Information On CE Marking and On The EC Declaration of Conformity Based On Testing Services and Certificates of The VDE Testing and Certification Institute

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PM 92E

August 2002

Information on CE marking and on the


EC Declaration of Conformity based on
testing services and certificates of the
VDE Testing and Certification Institute

ASSOCIATION FOR ELECTRICAL, ELECTRONIC & INFORMATION TECHNOLOGIES


Testing and Certification Institute Merianstrae 28 D-63069 Offenbach Phone +49 69 8306-0 Fax +49 69 8306-555 e-mail: [email protected]
Nachdruck, auch auszugsweise, nur mit Genehmigung des VDE Prf- und Zertifizierungsinstituts / copyright reserved
PM 92E
August 2002

Contents Page

1 General Information on CE Marking as per EC 2


Directives

2 Routes to CE Marking 3

3 Harmonized EC Directives (Selection) 4

4 Procedures of Conformity Assessment and Marking 5

5 Modules of Conformity Assessment 6

6 Useful information 7

7 CE Marking made easy 8

8 Statements of Conformity 9

9 EC Declaration of Conformity 10

10 Testing and Certification by the VDE Institute 11

11 Certification with VDE Certification Marks and VDE- 12


Register-Number

ASSOCIATION FOR ELECTRICAL, ELECTRONIC & INFORMATION TECHNOLOGIES


Testing and Certification Institute Merianstrae 28 D-63069 Offenbach Phone +49 69 8306-0 Fax +49 69 8306-555 e-mail: [email protected]
Nachdruck, auch auszugsweise, nur mit Genehmigung des VDE Prf- und Zertifizierungsinstituts / copyright reserved
1 General Information

General Information on CE Marking as per EC Directives


For the protection of the consumer or user, the EC Directives stipulate that products may only be
brought onto the market if they comply with essential requirements of safety, health and with the
essential protection objectives of electromagnetic compatibility (EMC).

Compliance with these requirements shall be assured by adequate measures in the phases of
design and production.

In the frame of the new approach, compliance with the protection objectives of the EC Directives
shall be confirmed by an EC Declaration of Conformity to be issued by the manufacturer and
- in certain cases - by a EC Declaration of Conformity issued by a notified body (certification
body notified to the European Union) - according to EMC Law also by the involvement of a
Competent Body. These bodies must have undergone successfully and accreditation procedure
for verification of their competence.

In case of products without mandatory testing, verification and documentation of conformity with
EC Directives may be done by the manufacturer. Alternatively, he may entrust a neutral institute
with this task.

The VDE Testing and Certification Institute (VDE Institute) was granted accreditation for its
testing laboratories as well as for its certification activities and was notified for the Single Market
of the European Union (EU) under the identification No. 0366. Testing is conducted according to
national and international standards. Beyond that, the VDE Institute offers a variety of conformity
attestations enjoying appreciation world-wide.

Besides the A Mark and the D Mark which can be found on a variety of electrotechnical
products, conformity marks for cables and cords as well as for electronic components are
equally treasured attestations of compliance with standards and directives.

These marks allow easy identification of safe and electromagnetically compatible products. The
continous validity of this statement is assured by factory and market surveillance.

Various certification schemes allow the recognition of marks license certificates and conformity
attestations on national, European and international level. The confidence thus established
equally serves the competitiveness on the market, the product liability and the consumer
protection.

CE marking - addressed to the surveillance authorities - governs the marketing of products in the
European Single Market. The VDE Certification Marks confirm compliance with harmonized
standards and take their important role as competent proof of compliance with requirements of
safety, quality and EMC.

2
2 Routes to CE Marking

EC Directives Standards

Essential protection, safety Detailed protection, safety


and health requirements and health requirements

Measures of the manufacturer to meet protection targets

Conformity Assessment
Product certification
as per EC Directives

Involvement of
notified body?
* notified or
approved body
*
N Y

Module Modules
A Aa B G H Initial factory inspection
plus C, D,
In conjunction with Module A:

E or F
certain aspects on request
control by manufacturer

Assessment of
spot check verification of

EC Type-examination

Assessment of quality

management system
management system
Product verification
Internal production

Product testing

Conformity surveillance

VDE Marks Licence Certificate


Attestation of conformity confirms conformity with
standards and compliance
with protection requirements
of relevant directives
Technical documentation

D
EC Declaration of Conformity by manufacturer

CE Marking by manufacturer

FA
* e.g. VDE Testing and Certification Institute
Notified Body = accredited independent testing and certification body according to EC Directives
Approved Body = accredited independent testing and certification body according to Appliance Safety Law

3
3 Harmonized EC Directives (Selection)
Since the implementation of the EU Single Market, EC Directives for safety and health
as well as for electromagnetic compatibility (EMC) were released.

