FITNESS EQUIPMENT STANDARDS
FITNESS EQUIPMENT STANDARDS
FITNESS EQUIPMENT STANDARDS
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MAY/JUNE 2005<br />
RUNNING WITH THE RIGHT<br />
<strong>FITNESS</strong><br />
<strong>EQUIPMENT</strong><br />
<strong>STANDARDS</strong><br />
ASTM Cautions User of<br />
the Need for Safety and<br />
Health Practices<br />
AUTOMOTIVE ▲ EMC ▲ ERGONOMICS ▲ FIELD EVALUATION ▲ INDUSTRIAL MACHINERY<br />
MANAGEMENT SYSTEMS ▲ MEDICAL ▲ PRESSURE <strong>EQUIPMENT</strong> ▲ SAFETY ▲ TELECOM
MAY/JUNE 2005<br />
LATE-BREAKING NEWS<br />
Wanted: Customer Feedback<br />
Rheinland of North America, Inc. has a long tradition of searching for the<br />
TUV<br />
best ways in which to help our clients accomplish their testing and<br />
certification objectives. While the services offered by TUV have made us the industry<br />
leader, it is our core values of commitment, integrity, teamwork and professional excellence<br />
that have allowed us to help our clients succeed.<br />
As a continuing part of this initiative, please be sure to direct your<br />
customers to the "TUViewpoints" customer feedback form link from<br />
the homepage www.us.tuv.com as the appropriate forum for their<br />
comments and suggestions for improvement. ▲<br />
2 LATE-BREAKING NEWS<br />
Wanted: Customer Feedback<br />
3 INTERNATIONAL APPROVALS<br />
New Standards for Japan’s<br />
Electrical Appliances and<br />
Materials<br />
3 INTERNATIONAL APPROVALS<br />
New EMC Standards<br />
Introduced in Russia<br />
4 SAFETY<br />
Alliance Formed with<br />
Eastman Kodak Company<br />
5 QUALITY<br />
Atsec Information<br />
Security Corporation<br />
ISO 9001:2000 Certified<br />
6-7 INDUSTRIAL MACHINERY<br />
ASTM Updates a<br />
Key Fitness<br />
Equipment Standard<br />
8 ASK THE EXPERTS<br />
10 DID YOU KNOW?<br />
Update on the WEEE/RoHS<br />
Directives<br />
A PUBLICATION OF THE TÜV RHEINLAND A PUBLICATION GROUP OF THE TÜV RHEINLAND GROUP<br />
Traci Conroy • Managing Editor<br />
TUV Rheinland of North America, Inc.<br />
12 Commerce Road • Newtown, CT 06470 USA<br />
Tel: 203-426-0888 • Fax: 203-426-4009 • Email: tconroy@us.tuv.com<br />
Gabi Kimura • Asian Editor<br />
TÜV Rheinland Japan Ltd.<br />
Shin Yokohama Daini Center Building • 19-5 Shin Yokohama 3-chome<br />
Kohoku-ku, Yokohama 222-0033 Japan<br />
Tel: 81-45-470-1928 • Fax: 81-45-470-1863 • Email: gki@jpn.tuv.com<br />
Ralf Diekmann • European Editor<br />
TÜV Rheinland Group<br />
Am Grauen Stein • 51105 Cologne, Germany<br />
Tel: 49-221-806-1972 • Fax: 49-221-806-1358 • Email: diekmann@de.tuv.com<br />
TÜV Rheinland World News is published six times a year by<br />
TÜV Rheinland Group. Subscriptions are free.<br />
This newsletter is published for the convenience of our customers, clients and professional<br />
associates. Although it is intended to provide accurate and authoritative information<br />
with respect to the subject matter covered, the information and opinions contained<br />
in this publication are those of the authors or advertisers and not of the editors<br />
or publishers. The authors, editors and publishers disclaim any liability for any inaccuracies<br />
contained herein. Before any action is taken based upon the published information,<br />
it is essential that competent and individual professional advice is obtained.
