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BSI 24/30465361 DC:2024 Edition

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BS IEC 62278-2 Railway applications — Specification and demonstration of Reliability, Availability, Maintainability and Safety (RAMS) – Part 2: Systems approach to safety

Published By Publication Date Number of Pages
BSI 2024 77
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PDF Catalog

PDF Pages PDF Title
8 FOREWORD
10 INTRODUCTION
11 1 Scope
12 2 Normative references
3 Terms and definitions
4 Abbreviations
13 5 Safety process
5.1 Hourglass model for risk assessment and hazard control
14 Figure 1 — The Hourglass Model
5.2 A. Risk assessment
5.2.1 General
15 5.2.2 Conducting risk assessment
5.3 B. Outcome of the risk assessment
5.4 C. Hazard control
16 Figure 2 — Illustration of hazards with respect to the system boundary
5.5 D. Revision of risk assessment
17 5.6 Responsibilities
6 Safety demonstration and acceptance
6.1 Introduction
6.2 Safety demonstration and safety acceptance process
20 Figure 3 — Example of safety acceptance processes
21 6.3 Responsibility in managing the Safety Case
6.4 Modifications after safety acceptance
6.5 Dependencies between Safety Cases
22 Figure 4 — Examples of dependencies between safety cases
6.6 Relationship between safety cases and system architecture
23 7 Organisation and Independence of Roles
7.1 General
7.2 Early phases of the lifecycle (phases 1 to 4)
24 Figure 5 — Independence of Roles in the early phases (phases 1 to 4) of the lifecycle
7.3 Later phases of the lifecycle (starting from phase 5)
25 Figure 6 — Independence of Roles in later phases of the lifecycle (starting from phase 5)
7.4 Personnel Competence
26 8 Risk assessment
8.1 Introduction
8.2 Risk Analysis
8.2.1 General
8.2.2 The risk model
27 Figure 7 — An example of risk model
28 Table 1 — Examples of hazards
29 8.2.3 Techniques for the consequence analysis
8.2.4 Expert Judgement
30 8.3 Risk acceptance principles and risk evaluation
8.3.1 Use of Code of Practice
8.3.2 Use of a reference system
31 8.3.3 Use of Explicit Risk Estimation
32 8.4 Application of explicit risk estimation
8.4.1 Quantitative approach
8.4.1.1 General
33 Figure 8 — Tolerable rates in an example of risk model
8.4.1.2 Accident safety targets
34 8.4.1.3 Tolerable Hazard Rate (THR)
8.4.1.4 Responsibilities
35 8.4.2 Variability using quantitative risk estimates
8.4.2.1 General
8.4.2.2 “Worst possible scenario”
36 8.4.2.3 “Reasonable estimates”
8.4.2.4 “Reasonable worst case”
8.4.3 Qualitative and semi-quantitative approaches
9 Specification of System Safety Requirements
9.1 General
37 9.2 Safety requirements
9.3 Categorization of Safety Requirements
9.3.1 General
38 Figure 9 — requirements classification
9.3.2 Functional safety requirements
39 9.3.3 Technical safety requirements
9.3.4 Contextual safety requirements
40 10 Apportionment of functional Safety Integrity requirements
10.1 Introduction
10.2 Functional safety integrity for electronic systems
10.2.1 General
10.2.2 Apportioning safety requirements
41 Figure 10 — Apportionment of functional safety requirements
43 10.2.3 Safety Integrity Factors
10.2.4 Functional safety integrity and random failures
10.2.5 Systematic aspect of functional safety integrity
10.2.6 Balanced requirements controlling random and systematic failures
44 Figure 11 — Categorisation of Safety Integrity measures
10.2.7 The SIL table
45 Table 2 — SIL quantitative and qualitative measures
10.2.8 SIL allocation
10.2.9 Apportionment of TFFR after SIL allocation
10.2.10 Demonstration of quantified targets
46 10.2.11 Requirements for Basic Integrity
47 10.2.12 Prevention of misuse of SILs
10.3 Safety Integrity for non-electronic systems – Application of CoP
48 11 Design and implementation
11.1 Introduction
11.2 Causal analysis
49 11.3 Hazard identification (refinement)
11.4 Common cause analysis
50 Figure 12 — Common Cause Failures (CCF)
Figure 13 — Impact of functional dependence in a fault-tree analysis
51 Annex A (informative) ALARP, GAME, MEM
A.1 ALARP, GAME, MEM as methods to define risk acceptance criteria
Table A.1 — Overview of ALARP, GAME, MEM
52 A.2 ALARP (As Low As Reasonably Practicable)
A.2.1 General
53 A.2.2 Tolerability and ALARP
A.3 Globalement Au Moins Equivalent (GAME) principle
A.3.1 Principle
54 A.3.2 Using GAME
A.3.2.1 General
A.3.2.2 Basic principles
A.3.2.3 Using GAME to construct a qualitative safety argument
A.3.2.4 GAME using quantitative risk targets
55 A.4 Minimum Endogenous Mortality MEM
Figure A.1 — Differential risk aversion
57 Annex B (informative) Using failure and accident statistics to derive a THR
58 Annex C (informative) Guidance on SIL Allocation
60 Annex D (informative) Safety target apportionment methods
D.1 Analysis of the system and methods
D.2 Example of qualitative apportionment method
D.2.1 General
61 Figure D.1 — Example of qualitative apportionment method
D.2.2 Example of qualitative/semi-quantitative method for barrier efficiency
62 Table D.1 — Efficiency based on the component’s failures
Table D.2 — Efficiency based on the component’s knowledge
Table D.3 — Efficiency based on the use of the component
63 Table D.4 — Efficiency based on the maintenance of the component
D.3 Example of quantitative apportionment method
D.3.1 Introduction
64 Figure D.2 — Interpretation of failure and repair times
D.3.2 Functions with independent failure detection and negation mechanisms
65 Figure D.3 — Combination of two functions with independent failure detection and negation mechanism
66 Figure D.4 — Allocation of Safety Integrity requirements
D.3.3 Function and independent barrier acting as failure detection and negation mechanism
67 Figure D.5 — Combination of Function and independent barrier acting as failure detection and negation mechanism
D.3.4 Apportionment of a probability safety target
68 D.3.5 Apportionment of a “per hour” safety target
Figure D.6 — Example of quantified apportionment
69 Annex E (informative) Common mistakes in quantification
E.1 General
E.2 Mixing failure rates with probabilities
Figure E.1
70 E.3 Using formulas out of their range of applicability
71 Annex F (informative) Techniques / methods for safety analysis
Table F.1 — Techniques / Methods for safety analysis
72 Table F.2 — Techniques / Methods for BI and SILs
73 Annex G (informative) Key system safety roles and responsibilities
Table G.1 — Role specification for Designer
74 Table G.2 — Role specification for Verifier
Table G.3 — Role specification for Validator
75 Table G.4 — Role specification for Independent Safety Assessor
76 Table G.5 — Role specification for Project Manager
77 Bibliography
BSI 24/30465361 DC
$13.70