s**********8
发帖数: 25265 | 1 The CE markCE marking (also known as CE mark) is a mandatory conformance
mark on many products placed on the market in the European Economic Area (
EEA). With the CE marking on a product the manufacturer ensures that the
product is in conformity with the essential requirements of the applicable
EC directives.[1] The letters "CE" stand for "Conformité Européenne" ("
European Conformity").[2]
Contents [hide]
1 Meaning
2 Countries requiring the CE marking
3 Rules underlying CE marking
4 Self-certification
5 Declaration of conformity
6 Product groups
7 Mutual recognition of conformity assessment
8 Characteristics of the CE marking
9 Dimensions
10 The e mark
11 Misuse
11.1 China Export
11.2 Legal implications
12 See also
13 References
14 External links
[edit] MeaningExisting in its present form since 1993, the CE marking is a
key indicator of a product’s compliance with EU legislation and enables the
free movement of products within the European market. By affixing the CE
marking on a product, a manufacturer is declaring, on ones sole
responsibility, conformity with all of the legal requirements to achieve CE
marking and therefore ensuring validity for that product to be sold
throughout the European Economic Area. This also applies to products made in
third countries which are sold in the EEA.[3]
CE marking does not indicate that a product was made in the EEA,[4] but
merely states that the product is assessed before being placed on the market
and thus satisfies the legislative requirements (e.g. a harmonised level of
safety) to be sold there. It means that the manufacturer has verified that
the product complies with all relevant “essential requirements” (e.g.
safety, health, environmental protection requirements) of the applicable
directive(s) – or, if stipulated in the directive(s), had it examined by a
notified conformity assessment body.
However, not all products must bear the CE marking. Only those product
categories subject to specific directives that provide for the CE marking
are required to be CE marked. CE marked products are bought not only by
professionals (e.g. medical devices, lifts, machinery and measuring
equipment) but also by consumers (toys, PCs, mobile phones and light bulbs).
[edit] Countries requiring the CE markingThe CE marking is mandatory for
certain product groups in the European Economic Area (EEA), consisting of
the 27 Member States of the EU and EFTA countries Iceland, Norway,
Switzerland and Liechtenstein. It is also obligatory for all products made
in third countries (non-member states) which are sold in the EEA. In that
case, the importer has to make sure that the manufacturer outside the EU has
taken the necessary steps that allow him to affix the CE marking.[5]
It is still not required within the member countries of the Central European
Free Trade Agreement (CEFTA), although some of them (Republic of Macedonia,
Croatia, Serbia, Montenegro) are official candidates for membership to the
European Union, and are already adopting many of its standards within their
legislation (like most of the former Central European countries that were
members of CEFTA before joining the EU).
[edit] Rules underlying CE markingThe manufacturer of a product himself
affixes the CE marking to it, but has to take certain obligatory steps
before the product can bear CE marking. He has to carry out a conformity
assessment, set up a technical file and sign an EC declaration of conformity
. The documentation has to be made available to authorities on request.
Importers of products have to verify that the manufacturer outside the EU
has undertaken the necessary steps and that the documentation is available
upon request. Importers should also make sure that contact with the
manufacturer can always be established.
Distributors must be able to demonstrate to national authorities that they
have acted with due care and must have affirmation from the manufacturer or
importer that the necessary measures have been taken.
If importer or distributor market the products under their own name, they
then take over the manufacturer’s responsibilities. In this case they must
have sufficient information on the design and production of the product, as
they will be assuming the legal responsibility when they affix the CE
marking.
There are certain rules underlying the procedure to affix the marking:
Products that are subject to certain EC directives providing for CE marking,
have to be affixed with the CE marking before they can be placed on the
market
Manufacturers have to check on their sole responsibility, which EU
directives they need to apply for their products
The product may only be placed on the market if it complies with the
provisions of all applicable directives and if the conformity assessment
procedure has been carried out accordingly
The manufacturer draws up an EC declaration of conformity and affixes the CE
marking on the product
If stipulated in the directive(s), an authorized third party (Notified Body)
must be involved in the conformity assessment procedure
If the CE marking is affixed on a product, it can only bear additional
markings under the condition that they are of different significance, do not
overlap with the CE marking and are neither confusing nor impairing the
legibility and visibility of the CE marking
[edit] Self-certificationDepending on the level of risk of the product, the
CE Mark is affixed to a product by the manufacturer or authorized
representative who decides whether the product meets all the CE mark
requirements.[6] If a product has minimal risk it can be self certified
where the manufacturer prepares a Declaration of Conformity and affixes the
CE Marking to their own product. In doing this the manufacturer has to do
several things[7]:
1. Decide whether the product needs to have a CE mark and if the product
applies to more than 1 directive it needs to comply with all of them.
