| | Q: What is a Technical Construction File?
A: A Technical Construction File (TCF) is a loose-leaf document containing all relevant information to the compliance of the product. The file contains, among other things, the technical rationale for the test methods chosen, the product’s design details including designed-in EMC, test results and the declaration of conformity. The TCF also needs to be checked and signed off by a Competent Body and a certificate issued, and must be made available for a period of ten years. |
| | Q: What is a Declaration of Conformity?
A: A Declaration of Conformity (DoC) is a standardized document used to summarize the details of the apparatus' compliance. The manufacturer is required to issue the DoC and is responsible for it's content. All other third party references and signatures have no legal standing. You must hold your DoC "at the disposal of the Competent Authority" for ten years after the product enters the market. |
| | Q: What should be in a Technical Construction File?
A: As well as general product information, procedures used to ensure comformity should be included. These can be- technical rationale, details of significant design elements, test evidence. And also a Notified / Competent Body report. |
| | Q: What should be in a Declaration of Conformity?
A: Name and address of manufacturer (and agent), Name of Product, Name and number of directive, Standards used or TCF, Signature and date. |
| | Q: What is pre-compliance testing and how can it benefit our company?
A: The role of pre-compliance testing is to provide an early indication of whether equipment is likely to meet the requirements when full testing is carried out. It acts as a good guide to how close the product is to passing, without being too costly. |
| | Q: If my equipment fails a test and is modified, is it necessary to repeat all the tests?
A: This is a commercial issue. To be totally confident, testing should be carried out with the equipment in a final, production state. However if the modification is small, Engineering judgement could be used to decide whether further testing in necessary. |
| | Q: Can I relate the test results from one product to a range of similar products?
A: Generally the answer is yes, depending upon how similar the products are. The mechanism is called "Type Approval" with the principle being to show the worst case model passes, and thus all similar products should also pass comfortably. |
