§112 欧州で標準化されたATEX試験・評価報告書の最低限の内容

The term "test report" is used in a twofold way. In fact certification in scope of the Directive 2014/34/EU is based on three levels of reports: - test in a laboratory, for example the measurement of a temperature, called "test report"; - assessment to the requirements of harmonised standards, called "assessment report"; - assessment to the essential health and safety requirements of the Directive, called "assessment report", too.

Having the possibility for very different types of test reports to be issued, varying from very poor reports, hardly including any information, to test reports with detailed test and evaluation results, a standardised ATEX assessment report format enables and ensures the following goals:

a) Recognizable as an ATEX assessment report. b) Specified minimum content. c) Meeting the requirements for test reports as laid down in EN ISO/IEC 17025 and other applicable standards. d) Easy to use/integrate with existing formats currently used by all ATEX notified bodies. e) An ATEX assessment report is only issued if all applicable requirements are met and if all tests have been conducted with positive results (but still allowing waiving tests provided that the reasoning is given in the test report).

a) Recognizable as ATEX assessment report

The ATEX assessment report should be easy to identify as such by manufacturers, Ex notified/certification bodies and any other party as a genuine ATEX assessment report. Another possibility is to just require the use of the wording "ATEX assessment report" (exact wording to be agreed upon) on the cover page of the report; without the need for a standardized template for the ATEX assessment report as has been done for Annex III certificates.

b) Specified minimum content

The report shall contain a minimum amount of information that enables manufacturers to easily obtain other local/regional approvals/certificates based on the information in the report and any associated test documentation. An assessment report issued by an ATEX notified body that supports the issue of an EU-type examination shall contain:

General information about the product, type designation, applicant, manufacturer, types of protection, technical data.

Technical evaluation of the construction of the equipment. For most types of protection this can be a checklist (Yes / No / Not applicable + remarks) combined with the test documentation that specifies the construction; for intrinsic safety however a descriptive format is usually the best (if not the only) useable format. A detailed assessment narrative that confirms compliance with the standards used to support compliance with the ATEX Directive. For all aspects not covered by harmonised standards or if no standards are used, then the assessment narrative shall confirm compliance with the Directive. Since explosion safety standards are concept standards occasionally some interpretation is involved: the report should make clear how the assessment has been carried out.

Results of tests:

o details of tests carried out, relevant information about the test conditions, method and results shall be provided as part of the test report;

o details of tests that have been waived and the justification for waiving those tests (the standard EN 60079-0 calls for a justification for waiving tests) shall be part of the assessment report;

o details of tests that have been accepted from other organisations, test laboratories, etc. and a justification for accepting those tests shall be part of the assessment report. If tests are being accepted from other sources, then this should be clear, because the body that produces that data should be scrutinised. It could easily be disguised that test data from unsuitable sources had been used.

Routine tests, if any: applicable to the product and agreed upon between the manufacturer and the notified body (applicable standards are EN 80079-34 Explosive atmospheres - Part 34: Application of quality systems for Ex product manufacture (ISO/IEC 80079-34), too).

c) Requirements for reporting

An ATEX test report shall meet all requirements for the content of test reports as specified in EN ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories (ISO/IEC 17025). In practice, this should not be any problem for a notified body since all of them conduct and report testing according to EN ISO/IEC 17025. An ATEX assessment report shall meet all requirements as specified in EN ISO/IEC 17065 Conformity assessment - Requirements for bodies certifying products, processes and services (ISO/IEC 17065).

d) Easy to use and integrate by notified bodies

It should be easy to integrate the European standardized ATEX assessment report in the operational procedures and documents used by a notified body. This requires that the format itself should not be 100% specified in detail, but only to the extent that all parties involved – issuing and receiving notified bodies and manufacturers – know what to find in the test report. So the focus is on the content of the report, not its layout, numbering, etc. This should make it easy to implement the ATEX assessment report in the existing way of working of all individual notified bodies. It should not cause a significant increase (if any) in the costs for the manufacturer to obtain an ATEX certificate.

e) Full report

To avoid any confusion about the expected content of an ATEX assessment report, such a report should only be issued when the product involved meets all applicable requirements and has passed all applicable tests with positive results. An ATEX Assessment Report shall not be issued in case of any negative results or in case that only a part of the applicable requirements (for example IP54 requirements) have been evaluated or tested. This does not preclude the issuance of an ATEX assessment report for an Ex component, certified under a "U" certificate.

If a report with negative results or not fully assessed applicable requirements is given to the manufacturer is must be unambiguous that this is not an ATEX assessment report.