Type Documentation

Technical type documentation serves as the basis for product conformity assessment. Where applicable, it includes the following points:

a general description of the product (including all variations, if any),
design and manufacturing drawings and diagrams,
explanations necessary for understanding the aforementioned drawings and diagrams,
a list of the essential health and safety requirements taken into account,
a list of the harmonized standards applied in full or in part, the references of which have been published in the Official Journal of the European Union, and where those harmonized standards have not been applied, descriptions of the solutions adopted to meet the essential health and safety requirements of the Directive, including a list of other relevant technical specifications applied; in the case of partly applied harmonized standards, the technical documentation shall specify the parts which have been applied,
results of design calculations performed by or for the manufacturer,
a copy of the operating instructions,
a risk assessment with analysis,
a sample declaration of conformity,
measures taken to ensure that the series-manufactured product is in conformity with the essential health and safety requirements.