International Approvals<br />
New Standards for Japan’s Electrical Appliances and Materials<br />
Imported Products Must Comply Within 3 Years<br />
Electrical appliances and materials<br />
manufactured in or imported to Japan<br />
must meet new testing standards that<br />
have been in place since August 27, 2004.<br />
The new standards, defined under the<br />
DENAN Law, were implemented in<br />
accordance with an announcement issued<br />
by Japan’s Ministry of Economy, Trade and<br />
Industry (METI) in February 2004.<br />
The J60950 (H14) standard, issued on<br />
March 13, 2002, was amended to J60950<br />
(H16), and took effect August 27, 2004. All<br />
test reports, S-Mark certificates, and<br />
Conformity of Compliance assessments for<br />
products in Specified Appliance and<br />
Materials categories must now be in<br />
accordance with J60950 (H16). For<br />
New EMC Standards<br />
Introduced in Russia<br />
GOST-R Certificates Previously Issued Still Valid<br />
New EMC standards for electric,<br />
electronic, kitchen and home appliances<br />
for the Russian market went into effect on<br />
July 1, 2004.<br />
The new standards are:<br />
• GOST R 51317.3.2-99<br />
“Electromagnetic compatibility of<br />
technical equipment. Harmonic<br />
current emissions (equipment input<br />
current ≤ 16 A per phase). Limits and<br />
test methods.”<br />
• GOST R 51317.3.3-99<br />
“Electromagnetic compatibility of<br />
technical equipment. Voltage<br />
fluctuation and flicker impressed on<br />
low-voltage supply systems by<br />
equipment with rated current ≤ 16 A.<br />
Limits and test methods.”<br />
Products of these types for the Russian<br />
market must now be in full compliance. It<br />
should be noted that GOST R 51317.3.2-99<br />
is identical to EN 61000-3-2, and that GOST<br />
R 51317.3.3-99 is identical to EN 61000-3-3.<br />
TÜV Info Resources<br />
NORTH AMERICA<br />
ASIA<br />
Dan Sullivan<br />
Eric Chow<br />
203-426-0888, Ext. 121 81-45-470-3148<br />
Email: dsullivan@us.tuv.com Email: eric.chow@jpn.tuv.com<br />
Or contact your nearest TÜV office.<br />
products already being imported into<br />
Japan, the new testing standard must be<br />
applied within three years, reduced from<br />
the old standard’s five-year Conformity of<br />
Compliance requirement.<br />
The contents of J60950 (H14) and J60950<br />
(H16) are quite similar, with minor changes<br />
in Appendix U. The changes are<br />
applicable only to transformers<br />
using triple insulation wire.<br />
However, if the triple<br />
insulation wire has<br />
been granted prior<br />
approval, no<br />
further<br />
evaluation will<br />
be necessary.<br />
GOST-R<br />
certificates<br />
previously<br />
issued for<br />
products are<br />
not affected by<br />
the introduction<br />
of the new<br />
standards and will<br />
remain valid until the<br />
original date of expiration.<br />
Samples for new<br />
applications submitted in the<br />
future, however, will be tested for<br />
compliance with the requirements of<br />
the new standards now in effect.<br />
For more<br />
information,<br />
please<br />
contact TÜV<br />
Rheinland. ▲<br />
EUROPE<br />
Glenn Zimmermann<br />
49-221-806-1980<br />
Email: glenn.zimmermann@de.tuv.com<br />
A PUBLICATION OF THE TÜV RHEINLAND GROUP<br />
TÜV RHEINLAND WORLD NEWS<br />
This announcement also encompasses<br />
such new standards as J60320-1 (H16),<br />
J60320-2-1 (H16), J60320-2-3 (H16),<br />
J60320-2-J1 (H16), J60335-2-40 (H16) and<br />
J60669-2-3 (H16).<br />
For more information, please contact<br />
TÜV Rheinland. ▲<br />
AFRICA<br />
Josef Peters<br />
27-12-349-1351<br />
Email: josef.peters@za.tuv.com<br />
SOUTH AMERICA<br />
Maria Sanz<br />
54-11-437-25033<br />
Email: msanz@ar.tuv.com<br />
3
MAY/JUNE 2005<br />
Alliance Formed with<br />
Eastman Kodak Company<br />
Services Will Reach Across the Globe<br />
Authored by Jeff Langdon, Regional Sales Manager (USA), 315-569-7524<br />
TÜV<br />
Rheinland Group recently formed an alliance with Eastman Kodak<br />
Company to provide testing and certification services<br />
for the well-known camera producer.<br />
As the digital revolution has unfolded,<br />
Kodak has led the way in developing new<br />
state-of-the-art cameras for personal and<br />
professional use and has brought the<br />
latest in digital radiography all over the<br />
world for medical technology applications.<br />
Although Eastman Kodak Company is<br />
based in Rochester, New York, its market<br />
reaches across the globe; thus TÜV<br />
Rheinland Group was a perfect fit, with its<br />
outstanding reputation and locations<br />
throughout the world. Kodak also<br />
recognized that TÜV Rheinland is a<br />
network of colleagues collectively helping<br />
its clients to bring their products into yetunrealized<br />
markets.<br />
How the Alliance Will Work<br />
The intent of Kodak is to efficiently direct<br />
the deployment of their product in a timely<br />
manner with testing and compliance<br />
processes being performed at their<br />
headquarter labs in Rochester. As new<br />
products are being developed in Kodak<br />
facilities abroad, Kodak will rely on the<br />
expertise of TÜV Rheinland all over the<br />
world. TUV Rheinland of North America<br />
will work directly with Kodak to coordinate<br />
the work to be performed between TÜV<br />
Rheinland and Kodak facilities outside the<br />
United States. The work will be carried out<br />
by our experts already based in the<br />
