participating agencies throughout the world.
TOP

Notified Body

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 allow you to get your product into Europe in a timely manner.

Performance Testing

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, catheters, electrical 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 with FDA requirements and procedures
• Less than one hour drive from the FDA to conduct face to face meetings and help expedite a clearance

TOP

Wheelchairs MET is recognize for testing of electrical wheelchairs to the ANSI/RESNA/FDA and European EN 12184 requirements. MET is the expert on regulatory requirements throughout the world for wheelchairs and scooters and can help a manufacturer meet all of these requirements. For more information on MET Labs ANSI/RESNA testing and related matters for wheelchairs click here.

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 timely and properly the first time.

TOP