2. Choose the conformity assessment procedure from the modules called out by
the directive for the product. There are several modules available for the
Conformity Assessment Procedures as listed below:
Module A – Internal production control.
Module A – Intervention of a Notified Body.
Module B – EC type-examination.
Module C – Conformity to type.
Module D – Production quality assurance.
Module E – Product quality assurance.
Module F – Product verification.
Module G – Unit verification.
Module H – Full quality assurance.
These will often ask questions about the product to classify the level of
risk and then refer to the "Conformity Assessment Procedures" chart. This
shows all the acceptable options available to a manufacturer to certify the
product and affix the CE mark.
Products which are considered to have a greater risk have to be
independently certified by a notified body. This is an organization that has
been nominated by a Member Government and has been notified by the European
Commission. These notified bodies act as test labs and carry out the steps
as listed in the directives mentioned above and then decided whether the
product has passed. A manufacturer can choose their own notified body in any
member state of the European Union but should be independent of the
manufacturer and a private sector organization or a government agency[8].
[edit] Declaration of conformityThe DoC must include: manufacturer's details
(name and address, etc.); essential characteristics the product complies;
any European standards and performance data; if relevant the identification
number of the Notified Body; and a legally binding signature on behalf of
the organization.
[edit] Product groupsThe EC directives for CE marking[9] affect the
following product groups:
Active implantable medical devices
Appliances burning gaseous fuels
Cableway installations designed to carry persons
Eco-design of energy related products
Electromagnetic compatibility
Equipment and protective systems intended for use potentially explosive
atmospheres
Explosives for civil uses
Hot-water boilers
In vitro diagnostic medical devices
Lifts
Low voltage
Machinery
Measuring Instruments
Medical devices
Noise emission in the environment
Non-automatic weighing instruments
Personal protective equipment
Pressure equipment
Pyrotechnics
Radio and telecommunications terminal equipment
Recreational craft
Safety of toys
Simple pressure vessels
[edit] Mutual recognition of conformity assessmentThere are numerous '
Agreements on Mutual Recognition of Conformity Assessment' between the
European Union and other countries such as the USA, Japan, Canada, Australia
, New Zealand and Israel. Consequently the CE mark is now found on many
products from these countries.
Turkey (which is not a member of the EEA) also requires products to show CE
marking as affirmation of conformity.
[edit] Characteristics of the CE markingThe CE marking has to be affixed by
the manufacturer or its authorized representative in the European Community
according to its legal format visibly, legibly and indelibly to the product
The size of the CE marking must be at least 5 mm, if enlarged its
proportions have to be kept
If the appearance and workmanship of a product do not allow for the CE
marking to be affixed on the product itself, the marking has to be affixed
to its packaging or accompanying documents
If a directive requires the involvement of a Notified Body in the conformity
assessment procedure, its identification number has to be put behind the CE
marking. This is done under the responsibility of the Notified Body.[10]
[edit] DimensionsThe CE logo must be at least 5 mm high (This minimum is
waived for small-scale equipment/machinery (e.g. spectacles) and where it
cannot be placed on the product itself, it must be placed on the packaging (
e.g. contact lens solution). The letters "CE" are not enough. The logo must
not be modified.
[edit] The e markThe similar "e mark", rather than the CE logo, is used on
motor vehicles and electronic components used in motor vehicles.[11]
(The "e mark" for motor vehicles is not to be confused with the estimated
sign on food labels.[12])
[edit] Misuse
Proximal location of CE mark and Made in China textThe European Commission
is aware that CE marking, like any other mark, is misused. CE marking may
sometimes be affixed to products which do not fulfil the requirements and
conditions for its affixing or it is affixed to products for which the
affixing is not foreseen. There are also cases where, whilst the product is
in compliance with the applicable requirements the CE marking itself does
not respect the formal requirements, namely the form of the CE marking or
the dimensions and proportions prescribed in the legislation.[13]
[edit] China ExportThe CE symbol has been alleged or believed to stand for
China Export or China Electronics because some Chinese manufacturers apply a
very similar marking to their products.[14][15] As Chinese exporters have
used the CE logo incorrectly, the matter was raised at the EU parliament in
2008,[16] and the Commission responded that they will look into trade-
marking the logo, and are in discussion with Chinese authorities to ensure
compliance with European standards.[17]
[edit] Legal implicationsThere are mechanisms in place to ensure that the CE
marking is put on products correctly. Controlling CE marked products is the
responsibility of public authorities in the Member States, in cooperation
with the European Commission. Citizens may contact national market
surveillance authorities if the misuse of the CE marking is suspected, or if
a product’s safety is questioned.
