Revision of ATEX harmonised standards

The EN50014 series of standards has been the backbone of ATEX compliance for many years. However, by the end of 2008 most of the series will have been superseded by standards from the EN60079 series and will be withdrawn.

Once withdrawn, these standards will be removed from the EU list of harmonised standards and will no longer provide a presumption of conformity for the purposes of CE marking. However, this presents a potential problem for holders of ATEX EC Type Examination certificates to these withdrawn standards.

What should manufacturers’ do in this situation?

According to (the revised) section 10.3 of the ATEX Guidelines, it is the responsibility of the manufacturer to determine whether or not changes in the "state of the art" reflected in revisions of harmonised standards apply to their equipment.  The ATEX Notified Bodies have responsibilities to provide information to assist the manufacturer to make this decision. The contents of the Declaration of Conformity remain the responsibility of the manufacturer. All manufacturers with EC Type Examination Certificates citing withdrawn standards should review their equipment against the requirements of the new standard.

A "state of the art" change would include the situation where new tests or more severe interpretations of existing tests are introduced in the new edition of the harmonised standard. The EU Commission now requires CEN and CENELEC to indicate in future standards where a "state of the art" change has been implemented. However this requirement has not yet impacted the current generation of standards.

Plan of action

• Review all EC Type Examination certificates and determine if more arduous tests or requirements have been introduced.

• If more arduous tests or requirements have not been introduced then a change is required to the Declaration of Conformity.

• If more arduous tests or requirements have been introduced then re-testing is required by Notified Body.

Examples

According to the manufacturer’s decision as to whether or not changes in the "state of the art" are relevant, the following three cases relating to EC Type Examination Certificates are particularly foreseen, although other outcomes may be possible:

Case 1:  Equipment certified to earlier standards where there is not considered to be a relevant modification to "state of the art".

• The review of the standards has identified that there have been no changes that bring in more onerous requirements.

• The manufacturer continues to use their existing certificate because it is still considered to demonstrate compliance with the Essential Health and Safety Requirements (EHSRs) of the Directive.

• The EC Type Examination Certificate and the marking of equipment are not modified (for standards in the EN 50014 series, the marking remains ”EEx” as the equipment does not necessarily comply with the standards EN 60079-0, etc.)

• Because the standards listed in the EC Type Examination Certificate are no longer harmonised (and therefore have lost their automatic presumption of conformity with the EHSRs) it is necessary for the manufacturer to record the correct (changed) status of the standards in their Declaration of Conformity (e.g. add a statement under the harmonised standards section that explains that a review has been undertaken and that no changes affecting the EHSRs were identified).

• Justification for fulfilling the EHSR is required within the ATEX technical documentation file. For example, this may take the form of a statement (if correct) that the revised (now harmonised) standards have been compared to the standards used for certification purposes and that no changes in the “state of the art” apply to the equipment.

• Note: Under the situation of Case 1, the manufacturer also has the option of following the methodology of Case 2 or Case 3, if they so choose.

Case 2:  Equipment certified to earlier standards where there is considered to be a relevant modification to "state of the art".

• The review of the standards has identified that there have been minor changes that bring in more onerous requirements.

• The manufacturer cannot continue to use the existing EC Type Examination Certificate without modification as the basis for a Declaration of Conformity, as it no longer can be considered to confirm compliance with the EHSRs of the Directive.

• The manufacturer engages a Notified Body to carry out all examination and tests according to the revised standards which are different from the standards mentioned on the existing EC Type Examination Certificate.  Upon confirming compliance, the Notified Body issues a variation to the existing EC Type Examination Certificate, confirming compliance with relevant parts of the new harmonised standards.  (In the case of change from the 50014 series of standards to EN 60079-0, etc., the marking may also change from “EEx” to “Ex”.)

• The EC Declaration of Conformity, the instructions and the marking are updated to show compliance with the new harmonised standards alongside the earlier standards.

• Case 2 would normally be followed if the manufacturer requests consideration by the Notified Body of a small technical change to the equipment.

• Under the situation of Case 2, the manufacturer also has the option of following the methodology of Case 3, if he so chooses.

Case 3:  Equipment certified to earlier standards where there is considered to be a substantial relevant modification to "state of the art".

• The review of the standards has identified that there have been significant changes that bring in more onerous requirements.

• The manufacturer cannot continue to use the existing EC Type Examination Certificate without modification as the basis for a Declaration of Conformity, as it no longer can be considered to confirm compliance with the EHSRs of the Directive.

• The manufacturer engages a Notified Body to carry out all examination and tests according to the revised standards which are different from the standards mentioned on the existing EC Type Examination Certificate.  Upon confirming compliance, the Notified Body issues a new EC Type Examination Certificate, confirming compliance with the new harmonised standards.

• The EC Declaration of Conformity, the instructions and the marking shall be updated to refer only to the new standards and the new EC-Type Examination Certificate.