relevant countries.<br />
Most recently, TÜV Rheinland and Kodak<br />
executed a pilot program in Bangalore and<br />
Shanghai in which a new consumer<br />
camera was being developed, tested and<br />
deployed. Testing was done at TÜV<br />
TÜV Info Resources<br />
NORTH AMERICA<br />
ASIA<br />
Dan Sullivan<br />
Dirk Borchert<br />
203-426-0888, Ext. 121 81-45-470-3472<br />
Email: dsullivan@us.tuv.com Email: dirk.borchert@jpn.tuv.com<br />
Or contact your nearest TÜV office.<br />
4 A PUBLICATION OF THE TÜV RHEINLAND GROUP<br />
Rheinland labs in<br />
those two cities<br />
and then<br />
uploaded to<br />
TUVdotCOM,<br />
a File<br />
Transfer<br />
Protocol<br />
(FTP) server,<br />
and made<br />
accessible to<br />
relevant Kodak<br />
personnel. The<br />
pilot worked<br />
effectively and Kodak<br />
was pleased. This laid the<br />
groundwork for what will most<br />
likely be all of Kodak’s products being<br />
transferred onto TUVdotCOM.<br />
With health, safety and compliance the<br />
ultimate objectives of Kodak, they are<br />
using TÜV Rheinland’s expansive network<br />
to gain accessibility to markets including<br />
Japan, Korea, Australia and South<br />
America. They have also sought TÜV<br />
Rheinland’s assistance on EU compliance<br />
inspections in Mexico and establishing<br />
new factories for X-ray machinery being<br />
built in Shanghai. No matter where Kodak<br />
wants to go, TÜV Rheinland has the<br />
infrastructure and the expertise to<br />
accommodate them.<br />
For the bulk of the work ahead, Kodak has<br />
a contract in place that serves somewhat<br />
as a blanket agreement between the two<br />
companies. For instance, design<br />
consultation and product certifications are<br />
part of that agreement. When Kodak<br />
EUROPE<br />
Stephan Scheuer<br />
49-221-806-1654<br />
Email: stephan.scheuer@de.tuv.com<br />
introduces a new concept and places it in<br />
the hands of their research and<br />
development team, TÜV Rheinland<br />
engineers are called in to assist in<br />
getting that product to market on time, if<br />
not sooner.<br />
When testing or consultation services are<br />
performed outside the United States, we<br />
will issue a separate quote to Kodak. The<br />
subsidiary of TÜV Rheinland that is<br />
performing the work will then bill TUV<br />
Rheinland of North America and TUV<br />
Rheinland of North America will<br />
send a bill to Kodak in<br />
Rochester. This is<br />
another measure to<br />
assure efficiency to<br />
Kodak in that there<br />
is always a Point<br />
“A” to Point “B”<br />
billing structure.<br />
“This is a solid<br />
opportunity to<br />
not only land<br />
unrealized<br />
business, but to be<br />
part of an alliance<br />
with one of the<br />
world’s foremost<br />
leaders in digital<br />
technology,” said Deep<br />
Krishnan, TUV Rheinland of North<br />
America Marketing & Sales Director.<br />
“We are very proud to have been named<br />
the exclusive other party in this alliance<br />
with Kodak, who replaced several different<br />
vendors with ONE – TUV Rheinland.”<br />
The Eastman Kodak Company (Kodak)<br />
headquarters are located in Rochester,<br />
New York, USA. Kodak is a world leader in<br />
photographic film and imaging products<br />
supporting leisure, medical, business,<br />
entertainment and scientific applications.<br />
Kodak has a market reach of virtually<br />
every nation in the world. The Rochesterbased<br />
product safety and EMC testing<br />
laboratories are owned and operated by<br />
Kodak and are accredited by several<br />
national product safety and EMC<br />
certification agencies to perform testing<br />
and certification support for such<br />
categories of products as information<br />
technology, laboratory and medical<br />
equipment. ▲<br />
AFRICA<br />
Josef Peters<br />
27-12-349-1351<br />
Email: josef.peters@za.tuv.com<br />
SOUTH AMERICA<br />
Pablo Gilardoni<br />
54-11-4372-5033<br />
Email: pgilardoni@ar.tuv.com
atsec was certified by TUV Rheinland of<br />
North America. TUV Rheinland is<br />
accredited to perform ISO 9001:2000<br />
certifications by the American National<br />
Standards Institute - American Society for<br />
Quality National Accreditation Board<br />
(ANAB). The scope of the assessed<br />
system embraces all of atsec’s activities,<br />
which encompass the provision of<br />
information security services, including<br />
accredited IT testing and evaluation<br />
laboratories. “TUV Rheinland is proud to<br />
have provided certification services for<br />
atsec,” said Thomas McCarthy, TUV<br />
Rheinland of North America Quality<br />
Manager. “Their commitment to the<br />
certification process shows that high<br />
quality is of the utmost importance in<br />
servicing the needs of their clients.”<br />
TÜV Info Resources<br />
NORTH AMERICA<br />
ASIA<br />
Thomas McCarthy<br />
Ralf Schunk<br />
203-426-0888, Ext. 700<br />
86-755-82370898, Ext. 149<br />
Email: tmccarthy@us.tuv.com Email: ralf.schunk@sz.chn.tuv.com<br />
Or contact your nearest TÜV office.<br />
Fiona Pattinson, atsec’s U.S. quality<br />
manager, notes, “We have several reasons<br />
for making this effort. Like all global<br />
players in the information-security market,<br />
we value international standards for their<br />
mutual recognition and interoperability<br />
across cultures.<br />
Our role as assessors and evaluators of<br />
standards demands the highest levels of<br />
