GB/T 41295.1-2022 English PDF (GBT41295.1-2022)

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GB/T 41295.1-2022: Application guide of functional safety - Part 1: Hazard identification and requirements analysis
GB/T 41295.1-2022
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 25.040
CCS N 10
Application guide of functional safety - Part 1: Hazard
identification and requirements analysis
ISSUED ON: MARCH 09, 2022
IMPLEMENTED ON: OCTOBER 01, 2022
Issued by: State Administration for Market Regulation;
Standardization Administration of the People’s Republic of China.
Table of Contents
Foreword ... 3 
Introduction ... 4 
1 Scope ... 5 
2 Normative references ... 5 
3 Terms and definitions... 5 
4 Abbreviations ... 7 
5 General ... 7 
5.1 Stages of the life cycle where hazard identification and requirements analysis are
located ... 7 
5.2 Basic considerations for hazard identification and requirements analysis ... 7 
5.3 Process considerations for hazard identification and requirements analysis ... 8 
5.4 Change considerations for hazard identification and requirements analysis ... 8 
5.5 Documentation considerations for hazard identification and requirements analysis ... 9 
6 Risk identification ... 9 
6.1 General process for hazard identification ... 9 
6.2 Impact analysis of natural environment in the process of hazard identification ... 10 
6.3 Impact analysis of laws and regulations in the process of hazard identification ... 10 
6.4 Impact analysis of technological process in the process of hazard identification ... 11 
6.5 Risks of controlled equipment ... 11 
6.6 Risks of safety systems ... 11 
6.7 Risk record ... 12 
7 Requirements analysis ... 12 
References ... 16 
Application guide of functional safety - Part 1: Hazard
identification and requirements analysis
1 Scope
This document provides guidance on hazard identification and requirements analysis in
the application guide of functional safety systems.
This document applies to the concept stage of functional safety system development.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this
document and are indispensable for its application. For dated references, only the
version corresponding to that date is applicable to this document; for undated references,
the latest version (including all amendments) is applicable to this document.
GB/T 20438.1-2017, Functional safety of electrical/electronic/programmable
electronic safety-related systems - Part 1: General requirements
GB/T 20438.2-2017, Functional safety of electrical/electronic/programmable
electronic safety-related systems - Part 2: Requirements for
electrical/electronic/programmable electronic safety-related systems
GB/T 20438.3-2017, Functional safety of electrical/electronic/programmable
electronic safety-related systems - Part 3: Software requirements
GB/T 20438.4-2017, Functional safety of electrical/electronic/programmable
electronic safety-related systems - Part 4: Definitions and abbreviations
3 Terms and definitions
Terms and definitions determined by GB/T 20438.4-2017, and the following ones are
applicable to this document.
3.1
hazard identification
The occurrence risk of potential hazards in the controlled equipment, process, operating
environment and functional safety system itself, which is identified by methods such as
theoretical derivation and experience summarization to mark the acceptable degree of
risk.
3.2
requirements analysis
The process of formulating the safety requirements of the functional safety system
according to the conclusion of hazard identification (3.1), and decomposing the safety
requirements into components according to the structure of the functional safety system.
3.3
system related personnel
Personnel who may have a direct relationship with the system during the entire life
cycle of the functional safety system.
Note: Including system definition, requirements, design, implementation, testing,
operation, maintenance, business and other personnel.
3.4
operation scenario
When the functional safety system is running, the set of relevant natural environment,
technological process, controlled equipment and functional safety systems. This
scenario is figurative and can be observed and studied through physical simulation.
3.5
safety requirements
In order to reduce the risk to a tolerable level, the functional safety integrity level
requirements that the functional safety system needs to meet.
Note: Safety requirements are called safety demands in GB/T 20438, and both have the
same meaning.
3.6
functional safety system
A system that performs safety-related functions, has functional safety-related
characteristics, and satisfies a specific Safety Integrity Level (SIL).
Note: The system here is a generalized concept that includes different levels, such as
safety components, safety equipment or safety control systems. In an actual
● system developers;
● maintenance and repair personnel;
● business personnel, etc.
-- When formulating safety requirements, it is necessary to take into account the
basic control functions of the system.
-- Safety requirements do not create new hazards and require iterative analysis.
5.3 Process considerations for hazard identification and requirements analysis
During hazard identification and requirements analysis, the following implementation
processes need to be followed:
-- Select the operation scenarios required and the controlled scope required by the
functional safety system;
-- Collect data on hazardous events that have occurred in similar scenarios, including
the identified hazardous event and the sequence of events that led to the hazardous
event;
-- Consult system related personnel for opinions on hazardous events and
requirements for the system;
-- Record the hazard identification results, and formulate safety measures one by one
for unacceptable hazards;
-- Analyze the effectiveness of safety measures, summarize and compile safety
requirements;
-- Consult system related personnel for their opinions on the rationality of safety
requirements;
-- The safety requirements shall be the basis for the development of the functional
safety systems after approval;
-- According to the architectural design of the system, allocate the realization method
of safety requirements to each subsystem or component.
5.4 Change considerations for hazard identification and requirements analysis
During hazard identification and requirements analysis, the following changes need to
be considered:
-- Changes are generally initiated by system developers;
-- Change impact analysis needs to be carried out, focusing on the difference
comparison between the operating scenarios before and after the change;
-- The change shall be sufficiently reasonable, and a reasonable change has the
following characteristics:
● All system related personnel do not strongly oppose this requirement change,
● This requirement change can be approved by the authorized signatory,
● There are specific reasons for the change; these reasons include: errors or
omissions in hazard identification, market competition reasons, the existing
technical conditions cannot meet this requirement, the requirement cannot be
verified at all, etc.;
-- Changes require notification to all personnel citing hazard identification records
and safety requirements.
5.5 Documentation considerations for hazard identification and requirements
analysis
During hazard identification and requirements analysis, the contents that need to be