Safety Justification for machines or equipment
Safety Justification is a document containing detailed risk analysis and process, operating and design document data on the minimal safety measures of machines and equipment required at each stage of their operational service life including post overhaul availability and disposal stage.
The terms “machine” and “equipment” are determined in the Technical Regulation of the Customs Union “On safety of machines and equipment” (TR CU 010/2011):
- “Machine” (machinery)– assembly of linked parts or components, at least one of which moves with the help of the appropriate machine actuators, control and power circuits joined together for a specific application (for example, treatment, processing, moving or packaging of material);
- “Equipment” – technical device applied individually or installed on a machine and required for performing its main and/or additional functions, as well as for combining several machines into one unit.
Safety Justification Preparation Requirements
The document shall be prepared in accordance with GOST R 54122-2010 requirements. Two variants are possible:
- A brief safety justification which does not include the results of test and measurements and is informative only. Such document is used for confirmation of product compliance with the respective technical regulation.
- Full safety justification. The document includes the results of all tests and measurements and is accompanied with documented safety measures justification. It is necessary for supervision and control purposes.
Preparation of Safety Justification
Safety justification is developed at machine (equipment) design stage. Safety justification can be developed for several product modifications or models.
The document can be developed by the product designer or the company responsible for preparation of operating and design documents.
The full safety justification consists of 11 sections:
- Key parameters and specifications (product image, drawings, its specifications, components, as well as project documents).
- General approach to safety at design and production stage.
- Reliability requirements (reliability values, failure criteria, requirements to structural, operating and technological reliability measures).
- Staff/user requirements, including those who may be admitted to operate the product.
- Application (operation) risk analysis and recommended measures to reduce the risk.
- Commissioning safety requirements.
- Safety management requirements at equipment operation.
- Quality management requirements at equipment operation.
- Environmental management requirements at equipment commissioning, operation and disposal.
- Safety data collection and analysis requirements at equipment commissioning, operation and disposal.
- Safe disposal requirements.
It is possible to work out safety justification for the product intended for export to the Eurasian Economic Union (EAEU) using manufacturer’s technical documents (technical file for machinery or relevant technical documentation for partly completed machinery), required in accordance with Annex VII of Directive 2006/42/EC “On machinery”.
Irrespective of the country of machinery and (or) equipment origin, safety justification shall be prepared in accordance with the following standards:
- GOST EN 1070-2003 “Safety of machinery. Terms and definitions”;
- GOST R ISO 12100-1-2007 “Safety of machinery. Basic concepts, general principles for design. Part 1: Basic terminology, methodology”;
- GOST R ISO 12100-2-2007 “Safety of machinery. Basic concepts, general principles for design. Part 2. Technical principles”;
- GOST R ISO 13849-1-2003 “Safety of machinery. Safety-related parts of control system. Part 1. General principles for design”;
- GOST R 27.002-2009 “Dependability in technics. Terms and definitions”;
- GOST 27.310-95 “Dependability in technics. Failure mode, effects and criticality analysis. Basic principles.
- GOST R 51344-99 “Safety of machinery. Principles for risk assessment”.
The service list of EasyGOST EAC includes the preparation of Safety Justifications for various types of equipment. If you require a Safety Justification, please contact our company, which has extensive experience in this field.