quality. Although our U.S. laboratories are<br />
subject to thorough assessments under<br />
the National Institute of Standards and<br />
Technologies (NIST) National Voluntary<br />
Laboratory Accreditation Program (NVLAP),<br />
we also wanted to ensure that our entire<br />
business meets the appropriate standards;<br />
compliance with ISO 9001:2000 ensures<br />
that we have the capability to do so.<br />
TÜV RHEINLAND WORLD NEWS<br />
Atsec Information Security Corporation<br />
Announces ISO 9001:2000 Certification<br />
Company Demonstrates First-hand its Commitment to<br />
International Standards<br />
Authored by Traci Conroy, Managing Editor (USA) 203-426-0888, Ext. 105<br />
T<br />
he atsec information security corporation quality system has been certified<br />
as compliant with ISO 9001:2000, the international standard for quality<br />
management systems. atsec information security is the leading provider of high-<br />
quality information security services, including product evaluations, as well as<br />
general consulting in a wide range of information security areas such as<br />
Information Security Management Systems (ISMS), risk management, PKI<br />
consulting, privacy assessment and security auditing.<br />
EUROPE<br />
Reiner Woll<br />
49-221-806-2718<br />
Email: reiner.woll@de.tuv.com<br />
We know from our own experience that<br />
information security is a quality factor,<br />
and our customers also understand<br />
that information security is a vital part<br />
of the customer-satisfaction picture.<br />
atsec’s principles ensure that we are<br />
first and foremost service providers.<br />
Our customers ask us to scrutinize their<br />
processes, systems and products, and<br />
it is important that atsec understands<br />
first-hand the commitment and<br />
resources that this level of scrutiny<br />
requires of an organization.<br />
Building on our quality management<br />
system, atsec also takes a strong<br />
process view when it comes to<br />
ensuring the security of its information<br />
assets. Recent events have<br />
demonstrated that no information asset<br />
should be more important to a global<br />
information-security company than its<br />
stored customer data. atsec is<br />
currently pursuing BS 7799-2:2002<br />
certification as evidence of its<br />
commitment to holistic information<br />
security and will continue to<br />
demonstrate its support for emerging<br />
security standards.”<br />
atsec information security was founded<br />
in 2000 and operates in the U.S. and<br />
Europe, in such cities as Austin,<br />
Munich, Cologne and Stockholm.<br />
For more information about atsec<br />
information security, please visit<br />
www.atsec.com. ▲<br />
AFRICA<br />
Josef Peters<br />
27-12-349-1351<br />
Email: josef.peters@za.tuv.com<br />
SOUTH AMERICA<br />
Thorsten Malchow<br />
54-11-4372-5033<br />
Email: tmalchow@ar.tuv.com<br />
A PUBLICATION OF THE TÜV RHEINLAND GROUP 5
MAY/JUNE 2005<br />
ASTM Updates a Key<br />
Fitness Equipment Standard<br />
Standard Cautions User About the Need for Safety and<br />
Health Practices<br />
Authored by Frank West, Machinery Engineer (USA), 503-469-8880<br />
I<br />
n North America, the safety of fitness equipment is established by two sets of<br />
standards. For electrical aspects of equipment, the appropriate standards are<br />
UL1647 and CAN/CSA C22.2 No 68. They are required by national legislation for<br />
cord-connected products. Mechanical hazards for fitness equipment can be<br />
mitigated by applying voluntary ASTM standards. Although these standards are<br />
voluntary, failure to apply them leaves the fitness equipment manufacturer open to<br />
potentially costly liability claims in case of injury related to the use of this equipment.<br />
In January 2005, three of the most<br />
commonly used ASTM standards for<br />
fitness equipment were revised. This<br />
article examines the changes made in the<br />
basic fitness equipment standard and<br />
provides guidance on complying with the<br />
new requirements. Changes in the other<br />
standards will be described in future<br />
articles.<br />
ASTM F2276-05<br />
ASTM F2276, Standard Specification for<br />
Fitness Equipment, is the standard applied<br />
when a more specific fitness equipment<br />
standard does not exist. An enormous<br />
amount of fitness equipment in the<br />
marketplace, from sit-up boards to<br />
inversion tables, falls within the scope of<br />
this standard.<br />
The Standard in Relation to Children<br />
The significant change in the new version,<br />
published in January 2005, is the addition<br />
of language that prevents the standard<br />
being applied to equipment for use by<br />
children under 12 years of age (clause 1.2).<br />
Previously, for equipment intended for use<br />
by children under 12, the standard<br />
specified that ASTM F963, Consumer<br />
Safety Specification on Toy Safety, would<br />
be the primary standard, and ASTM F2276<br />
would be a reference standard. This is no<br />
longer the case. ASTM F2276 is now<br />
barred for use on any equipment intended<br />
for use by children under 12. In support of<br />
this, the reference to ASTM F963 has been<br />
6<br />
A PUBLICATION OF THE TÜV RHEINLAND GROUP<br />
removed from the standard wherever<br />
it previously appeared.<br />
Manufacturers of most fitness equipment<br />
should have no difficulty with these<br />
changes, since most fitness equipment is<br />
