market access market access MAR/08/APR
market access market access MAR/08/APR
market access market access MAR/08/APR
You also want an ePaper? Increase the reach of your titles
YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.
<strong>market</strong> <strong>market</strong> <strong>access</strong> <strong>access</strong> mar/<strong>08</strong>/apr<br />
www.us.tuv.com<br />
www.tuv.com<br />
Your KeYs to NatioNal aNd iNterNatioNal CompliaNCe<br />
The GS Mark<br />
MaGnify your MarkeTabiliTy<br />
wiTh Third parTy cerTificaTion<br />
The Inside View 2<br />
Overview From Our Product<br />
Safety Division Manager<br />
Cover Story: 3<br />
Product Safety<br />
The GS Mark<br />
Late-Breaking News 6<br />
Testing And Analysis Of Polycyclic<br />
Aromatic Hydrocarbons (PAH) For<br />
GS Mark Certification<br />
Late-Breaking News 8<br />
Announcing The Monthly Customer<br />
Feedback Survey Winners<br />
Wireless 9<br />
Introducing The Wi-NOT Alliance<br />
Machinery 12<br />
The EU’s New Machinery Directive<br />
And Its Impact On Certification<br />
Product Safety 18<br />
Rochester, N.Y. Office Receives<br />
NVLAP Accreditation<br />
News 20<br />
TUVdotCOM Launches A New<br />
Look And Feel On The Web<br />
TÜVRheinland ® Resources 22<br />
Tradeshows
<strong>market</strong> <strong>access</strong> mar/<strong>08</strong>/apr<br />
The Inside View<br />
Dear Valued Customers,<br />
Consumers can distinguish whether a product has<br />
been tested and is harmless by simply looking for the<br />
certification mark on a product. The GS Mark is proof that<br />
it has been tested for product safety by an independent<br />
testing organization.<br />
GS Mark is currently not mandated by law, allowing potential<br />
for dangerous products in the <strong>market</strong>place. GS Mark is a<br />
key differentiator when a product’s malfunction leads to an<br />
accident, where the manufacturer could be held responsible<br />
under Germany’s (and the EU’s) strict product liability laws.<br />
These types of incidents can be prevented by GS Mark<br />
certification.<br />
The GS Mark was created to meet the safety demands<br />
of the industry, importers, distributors, trade-houses,<br />
public insurance and consumer organizations in<br />
Germany. Many organizations were experiencing<br />
difficulty controlling safety compliance of their products,<br />
to curtail uncertainties concerning product liability and<br />
sustain customer satisfaction. The GS Mark certification<br />
validates product’s compliance under German safety<br />
laws and assures product safety.<br />
In addition, the GS Mark is a convincing <strong>market</strong>ing<br />
aid creating customer confidence and purchasing<br />
motivation. The GS Mark is valid for most electrical<br />
consumer products such as toys, household appliances,<br />
handheld tools and IT/office and AV Equipment. The idea<br />
of the GS-mark was so successful, not only did it become<br />
a <strong>market</strong>ing criterion but also received recognition<br />
by consumers and distributors in countries outside of<br />
Europe.<br />
In this issue of Market Access, our cover story explores<br />
the significance of the GS Mark and delves into<br />
clarifying its difference from the CE Marking. You will<br />
also find articles on the EU’s new machinery directive<br />
and details into the Wi-Not organization. You’ll get to<br />
discover timely news items, such as the TUVdotCOM<br />
enhancements, customer feedback contestant winner,<br />
tradeshows and more.<br />
Sincerely,<br />
Dan Sullivan<br />
Product Safety Division Manager<br />
Dan Sullivan<br />
PRODUCT SAFETY DIVISION MANAGER<br />
TüVRheinland ®<br />
2
<strong>market</strong> <strong>access</strong><br />
Cover Story<br />
Product Safety<br />
The GS Mark<br />
Clarifying The Significance And Difference Between GS Mark and CE Marking<br />
Authored by Dan Sullivan, (Newtown, CT) Product Safety Division Manager<br />
The TüVRheinland ® GS Mark has its roots in<br />
the German equipment safety law but the literal<br />
translation of “GS” does not stand for German safety,<br />
but rather “safety-tested”. Typically, the electrical<br />
safety aspects of a product are evaluated, tested<br />
and certified in conjunction with the issuance of this<br />
marking.<br />
The TüVRheinland ® GS Mark signifies:<br />
• A representative sample of the product has been<br />
evaluated, tested and approved for safety.<br />
•<br />
The production line is inspected on an annual<br />
basis.<br />
The TüVRheinland ® GS Mark may also provide a<br />
<strong>market</strong>ing advantage since it is a voluntary mark.<br />
CoNTiNueD oN PAge 4<br />
mar/<strong>08</strong>/apr<br />
GS Mark vs. ce Marking<br />
There is often confusion about the terms CE and<br />
GS among non-European manufacturers. To better<br />
understand the differences between each, and avoid<br />
misunderstandings, a brief explanation follows.<br />
The TüVRheinland ® , GS Mark is a voluntary testmark.<br />
It is attached to a product to highlight<br />
that a third party has tested its safety and that a<br />
continuous production control is maintained. The<br />
GS Mark was created to meet the demands of<br />
industries, importers, distributors, trade-houses,<br />
public insurance and consumer organizations in<br />
Germany. It verifies the compliance of technical<br />
products with the safety requirements of the<br />
German safety law. These organizations could<br />
not afford to control the compliance of articles<br />
from all over the world by themselves, but wanted<br />
to avoid uncertainty concerning product liability<br />
and customer satisfaction. The concept of the GS<br />
Mark was so successful that it became not only a<br />
<strong>market</strong>ing tool but also found wide acceptance from<br />
consumers and distributors in other countries in and<br />
outside of Europe.<br />
On the other hand, CE Marking is a mandatory<br />
regulation and not a test-mark. It was created by<br />
the European Union as an authorization for customs<br />
officials - proving that the product may be traded<br />
freely within Europe. Since the CE Marking has to<br />
be attached to each and every product within the<br />
3
<strong>market</strong> <strong>access</strong><br />
Cover Story<br />
Product Safety<br />
The GS Mark (continued)<br />
scope of the European directives, it has no special<br />
<strong>market</strong>ing value. Prior to the introduction of the CE<br />
