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September 24, 2003:
The third Meeting
Report of the Ad Hoc Group on Portable Power Supplies is now available. The
Ad Hoc Group has representation from Underwriters Laboratories Inc., and
industry leading companies from the ITE, portable power supply, connector and
power supply cord industries. The meeting was held on August 26th and 27th in
Fremont California, and the group has made progress developing
"wiggle" test performance/compliance criteria that can be used to
identify more robust appliance couplers. It is likely that a new test eventually
will be proposed to IEC SC 23G to revise IEC 60320. Please check back for
periodic updates on the Group's activities.
September 16, 2003:
The August 27th Meeting Report
on the last meeting of the Bi-National Working Group (BNWG) for Information
Technology and Telecommunication Equipment is now available for download. The
purpose of the meeting was to discuss various topics related to our bi-national
ITE safety standards and future revisions to them, including likely changes
based on proposed revisions to IEC 60950-1 and proposed new standards IEC
60950-21 (ITE - Remote Power Feeding), IEC 60950-22 (Outdoor Equipment) and IEC
60950-23 (Large ITE with Robotics). Also discussed was the future convergence of
our ITE and audio-video standards development processes, and miscellaneous other
technical and applications topics related to our bi-national ITE safety
standards.
August, 2003:
See the attached PDF file for more information.
June 11, 2003:
UL issues easier to use Standard for medical devices
UL 60601-1 puts all requirements at manufacturer's fingertips
NORTHBROOK, Ill., USA - For users of UL's 2601-1 medical standard who
may have been frustrated by having to flip back and forth for clauses,
amendments, deviations and rationales, Underwriters Laboratories Inc. (UL) has a
solution. UL recently published UL 60601-1, a reformatted, easier-to use version
of the Medical Equipment Standard.
Highlights of the new version include: a new number that matches the IEC and
EN medical equipment standards; Amendments One and Two fully incorporated into
the text; US national differences placed with their relevant clause, making it
easy to apply these requirements when needed; and clickable hyperlinks to
rationales placed directly within requirements.
"The publication of this reformatted Standard reinforces UL's approach
to simplifying medical device manufacturers' worldwide conformity assessment
needs," says Dale Hallerberg, senior staff engineer at UL's Northbrook,
Ill., USA office. "UL always strives to provide medical device
manufacturers with services that will enhance their market access and buyer's
acceptance of their products."
To view a demo version of the electronic UL 60601-1, visit www.ul.com/medical.
For additional information regarding this newly reformatted Standard, contact
Hallerberg at +1 847-664-3224 or via e-mail at Dale.A.Hallerberg@us.ul.com.
Underwriters Laboratories Inc. (UL) is an independent, not-for-profit product
safety certification organization that has been testing products and writing
Standards for Safety for more than 109 years. UL tests more than 18,000 types of
products annually, and more than 17 billion UL Marks appear on products each
year. Worldwide, UL's family of companies and its network of service providers
include 55 laboratories, and testing and certification facilities.
April 11, 2003:
The second Meeting Report of
the Ad Hoc Group on Portable Power Supplies is now available. The Ad Hoc Group
consists of representation from Underwriters Laboratories Inc., the U.S.
Consumer Product Safety Commission (CPSC) and industry leading companies from
the portable power supply and ITE industries. The meeting was held on February
19th and 20th in Fremont California. The objective of this Ad Hoc Group is to
review present designs and past safety recalls of portable power supplies and
determine through use of hazard-based safety engineering principles whether
present technical-and certification-based safety requirements are adequate.
Please check back for periodic updates on the Group's activities.
The first Meeting Report of
the Ad Hoc Group on ITE Power Distribution is now available. The Ad Hoc Group
consists of representation from Underwriters Laboratories Inc., and industry
leading companies producing ITE, ITE power distribution units and overcurrent
protection devices. The initial meeting was held on November 4-5, 2002 at UL’s
Santa Clara office. The objective of this Ad Hoc Group is to study the adequacy
of current safety and certification requirements for ITE power distribution
equipment and associated overcurrent protection devices typically used in the
localized distribution of ITE power, such as found in ITE racks and cabinets.
Please check back for periodic updates on the Group's activities.