not intended for use by children.<br />
Manufacturers who make equipment<br />
intended for use by children are now<br />
barred from using ASTM F2276 in any way.<br />
Although not required by the standard, it<br />
may be advisable for equipment marked<br />
“Keep Children Away” to now define<br />
children as being under 12 years of age in<br />
the documentation for that equipment (as<br />
required by the standard, clauses 7.2.1.1<br />
and 7.2.2.1). In addition, a specific<br />
statement in the user documentation may<br />
be helpful, such as “this equipment is<br />
intended for use by adults and children 12<br />
years or older.”<br />
The Standard in Relation to Risk<br />
The standard contains a new clause,<br />
clause 1.4, which is a risk-based<br />
disclaimer. It now specifies that<br />
compliance with the text of the standard<br />
alone does not give presumption that all<br />
safety concerns associated with use of the<br />
fitness equipment have been addressed.<br />
According to the standard, “It is the<br />
responsibility of the user of this standard<br />
to establish appropriate safety and health<br />
practices and determine the application of<br />
regulatory limitations prior to use.” This<br />
means that in addition to complying with<br />
the requirements of ASTM F2276,<br />
manufacturers will now be required to<br />
perform a general risk assessment, and<br />
demonstrate that all hazards identified in<br />
the risk assessment have been addressed<br />
by application of the standard. Any<br />
hazards which present unacceptable risk<br />
after application of the requirements of<br />
ASTM F2276 will be required to be<br />
addressed using standard risk reduction<br />
and mitigation engineering techniques.<br />
This may be a significant change for some<br />
manufacturers, especially those who<br />
produce complex equipment. The move<br />
toward risk assessment in the application<br />
of most standards is an industry-wide<br />
move, and hazard-based safety<br />
engineering will become increasingly<br />
important. The move by ASTM F2276 to<br />
include language that requires a risk<br />
assessment is, therefore, not done in<br />
isolation. However, the move also requires<br />
that manufacturers increase the expertise<br />
of their engineering team to include risk<br />
assessment techniques and methods, so<br />
that risk may be eliminated in design and<br />
not become an issue when the compliance<br />
of the product to the standard is<br />
determined. In addition, compliance<br />
projects for fitness equipment will become<br />
more complex as risk assessment and risk<br />
mitigation layers are added to the required<br />
criteria for assessment.<br />
The Standard in Relation to New Units<br />
of Measure<br />
Another new clause that was added is<br />
clause 1.3. In the United States, it is still<br />
common practice for engineering groups<br />
to use English units in the design and<br />
construction of fitness equipment.<br />
However, the standard now specifies that<br />
in terms of safety, all critical dimensions<br />
and values will be measured in SI units.<br />
This language does not, of course, mean<br />
that conventional English units of measure<br />
cannot continue to be used for design. It<br />
does mean, however, that when assessing<br />
compliance, the official unit of measure<br />
will be SI units, and SI units must be used<br />
on all compliance documents. This change<br />
should have little effect on manufacturers,<br />
since most do this already.
Miscellaneous Changes<br />
Finally, a new section, Section 8, Keywords, has been added. This<br />
section has no effect on regulatory compliance, and merely provides<br />
guidance on establishing keywords for electronic indexing of the<br />
standard in libraries.<br />
Summary<br />
UL1647 and CAN/CSA C22.2 No 68<br />
are voluntary standards,<br />
but failure to apply them<br />
leaves the fitness equipment<br />
manufacturer open to<br />
potentially costly<br />
liability claims.<br />
The changes to ASTM F2276 will modify how manufacturers design and<br />
assess the compliance of fitness equipment for North America. The<br />
prohibition of using the standard for equipment intended for use by<br />
children under 12, and the formal adoption of SI units for compliance<br />
measurements, should have little impact on manufacturers. However,<br />
the inclusion of language that specifically bars a presumption that all<br />
risk has been mitigated through application of ASTM F2276 is important.<br />
Because of this new language, manufacturers are now responsible to<br />
determine if any risk exists even after ASTM F2276 has been complied<br />
with. Any remaining risk will need to be addressed using standard risk<br />
reduction techniques. This adds complexity to both the design and<br />
evaluation for compliance of fitness equipment. ▲<br />
TÜV Info Resources<br />
NORTH AMERICA ASIA<br />
Richard Grumski Werner Feuker<br />
734-207-9852 886-4-2301-9898, Ext. 030<br />
Email: rgrumski@us.tuv.com Email: few@twn.tuv.com<br />
EUROPE AFRICA<br />
Reiner Woll Josef Peters<br />
49-221-806-2718 27-12-349-1351<br />
Email: reiner.woll@de.tuv.com Email: josef.peters@za.tuv.com<br />
SOUTH AMERICA<br />
Mauricio Schamber<br />
54-11-4372-5033<br />
Email: mschamber@ar.tuv.com<br />
Or contact your nearest TÜV office.<br />
2005 WEB SEMINARS<br />
To learn more, visit www.us.tuv.com/<br />
training_and_education/index.html<br />
WEEE and RoHS Directives<br />
