UL Medical Experts to Provide Instruction on Guidance for Risk Management in IEC 60601-1:2005 at IECEE Workshop



    NORTHBROOK, Ill., April 10 /CNW/ -- 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.
    

    About Underwriters Laboratories
    
    Underwriters Laboratories (UL) is an independent product safety
certification organization that has been testing products and writing
Standards for Safety for over a century. UL evaluates more than 19,000 types
of products, components, materials and systems annually with 20 billion UL
Marks appearing on 72,000 manufacturers' products each year. UL's worldwide
family of companies and network of service providers includes 64 laboratory,
testing and certification facilities serving customers in 98 countries. For
more information, visit: http://www.ul.com/newsroom.
    





    




For further information:

For further information: Joe Hirschmugl, Media Relations Manager of
Underwriters Laboratories, +1-847-664-1508, Joseph.F.Hirschmugl@us.ul.com; or
Chris Suttile of GolinHarris, +1-312-729-4224, csuttile@golinharris.com for
Underwriters Laboratories

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