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The type approval provides the proof that the product meets the requirements of the relevant product standards and can be used in the specified range of operation. It can be used as a basis for the producer's CE declaration of conformity, as all relevant European Directives (at least low voltage- and emc-directives) necessary for the proof of conformity have been applied.
Because of the complexity of todays devices these tests are carried out parallel to product development. The testing authority already cooperates with the manufacturer during the product specification and conception phases. This is an important advantage to the manufacturer, to streamline his development efforts.
An according type approval is structured in the following phases:
- Concept Inspection
- Main Inspection
- Certification
During phase 1, the so-called Concept Inspection, the product specification and the design and safety concept are examined, whether the requirements of the relevant standards have been followed and whether the safety concept meets the requirements of functional safety according to the required safety level. A failure effect analysis on structure and functional block level is carried out to determine whether the necessary measures for failure detection and control are included.
If necessary, an estimation is made, whether the quantitative numbers (HFT, SFF, PFD, PFH) according to IEC 61508 are achieved.
The Concept Inspection also assesses, whether all requirements concerning failure avoidance (quality assurance) are included in accordance with the required efficiency.
The Concept Review concludes the Concept Inspection with a statement concerning the principle qualification of the realization concept.
During the Main Inspection all safety-related functions of the product are verified and analyzed. According to the desired safety level a detailed FMEA (failure mode and effects analysis) is made, which includes not only the failure at internal compnents but also the external circuit wiring as well as conscious and unconscious faulty operation and use. The behavior of the product under these abnormal conditions is analyzed.
Further tests:
- Calculation of quantitative numbers acc. to IEC 61508, that have to be met for a safety integrity level
- Climatic, mechanical and electric test for environmental acceptability
- Electric safety and equipment
- Assessment of intended measures for failure avoidance (quality assurance) covering the product's total life cycle
- Inspection and evaluation of product documentation, especially of Installation and Operating Instructions and the Safety Manual.
The Main Inspection concludes with a final test report.
After the successful conclusion of the Main Inspection the 3rd phase follows, in which the Certification of the product is implemented.
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