Marking, products had to comply with each country’s<br />
safety regulations. Today, products must fulfill the<br />
same requirements as before, but now have to show<br />
it through CE Marking.<br />
In contrast to the TüVRheinland ® GS Mark, the<br />
CE Marking is the manufacturer’s self-declaration<br />
and does not prove compliance to all applicable<br />
directives. For most products sold in the EU, the use<br />
of the CE Marking and a Declaration of Conformity<br />
are mandatory.<br />
Voluntary<br />
CoNTiNueD oN PAge 5<br />
TÜVrheinland ® GS Mark<br />
Only appears on approved products<br />
Proof of testing and certification through an<br />
independent third party test laboratory<br />
Continuous product and production surveillance<br />
by independent third party for the life of the<br />
certification<br />
TüVRheinland ® GS Mark: A symbol for safety and<br />
compliance of products<br />
tÜVrheinland ® Gs mark vs. Ce marking<br />
With the exception of some high risk<br />
products, most products can be self-declared<br />
by the manufacturer to meet the “essential<br />
requirements”. The CE Marking grants a<br />
product: placement on the European Market, the<br />
free movement within this <strong>market</strong>, and also permits<br />
the withdrawal of non-conforming products.<br />
However, the CE Marking is not an approval,<br />
certification or quality mark; nor is it a <strong>market</strong>ing<br />
tool. The CE Marking is only a declaration of the<br />
supplier’s own responsibility.<br />
Required<br />
ce Marking<br />
Appears on all products<br />
mar/<strong>08</strong>/apr<br />
Testing is assumed but not proven<br />
No <strong>market</strong> advantage, simply a manufacturer’s<br />
self declaration of conformity<br />
CE Marking: A symbol for trade with the<br />
assumption of conformity<br />
4
<strong>market</strong> <strong>access</strong> mar/<strong>08</strong>/apr<br />
Cover Story<br />
Product Safety<br />
The GS Mark (continued)<br />
The world of the TÜVrheinland ® GS Test Mark<br />
In today’s <strong>market</strong>, many products can seem like<br />
“peas in a pod”. Consumers often don’t know what<br />
criteria to apply when making their final buying<br />
decision. It is impossible to immediately determine<br />
the “inner values” of a device. For manufacturers,<br />
dealers and importers who want to place their<br />
products on the <strong>market</strong> successfully, it is therefore a<br />
question of displaying a mark standing for safety. The<br />
TüVRheinland ® , GS Mark, in existence for more than<br />
20 years, is highly regarded in the field of equipment<br />
safety. In the present <strong>market</strong> situation, with products<br />
from all over the world competing for consumers,<br />
the TüVRheinland ® , GS Mark is more important<br />
than ever. This mark, awarded by an independent<br />
testing institution such as TüVRheinland ® , has the<br />
trust of consumers, not only in Germany, but now<br />
in neighboring countries in the east and west as<br />
well. The TüVRheinland ® GS Mark not only provides<br />
<strong>market</strong> value, but also protects consumers. This can<br />
be seen in the most recent compulsory regulations<br />
which protect consumers of GS Marked products<br />
from Polycyclic Aromatic Hydrocarbons (PAH). See<br />
“Late Breaking News” for more details on this new<br />
GS Mark requirement.<br />
For more information, please call 1-TuV-rheinland<br />
(1-888-743-4652).<br />
5
<strong>market</strong> <strong>access</strong><br />
Late-Breaking News<br />
Testing And Analysis Of Polycyclic Aromatic Hydrocarbons<br />
(PAH) For GS Mark Certification<br />
current requirements<br />
On November 20, 2007, the Committee for Technical Work Equipment and Consumer Products (AtAV)<br />
decided to include the test for PAH as a mandatory requirement for GS Mark certification. Up till now,<br />
PAH tests and analyses were conducted voluntarily, independent of GS Mark certification.<br />
As of April 1st of 20<strong>08</strong>, GS Mark certification of products must comply with the PAH thresholds as defined<br />
in the following table.<br />
parameter<br />
Benzo[a]pyrene<br />
mg/kg<br />
Sum of 16 PAH<br />
(EPA) mg/kg<br />
category 1<br />
Materials in direct<br />
contact with food, or<br />
materials intended to be<br />
put into the mouth, and<br />
toys for children aged<br />
< 36 months<br />
Not detectable (
<strong>market</strong> <strong>access</strong><br />
Late-Breaking News<br />
Testing And Analysis Of Polycyclic Aromatic Hydrocarbons (PAH) For GS Mark<br />
Certification (continued)<br />
current Timescale<br />
On February 4, 20<strong>08</strong>, the ZLS(Central Authority of the German Federal States for Safety) also stipulated on<br />
the timeframe for existing and new GS certificates:<br />
• For certification from 04-01-20<strong>08</strong> onwards (including ongoing projects which will be completed after this<br />
date), the provision defined above is mandatory.<br />
• For ongoing certification projects to be completion before 04-01-20<strong>08</strong>, the provision defined above is<br />
recommended.<br />
•<br />
Certification issued before 04-01-20<strong>08</strong> will remain valid for the time being. Within the framework of<br />
periodical control measures, the provision defined above is mandatory. In case it can be concluded that<br />
the respective requirements are not kept, the certification has to be withdrawn immediately.<br />
The testing method to be used is bindingly stipulated by the ZLS (Central Authority of the German Federal<br />
States for Safety). But due to the large number of PAH-relevant materials in products, the testing costs<br />
using the prescribed testing methods can be considerable. TüV Rheinland Produkt und Umwelt GmbH has<br />
therefore developed a PAH quick test.<br />
The PAH quick test can be used as a partial quantitative preliminary test on PAH-relevant materials.<br />
This test can help significantly reduce the number of laboratory analyses actually needed. It can even be<br />
carried out by “laymen” under instruction. This means you can begin to take action immediately.<br />
For more information, please call 1-TuV-rheinland (1-888-743-4652).<br />
mar/<strong>08</strong>/apr<br />
7
<strong>market</strong> <strong>access</strong> mar/<strong>08</strong>/apr<br />
Late-Breaking News<br />
Announcing The Monthly Customer Feedback Survey Winners<br />
Management System Certification Response Yields Valuable Prize For<br />
