UL medical experts to provide instruction on guidance for risk management in IEC 60601-1:2005 at IECEE workshop
NORTHBROOK, Ill., April 10, 2009 — On April 14-17, 2009, Underwriters Laboratories Inc.’s (UL) Primary Designated Engineer (PDE) Steve McRoberts and GMA Certification Department Manager Jola Wroblewska will present International Electrotechnical Committee for Conformity Testing to Standards for Electrical Equipment (IECEE) CB Test Laboratories and National Certification Bodies (NCBs) with IEC 60601-1:2005 3rd Edition training to promote common application of the guidelines prepared by the IECEE Risk Management Task Force (RMTF).
UL PDEs Joe Murnane and McRoberts have been active members of the RMTF since it was established by the IECEE in September 2007, which puts UL in the unique position to help other NCBs and CBTLs understand the intent behind the guidelines and how to apply them during a certification assessment. This workshop will take place in Milano, Italy and is intended for NCB and CBTL staff.
The guidelines, functionally known as an IECEE guidance document, were developed to provide clarity on application of risk management for clauses that reference risk management in the latest edition of IEC 60601-1:2005 (3rd Edition). During the workshop, UL experts will demonstrate how to apply the guidance in issuing CB Certificates to the IECEE CB Scheme category "MED." UL experts will also provide examples on what to look for during the assessment of a manufacturer’s risk management file which can take place as a desktop review of the report or an on-site assessment. All options for certification are available from UL.
Through participation in the committees by Murnane and McRoberts, UL is ideally positioned to provide CB Scheme Test Labs, certification bodies and manufacturers clarity on the requirements.
"Application of consistent requirements is essential to the CB Scheme and certification systems. As the leading CB Test Certificate issuing agency for the medical standard IEC 60601-1, UL is working with the IECEE to help insure consistent certification requirements are established" said Anil Patel, general manager, UL Health Sciences. "This commitment is an obligation to our clients, accreditors, regulators, and the industry as a whole. Our investment in participating in these activities insures we bring the most value to our customers’ regulatory needs across multiple markets."
UL has been at the forefront of supporting the industry by committing expert resources to participate in the committees. Patel adds "The key is for us to meet the growing demands of our customers and offer the most flexible options for industry to demonstrate conformity to IEC 60601-1." In addition to the staff providing presentations on the RMTF guidance document, UL staff representing CBTLs located in the USA, Japan, Denmark, Taiwan, and Canada will also be attending this workshop.