PRZOOM - /newswire/ -
Baltimore, MD, United States, 2013/03/13 - 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 - METLabs.com.
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 which 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 (metlabs.com) is hosting an Electro-Medical Device Regulatory Compliance Seminar in Austin, Texas. 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.