Lucky Contestants<br />
Congratulations to Brenda Frank from Bemis<br />
Manufacturing - the December winner and<br />
Rick Linville from Conmet-the January winner<br />
of TüVRheinland ® ’s customer feedback survey<br />
drawings for the Management System Certification<br />
(MSC) Division. Brenda and Rick are proud<br />
winners of an elegant TüVRheinland ® clock,<br />
which was recently sent to them, compliments of<br />
TüVRheinland ® .<br />
Providing customer service is critical to the MSC<br />
Division of TüVRheinland ® . The customer feedback<br />
survey is given to all customers at the completion of<br />
their audit and is used to identify the following key<br />
points in providing good customer service:<br />
• Response time of services<br />
• Quality of services<br />
• Communications with staff<br />
• Technical competence<br />
• Level of knowledge<br />
• Level of courtesy<br />
• Overall impression<br />
• Professionalism of auditor<br />
If you are a quality customer, please take a few<br />
moments to respond to this mutually beneficial<br />
survey and qualify as the winner of TüVRheinland ® ’s<br />
monthly prize. Other response vehicles are available<br />
to TüVRheinland ® customers through an online<br />
feedback form available at www.us.tuv.com.<br />
For any certification, testing or compliance questions,<br />
please call 1-TuV-rheinland (1-888-743-4652).<br />
8
<strong>market</strong> <strong>access</strong> mar/<strong>08</strong>/apr<br />
Wireless<br />
Introducing the Wi-NOT Alliance<br />
Business Not-As-Usual For The Worldwide Certification Agency<br />
Authored by Dr. Farouk Zanaty, (Pleasanton, CA) Wireless Development Manager<br />
Similar existing alliances like Wi-Fi and Wi-Max<br />
are mainly to test and certify wireless products for<br />
“Interoperability”. The Wi-NOT Alliance will focus on<br />
testing and certifying wireless devices and wireless<br />
networks of all scales for wireless “performance”.<br />
TüVRheinland ® is taking the initiative to create a new<br />
alliance for wireless testing. The new alliance will be<br />
referred to as the “Wireless Networks Optimum Trends<br />
Alliance” or the “Wi-NOT” Alliance.<br />
The Wi-NOT Alliance is a “Not-for-profit” organization<br />
registered in the state of California, USA. It is founded<br />
by TüVRheinland ® , which is referred to as the “Principal<br />
Founder”, and Veriwave Systems, which is referred to as<br />
the “Principal Co-founder”.<br />
The <strong>market</strong> for the Wi-NOT alliance is based on the<br />
membership of companies that manufacturer, integrate<br />
and use wireless devices and wireless networks of<br />
all sizes. These particular companies have interest<br />
in showing their clients that their wireless products,<br />
whether individually or as parts of networks, perform<br />
to the internationally recognized standards. When<br />
products exceed some performance criteria metrics<br />
(as to be finalized by the Wi-NOT Alliance), the<br />
CoNTiNueD oN PAge 10<br />
member companies will make best effort to present<br />
corresponding performance certifications, along with<br />
quality indicators. For this reason, the Wi-NOT Alliance<br />
designates a testing house (TüVRheinland ® ) to perform<br />
certification tests that will lead to the granting of the<br />
Wi-NOT Alliance logo to be printed on the certified<br />
products. In addition to the logo, the certified products<br />
will be authorized to have the quality indicator printed<br />
on them as well. The logo and the quality indicator will<br />
be trademarked under the Wi-NOT Alliance.<br />
The Wi-NOT alliance will be self-funded with revenue<br />
streams from membership fees, parts of testing fees<br />
and from promotions of specific products on its web<br />
site. Also, the Wi-NOT alliance may accredit other<br />
testing houses (with focus on TüVRheinland ® as a<br />
principal founder with unparallel privileges to open<br />
additional worldwide locations) to add other labs<br />
where TüVRheinland ® and Veriwave may provide<br />
training materials, as well as hands-on training.<br />
Mission<br />
• Establish performance, benchmark testing alliance<br />
for low and high mac levels for WLAN devices,<br />
networks and services based on IETF drafts and<br />
standards (RFCs)<br />
• Establish standard ranking for performance criteria<br />
based on associated test plans corresponding to<br />
the IETF releases<br />
•<br />
Standardize “quality” indicator to be recognized<br />
when combined with Wi-NOT logo on certified<br />
products<br />
9
<strong>market</strong> <strong>access</strong><br />
Wireless<br />
Introducing the Wi-NOT Alliance (continued)<br />
performance Metrics<br />
These performance metrics will apply to Units Under<br />
Test (UUT). The UUT is considered a black box that<br />
contains only one wireless unit, many units or integrated<br />
networks of all scales. Examples of the performance<br />
metrics will be:<br />
• Throughput<br />
• Latency (and Jitter)<br />
• Packet Loss<br />
• Back to Back burst packet loss<br />
objectives<br />
• Convince wireless networks end users that wireless<br />
devices of all types (APs, Routers, Clients), and<br />
wireless networks of all scales (WLAN – WWAN<br />
– WMAN), to be commissioned for service only if it is<br />
“Wi-NOT Certified” for performance<br />
•<br />
Be recognized as an international body for certifying<br />
the performance of wireless devices and networks<br />
Management Team<br />
Officers: The principal officers of this Corporation will<br />
be a Chairman, Vice Chairman, Chief Financial Officer<br />
or Treasurer, Secretary and other officers as the Board<br />
of Directors may appoint. One person may hold two or<br />
more offices. Officers of the Corporation may be any<br />
person nominated by a Director and duly elected by the<br />
Board as long as they are an employee or duly authorized<br />
representative of any Member of the Corporation.<br />
CoNTiNueD oN PAge 11<br />
mar/<strong>08</strong>/apr<br />
It is anticipated that the Chairman and Vice Chairman<br />
positions be filled by TüVRheinland ® . The remaining<br />
two positions for Chief Financial Officer or Treasurer,<br />
and Secretary may be filled by managers from Veriwave<br />
(2) or a manager from Veriwave (1) and a manager from<br />
the first companies to join as a BoD member (1).<br />
Membership levels<br />
There will be 3 membership levels of the Wi-NOT Alliance:<br />
