Transcript Agenda - IECEE

The European View on Safety
The European View
Electrical Safety Aspects
Workshop
IECEE as a Means to Lower Technical Barriers
to Trade
Moscow, June 25, 2007
Dr. Wolfgang Kreinberg
TÜV SÜD Product Service GmbH, München
TÜV SÜD Product Service GmbH
(c) Dr. Wolfgang Kreinberg
Jul-15
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The European View on Safety
Definition Sicherheit
Our Dream ?
TÜV SÜD Product Service GmbH
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The European View on Safety
Definition Sicherheit
Our Dream ?
2006 CMC Meeting
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The European View on Safety
Definition Sicherheit
One Standard?
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The European View on Safety
TÜV SÜD Product Service GmbH
(c) Dr. Wolfgang Kreinberg
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The European View on Safety
European Directives related to electrical safety
• European Directives are related to products
• More than one directive might be valid for one
product
• Directives are issued on European level, they
must be implemented in all 27 member states
without modification (no national requirements
are allowed)
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(c) Dr. Wolfgang Kreinberg
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The European View on Safety
Directives based on the principles of the "New
Approach" are available at
http://europa.eu.int/comm/enterprise/newapproach/inde
x.htm
Notified bodies are available at
http://europa.eu.int/comm/enterprise/newapproach/legi
slation/nb/notified-bodies.htm.
TÜV SÜD Product Service GmbH
(c) Dr. Wolfgang Kreinberg
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The European View on Safety
European Directives related to electrical safety
• They do not require conformity with standards
but with essential requirements, which are
summarized in Annex I of the relevant directive
• Harmonized standards may lead to the
assumption of conformity with requirements
Assumption of conformity with
requirements?
TÜV SÜD Product Service GmbH
(c) Dr. Wolfgang Kreinberg
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The European View on Safety
Assumption of Conformity with Directive
- only applies if referenced harmonized standard
covers all possible hazards
Examples:
EN 60 335 covers electrical safety but no Food!
So LFBG (Act on food products and commodities) has to be
added to obtain the GS Mark
EN 60 950 covers electrical safety but no Ergonomics.
So Ergonomics standards has to be applied additionally to
obtain the GS Mark
TÜV SÜD Product Service GmbH
(c) Dr. Wolfgang Kreinberg
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The European View on Safety
Directive
2006/95/EC
88/378/EEC
89/106/EEC
2004/108/EC
89/686/EEC
90/384/EEC
90/385/EEC
TÜV SÜD Product Service GmbH
New Approach Directive
Low voltage (73/23/EEC)
Safety of toys
Construction products
Electromagnetic compatibility 89/336/EEC
Personal protective equipment
Non-automatic weighing instruments
Active implantable medical devices
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The European View on Safety
92/42/EEC
93/42/EEC
94/9/EC
Hot-water boilers
Medical devices
Equipment and protective systems
intended for use in potentially
explosive atmospheres
2006/42/EC Machinery 98/37/EC
98/79/EC
In vitro diagnostic medical devices
99/5/EC
Radio and telecommunications
terminal equipment
2000/14/EC Noise emission in the environment
by equipment for use outdoors
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(c) Dr. Wolfgang Kreinberg
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The European View on Safety
Examples for more than one applicable Directive
93/42/EEC
99/5/EC
Medical devices
Radio and telecommunications
terminal equipment
applicable for implantable and programmable
pacemakers
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The European View on Safety
Examples for more than one applicable Directive
2006/95/EEC
2004/108/EC
2006/42/EC
2000/14/EC
Low voltage 73/23/EEC
Electromagnetic compatibility 89/336/EEC
Machinery 98/37/EC
Noise emission in the environment
by equipment for use outdoors
applicable for Tools (like chain saws)
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The European View on Safety
How many accreditations do we need in Germany for
Chainsaws?
•
Chainsaw as Annex IV Machine
– Notified Body acc Machine Directive
•
Chainsaw makes noise:
– Notified Body acc Outdoor Directive
Accreditation
#1, 2 und 3
Accreditation #4
Accreditation #5
•
Chainsaw makes exhaust :
– Notified Body acc exhaust requirements after 2008
When does it need an approval for the turn signal??? Accreditation
#6???
TÜV SÜD Product Service GmbH
(c) Dr. Wolfgang Kreinberg
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The European View on Safety
Examples for more than one applicable Directive
2006/95/EC Low voltage 73/23/EEC
2004/108/EC Electromagnetic compatibility 89/336/EEC
99/5/EC
Radio and telecommunications
terminal equipment
applicable for Computer (OFF)
plus: ergonomics in Germany
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The European View on Safety
Examples for more than one applicable Directive
applicable for Computer (OFF)
plus: ergonomics in Germany
What does it mean, isn’t IEC 60950 enough?
- black laptops may be sold in Germany
- black laptops must not have a GS Mark
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(c) Dr. Wolfgang Kreinberg
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The European View on Safety
Modules for conformity assessment
Self declaration plus CE marking:
2006/95/EC Low voltage
2004/108/EC Electromagnetic compatibility
2006/42/EC Machinery (exception Annex IV)
Normally no mandatory testing or certification!
