In the absence of harmonized standards, the manufacturer shall refer to an existing document (draft standard candidate for harmonization, professional document, guide, recognised third party/notified body document, company document, etc.) or shall establish a specific document.
Such a document shall define at least:
- equipment to be used by the personnel;
- degree of automatization of the process and the operations to be carried out by the personnel;
- conditions to apply when making the test piece to be used for the test approval and results to be achieved;
- range of validity and conditions for the duration of the validity.
See also PED Guideline F-01.
For welding, see PED Guideline F-12.