1. Sponsor – This level will include the principal<br />
founders and all member companies that pay the full<br />
annual duties of the alliance. The member companies<br />
at this level will actively participate in task groups,<br />
formulate test plans and test their products/networks<br />
for performance and seek alliance certification.<br />
Furthermore, they will be privileged to be on the Board<br />
of Directors, subject to the alliance bylaws.<br />
2. Promoter – This level entitles its members to all<br />
privileges of the Sponsor members without the<br />
possibility of being a BoD member.<br />
3. Observer – This level entitles its members to<br />
participate in the alliance meetings. In return, the<br />
alliance may display the company names on its web<br />
site.<br />
distinct competencies<br />
• The capabilities and the combined track record for<br />
the Principal Companies to offer testing services<br />
according to internationally recognized standards<br />
and to build own testing systems and test plans<br />
• Accreditation of other alliances like Wi-Fi and<br />
Zigbee for the Principal Founder to perform tests<br />
for wireless devices<br />
10
<strong>market</strong> <strong>access</strong><br />
Wireless<br />
Introducing the Wi-NOT Alliance (continued)<br />
•<br />
Ability for the Principal Co-founder to contribute to<br />
the world standards from the Internet Engineering<br />
Task Force (IETF) as a co-author for benchmarking<br />
testing criteria<br />
product or Service<br />
Description:<br />
The testing and certification of wireless devices and<br />
networks according to IETF and other international<br />
performance benchmarking standards.<br />
Benefits to customer:<br />
The ability to label products with the alliance logo and<br />
trade mark. This increases sales, guarantees projects of<br />
a large scale and increases revenues that help with the<br />
R&D of other new products and new technologies for the<br />
manufacturer.<br />
Differences from current offerings:<br />
At this time there is no other similar alliance in the world<br />
that offers these services to a group of allied companies.<br />
mar/<strong>08</strong>/apr<br />
11<br />
keys to Success<br />
• Participation of influential companies as Promoter<br />
level members, who are leaders in the industry in<br />
their respective wireless categories. Examples of<br />
these companies are Cisco, RIM, and Verizon.<br />
• Convincing the end users of all scales of wireless<br />
devices and networks to demand performance<br />
certification and to include these wireless entities<br />
in their operational networks as a condition.<br />
Examples of these are; metropolitan network<br />
organizers, healthcare organizations, and large<br />
service providers.<br />
location and facilities<br />
The Wi-NOT alliance will have its first location in<br />
Pleasanton, California. The plan is to expand to other<br />
locations in Taipei, Taiwan; TüV headquarters in<br />
Germany; and Tokyo, Japan.<br />
For more information, please call 1-TuV-rheinland<br />
(1-888-743-4652).<br />
The Wi-NOT Alliance will test and<br />
certify performance of individually<br />
devised and integrated wireless<br />
networks
<strong>market</strong> <strong>access</strong><br />
Machinery<br />
The EU’s New Machinery Directive And Its Impact On Certification<br />
To Avoid Issues In 2009, Compliance Efforts Should Start Today<br />
Reprinted with permission, this article originally appeared in the January 20<strong>08</strong> issue of Conformity, www.conformity.com , authored by udo<br />
Heinz, (uSA) industrial Machinery Division Manager<br />
The European Union’s (EU’s) new Machinery Directive<br />
(2006/42/EC) is almost here. Adopted by the European<br />
Parliament and the Council of Ministers in June 2006,<br />
it was enforced 20 days later. Since then, conformity<br />
experts have been examining the documents for<br />
differences. On December 29, 2009, the new provisions<br />
will become effective and replace the current version<br />
of the Machinery Directive (98/37/EC).<br />
Fortunately, we have already had some time to test the<br />
waters with respect to this new legislation. For the next<br />
two years, we will see members of the EU adopt them<br />
into national law. Until this adaptation period ends in<br />
December 2009, EU countries are still accepting the<br />
current Machinery Directive as applicable.<br />
Most impacted by these changes are manufacturers<br />
of machines and machine assemblies as well as<br />
machine importers. Specifically, manufacturers of<br />
partly complete machines must abide by the Machinery<br />
Directive and issue a Declaration of Incorporation.<br />
CoNTiNueD oN PAge 13<br />
mar/<strong>08</strong>/apr<br />
12<br />
Additionally, the requirements for machine importers<br />
have also been expanded under this new legislation.<br />
Now, they will need to have a technical file in Europe<br />
and, on the Declaration of Conformity, must list the<br />
machine manufacturer’s name and address, in addition<br />
to the authorized representative’s contact information in<br />
the EU (identical to what is required in the Low Voltage<br />
Directive (2006/95/EC), and the technical file contact.<br />
changes address circulation, advancements and Safety<br />
While the new Machinery Directive has several<br />
consistencies with the current version, there are several<br />
differences between the two – none of which can be<br />
considered radical. Overall, the new legislation focuses<br />
more on free circulation within the EU <strong>market</strong>, as well as<br />
on various health and safety rulings. More importantly,<br />
the new legislation clarifies many passages of text that<br />
were previously considered a challenge for conformity<br />
experts to interpret.<br />
With the new directive, the EU addresses advancements<br />
in machinery that occurred after the current directive<br />
was implemented. As expected, the technology to<br />
produce or run machinery has evolved and the current<br />
directive, as it was written, could not accommodate<br />
some of these technological leaps. Over the years, the<br />
Commission issued guides to update the current directive.<br />
Compliance experts also spent a considerable amount<br />
of time interpreting parts of the directive to make sure<br />
new technology could meet certification requirements.<br />
In time, this methodology became an accepted part of<br />
the industry.
