Glossary entry (derived from question below)
French term or phrase:
Certificat d’ensemble CE
English translation:
CE marking assembly certificate
Added to glossary by
jethro
Oct 31, 2023 19:30
7 mos ago
23 viewers *
French term
Certificat d’ensemble CE
French to English
Tech/Engineering
Electronics / Elect Eng
Help please. would this be a combined certificate (CE) in the context of electrical installations?
Proposed translations
(English)
4 | CE marking assembly certificate | José Julián Díaz |
References
There is no CE Certification | Johannes Gleim |
Proposed translations
8 days
Selected
CE marking assembly certificate
CE marking – obtaining the certificate, EU requirements
https://europa.eu/youreurope/business/product-requirements/l...
Electrical products intended for Zone 0 and Zone 1 installations still require testing by a third party and a documented quality system by the manufacturer. This implies that Zone 2 material does not have to undergo third party testing and approvals, but can be self‐certified by the manufacturer. The CE mark is a manufacturers self declaration that the products meet a standard. It is not an approval and is only required in the European market.
https://www.sourceiex.com/Catalogs/Chapter 4 CE Marking.pdf
https://europa.eu/youreurope/business/product-requirements/l...
Electrical products intended for Zone 0 and Zone 1 installations still require testing by a third party and a documented quality system by the manufacturer. This implies that Zone 2 material does not have to undergo third party testing and approvals, but can be self‐certified by the manufacturer. The CE mark is a manufacturers self declaration that the products meet a standard. It is not an approval and is only required in the European market.
https://www.sourceiex.com/Catalogs/Chapter 4 CE Marking.pdf
Note from asker:
Thanks a lot. |
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Comment: "Thanks a lot."
Reference comments
21 hrs
Reference:
There is no CE Certification
There is no CE certificate, but a CE marking as a self-declaration, which the manufacturer affixes on his own responsibility, thus also no Certificat d'ensemble CE.
However, the manufacturer must ensure that the appliance and all its components comply with the applicable EU directives and the standards referred to therein. Only in the case of equipment groups specified in the directives must the equipment be tested by a notified body, which then issues a corresponding certificate or approval (as called in USA or Canada).
Note: I myself was tester and inspector in 2 notified bodies.
The CE‐marking of an assembly represents a declaration by the manufacturer (or his authorized representative in the EU, in the case of products imported into Europe) that it complies with the essential requirements of all Directives relevant to assemblies.
:
The CE mark is a manufacturers self-declaration that the products meet a standard. It is not an approval and is only required in the European market.
https://www.sourceiex.com/Catalogs/Chapter 4 CE Marking.pdf
Originally CE stood for Communauté Européenne (European Community) later for Conformité Européenne. With the CE mark a manufacturer expresses conformity with the European legislation, specifically with European directives and European regulations.
For of medical devices there are (or have been) the Medical Device Directive MDD, the Active Implantable Medical Device Directive AIMDD and the In-vitro Device Directive IVDD.
These directives are going to be replaced by the Medical Device Regulation MDR and the In-vitro Device Regulation IVDR. The manufacturers still declare conformity and affix the CE mark (sometimes also referred to as "CE label") themselves.
:
For class I devices the manufacturer does not have to involve any external party such as a notified body. In this case they affixes the CE mark with no number.
For all the other classes it is mandatory to involve a notified body. The CE mark must bear the notified body's number.
There is no CE Certification.
https://www.johner-institute.com/articles/regulatory-affairs...
CE marking indicates that a product has been assessed by the manufacturer and deemed to meet EU safety, health and environmental protection requirements.
:
As the product's manufacturer, you bear sole responsibility for declaring conformity with all requirements. You don't need a license to affix the CE marking to your product, however, before doing so, you must:
• ensure conformity with all relevant EU-wide requirements
• determine whether you can assess your product by yourself or if you have to involve a notified body
• put together a technical dossier documenting conformity: find out about technical documentation
• draft and sign an EU declaration of conformity
:
You need to check if your product has to be tested by a notified body.
