GOST 33855-2016 PDF

Full title and description

GOST 33855-2016 — "Safety justification. Recommendations for preparation" (Russian: ГОСТ 33855-2016, Обоснование безопасности оборудования. Рекомендации по подготовке). The standard provides recommendations for preparing a safety justification (safety case) for machines and equipment where technical regulations require a documented safety justification to confirm conformity with applicable safety requirements.

Abstract

This national (interstate) standard establishes recommended content, structure and procedures for preparing a safety justification for equipment throughout its life cycle. It addresses hazard identification, risk assessment (including estimating probability and severity of dangerous events), selection of risk reduction measures, and the documentation and presentation of evidence required to demonstrate compliance with technical regulations. The guidance is intended to support manufacturers, designers and conformity assessment bodies in compiling the safety justification that accompanies machinery and equipment.

General information

• Status: Effective / active — introduced for the first time (IUS 11‑2017).
• Publication date: Adopted 2016 (protocol of adoption 25 October 2016); published/entered into national registry and made available 1 September 2017.
• Publisher: Adopted by the Interstate Council for Standardization, Metrology and Certification; published/approved through the Federal Agency for Technical Regulation and Metrology (Rosstandart) procedures.
• ICS / categories: 21.020 (Mechanical systems and general-purpose devices; characteristics and design of machines, apparatus and equipment).
• Edition / version: GOST 33855-2016 — first edition (2016).
• Number of pages: 15 (some commercial listings note 15–16 pages depending on language/format).

Scope

The standard applies to equipment for which a safety justification is required by technical regulations (for example TR CU 010/2011 and TR CU 032/2013 and similar national/regional regulations). It establishes recommended rules for preparing the safety justification used to confirm compliance with the requirements of those regulations and to document risk analysis and measures necessary to ensure safety across the equipment life cycle (design, manufacture, operation, maintenance, repair and decommissioning). The guidance is generic and intended to be applicable across types of machinery and equipment subject to regulatory safety justification.

Key topics and requirements

• Definition of the safety justification (safety case) structure and required sections (scope, description of equipment, normative references, hazard analysis, risk assessment results, risk reduction measures, verification and validation evidence, operational instructions and limits).
• Hazard identification methods and criteria for assessing probability of hazardous events and severity of consequences.
• Risk assessment approach and documentation of risk reduction (demonstration of ALARP/acceptable risk where applicable and justification of chosen protective measures).
• Requirements to link safety measures to design, manufacturing and operational controls; lifecycle coverage including post‑repair/major maintenance updates.
• References and harmonization with related standards (for example GOST ISO 12100 on general principles of machine safety, and other national GOST/R standards on risk management and safety terminology).

Typical use and users

Primary users are manufacturers, design organizations, safety engineers, conformity assessment and certification bodies, notified bodies and regulators who must prepare, review or assess safety justification documentation for equipment subject to technical regulations. It is also used by inspection and maintenance organizations and by consultants preparing safety dossiers to support market access or certification.

Related standards

Typical related documents and standards referenced in GOST 33855-2016 include TR CU 010/2011 and TR CU 032/2013 (technical regulations), GOST ISO 12100 (safety of machinery — general principles for design, risk assessment and risk reduction), GOST R 54124‑2010 (risk assessment) and related GOST/GOST‑R standards on documentation, terminology and reliability. The standard itself cites and aligns with national and interstate normative documents used for conformity evidence.

Keywords

safety justification; safety case; hazard identification; risk assessment; risk reduction; equipment safety; technical regulations; conformity evidence; lifecycle safety; GOST.

FAQ

Q: What is this standard?

A: GOST 33855-2016 is an interstate/national standard that provides recommendations for preparing a safety justification (safety case) for equipment where regulatory requirements call for documented demonstration of safety.

Q: What does it cover?

A: It covers the recommended content, structure and preparation procedures for a safety justification, including hazard identification, estimation of probability and severity of hazardous events, risk assessment, selection and documentation of risk reduction measures, and the evidence needed to demonstrate compliance with technical regulations throughout the equipment life cycle.

Q: Who typically uses it?

A: Manufacturers, designers, safety engineers, conformity assessment and certification bodies, regulatory authorities and consultants preparing or reviewing safety justifications and related conformity documentation.

Q: Is it current or superseded?

A: As published it is the 2016 standard (GOST 33855-2016) and is listed as effective/active (introduced for the first time, IUS 11‑2017). Users should check national registries or standards catalogs for any later amendments or superseding documents before use.

Q: Is it part of a series?

A: It is a standalone recommendation-type GOST focused on safety justification but references and aligns with a set of related standards and technical regulations (for example GOST ISO 12100 and various GOST/GOST‑R documents on risk management, terminology and documentation). It forms part of the normative framework used when preparing conformity evidence under applicable technical regulations.

Q: What are the key keywords?

A: Safety justification, safety case, hazard identification, risk assessment, risk reduction, equipment safety, technical regulations.