<strong>market</strong> <strong>access</strong><br />
Machinery<br />
The EU’s New Machinery Directive And Its Impact On Certification (continued)<br />
The new Machinery Directive (2006/42/EC) will act<br />
as an umbrella for harmonized safety standards,<br />
eliminate previously ambiguous text and accommodate<br />
potential advances within the machinery industry. As<br />
such, we will find that the directive’s language will be<br />
general enough to encompass anticipated changes<br />
in technology and to consider a wide range of issues.<br />
The final list of harmonized standards under the new<br />
Machinery Directive is not yet known, but will be similar<br />
to what is available now.<br />
The current Machinery directive (98/37/ec)<br />
The development of the new Machinery Directive<br />
has been 30 years in the making. Some of the current<br />
directive dates as far back as the 1970s, but the most<br />
recent updates were implemented about 10 years<br />
ago. Most of these changes became law through<br />
implementation into national legislation of the directive’s<br />
essential requirements, which took effect in 1993 with a<br />
two-year transitional period.<br />
At the time, many in the industry were unclear about<br />
these new requirements. The Commission offered<br />
interpretive guides and additional training to aid<br />
compliance professionals. On January 1, 1995, the<br />
directive became mandatory. By this time, EU member<br />
states had time to work through questions regarding the<br />
provisions of the directive, and compliance specialists<br />
learned how to interpret and apply the directive’s<br />
wording to the machinery at hand.<br />
The evolution of machinery over the last decade has<br />
spawned new issues concerning health and safety,<br />
thereby providing further reason to update the directive.<br />
However, some wonder why it has taken over 10 years<br />
to update this legislation. Ultimately, it takes time to<br />
harmonize the directive and then transfer it into law in<br />
each of the member states.<br />
CoNTiNueD oN PAge 14<br />
mar/<strong>08</strong>/apr<br />
13<br />
As will be seen with the new Machinery Directive, it will<br />
take roughly three-and-a-half years for the new law to<br />
be adopted throughout the EU. After that happens, it is<br />
a time-intensive process to update the text. In fact, the<br />
more people who have an opinion about the legislation,<br />
the more time it will take to make further changes. As a<br />
result, we predict that the new Machinery Directive will<br />
be around for quite some time.<br />
Major changes to the new Machinery directive<br />
As previously mentioned, many of the changes found<br />
in the new Machinery Directive are clarifications of<br />
previous amendments to the current directive, and still<br />
only define the minimum level of safety required for<br />
machines entering the EU <strong>market</strong>place. Upon review,<br />
compliance experts will ultimately need to look at six<br />
major changes in this updated directive. The areas most<br />
impacted concern changes to: the Low Voltage Directive,<br />
Lifts, Essential Health and Safety Requirements,<br />
Conformity Assessment, Market Surveillance.
<strong>market</strong> <strong>access</strong><br />
Machinery<br />
The EU’s New Machinery Directive And Its Impact On Certification (continued)<br />
low Voltage directive (lVd, 2006/95/ec)<br />
The Low Voltage Directive (LVD) covers electrical<br />
equipment designed for use with a voltage rating of<br />
between 50 and 1000 V for alternating current and<br />
between 75 and 1500 V for direct current.<br />
Typically, the standard equipment covered under the<br />
LVD are household appliances (EN 60335 series of<br />
standards); information technology equipment such<br />
as PCs (EN 60950-1); or laboratory, measurement and<br />
control equipment (EN 61010-1).<br />
The primary differences between the LVD and the<br />
Machinery Directive include devices’ moving parts and<br />
the ranking of their risks. To sum, the risks involved with<br />
moving parts on a device are more severe under the<br />
Machinery Directive.<br />
On the subject of “main risk,” the new Machinery<br />
Directive eliminates the gray area that used to exist<br />
between the Machinery and the Low Voltage Directives.<br />
Now, there are six defined categories of electrical<br />
machinery that are specifically excluded from the scope<br />
of the Machinery Directive, and which must comply with<br />
the Low Voltage Directive. Those categories include:<br />
• Domestic household appliances<br />
• Audio and video equipment<br />
• Information technology equipment<br />
• Office machinery<br />
• Low-voltage switchgear and control gear<br />
•<br />
Electric motors<br />
The office machinery category required special<br />
clarification. Manufacturers of those devices ran into<br />
problems during the certification process, depending<br />
on their jurisdiction in Europe. Within the first 12 - 18<br />
months after the new directive is in place, the EU<br />
Commission will probably give some guidance on which<br />
devices are covered and where they fall within those<br />
categories.<br />
CoNTiNueD oN PAge 15<br />
mar/<strong>08</strong>/apr<br />
14<br />
There are numerous types of electrical machinery that<br />
do not fall into these categories, but which still pose<br />
some level of electrical risk. In that case, they must<br />
follow the Low Voltage Directive’s safety requirements.<br />
Additionally, this machinery must comply with the<br />
Machinery Directive regarding conformity assessment<br />
and <strong>market</strong> placement.<br />
EN 60204-1, the standard that covers machinery’s<br />
electrical safety requirements, is the most useful<br />
standard when assessing the electrical compliance of<br />
machines.<br />
lift directive (95/16/ec)<br />
In effect since July 1, 1999, the Lift Directive oversees the<br />
design, manufacture and installation of lifts (elevators)<br />
and ensures their safety and free circulation within the<br />
EU <strong>market</strong>. As can be expected, lifts have become faster<br />
over the past decade, and updates to the directive have<br />
become more ambiguous over time. The new Machinery<br />
Directive will include some essential clarifications to<br />
this section. Briefly, the Lift Directive will not consider
<strong>market</strong> <strong>access</strong><br />
Machinery<br />
The EU’s New Machinery Directive And Its Impact On Certification (continued)<br />
lifts that are incapable of surpassing 0.15 m/s in speed.<br />
Equipment that does not reach this velocity will look to<br />
the Machinery Directive’s requirements instead.<br />
These types of lifts are commonly not open to the public,<br />
and are more likely to be located at industrial sites,<br />
such as refineries or other larger industrial installations.<br />
These lifts are commonly used to bring workers to their<br />
workplace (i.e., maintenance personnel to the top of a<br />
tower on a drill platform), and could be considered an<br />
“<strong>access</strong>ory” to an existing machinery installation.<br />
Safety components annex<br />
Safety has become an overriding issue over the past<br />
decade, and the new Machinery Directive will deliver a<br />
detailed list of 17 safety components in a new Annex V.<br />
This particular list is distinct in that the EU’s Machinery<br />
Committee can update the range of safety components to<br />
cover new products. A sample of items on this list include:<br />
• Logic units to ensure safety functions<br />
• Emergency stop devices<br />
• Locking landing doors<br />
• Devices to prevent falls referred to in Section 3.2 of<br />
Annex I to prevent the car from falling or unchecked<br />
upward movements<br />
• Over speed limitation devices<br />