TÜV SÜD Product Service GmbH
(c) Dr. Wolfgang Kreinberg
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The European View on Safety
Modules for conformity assessment
Mandatory Notified Body plus CE marking:
93/42/EEC
Medical devices
0123
Normally far beyond just electrical safety
TÜV SÜD Product Service GmbH
(c) Dr. Wolfgang Kreinberg
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The European View on Safety
Essential Requirements concerning Medical Devices
Annex I, II, Requirements regarding Design and Construction
Requirement
Chemical physical and biological properties
Evaluation module
Biocompatibility
Infection and microbial contamination
Constructional safety IEC601-1
Construction and environmental properties
EMC / Radiation
Measuring function
Functional safety
Protection against radiation
Environmental aspects
Devices with an energy source
Information supplied by the manufacturer
Clinical data
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Performance
Clinical Data
(c) Dr. Wolfgang Kreinberg
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The European View on Safety
Principles of CE marking
• The CE marking symbolises the conformity of the
product with the applicable Community requirements
imposed on the manufacturer.
• The CE marking affixed to products is a declaration by
the person responsible that:
* the product conforms to all applicable Community
provisions, and
* the appropriate conformity assessment procedures
have been completed.
TÜV SÜD Product Service GmbH
(c) Dr. Wolfgang Kreinberg
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The European View on Safety
• The CE marking is mandatory and must be affixed
before any product subject to it is placed on the market
and put into service, unless specific directives require
otherwise.
• Where products are subject to several directives, which
all provide for the affixing of the CE marking, the
marking indicates that the products are presumed to
conform to the provisions of all these directives.
• A product must not be CE marked, unless it is covered
by a directive providing for its affixing.
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The European View on Safety
Article 13
General principles of the CE marking
• ….
• By affixing or having affixed the CE marking the
manufacturer declares that his product is in conformity with
all applicable Community requirements which provide for its
affixing. The CE marking may only be affixed by the
manufacturer or his authorised representative.
TÜV SÜD Product Service GmbH
(c) Dr. Wolfgang Kreinberg
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The European View on Safety
Article 13
Clearly no third
party
certification
General principles of the CE marking
• ….
• By affixing or having affixed the CE marking the
manufacturer declares that his product is in conformity with
all applicable Community requirements which provide for its
affixing. The CE marking may only be affixed by the
manufacturer or his authorised representative.
TÜV SÜD Product Service GmbH
(c) Dr. Wolfgang Kreinberg
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The European View on Safety
Where a notified body is involved in the production
control phase according to the applicable directives, its
identification number must follow the CE marking.
The manufacturer or the authorised representative
established in the Community affixes the identification
number, under the responsibility of the notified body.
TÜV SÜD Product Service GmbH
(c) Dr. Wolfgang Kreinberg
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The European View on Safety
Certification Mark versus CE-Marking





Voluntary certification mark
Well known mark for consumers
“Good name” in home countries
The product is safe
Continuous surveillance of the production
 Legal requirement





Marking for the authorities
85% Manufacturers self declaration
Product conforms to requirements of a directive
Surveillance of the production: ???
CE = Communauté Européenne
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The European View on Safety
New Developments in Europe
Brussels, 14.2.2007
COM(2007) 53 final
2007/0030 (COD)
Proposal for a
DECISION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
on a common framework for the marketing of products
(presented by the Commission)
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The European View on Safety
Article 16
General principles of the CE marking
1. The CE marking may only be affixed by the manufacturer or his authorised
representative.
By affixing or having affixed the CE marking the manufacturer shall assume the
responsibility for the conformity of the product with the requirements laid down in
this … [act].
2. The CE marking shall be the only marking which attests conformity of the product
with the applicable requirements. Member States shall refrain from introducing
into their national regulations or shall withdraw any reference to a conformity
marking other than the CE marking in connection with conformity to the
provisions contained in the legislation on CE marking.
3. The affixing on a product of markings, signs and inscriptions which are likely to
mislead third parties as to the meaning or form of the CE marking, or both, is
prohibited. Any other marking may be affixed to the product provided that the
visibility, legibility and meaning of the CE marking are not thereby impaired.
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The European View on Safety
Article 16
General principles of the CE marking
1. ...
2. The CE marking shall be the only marking which attests conformity of the product
with the applicable requirements. Member States shall refrain from introducing
or shall withdraw
into their national regulations
any reference to
a conformity marking other than the CE marking in connection with conformity to
the provisions contained in the legislation on CE marking.
3. ...
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The European View on Safety
The Challenge
• CE-Marking, “self declaration” vs. “3rd party certification”?
Market surveillance authorities in Europe are
blaming third party organisations for not
contributing to safe products.