May 25 and June 23<br />
2005 SEMINARS<br />
ATEX Directive<br />
May 11 • New Brunswick, NJ<br />
Medical ISO 13485:2003<br />
May 24 • San Francisco, CA<br />
2005 TRADESHOWS<br />
To learn more, visit www.us.tuv.com/<br />
news_and_events/trade_shows_2005<br />
June 2 • CT Expo for Business 2005<br />
Connecticut Convention Center<br />
Booth #822 • Hartford, CT<br />
June 7-9 • SUPERCOMM 2005<br />
McCormick Place<br />
Booth #10026 • Chicago, IL<br />
June 13-15 • MDM East 2005<br />
Medical Design & Manufacturing<br />
Jacob J. Javits Center<br />
Booth #1064 • New York, NY<br />
July 12-14 • SEMICON West 2005<br />
Semiconductor Equipment and Materials<br />
International<br />
Moscone Center, North Hall<br />
Booth #5882 • San Francisco, CA<br />
July 14 • NCAEC 2005<br />
North Carolina Association of Electrical<br />
Contractors<br />
Sheraton Atlantic Beach Oceanfront Hotel<br />
Booth #TBA • Atlantic Beach, NC<br />
July 26-28 • Clinical Lab Expo 2005<br />
Orange County Convention Center<br />
Booth #2504 • Orlando, Fl<br />
ADVERTISING<br />
OPPORTUNITIES<br />
Advertising in TÜV Rheinland World News is a proven<br />
way to get your product or service in front of product<br />
and design engineers as well as compliance, regulatory<br />
and quality assurance managers. When you advertise in<br />
TÜV Rheinland World News, your ad will appear along<br />
with the corresponding issue on TÜV’s website at<br />
www.us.tuv.com/news_and_events/newsletter. With<br />
hundreds of visitors reading each issue online, this<br />
significantly increases the value of your advertising<br />
dollar, with exposure both in print and online. To<br />
advertise, please contact tconroy@us.tuv.com.<br />
SUBSCRIBE TODAY –<br />
IT’S EASY AND FREE!<br />
To subscribe or to change/cancel an existing<br />
subscription, fax your corrected mailing label to your<br />
nearest TÜV Rheinland World News (see page 2). In<br />
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response form.<br />
www.tuv.com<br />
A PUBLICATION OF THE TÜV RHEINLAND GROUP 7
MAY/JUNE 2005<br />
Q: How do I know if my<br />
product falls within the<br />
parameters of the Pressure<br />
Equipment Directive<br />
(97/23/EC)?<br />
A: The PED applies to pressure<br />
equipment (vessels, piping, pressure<br />
accessories), safety accessories or<br />
assemblies with a maximum allowable<br />
pressure (PS) greater than 0.5 Bar (7.25<br />
psi). Manufacturers or assemblers of<br />
pressure equipment above this pressure<br />
must review the requirements of the<br />
directive to determine if their products fall<br />
under the directive. In determining the<br />
category of the product, the fluid and<br />
volume (vessels) or nominal size DN<br />
(piping) must be considered. The fluid (e.g.<br />
gases, liquids, vapors) in combination with<br />
the pressure will determine the applicable<br />
category. Depending on the product of the<br />
PS x Volume/DN, and the fluid, a product<br />
Category<br />
Art.3.3<br />
I<br />
II<br />
III<br />
IV<br />
NB required?<br />
Outside Scope of PED<br />
No<br />
QA + Surveillance<br />
Type or Design<br />
Examination and<br />
Surveillance by NB or QA<br />
Approval<br />
Type Examination and<br />
Verification by NB or QA<br />
Approval (+ add.<br />
requirements)<br />
(e.g. H1 Design Exam)<br />
8 A PUBLICATION OF THE TÜV RHEINLAND GROUP<br />
TUV Rheinland of North America, Inc. invites you to ask the experts. Your questions can<br />
pertain to anything that you want to know about product testing and certification services<br />
regarding Automotive, EMC, Ergonomics, Field Evaluation, Industrial Machinery,<br />
Management Systems, Medical, Pressure Equipment, Product Safety and Telecom. Please<br />
check back each issue to find out what questions have been answered.<br />
Please submit questions to tconroy@us.tuv.com and write in the subject line “Ask the Experts.”<br />
will be classified as Sound Engineering<br />
Practice SEP (no CE Marking allowed),<br />
Category I, II, III or IV. The lower the<br />
category, the less mandated involvement<br />
by a Notified Body.<br />
(Please refer to chart below.)<br />
Q: How do I pick the proper<br />
PED (97/23/EC) Conformity<br />
Assessment Module for my<br />
product?<br />
A: The first step to evaluating the best<br />
choice of modules is to properly categorize<br />
the product. Under the PED, products and<br />
systems are reviewed, approved and/or<br />
monitored on a regular basis. Module<br />
choice is based on category, and the<br />
choice of modules can be impacted by<br />
several variables: 1) Category; 2)<br />
Production Schedule (e.g. one-of-a-kind<br />
vs. serial); and 3) Quality System.<br />
A<br />
Modules<br />
A1 D1 E1<br />
B1+D B1+F B+E B+C1 H<br />
B+D B+F G H1<br />
Q: Can I use the ASME Code<br />
to satisfy the Essential<br />
Safety Requirements (ESR)<br />
of the Pressure Equipment<br />
Directive (PED)?<br />
A: Yes. Manufacturers that use the ASME<br />
Code have to prove that the pressure<br />
equipment complies with the Essential<br />
Safety Requirements (ESR). Additional<br />
requirements to ensure compliance with<br />
PED also have to be met:<br />
Proof Test – A basic of 1.43 times its<br />
Maximum Allowable Working Pressure<br />
has to be met.<br />
Stability – The respective loads for wind,<br />
snow, earthquake, etc., as well as special<br />
building regulations have to be considered.<br />
Operating Instructions – Operating<br />