• Energy-accumulating shock absorbers (non-linear<br />
or with damping of the return movement) or energydissipating<br />
shock absorbers<br />
CoNTiNueD oN PAge 16<br />
mar/<strong>08</strong>/apr<br />
15<br />
• Safety devices fitted to jacks of hydraulic power<br />
circuits used to prevent falls<br />
• Electric safety devices in the form of safety switches<br />
containing electronic components<br />
The current Machinery Directive lists just five safety<br />
devices in section B of Annex IV, and the new, more<br />
detailed list in the new directive accounts for the added<br />
focus of such safety devices and functions.<br />
essential health and Safety requirements<br />
There has been much discussion about the changes<br />
made to the directive’s health and safety requirements. In<br />
reality, these requirements are not drastic modifications<br />
but simple clarifications. The most significant alterations<br />
have been the following:<br />
• The discussion of risk assessment is now clearer to<br />
avoid ambiguity<br />
• Risk requirements were added for machinery<br />
serving fixed landings to take into account the newly<br />
expanded scope of construction site hoists and<br />
slow-moving lifts<br />
• Certain risk requirements for mobile machinery<br />
or machinery for lifting are now applicable to all<br />
machinery types<br />
• Noise and vibration emissions now have specific<br />
requirements<br />
• The integration of safety devices must now take into<br />
account any reasonably foreseeable misuse of such<br />
devices<br />
• The different life phases have been detailed and now<br />
include transport, assembly, dismantling, disabling<br />
and scrapping in addition to the normal use phase
<strong>market</strong> <strong>access</strong><br />
Machinery<br />
The EU’s New Machinery Directive And Its Impact On Certification (continued)<br />
The first item in Annex I (under General Principles) is now<br />
a statement about the necessity and the responsibility<br />
of a risk assessment. In the past, risk assessments were<br />
either documented in the machine’s final design stage or<br />
not at all. Therefore, the new requirement underscores<br />
the EU’s increased focus on the proper application of<br />
risk assessments.<br />
Risk assessments also play a vital role in determining<br />
which safety requirements apply to the machine. We<br />
assume that the EU Commission will implement stricter<br />
enforcement to ensure the correct application of risk<br />
assessments.<br />
Studies show that the misuse of safety devices (i.e.,<br />
unauthorized bypass for maintenance or service tasks)<br />
results in an increased number of accidents. The<br />
manufacturer must confirm that a deliberate bypass of<br />
safety functions can be avoided within reason. In the<br />
future, this requirement will probably need additional<br />
clarification from the EU Commission or from industry<br />
groups.<br />
conformity assessment procedures<br />
Currently, the manufacturer can certify most machinery<br />
for conformity and that requirement will remain the<br />
same. Annex IV in the new directive provides a list of<br />
CoNTiNueD oN PAge 17<br />
mar/<strong>08</strong>/apr<br />
16<br />
machinery categories that must comply with certain<br />
conformity assessment procedures. Fortunately,<br />
manufacturers of Annex IV machinery will now have<br />
many procedures from which to choose:<br />
• If the machinery is designed according to harmonized<br />
standards and fulfills the directive’s requirements,<br />
the manufacturer can certify the product;<br />
• For other Annex IV machinery, the manufacture can<br />
choose either a review by a Notified Body (NB) or<br />
have its quality assurance system approved by an<br />
NB.<br />
It is important to note that, under the new directive, EU<br />
member states constantly review NBs. If an NB does not<br />
pass muster, then the member state can withdraw or<br />
suspend the NB’s notification.<br />
The full quality assurance route for manufacturers<br />
of Annex IV equipment, as indicated in Annex X, adds<br />
certification options for manufacturers and will therefore<br />
decrease a product’s time to <strong>market</strong>.<br />
Market Surveillance<br />
In the new directive, EU member states have clearly<br />
defined responsibilities regarding <strong>market</strong> surveillance.<br />
These measures were inspired by the General Product<br />
Safety Directive (GPSD), which oversees consumer<br />
health and safety. The ruling uses a systematic approach<br />
of <strong>market</strong> surveillance to encourage collaboration among<br />
EU authorities and ensure a high level of consumer<br />
protection.<br />
The obligations include cooperation with <strong>market</strong><br />
surveillance authorities and require confidentiality and<br />
transparency. Such rules help manufacturers maintain
<strong>market</strong> <strong>access</strong><br />
Machinery<br />
The EU’s New Machinery Directive And Its Impact On Certification (continued)<br />
their competitiveness within the <strong>market</strong>, as well as keep<br />
EU member states neutral throughout the conformity<br />
assessment process.<br />
After consultation with the Machinery Committee, the<br />
European Commission can also adopt a decision to<br />
prohibit or restrict a category of machines from being<br />
placed on the <strong>market</strong> if it might present a risk.<br />
compliance efforts Should Start Today<br />
Conformity experts may wonder how this new directive<br />
will impact current compliance efforts. As a quick<br />
comparison, we can look at what occurred when<br />
changes were made to the EMC and Low Voltage<br />
Directives – two directives similar to the new Machinery<br />
Directive. When they were replaced, the updates<br />
occurred with minimal impact to the industry. It can<br />
therefore be presumed that updates to the Machinery<br />
Directive will not significantly disrupt compliance<br />
efforts. The only caveat is that manufacturers should<br />
take the time now to evaluate the directive’s impact on<br />
their equipment, and to prepare accordingly before the<br />
new directive becomes mandatory.<br />
mar/<strong>08</strong>/apr<br />
17<br />
However, for many companies, the question remains:<br />
When do I start designing my products to comply with the<br />
new Machinery Directive? The answer is now. Current<br />
harmonized standards may not fully comply with the new<br />
directive because of the changes to the essential health<br />
and safety requirements in Annex I. In addition, it cannot<br />
be assumed that EC type-examination certificates issued<br />
before December 29, 2009 will remain valid. In fact, these<br />
certificates will need to be updated to reference the new<br />
directive.<br />
Manufacturers are encouraged to start adapting their<br />
products to the new Machinery Directive right now.<br />
From a legal standpoint, only machinery in compliance<br />
will be allowed to be sold within the EU. All others will<br />
be effectively blocked from the <strong>market</strong>. From a practical<br />
point of view, it is more cost-effective for manufacturers<br />
to begin designing according to the new requirements<br />
today, instead of making adjustments to their products<br />
in two years.<br />
The same holds true for compliance professionals. It<br />
is a time-intensive and costly process to review, notify<br />
and/or CE mark products. The European Commission<br />
recommends that conformity experts begin reviewing<br />
certificates now to avoid a bottleneck in the months<br />
leading to the December 2009 deadline. Ultimately, it is<br />
a more effective use of resources to consider all of the<br />
new legislation today rather than repeat the process in<br />
two years.<br />
For more information, please call 1-TuV-rheinland<br />
(1-888-743-4652).