Harmonized EC Directives (Selection)


Number Title in brief

73/23/EEC*) Low-voltage equipment


87/404/EEC*) Simple pressure vessels 90/488/EEC
88/378/EEC*) Safety of toys
89/106/EEC*) Construction products
89/336/EEC*) Electromagnetic compatibility
89/686/EEC*) Personal protective equipment 93/95/EEC 96/58/EC
90/384/EEC*) Non-automatic weighting equipment
90/385/EEC*) Active implantable medical devices 93/42/EEC
90/396/EEC*) Appliances burning gaseous fuels
92/42/EEC*) New hot-water boilers fired with liquid or gaseous fuels
93/42/EEC Medical devices 98/79/EC 2000/70/EC
95/54/EC Electromagnetic compatibility of motor vehicles (e marking)
98/37/EC Machinery 98/79/EC
1999/5/EC Radio & Telecommunication Terminal Equipment (R&TTE)

*) amended by Directive 93/68/EEC of 22 July 1993 - as "this harmonization of the provisions


concerning the affixing of the CE marking requires that existing Directives undergo detailed
amendment to bring them into line with the new arrangements".

4
4 Procedures of Conformity Assessment and Marking
In the frame of the modular concept of conformity assessment of the "New Approach" Directives,
various modules are applied depending on the hazard level of a product.

Harmonized EC Directives Applicable Modules Marking


(Selection) acc. to 93/465/EEC
(Conformity assessment
procedure)

Number Title in brief CE Year Notified body


Indication identification

98/37/EC Machinery A; Aa1; B2 X on machine


(year of
manufacture)

89/336/EEC EMC A3; ** X

73/23/EEC Low-voltage Equipment A X in conformity


declaration

93/42/EEC Medical Devices A4; (C;D;E;H)5 X besides CE12


(H; B+C; B+D; B+E)6
(H*; B+C; B+D)7

90/385/EEC Active Implantable H*; B+C; B+D X besides CE12


Medical Devices

88/378/EEC Safety of Toys A; B8 X

89/686/EEC Personal Protective Equ. B+C; B+E; A9 X besides CE11 besides CE12

1999/5/EC Radio & Telecommunication A, B10 X besides CE13


Terminal Equipment

Legend
1 voluntary as per Annex V
2 for machines and safety relevant components as per Annex IV
3 for production as per harmonized standards
4 Class I equipment
5 Class IIa equipment
6 Class IIb equipment
7 Class III equipment
8 production without or only with partial consideration of standards
9 for types with minor risks
10 in case of manufacture without or with only partial consideration of harmonized
standards, involvement of a notified body is mandatory
11 not for simple types as per Article 8 (3)
12 in case of involvement of a notified body for production surveillance
13 in case of involvement of a notified body
* plus EC Design-Examination Certificate by notified body
** in case of manufacture without or with only partial consideration of harmonized
standards, involvement of a competent body is mandatory.

5
5 Modules of Conformity Assessment
Each conformity assessment procedure aims at compliance with relevant regulations. The
prescribed control measures vary from procedure to procedure.

Module "A"
The manufacturer issues a Declaration of Conformity. Invovelment of a third party
such as the interference of a notified body is not required.

Module "Aa"
Same as "A", but - if required - verification of specific aspects of the product at
random intervals by an independent body.

Module "B"
The manufacturer submits his product in the design phase to a notified body for EC
type examination.

Module "C"
The manufacturer declares conformity with approved type. Notified body checks at
random intervals.

Module "D"
After type examination, the manufacturer declares conformity with certified type and
maintains an approved quality management system for production and testing.

Module "E"
After type examination, the manufacturer declares conformity with certified type and
maintains an approved quality management system for inspection and testing.

Module "F"
Subsequent to type examination, the manufacturer submits his product to a notified
body for type testing.

