Radiological Hazards Information for Safe use - Guidelines for Manufacturers

Publication Date: Nov 18th, 2019 19:45, Category: EFOMP Announcements

A document has been developed jointly by COCIR, EFOMP and ESTRO to meet the requirements of article 78.2 of the BSS Directive (Council Directive 2013/59/Euratom of 5 December 2013 laying down basic safety standards for protection against the dangers arising from exposure to ionizing radiation). The guidelines provide guidance to manufacturers how to compile the document for undertakings with adequate information to carry out risk assessments, as required by article 63 and 78.2 of the BSS Directive.

Article 63
Member States shall ensure that:
(b) for radiotherapeutic practices the quality assurance programme includes a study of the risk of accidental or unintended exposures;

Article 78.2
2. Member States shall ensure that any undertaking acquiring medical radiological equipment is provided with adequate information on the risk assessment for patients, and on the available elements of the clinical evaluation

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