The procedures, measures and sanctions applying to counterfeiting of the CE
marking vary according to the respective Member State's national
administrative and penal law. Depending on the seriousness of the crime,
economic operators may be liable to a fine and in some circumstances,
imprisonment. However, if the product is not regarded as an imminent safety
risk, the manufacturer may be given a second opportunity to ensure that the
product is in conformity with the applicable legislation, before being
obliged to take the product off the market.
[edit] See alsoCountry of origin
[edit] References1.^ "What does the CE marking on a product indicate?".
European Union. http://ec.europa.eu/enterprise/policies/single-market-goods/cemarking/faq/index_en.htm.
2.^ "What does CE marking stand for?". European Union Enterprise and
Industry. http://ec.europa.eu/enterprise/faq/index_en.htm#09012624859cd715.
3.^ What is CE marking
4.^ European Commission: CE marking: further information
5.^ Exporting to Europe and CE marking
6.^ http://www.ce-marking.org/what-is-ce-marking.html
7.^ http://www.ce-marking.org/how-obtain.html
8.^ http://www.ce-marking.org/EU-representative.html
9.^ "The EC directives for CE marking". CE marking Nordic AB. http://www.cemarkingnordic.se/pdf/english/what_is_ce_marking.pdf.
10.^ Council Directive 93/68/EEC of 22 July 1993 amending Directives 87/404/
EEC (simple pressure vessels), 88/378/EEC (safety of toys), 89/106/EEC (
construction products), 89/336/EEC (electromagnetic compatibility), 89/392/
EEC (machinery), 89/686/EEC (personal protective equipment), 90/384/EEC (non
-automatic weighing instruments), 90/385/EEC (active implantable medicinal
devices), 90/396/EEC (appliances burning gaseous fuels), 91/263/EEC (
telecommunications terminal equipment), 92/42/EEC (new hot-water boilers
fired with liquid or gaseous fuels) and 73/23/EEC (electrical equipment
designed for use within certain voltage limits)
11.^ Jarvis, Tim. ""e" is for Automobile Electronics". Compliance
Engineering. http://www.ce-mag.com/archive/03/ARG/jarvis.html. Retrieved 28 December 2008.
12.^ "estimated" sign for food weight/volume, information by the UK
government.
13.^ Misconception attributing CE marking the meaning ‘Chinese export’
14.^ CE China Export/Electronics (mark) ;Be Aware of the China Export mark !
!!; The CE mark; The Inquirer: Fake Chinese chargers could kill
15.^ "Chinese Export...?". www.cemarking.net. http://www.cemarking.net/chinese-export/. Retrieved 9 March 2011.
16.^ Question to EU parliament about China Export
17.^ "Answer to a written question – China Export (CE) mark feeding off the
reputation of the European Conformité européenne (CE) mark – P-5938/2007
". www.europarl.europa.eu. http://www.europarl.europa.eu/sides/getAllAnswers.do?reference=P-2007-5938&language=EN. Retrieved 9 March 2011.
[edit] External linksEuropean Commission: Blue Guide
How to reproduce the CE mark
YouTube Video What is the CE Mark/CE Marking?
http://en.wikipedia.org/wiki/CE_mark | l*****f
发帖数: 359 | 2 Good morning Captain!
I am here to learn again!
【在 s**********8 的大作中提到】
: The CE markCE marking (also known as CE mark) is a mandatory conformance
: mark on many products placed on the market in the European Economic Area (
: EEA). With the CE marking on a product the manufacturer ensures that the
: product is in conformity with the essential requirements of the applicable
: EC directives.[1] The letters "CE" stand for "Conformité Européenne" ("
: European Conformity").[2]
: Contents [hide]
: 1 Meaning
: 2 Countries requiring the CE marking
: 3 Rules underlying CE marking
| s**********8
发帖数: 25265 | 3 lol. i guess u have enough reading material today.
【在 l*****f 的大作中提到】
: Good morning Captain!
: I am here to learn again!
| l*****f
发帖数: 359 | 4 yeah looks like i can get a second degree on this medical device thing now
haha
【在 s**********8 的大作中提到】
: lol. i guess u have enough reading material today.
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