January, 2002:
Effective January 3, 2003, medical
devices entering the Canadian marketplace must be licensed under CMDCAS
With UL's accreditation by the Standards Council of Canada (SCC), UL can
provide medical device manufacturers the quality management system assessments
called for by Health Canada's recently published Canadian Medical Devices
Conformity Assessment System (CMDCAS), governing medical devices entering the
Canadian market.
Developed by Health Canada, in collaboration with the SCC, the Canadian
Medical Devices Conformity Assessment System (CMDCAS) governs all medical
devices entering the Canadian market. The CMDCAS requires that, prior to Jan.
2003, quality management systems must comply with important quality standards
(CAN/CSA-ISO 13485/88:1998). After Jan. 2003, medical device manufacturers
(other than those in class 1) will not be able to sell their products in Canada
unless certified by an SCC-accredited registrar, such as UL.
The auditing of quality management systems ensures a manufacturer maintains
good practices for the ongoing manufacturing of a pre-approved safe and
effective medical device. Consistency with the original approved type affords
the consumer and the regulator a large measure of confidence that the ongoing
production continues to be safe and effective.
UL's expanded services for Canada complements its suite of global compliance
services for medical device manufacturers.
UL's affiliate, UL International (UK) Ltd., is a notified body in the U.K.
for both the Medical Devices Directive and the In Vitro Diagnostic Directive and
UL has been registering facilities to the ISO 13485/8 standards since their
inception.
When medical device manufacturers choose UL to deliver their compliance
services, they can tap into the convenience of a single provider who delivers a
comprehensive service portfolio for a broad range of markets enabling them to
save valuable time and money.
October 9, 2002:
Updated Certification Impact Analyses for UL
60950 and UL
60950-1 are now available! These analyses identify the significant
differences between (a) IEC 60950 and UL 60950 Third Editions and their
predecessors and (b) IEC 60950-1 First Edition and the pending UL 60950-1 First
Edition and their predecessors.
March 1, 2001:
UL Launches Online Plastics Database
UL launched its latest,
exciting, new online information product on the Internet March 1. The UL
IQ for Plastics database is a powerful tool for plastics buyers and specifiers
to use as a pre-selection tool in their search for UL Recognized plastics.
What is it?
UL IQ for Plastics is a
value-added, data-rich parametric database containing most of the contents of
UL's Plastics Recognized Component Directory. With this database, users
can select the criteria they need in a plastic material and execute a search of
more than 50,000 grades of plastics to find "yellow cards" for all the
grades that meet those requirements.
Additionally, database users can
search by company name, file number, grade of plastic, generic family name and
description. The database opened for general users March 1, and can be
accessed at http://data.ul.com/ULiQ_Link/index.asp
About UL IQ for Plastics
database:
1. It's easy to use
-- you simply identify as many criteria as you know about the material you need
and then execute a search of the database to find all the grades of plastic meeting or exceeding
those criteria. The results are returned in seconds.
2. It's data rich -- more
than 50,000 grades of plastics are included in UL IQ for Plastics database.
Essentially, this is the entire contents of the Plastics Recognized Component Directory.
3. It's available on
your schedule -- UL IQ for Plastics database is available 24 hours a day, seven
days a week to match your work schedules wherever you are in the world.
4. It's accurate --
the UL IQ for Plastics database is updated daily, so you have access to the
latest information on UL
Recognized Plastics.
5. It's free!
September
7, 1999:
Announcement of UL Services for Registration of
Firms of Assessed
Capability to ISO 13485; and for Registration of Firms of Assessed Capabilities
to ISO 13488
Medical device manufacturers are subject to national regulatory requirements,
many of which include the design and/or manufacture within a quality management
system based on ISO 13485 or ISO 13488*. Regulatory authorities often give
credit to third party certificates in support of a manufacturer's declaration of
conformity with regulatory quality system requirements. The two new
services noted in the Subject will assist manufacturers in demonstrating to
regulatory authorities their compliance with quality system requirements.
*The requirements of the ISO 13485 Standards are similar to the requirements
of the EN 46001 and CAN/CSA-ISO 13485-98 Standards, and equivalent national
standards adopted by other countries.
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