<strong>market</strong> <strong>access</strong><br />
Product Safety<br />
Rochester, N.Y. Office Receives NVLAP Accreditation<br />
FCC Approval Process Now Streamlined<br />
Authored by Traci Conroy, (Newtown, CT) Managing editor of Market Access<br />
TüVRheinland ® , the world leader in independent<br />
testing and certification services, received<br />
accreditation under the National Voluntary<br />
Laboratory Accreditation Program (NVLAP)<br />
for its electromagnetic compatibility (EMC),<br />
and telecommunications testing laboratory in<br />
Rochester, N.Y. The lab is the only commercial<br />
and independent test facility in the area to receive<br />
NVLAP accreditation.<br />
Administered by the National Institute of Standards<br />
and Technology, NVLAP confirms that a testing lab<br />
and its personnel have the technical qualifications<br />
and competency to perform specific EMC and<br />
telecommunications tests and/or calibrations.<br />
This accreditation allows TüVRheinland ® of<br />
North America to greatly accelerate the Federal<br />
Communications Commission’s (FCC) approval<br />
process in areas of EMC and telecommunications<br />
testing by having the ability to self-declare<br />
conformity to standards and bypass the FCC’s case<br />
review process. This can save our information<br />
technology equipment (ITE) and telecom clients<br />
Semi-anechoic Chamber<br />
CoNTiNueD oN PAge 19<br />
weeks or months of waiting. The accreditation<br />
conforms to all requirements of the ISO/IEC<br />
17025:2005 standard.<br />
The Federal Communications Commission (FCC)<br />
is an independent United States government<br />
agency, directly responsible to Congress. The FCC<br />
was established by the Communications Act of<br />
1934 and is credited with regulating interstate and<br />
international communications by radio, television,<br />
wire, satellite and cable.<br />
Currently TüVRheinland ® ’s North American division<br />
operates a total of 15 EMC testing laboratories and<br />
two EMC mobile lab units throughout the United<br />
States. Through this network of facilities, the<br />
company tests local clients’ products to assure<br />
compliance with various global requirements,<br />
including the FCC and the European EMC Directive<br />
2004/1<strong>08</strong>/EC.<br />
When requirements include heavy industrial<br />
equipment, one of TüVRheinland ® ’s convenient<br />
Semi-anechoic Chamber<br />
mar/<strong>08</strong>/apr<br />
18
<strong>market</strong> <strong>access</strong><br />
Product Safety<br />
Rochester, N.Y. Office Receives NVLAP Accreditation (continued)<br />
mobile labs with specialized equipment can test<br />
at the customer’s location -- outdoors, indoors, or<br />
right on the factory floor. From start to finish, on-site<br />
testing typically takes no more than three days.<br />
The Rochester, N.Y. office opened its doors in June<br />
of 2007, after signing an agreement with Rochesterbased<br />
Eastman Kodak Company to become its primary<br />
supplier of third-party testing and certification<br />
services. The facility is equipped with product safety<br />
and EMC test equipment, which has been upgraded<br />
to meet ever-evolving global standards.<br />
TüVRheinland ® ’s Rochester office provides EMC,<br />
product safety, industrial machinery and medical<br />
testing and certification services to product<br />
manufacturers throughout Northern and Western<br />
New York, the Ohio Valley and Pennsylvania. Other<br />
clients come from the information technology, audio/<br />
video, home appliance, wireless network, laboratory,<br />
mining, military, wireless, and telecommunications<br />
industries.<br />
For more information, please call 1-TuV-rheinland<br />
(1-888-743-4652).<br />
Ancillary Room<br />
mar/<strong>08</strong>/apr<br />
19
<strong>market</strong> <strong>access</strong><br />
News<br />
TUVdotCOM Launches A New Look And Feel On The Web<br />
Improved Performance And Aesthetics Make User Experiences More Valuable!<br />
Authored by Jessica Vitolo, (Newtown, CT) TuVdotCoM Program Manager<br />
On the surface, TUVdotCOM may resemble the<br />
average certification directory but take a closer look<br />
-- it is so much more than that! Beyond its capabilities<br />
as a robust compliance tool, TUVdotCOM is also a key<br />
<strong>market</strong>ing outlet that combines key product or service<br />
highlights with verifiable statements achieved through<br />
a certified evaluation process. With the launch of the<br />
new look and feel of www.TUVdotCOM.com finding<br />
information is now faster and more convenient.<br />
Early this year, the release of the enhanced online<br />
design and benefit features made navigating<br />
TUVdotCOM even easier. This exclusive<br />
TüVRheinland® web tool offers the public a view into<br />
the world of quality products, services, and systems<br />
24/7/365. Due to these exciting changes visitors to<br />
CoNTiNueD oN PAge 21<br />
mar/<strong>08</strong>/apr<br />
www.TUVdotCOM.com are encountering a more<br />
valuable experience.<br />
Valuable at its best<br />
The new TUVdotCOM look includes a revised main<br />
page with an easy to locate search box that will<br />
retrieve matching keyword results in seconds.<br />
(Keywords can consist of a TUVdotCOM ID,<br />
Certificate type, Certificate number, Manufacture<br />
name, Laboratory name, Test standard, Product or<br />
Service type or Certified professional). Once data<br />
is retrieved, TUVdotCOM posts the information into<br />
clear and distinct categories utilizing a colorful<br />
layout and bold hyper links. Now search results are<br />
not only accurate but visually appealing as well.<br />
20
<strong>market</strong> <strong>access</strong> mar/<strong>08</strong>/apr<br />
News<br />
TUVdotCOM Launches A New Look And Feel On The Web (continued)<br />
The Contact Us feature also boasts upgrades. From<br />
anywhere around the world, this feature not only<br />
connects online visitors to a local TUVdotCOM<br />
administrator, but the field also includes an amended<br />
online form that document specific issues about a<br />
TUVdotCOM experience, as well as process requests<br />
for TUVdotCOM IDs.<br />
TUVdotCOM IDs are ten digit numbers that further<br />
identify certified products, services, systems,<br />
people or organizations. When results are displayed<br />
on the current TUVdotCOM platform these IDs take<br />
center stage. Hyper links connect directly to the ID<br />
page location on the database where <strong>market</strong>ing<br />
test, compliance summary and much more can be<br />
21<br />
found. Web translations include over 12 languages<br />
and the upload capacity associated with each ID is<br />
virtually limitless.<br />
For a personal tour or live demonstration of<br />
TUVdotCOM, please call 1-TuV-rheinland<br />
(1-888-743-4652). Online, TUVdotCOM ID samples<br />
can be viewed by logging on to www.TUVdotCOM.<br />
com and entering 000000<strong>08</strong>88 into the search box<br />
on the main page.
