Safety Justification is an essential element of the technical file during conformity assessment according to the requirement of various technical regulations. Its elaboration is necessary if the technical file does not fully justify the safety of the equipment.
The Technical Regulations for which the presence of the Safety justification in the certification file is mandatory are listed below:
Some manufacturers may be required to present the Safety Justification even if their equipment is subject to the requirements of other technical regulations, for example:
- Technical Regulation CU TR 004/2011 on the safety of low-voltage equipment;
- Technical Regulation CU TR 010/2011 on safety of machinery;
- Technical Regulation CU TR 020/2011 on the electromagnetic compatibility of technical devices.
In general, Safety Justification should include the following sections :
- a description of the equipment;
- the main specifications and performance characteristics of the equipment;
- a risk assessment (if possible);
- evidence of conformity of the equipment to the requirements of the Technical Regulation
Safety Justification is drawn up at the design stage of the equipment. It is required for each model (brand / type) of an equipment or for several models or versions of an equipment.
The editor of Safety Justification may merge, eliminate certain sections of the document, add some new ones, or include them in an appendix.
The local standard which defines the rules for the elaboration of the Safety Justification is GOST 33855-2016 « Safety justification. Recommendations for preparation » which came into force in 2017. In 2019 this GOST was added to the list of standards of the Technical Regulation CU TR 032/2013 "Safety of pressure equipment". Until mid-2019 the implementation of this GOST in the certification procedure of CU TR 032/2013 was voluntary.