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The European View on Safety
Number of certificates issued by German
certification bodies per year
50.000
Percentage of products failing in first test
for safety problems
50 %
number of product types being unsafe
in first approach
25.000
Average number of individual products per type
40.000
number of unsafe products that would
come to the market without 3rd party
involvement
TÜV SÜD Product Service GmbH
1.000.000.000
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The European View on Safety
Safe Products through 3rd Party Involvement
Pro-active involvement of independent 3rd party testing
laboratories and certification bodies prohibits
1.000.000.000
to come to the market.
Without this these products have to be detected and removed
(re-called) re-active through market surveillance authorities.
The majority of these products fall under low voltage
directive which has pure CE Marking and no mandatory
involvement of notified bodies!
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(c) Dr. Wolfgang Kreinberg
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The European View on Safety
CB Scheme as Turntable for European Approvals
The aim of the CB Scheme is to provide
Manufacturers seeking worldwide third party
certification Marks, the most economic and cost
effective procedures within the best
certification time delays.
National Marks?
TÜV SÜD Product Service GmbH
Private Marks?
(c) Dr. Wolfgang Kreinberg
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The European View on Safety
CB Scheme as Turntable for European Approvals
Restrictions by national
accreditation bodies?
National Marks?
TÜV SÜD Product Service GmbH
Private Marks?
(c) Dr. Wolfgang Kreinberg
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The European View on Safety
Possible Test Data Sources for Certification
Test Data from own
Laboratory
Test Data from
Bilateral Partner
Test Data based on
CB Scheme
Certificate
?
Test Data from
Manufacturer
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The European View on Safety
Compliance with Directives
Test Data from own
Laboratory
Test Data from
Bilateral Partner
Test Data based on
CB Scheme
Test Data from
Manufacturer
TÜV SÜD Product Service GmbH
Germany
UK
OK!
Must be!
OK!
No!
Subcontracting
only for minority
of tests
OK!
OK!
But not for
WMT/SMT/RMT
OK!
No!!
OK!
(c) Dr. Wolfgang Kreinberg
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The European View on Safety
Compliance with Directives
Test Data from own
Laboratory
Test Data from
Bilateral Partner
Test Data based on
CB Scheme
Test Data from
Manufacturer
TÜV SÜD Product Service GmbH
Germany
OK!
Must be!
Germany
OK!
No!
Subcontracting
only for minority
of tests
OK!
OK!
But not for
WMT/SMT/RMT
OK!
No!!
OK!
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The European View on Safety
Continuum and Signatures
TTL
Testing at Testing
Laboratory
TMP
Testing on
Manufacturers
Premises
WMT
Witnessed
Manufacturers
Testing
SMT
Supervised
Manufacturers
Testing
RMT
Recognised
Manufacturers
Testing
Test by
CBTL
Continuum of activities between
CB Testing Laboratory (CBTL),
National Certification Body (NCB)
and Manufacturer
Witnessed
by NCB *
Slide 37
+
100 %
0%
Supervised
by NCB
100 %
Signature TRF
Tested by
Authorized by
Witnessed by
Supervised by
Test by
Manufacturer
TTL
CBTL
CBTL
0%
TMP
CBTL
CBTL
WMT
SMT
RMT
Manufacturer Manufacturer Manufacturer
CBTL
Manufacturer Manufacturer
CBTL
NCB *
NCB *
* might be delegated to a CBTL
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The European View on Safety
Testing outside
a CBTL
Testing on
Premises
Witnessed
Testing
Supervised
Testing
Recognized
Testing
TÜV Mark
OK
OK
OK
OK
GS Mark
OK
NO
NO
NO
NRTL
OK
OK
OK
OK
CB Scheme
OK
OK
OK
OK
UK certification
OK
OK
OK
OK
TÜV Mark
OK
OK
OK
OK
GS Mark
OK
NO
NO
NO
NRTL
OK
OK
OK
OK
CB Scheme
NO
NO
NO
NO
UK certification
OK
OK
OK
OK
TÜV SÜD Product Service GmbH
Manufacturer
Third Party
other than
CBTL
(c) Dr. Wolfgang Kreinberg
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The European View on Safety
Certification Body Locations
Possible regions
(Selection)
Germany Europe
Korea
USA
China
Japan
Private (TÜV) Mark
Yes
Yes
Yes
Yes
Yes
Yes
German GS Mark
Yes
Yes 1)
No
No
No
No
European
Directives
Yes
Yes
No
No
No
No
NRTL
Yes 2)
No
No
Yes
No
No
CB Scheme
Yes 3)
Yes 3)
Yes 3)
Yes 3)
Yes 3)
Yes 3)
1) selected countries 2) Through MRA, now no longer possible 3) According to adherence to standards
TÜV SÜD Product Service GmbH
(c) Dr. Wolfgang Kreinberg
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The European View on Safety
CB Scheme as Turntable for European Approvals
Yes, despite some
national restrictions the
CB Scheme offers the
best possible value for
international clients to
enter the European
Market
National Marks
Private Marks
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(c) Dr. Wolfgang Kreinberg
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The European View on Safety
Спасибо!
TÜV SÜD Product Service GmbH
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