<strong>market</strong> <strong>access</strong> mar/<strong>08</strong>/apr<br />
TÜVRheinland ® Resources<br />
Assisting Your Company With Testing, Certification,<br />
Compliance & More<br />
Tradeshows<br />
To view other tradeshows that TüVRheinland ® will be<br />
visiting, please visit http://www.us.tuv.com/news/tradeshows.aspx.<br />
retailVision Spring 20<strong>08</strong><br />
Grand Hyatt Hotel<br />
Orlando, FL<br />
April 14-17 | Booth #611<br />
del Mar electronics Show 20<strong>08</strong><br />
Del Mar Fairgrounds<br />
Del Mar, CA<br />
April 30-May 1 | Booth #212<br />
iaei-fl 20<strong>08</strong><br />
International Association of Electrical Inspectors<br />
Omni Hotel<br />
Jacksonville, FL<br />
May 7-10 | Booth #TBA<br />
railway Systems Suppliers inc. 20<strong>08</strong><br />
Gaylord Texan Resort & Convention Center<br />
Grapevine, TX<br />
May 21-22 | Booth #11<strong>08</strong><br />
Md&M east 20<strong>08</strong><br />
Medical Design & Manufacturing<br />
Jacob K. Javits Convention Center<br />
New York, NY<br />
June 3-5 | Booth #951<br />
nXT comm 20<strong>08</strong><br />
Las Vegas Convention Center<br />
Las Vegas, NV<br />
June 16-19, | Booth #SU6624<br />
SeMicon west 20<strong>08</strong><br />
North Hall, Moscone Center<br />
San Francisco, CA<br />
July 15-17 | Booth #6260<br />
ieee eMc 20<strong>08</strong><br />
Cobo Center<br />
Detroit, MI<br />
August 18-22 | Booth #TBA<br />
iMTS 20<strong>08</strong><br />
International Manufacturing Technology Show<br />
McCormick Place<br />
Chicago, IL<br />
September 8-13 | Booth #4795<br />
rapS 20<strong>08</strong><br />
Regulatory Affairs Professionals Society<br />
Hynes Convention Center<br />
Boston, MA<br />
September 14-17 | Booth #320<br />
international public Transportation expo 20<strong>08</strong><br />
San Diego Convention Center<br />
San Diego, CA<br />
October 6-8 | Booth #TBA<br />
iSa 20<strong>08</strong><br />
Reliant Center<br />
Houston, TX<br />
October 14-16 | Booth #2125<br />
22
<strong>market</strong> <strong>access</strong><br />
Traci conroy • Managing editor<br />
TüVRheinland ®<br />
12 Commerce Road, Newtown, CT 06470 USA<br />
Tel 203-426-<strong>08</strong>88<br />
Fax 203-426-4009<br />
Email tconroy@us.tuv.com<br />
www.us.tuv.com<br />
Market Access is published six times a year by TüVRheinland ®.<br />
Subscriptions are free. This newsletter is published for the<br />
convenience of our customers, clients and professional<br />
associates. Although it is intended to provide accurate and<br />
authoritative information with respect to the subject matter<br />
covered, the information and opinions contained in this<br />
publication are those of the authors and not of the editor or<br />
publisher. The authors, editor and publisher disclaim any liability<br />
for any inaccuracies contained herein. Before any action is<br />
taken based upon the published information, it is essential that<br />
competent and individual professional advice is obtained.<br />
TÜVRheinland®, inc. is an equal-opportunity/affirmative<br />
action employer.<br />
mission statement<br />
Employees and Leadership<br />
our employees are the most important success factor for the TÜVRheinland ®<br />
group. Their engagement, competence, neutrality and performance are key.<br />
Services and Products<br />
Demonstrable quality marks our services and products. This creates and<br />
secures competitive advantages.<br />
Technology and Safety<br />
We represent responsibly designed technology and set safety standard for<br />
the future.<br />
Customers and Markets<br />
Customers safeguard our existence. The customer must be convinced of the<br />
quality of our services in order for us to achieve success in the <strong>market</strong>place.<br />
Economic Success and a Secure Future<br />
Market-oriented thinking and efficient action secure the strength and<br />
independence of the TÜVRheinland ® group.<br />
Environment<br />
in our work, we demonstrate that environmental protection, technology and<br />
economics can be combined in a sustainable manner. This applies to both our<br />
services and our own product.<br />
The Public<br />
openness, competence, presence and neutrality as an independent third<br />
party determine our actions and shape our public image