This step is not obligatory for all products.
If you need to involve a notified body, the CE marking must be accompanied by the identification number of the notified body.
https://europa.eu/youreurope/business/product-requirements/l...
However, the manufacturer must ensure that the appliance and all its components comply with the applicable EU directives and the standards referred to therein. Only in the case of equipment groups specified in the directives must the equipment be tested by a notified body, which then issues a corresponding certificate or approval (as called in USA or Canada).
Note: I myself was tester and inspector in 2 notified bodies.
The CE‐marking of an assembly represents a declaration by the manufacturer (or his authorized representative in the EU, in the case of products imported into Europe) that it complies with the essential requirements of all Directives relevant to assemblies.
:
The CE mark is a manufacturers self-declaration that the products meet a standard. It is not an approval and is only required in the European market.
https://www.sourceiex.com/Catalogs/Chapter 4 CE Marking.pdf
Originally CE stood for Communauté Européenne (European Community) later for Conformité Européenne. With the CE mark a manufacturer expresses conformity with the European legislation, specifically with European directives and European regulations.
For of medical devices there are (or have been) the Medical Device Directive MDD, the Active Implantable Medical Device Directive AIMDD and the In-vitro Device Directive IVDD.
These directives are going to be replaced by the Medical Device Regulation MDR and the In-vitro Device Regulation IVDR. The manufacturers still declare conformity and affix the CE mark (sometimes also referred to as "CE label") themselves.
:
For class I devices the manufacturer does not have to involve any external party such as a notified body. In this case they affixes the CE mark with no number.
For all the other classes it is mandatory to involve a notified body. The CE mark must bear the notified body's number.
There is no CE Certification.
https://www.johner-institute.com/articles/regulatory-affairs...
CE marking indicates that a product has been assessed by the manufacturer and deemed to meet EU safety, health and environmental protection requirements.
:
As the product's manufacturer, you bear sole responsibility for declaring conformity with all requirements. You don't need a license to affix the CE marking to your product, however, before doing so, you must:
• ensure conformity with all relevant EU-wide requirements
• determine whether you can assess your product by yourself or if you have to involve a notified body
• put together a technical dossier documenting conformity: find out about technical documentation
• draft and sign an EU declaration of conformity
:
You need to check if your product has to be tested by a notified body.
This step is not obligatory for all products.
If you need to involve a notified body, the CE marking must be accompanied by the identification number of the notified body.
https://europa.eu/youreurope/business/product-requirements/l...
Discussion
Therefore, please provide the following information:
1) What type of equipment or installation is it?
2) Is there a number next to the CE mark?
3) Has the device or system been tested by a notified body?
4) Has this body confirmed that all relevant directives and standards have been complied with?
Only after all questions have been answered it can be assessed whether the term refers to a test certificate or to a manufacturer's declaration.
Juste une hypothèse, sans plus de contexte, la signification du CE semble être celle qui a été indiquée, et le « Certificat d’ensemble » pourrait peut-être lié à une directive (ATEX, MID, ...) et dans ce cas dans votre contexte pourrait être utilisé pour le distinguer clairement d'un certificat de partie par exemple.
Au cas où ça pourrait être utile (exemple p.8 certificat de partie)
https://www.welmec.org/welmec/documents/guides/8.8/welmec_Gu...
https://www.welmec.org/welmec/documents/guides/8.8/2017/WELM...
MID:
https://france.apave.com/News/News/Decouvrez-la-Norme-MID-po...
https://www.lne.fr/fr/service/certification/instrumentation-...
https://www.welmec.org/guides-and-publications/guides#panel-...
ATEX:
https://prestations.ineris.fr/fr/certification/appareils-ate...
As anyone will be able to tell you (if you disregard the blithering nonsense to be found here, https://www.proz.com/kudoz/french-to-english/law-patents/363... , for example), CE in an electrical context in 99% of cases means "conformité européenne", i.e. "European compliance".
Tony M, from here, is the guru and oracle for all things electrical and electronic. Maybe wait for the oracle to pronounce.