Module "G"
The manufacturer submits his product to a notified body for type testing.

Module "H"
The manufacturer declares conformity on the basis of an approved quality system for
design, production and testing.

In case of Module F and G, an independent body notified to the EU declares conformity


by issuing a Certificate of Conformity.

6
6 Useful Information
is available from the following institutions:

Directives and Bundesanzeiger Verlagsgesellschaft mbH Tel. 0221/97668-0


Official Journals Amsterdamer Str. 192 Fax 0221/97668-278
of the EU 50735 Kln http://www.bundesanzeiger.de

National Laws Bundesanzeiger Verlagsgesellschaft mbh Tel. 0228/38208-0


and Decrees Sdstr. 119 Fax 0228/38208-36
53175 Bonn http://www.bundesanzeiger.de

Standards VDE-VERLAG GMBH Tel. 030/348001-0


Bismarckstr. 33 Fax 030/3417093
10625 Berlin http://www.vde-verlag.de

Beuth Verlag GmbH Tel. 030/2601-2260


Burggrafenstr. 6 Fax 030/2601-1260
10787 Berlin http://www.beuth.de

The full text of EC Directives, lists of mandated standards etc. is available from the website
of the European Union under the following address:
http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/reflist.html

Others Zentralverband Elektrotechnik Tel. 069/6302-0


und Elektronikindustrie (ZVEI) e. V. Fax 069/6302-317
Stresemannallee 19 http://www.zvei.org
60596 Frankfurt

VDMA Verlag GmbH Tel. 069/6603-1580


Lyoner Str. 18 Fax 069/6603-1611
60528 Frankfurt http://www.vdma-verlag.de

Bundesanstalt fr Arbeitsschutz Tel. 0231/9071-0


und Arbeitsmedizin (BAuA) Fax 0231/9071-454
Friedrich-Henkel-Weg 1-25 http://www.baua.de
44149 Dortmund

7
7 Marking made easy
VDE-certified products moving freely on markets in Europe -
and world-wide
The VDE Testing and Certification Institute in Offenbach tests and certifies products of the
electrotechnical und electronic industries as per VDE standards which are in line with IEC
standards and with harmonized European standards (EN). The VDE marks enjoy world-wide
reputation and inspire confidence in the safety and quality of the product.

A
for equipment, components and
D
for equipment and components
wiring accessories
for certification of conformity with the protection requirements of
e.g. the EC Low-voltage Directive the EMC Directive
EC Directive for Machinery through conformity standards

With these marks, the manufacturer demonstrates conformity to standards in aspects relevant
to safety and EMC - in certain cases even more than that. The VDE Institute has verified this as
an independent institution. Furthermore, the VDE Institute makes sure that products brought
on the market continue to comply with relevant requirements.

For manufacturers holding a VDE Marks Licence it is easy to show compliance with legal
requirements in context with CE marking and EC Declaration of Conformity: The most
comprehensive part of this duty - the verification of compliance with essential protection
requirements of EC Directives as well as the compilation of the Technical Documentation
necessary in this context - is already covered by the VDE Institute.

With the stylized sequence of letters

the manufacturer declares in his own responsibility towards national authorities that he has
observed all legal provisions applicable for his product.

CE is taken as the passport for the free flow of a product in a Europe without internal borders,
whereas the VDE Mark as well as other certification marks of the address the end user
and take care of his need for protection.

8
8 Statements of Conformity
The Marks Licence Certificates and other certificates issued by the VDE Testing
and Certification Institute include the statement of conformity with the relevant
EC Directive(s).

Example: Steam iron

Testing and Certification Institute


ZEICHENGENEHMIGUNG
MARKS LICENCE

Licence holder
(Name and address)
ist berechtigt, fr Ihr Produkt /
is authorized to use for their product

Dampfbgeleisen
Steam iron

die hier abgebildeten markenrechtlich geschtzten Prfzeichen fr die


ab Blatt 2 aufgefhrten Typen zu benutzen /
the legally protected Certification Marks as shown below for the types referred to on page 2 ff.

oder oder
or or

The Marks Licence confirms conformity


on standards and keeping the requirements of
the German Appliance Safety Law (GSG).

The Marks Licence is the basis for the


EU Declaration of Conformity and the CE Marking
issued by the manufacturer or his authorized
representative.

