PED CE Marking
Pressure Equipment Directive (97/23/EC) is applicable to all those equipment which have an internal design pressure more than 1.5 bar. Design pressure is generally greater than maximum operating pressure.
Steps to get CE Certification
The process to get PED CE marking certification for pressure equipment includes following steps:
Identify harmonised standard for your product
Do the design calculation as per applicable EN standard
Qualify your welders and WPS as per applicable EN standard – for e.g. EN 287-1 from a Notified Body under PED
Raw material test certificates as per EN 10204
NDT inspector should be qualified as per ISO 9712
Apply for Audit from Notified Body
CE in Electronics/Electrical
Generally all three directives are applicable together especially in case of involvement of electronic components in the product.
It is mandatory to test your product according to applicable harmonised standards. While testing against EMC and RoHS directive is generally done against generic standards, the LVD directive however, generally requires testing as per product specific standards.
It is a good idea to get your product tested from a ISO 17025 accredited lab as Notified Body and importers in general are not really convinced by a simple DoC and really need more proof of compliance.
Put a WEEE logo on the product and make sure that your importer/distributor in Europe is registered with a producer compliance scheme.
Make sure that you declare the weight of your Electrical and Electronic product free from packaging and keep records of how much have you sent to which country. Make sure that the product is packed in compliance with the Packaging Directive (94/62/EC).
CE Mark for Medical Device
Medical Device Directive is one of the most complex directive and one which involves strict vigilance by the European Authorities. Steps to get CE mark for medical device of Class 1s, IIa, IIb and III are as follows:
Implement a quality management system ISO 13485:2012 as per annex II & V of MDD (not required for class I non sterile non measuring devices).
Appoint an European authorized representative (required by non EU manufacturer only).
Apply General & product specific standards as applicable to the medical device particularly Bio-compatibility ( ISO 10993 series for Implants and IEC 60601 series for Electromedical products).
Prepare a technical file comprising of detailed manufacturing process, devices description, test reports, risk analysis, Instruction for Use, labeling, applicable standards etc.
Submit the technical file & QMS documents to notified body for approval.
Notified Body conducts onsite audit through approved auditors.
Translate IFUs & labels to the local language of the country to which you want to export.
EMC Testing Services from an ISO 17025 accredited laboratory
We undertake professional testing services under a controlled environment for the following EMC testing in just
ESD (Electro Static Discharge) Immunity Testing as per EN/IEC 61000-4-2 (up to 30 kV)
Electric Fast Transient (Burst) Test as per EN/IEC 61000-4-4
Surge Immunity Test as per EN/IEC 61000-4-5 (up to 4.4 kV)
Voltage dip and short variation as per EN /IEC 61000-4-11
Limits of harmonic current emission testing as per EN/IEC 61000-3-2 (up to 1 kVA or 16 A)
Limitation for Voltage Fluctuation and Flicker as per EN/IEC 61000-3-3
Power Frequency Magnetic Field Immunity Test as per EN/IEC 61000-4-8
We undertake the following tests for additional 750 USD in anechoic chamber (3 meter)
Immunity to conducted disturbances, induced radio-frequency fields as per EN/IEC 61000-4-6
Radiated radio-frequency electromagnetic field immunity test as per EN/IEC 61000-4-3
Pressure Equipment Directive (97/23/EC) is applicable to all those equipment which have an internal design pressure more than 1.5 bar. Design pressure is generally greater than maximum operating pressure.
Steps to get CE Certification
The process to get PED CE marking certification for pressure equipment includes following steps:
Identify harmonised standard for your product
Do the design calculation as per applicable EN standard
Qualify your welders and WPS as per applicable EN standard – for e.g. EN 287-1 from a Notified Body under PED
Raw material test certificates as per EN 10204
NDT inspector should be qualified as per ISO 9712
Apply for Audit from Notified Body
CE in Electronics/Electrical
Generally all three directives are applicable together especially in case of involvement of electronic components in the product.
It is mandatory to test your product according to applicable harmonised standards. While testing against EMC and RoHS directive is generally done against generic standards, the LVD directive however, generally requires testing as per product specific standards.
It is a good idea to get your product tested from a ISO 17025 accredited lab as Notified Body and importers in general are not really convinced by a simple DoC and really need more proof of compliance.
Put a WEEE logo on the product and make sure that your importer/distributor in Europe is registered with a producer compliance scheme.
Make sure that you declare the weight of your Electrical and Electronic product free from packaging and keep records of how much have you sent to which country. Make sure that the product is packed in compliance with the Packaging Directive (94/62/EC).
CE Mark for Medical Device
Medical Device Directive is one of the most complex directive and one which involves strict vigilance by the European Authorities. Steps to get CE mark for medical device of Class 1s, IIa, IIb and III are as follows:
Implement a quality management system ISO 13485:2012 as per annex II & V of MDD (not required for class I non sterile non measuring devices).
Appoint an European authorized representative (required by non EU manufacturer only).
Apply General & product specific standards as applicable to the medical device particularly Bio-compatibility ( ISO 10993 series for Implants and IEC 60601 series for Electromedical products).
Prepare a technical file comprising of detailed manufacturing process, devices description, test reports, risk analysis, Instruction for Use, labeling, applicable standards etc.
Submit the technical file & QMS documents to notified body for approval.
Notified Body conducts onsite audit through approved auditors.
Translate IFUs & labels to the local language of the country to which you want to export.
EMC Testing Services from an ISO 17025 accredited laboratory
We undertake professional testing services under a controlled environment for the following EMC testing in just
ESD (Electro Static Discharge) Immunity Testing as per EN/IEC 61000-4-2 (up to 30 kV)
Electric Fast Transient (Burst) Test as per EN/IEC 61000-4-4
Surge Immunity Test as per EN/IEC 61000-4-5 (up to 4.4 kV)
Voltage dip and short variation as per EN /IEC 61000-4-11
Limits of harmonic current emission testing as per EN/IEC 61000-3-2 (up to 1 kVA or 16 A)
Limitation for Voltage Fluctuation and Flicker as per EN/IEC 61000-3-3
Power Frequency Magnetic Field Immunity Test as per EN/IEC 61000-4-8
We undertake the following tests for additional 750 USD in anechoic chamber (3 meter)
Immunity to conducted disturbances, induced radio-frequency fields as per EN/IEC 61000-4-6
Radiated radio-frequency electromagnetic field immunity test as per EN/IEC 61000-4-3
