CE Certification Machinery - Machinery Safety Testing IEC Standards IEC 60204: Ed 2.1 2009
If you are looking for CE Certification service for your Machinery, Eurotech Certification Body provide onsite testing for IEC 60204 provides requirements and recommendations relating to the electrical equipment of machines so as to promote:
- Safety of persons and property
- Consistency of control response
- Ease of maintenance.
High performance is not to be obtained at the expense of the essential factors mentioned above. An example of a possible application of these requirements is a group of machines used in the production of discrete parts where a failure in such production machines or manufacturing systems or cells can have serious economic consequences.
What is CE Marking?
CE marking ( conformity European) is a trade passport for the products destined for European market. It is the mandatory conformity procedure through which every product has to pass prior to its marketing, distribution & sales in Europe.
What does CE on a product implies?
CE marking affixed onto a product verifies that the product meets as many EC directives as applicable to them.
Steps for obtaining CE mark?
The steps for obtaining CE marking are:
a) Implement QMS as per annex II & V of MDD (not required for class I non sterile non measuring devices ).
b) Appoint an European authorized representative (required by non EU manufacturers only)
c) Identify the directive applicable to the medical device(MDD 93/42/EEC, IVD 98/79/EC, AIMD 90/385/EEC)
d) Classify the medical device as per Annex IX of MDD 93/42/EEC & 2007/47/EC.
e) Classify General & product specific standards as applicable to the medical device.
f) Prepare a technical dossier of product detailing manufacturing process, devices description, test reports, risk analysis, Instruction for Use, labeling, applicable standards etc.
g) Submit the technical dossier & QMS documents to notified body for approval.
h) Audits on site of QMS and technical files by notified body.
i) Prepare a declaration of conformity (DoC)(it is a declaration by manufacturer stating that the device is an compliance with the applicable directive )
j) Affix CE mark on the medical device.
k) Translate IFUs & labels to the local language of the country to which you want to export.
l) Start distribution of CE affixed medical device in Europe.
Eurotech scope for CE certification by the following directives:
- Medical Device Directive (MDD)
- Pressure Equipment Directive (PED)
- Transportable Pressure Equipment Directive (TPED)
- Simple Pressure Vessels Directive (SPVD)
- Lift Directive (LD)
- Machinery directive (MD)
- Low Voltage Directive (LVD)
- EMC Directive
- RoHS Directive
- Active Implantable Medical Device Directive
- General Product safety (GPS)
- Construction Product Directive (CPD)
CE Marking Certification from Notified Bodies
Eurotech ACSPL representing the European Notified Bodies for various certification.
We are engaged with the following 3-4 Notified Bodies for Certification like-
1. Eurocert of Greece to providing CE certification on LVD ,PED ,SPVD, MD and lift directive as well where notified body is mandatory. And its Notified Body No. is - 1128 on EU database.
2. DEDAL of Bulgeria to providing CE Marking Certification on Construction products which come in CPR directives. And from July 2013 It became mandatory to make CE certify your product if you are exporting your product in Europe. And its Notified Body No. is - 1922 on EU database.
3. Kiwa Cermet of Italy to providing CE marking certification on Medical products. And its notified Body no. is - 0476 on EU database.
Requirements of notified body:
- Availability of personnel and required Equipment
- Independence & equality of the personnel
- Technical competence to carry out the Conformity Assessment
- To have a secrecy Policy
- To take out personal Accountability Insurance
Why Eurotech :
1) -- Well experience team of technical expert & auditors
2) -- Always meet the committed period or dead line & 100% guidance from project start to the end.
3) -- Having own NABL approved lab for Testing against IEC/EN/IS/BS standard
4) -- Most Competitive pricing
5)-- Ultimate solution for CE certification requirements.
2) -- Always meet the committed period or dead line & 100% guidance from project start to the end.
3) -- Having own NABL approved lab for Testing against IEC/EN/IS/BS standard
4) -- Most Competitive pricing
5)-- Ultimate solution for CE certification requirements.
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