instructions should be available at the time<br />
of the design approval and must be<br />
evaluated by the Notified Body.<br />
Hazard Analysis – The manufacturer is<br />
obliged to accomplish a hazard analysis.<br />
The hazard analysis shall include the<br />
following:<br />
• Identification of hazards due to<br />
pressure<br />
• Elimination or reduction of hazards<br />
• Protection measures<br />
• Means of examination<br />
• Means of draining and venting<br />
• Corrosion or other chemical attack<br />
• Wear<br />
• Assemblies<br />
• Provisions for filling and discharge<br />
• Protection against exceeding the<br />
allowable limits<br />
• Safety accessories<br />
• External fire
Update on the WEEE/RoHS Directives<br />
1. Types of products that your company produces –<br />
CHECK ALL THAT APPLY.<br />
a. Large household appliances ........................... ( 0%)<br />
b. Small household appliances ............................ ( 6%)<br />
c. IT and telecommunication equipment ......... ( 39%)<br />
d. Consumer equipment ........................................ ( 9%)<br />
e. Lighting equipment ............................................. ( 6%)<br />
f. Electrical and electronic tools ....................... ( 12%)<br />
g. Toys, leisure and sporting equipment ........... ( 3%)<br />
h. Medical devices ............................................... ( 12%)<br />
i. Monitoring and control instruments ..............( 30%)<br />
j. Automatic dispensers ......................................... ( 9%)<br />
No answer .............................................................. ( 18%)<br />
2. Countries into which your company exports<br />
products – CHECK ALL THAT APPLY.<br />
a. European Union ................................................ ( 79%)<br />
b. Canada ................................................................ ( 70%)<br />
c. Mexico ................................................................. ( 45%)<br />
d. Russia .................................................................. ( 39%)<br />
e. China .................................................................... ( 42%)<br />
f. Japan .................................................................... ( 45%)<br />
g. Korea .................................................................... ( 39%)<br />
h. Taiwan ................................................................. ( 39%)<br />
i. Singapore ............................................................. ( 30%)<br />
j. Australia ............................................................... ( 52%)<br />
k. Argentina ............................................................. ( 27%)<br />
l. Brazil ...................................................................... ( 42%)<br />
No answer .............................................................. ( 21%)<br />
3. Countries in which your company currently<br />
manufactures – CHECK ALL THAT APPLY.<br />
a. European Union ................................................ ( 24%)<br />
b. Canada .................................................................. ( 3%)<br />
c. Mexico ................................................................. ( 12%)<br />
d. Russia .................................................................... ( 3%)<br />
e. China .................................................................... ( 33%)<br />
f. Japan ...................................................................... ( 6%)<br />
g. Korea ...................................................................... ( 6%)<br />
h. Taiwan ................................................................... ( 3%)<br />
i. Singapore ............................................................... ( 3%)<br />
j. Australia ................................................................. ( 0%)<br />
k. Argentina ............................................................... ( 0%)<br />
l. Brazil ........................................................................ ( 0%)<br />
No answer .............................................................. ( 52%)<br />
TÜV RHEINLAND WORLD NEWS<br />
“The clock is ticking. Manufacturers need to get on the ball before the EU curtain<br />
closes. A current poll shows that over 50% of U.S. manufacturers are either not<br />
preparing for these directives or have no idea that they exist!” says Geoffrey Bock,<br />
TUV Rheinland of North America WEEE/RoHS Specialist.<br />
Following are the results of a recent TUV Rheinland web seminar on the<br />
WEEE/RoHS Directives. For more information on upcoming seminars and web<br />
seminars, please go to: http://www.us.tuv.com/training_and_education/index.html.<br />
4. Countries in which your company currently has an<br />
established distributor – CHECK ALL THAT APPLY.<br />
a. European Union ................................................ ( 61%)<br />
b. Canada ................................................................ ( 39%)<br />
c. Mexico ................................................................. ( 33%)<br />
d. Russia .................................................................. ( 15%)<br />
e. China .................................................................... ( 21%)<br />
f. Japan .................................................................... ( 39%)<br />
g. Korea .................................................................... ( 21%)<br />
h. Taiwan ................................................................. ( 24%)<br />
