IECEE Expands MET Labs' Status for Medical Equipment Safety Certification
March 13, 2013 (Updated March 19). The IECEE has expanded MET Laboratories’ National Certification Body (NCB) status to include IEC 60601-1 3rd edition, the latest edition of the medical product safety standard. In addition, MET announced that it has signed a Memorandum of Understanding (MoU) with LCIE Bureau Veritas, in Paris.
With regard to IECEE, MET can now certify electro-medical products to IEC 60601-1 3rd edition for the IECEE Certification Body (CB) Scheme. At the same time, MET’s Baltimore Certification Body Test Laboratory (CBTL) also received accreditation for IEC 60601-1 3rd edition.
To receive IECEE CB Scheme accreditation, MET was required to provide evidence of many successful IEC 60601-1 3rd edition projects.
Accreditation to IEC 60601-1 third edition is essential for meeting the global market needs of MET’s medical client base, as it is mandatory in the EU and Canada that new product submissions comply with the national versions of third edition of IEC 60601-1 and the applicable particular and collateral standards.
IEC 60601-1 is used to certify the safety of electro-medical devices that can be found in the operating room, by a patient’s bedside or in a doctor’s office, including battery-operated thermometers, MRI and gamma imaging systems, endoscopic cameras, infusion pumps, defibrillators, and many others. The 3rd edition introduced several significant changes, including the requirement to provide a risk management file, enhanced testing requirements, and software analysis.
In addition to Medical (MED), MET Labs is capable of recognizing and/or issuing certificates for the following IECEE CB Scheme categories: Household (HOUS), Measurement (MEAS), Office (OFF), Tool (TOOL), and Electronic (TRON). As a recognized member, MET performs testing and provides an international test certificate that can be used to obtain product safety certification in the participating member countries and can also recognize such reports and certificates from other participating countries.
The CB Scheme is an International Scheme operated by the IECEE (IEC System for Conformity testing and Certification of Electrotechnical Equipment and Components). The Scheme is based on the principle of mutual recognition (reciprocal acceptance) by its members of test results for obtaining certification or approval at the national level. There are presently more than 55 countries participating in the Scheme.
In May, MET is hosting an Electro-Medical Device Regulatory Compliance Seminar in Austin, TX. This free seminar provides a good overview of Product Safety & FDA regulatory compliance requirements for medical products. Partner Emergo Group will be co-presenting with MET.
MoU with LCIE Bureau Veritas
In addition, MET Laboratories announced that it has signed a Memorandum of Understanding (MoU) with LCIE Bureau Veritas, in Paris, France, that allows for the mutual recognition of reports issued by both parties.
This agreement will allow French manufacturers requiring safety certifications for North America to gain it locally through working with LCIE, the largest electrical testing laboratory in France. North American-based customers can now attain market access in Europe by working with MET to gain European certification marks.
Both MET Laboratories and LCIE are members of the IECEE CB Scheme, and will benefit from the mutual recognition of CB reports issued by either party. LCIE is a French National Certification Body participating in the CB Scheme. French manufacturers will gain access to North American product safety certification according to OSHA NRTL and Standards Council of Canada Certification Body regulations.
Partnering with MET Laboratories, a leader in electrical product safety for more than 50 years, will expand the scope of LCIE’s electrical testing and certification services. Key industry sectors benefiting from this partnership include IT, consumer electronics, and medical and laboratory equipment.