selected equipment (in the field of peaceful uses of nuclear energy), packaging for transport, storage or disposal of radioactive or fissile substances

Draft Decree amending Decree No 358/2016 on requirements for quality assurance and technical safety and assessment and verification of conformity of selected equipment

The amendment to Decree No 358/2016 is prompted by the need to adapt current practice to the expected deployment of new nuclear sources. Proposed amendments:

• Formally and materially, there is a distinction between the processes of 'repair' and 'maintenance', which, especially in the operation of selected equipment, has not always been sharply and clearly delineated in practice.
• Implementation of the concept of ‘part of selected equipment’ introduced by the amendment to Act No 83/2025.
• Addition of measures to prevent so-called counterfeit or fraudulent items. This is equipment for which compliance with technical requirements was not adequately assessed, inadequate tests were carried out with varying degrees  of planning or intent, inadequate documents were produced, and this equipment was subsequently delivered and deployed in the operation of the nuclear installation as fully-fledged and fully legally compliant selected equipment.
• Changes in conformity assessment procedures (e.g. the operator of the nuclear installation, and thus of selected equipment, is accepted as a conformity assessment body for its own needs. This concept was introduced by the aforementioned amendment to the Atomic Act and is further developed in the Decree).
• Newly established framework requirements for persons carrying out conformity assessments.
• Amendments to the annexes to the Decree, namely in specific areas of technical requirements, where individual requirements are clarified, as well as in specific conformity assessment procedures, where new conformity assessment procedures are introduced in part, e.g. for assessing the conformity of parts of selected equipment by the operator. At the same time, certain changes are being made to existing conformity assessment procedures as required by practice.
The mutual recognition clause is set out in the Atomic Act (Act No 263/2016).
Keywords: technical safety, quality assurance, conformity assessment, selected equipment, packaging for transport, storage or disposal of radioactive or fissile materials