The Marks Licence confirms the


conformity with the mentioned standards
e.g. in line with the EU Low-voltage Directive
73/23/EEC including its amendments.

9
9 EC Declaration of Conformity
In addition to the VDE Marks Licence Certificate, the VDE Institute provides an EC
Declaration of Conformity to the manufacturer as a basis for the CE marking of his
product. Data available from the manufacturer are included in this Declaration.

Example:

EC Declaration of Conformity

Manufacturers Name
and Address:

Product:
Type designation:

The designated product is in conformity with the European Directive

89/336/EEC
including amendments

"Council Directive on the approximation of the laws of the


Member States relating to electromagnetic compatibility".

Full compliance with the standards listed below proves the conformity of the designated
product with the provisions of the EC Directive:

European standard National standard VDE classification

The VDE Testing and Certification Institute, Merianstr.28,


D-63069 Offenbach, has tested and certifiziert the product granting
the VDE Marks Licence for the mark(s) as displayed.

VDE Marks Licence:


VDE Reference No.

_________________________ ________________________________ __
(Place, Date) (Legally binding signature of the issuer)

Issuers address:
(if different from manufacturer)

10
10 Testing and Certification by the VDE Institute

Services you can trust


The VDE Testing and Certification Institute is accredited on national and international level
and notified for the EU Single Market under the EU Identification No. 0366 for the areas of
testing and certification of electrotechnical equipment, components and systems. Such
products are tested for safety, electromagnetic compatibility and other product characteristics.

Testing areas
n Lighting
n Electronics
n Information technology
n Industrial and medical technologies
n Appliances and systems for house and commercial use
n Installation technology
n electrical and electronic components
n Cables and cords
n Material testing
n Special testing
n EMC testing

The VDE Institute offers:


n Testing for VDE Marks Licences with subsequent periodic factory inspection and
product surveillance.
n Testing for EC Type-examination Certificates
n Assessment of technical documentation in the frame of EC Directives
n Safety analyses / risk assessment
n Expertise and opinions

Support in context with EC Declaration of Conformity


Together with the VDE Marks Licence Certificate, the VDE Institute issues documents forming
the basis of CE marking as well as an EC Declaration of Conformity ready for signing.

Global Service
The VDE Institute as recognized neutral and independent institution serving science and
accident prevention is ready to face the increasing challenges of international testing and
certification activities. Cooperation agreements with institutions in many countries around the
globe allow the recognition of VDE test reports. National approvals for other countries can be
obtained easily.

A mark known to consumers


66 % of the population know the VDE Mark. A further result of the recent survey is the fact that
78 % appreciate neutral safety testing. For the majority, the VDE Mark is a significant criterion
for the buying decision.

11
11 Certification with VDE Certification Marks
and VDE-Register-Number

A
Mark Name Application

VDE Mark Appliances as technical equipment


according to the Appliance Safety
Law (GSG), Medical devices
according to the Medical Products
Law (MPG), components and
installation materials

VDE GS Mark Appliances as technical equipment

I
(for heights up to 20mm) (more than 20mm)
according to the GSG

VDE Cable Mark Cables and insulated cords as well


as conduits and ducts

L VDE Identification Cables and insulated cords

M
Thread

VDE HARmonization Cables and insulated cords acc. to the


Marking HAR certification procedure

VDE HARmonization Cables and insulated cords acc. to the


Thread HAR certification procedure

D
VDE EMC Mark Electrotechnical products, which comply
with the standards for electromagnetic
compatibility (EMC; German "EMV";
emission and immunity)

E CECC Mark Electronic components according to

F
CECC Specifications

ENEC Mark of the Electrotechnical products according to


VDE the ENEC certification procedure

B
VDE-Register-Nr. VDE Certificate of Conformity in conjunc-
tion with factory surveillance for electro-
technical products

REG.-Nr. XXXX

12
ASSOCIATION FOR ELECTRICAL, ELECTRONIC & INFORMATION TECHNNOLOGIES
Testing and Certification Institute Merianstrae 28 D-63069 Offenbach Phone +49 69 8306-0 Fax +49 69 8306-555 e-mail: [email protected]
Nachdruck, auch auszugsweise, nur mit Genehmigung des VDE Prf- und Zertifizierungsinstituts / copyright reserved

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