i. Singapore ............................................................. ( 24%)<br />
j. Australia ............................................................... ( 30%)<br />
k. Argentina ............................................................. ( 18%)<br />
l. Brazil ...................................................................... ( 18%)<br />
No answer .............................................................. ( 33%)<br />
5. What is your role within the company? SELECT<br />
CLOSEST TITLE TO YOURS.<br />
a. Engineering ........................................................ ( 55%)<br />
b. Marketing .............................................................. ( 3%)<br />
c. Sales ....................................................................... ( 0%)<br />
d. Management ..................................................... ( 12%)<br />
e. Electrician ............................................................. ( 0%)<br />
f. Regulatory compliance .....................................( 15%)<br />
g. EHS / Safety management ................................( 6%)<br />
h. CEO / President ................................................... ( 0%)<br />
i. Other ........................................................................ ( 0%)<br />
No answer .............................................................. ( 18%)<br />
6. Who is/will be responsible for WEEE/RoHS within<br />
your company? SELECT CLOSEST TITLE FOR<br />
DECISION MAKER.<br />
a. Dedicated Environment Executive ................. ( 6%)<br />
b. Senior Service Executive .................................. ( 0%)<br />
c. Senior Marketing Executive ............................ ( 3%)<br />
d. Senior Sales Executive ..................................... ( 0%)<br />
e. Senior Production Executive ........................... ( 9%)<br />
f. I am Responsible ............................................... ( 48%)<br />
g. Do Not Know ...................................................... ( 18%)<br />
No answer .............................................................. ( 18%)<br />
A PUBLICATION OF THE TÜV RHEINLAND GROUP<br />
9
2005 IEEE Symposium On Product Safety Engineering<br />
October 3-4 October, 3-4, 2005<br />
The The IEEE Product Safety Engineering Society is holding its<br />
second annual Symposium on Product Safety Engineering on on<br />
3-4 October October, 3-4, 2005 in in the Chicago area. area. The The venue venue will will be: be:<br />
Hyatt Regency Woodfield<br />
1800 East Golf Road<br />
Schaumburg, Schaumberg, IL IL 60173 USA<br />
Direct: 847-517-6973 Fax: Fax: 847-605-8641<br />
http://woodfield.hyatt.com/groupbooking/ieee<br />
(Nine miles from O’Hare O'Hare Airport) airport)<br />
The Value of this Symposium:<br />
The IEEE PSES Symposium provides attendees an interactive<br />
experience on the latest advancements of product safety<br />
engineering. Through multi-disciplinary presentations and<br />
cross-functional dialogue, first time attendees and veteran<br />
attendees can take away the tools necessary to meet today’s<br />
challenges. Both IEEE members and non-IEEE members are<br />
welcome to attend.<br />
Who Should Attend:<br />
The symposium is is a forum for exchanging exchanging ideas, ideas, practical practical<br />
experiences, work experiences and business and business cards. The cards. targeted The<br />
targeted audiences audiences include, but include are not but limited not limited to, people to people involved involved with<br />
with safety safety engineering engineering in these in areas these of areas interest: of interest:<br />
* Inherently safer products and equipment<br />
* Product Safety services<br />
* Training and continuing education<br />
* Regulations and standards<br />
* Risk management<br />
* Workplace product safety<br />
* System and Software safety<br />
* Human factors<br />
Who will benefit:<br />
http://www.ieee-pses.org/symposium/<br />
Those people who would most benefit in attending the<br />
symposium include, are, but but not are limited not limited to: to:<br />
* Technicians<br />
* Engineers<br />
* Certified technicians and engineers<br />
* Consultants<br />
* Educators<br />
* Administrative personnel<br />
* Local, State and Federal regulators<br />
* National standards committee members<br />
* International standards committee members<br />
For additional information and for the the for very the very latest latest details details about<br />
about the symposium, the symposium, please visit please our visit symposium our symposium website: website.
Conformity Assessment<br />
for Worldwide Markets<br />
• Product Safety Testing and Certifications from<br />
TUV Rheinland, CSA and UL EMC Testing<br />
• Product Validation & Environmental Testing<br />
• Field Evaluations<br />
INTERTest Systems, Inc.<br />
www.intertest.net<br />
A PUBLICATION OF THE TÜV RHEINLAND GROUP<br />
PARTNER LAB<br />
1490 Garden of the Gods Rd., Ste. C<br />
Colorado Springs, CO 80907-3414<br />
Telephone: 719.522.1402 • Fax: 719.522.1086 • Email: info@intertest.net<br />
11
TUV Rheinland of North America, Inc.<br />
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TÜV Rheinland Group World Headquarters,<br />
Am Grauen Stein, 51105 Cologne, Germany –<br />
TEL (Int. + 49) 221-806-0, FAX (Int. + 49) 221-806-114<br />
MAY/JUNE 2005<br />
THE RIGHT<br />
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Printed on recyclable paper. TUV Rheinland of North America, Inc. is an equal-opportunity/affirmative action employer.