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BS EN IEC 62061:2021+A1:2024

$215.11

Safety of machinery. Functional safety of safety-related control systems

Published By Publication Date Number of Pages
BSI 2024 154
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PDF Pages PDF Title
2 undefined
12 CONTENTS
18 FOREWORD
20 INTRODUCTION
21 1 Scope
22 2 Normative references
Figures
Figure 1 – Scope of this document
23 3 Terms, definitions and abbreviations
3.1 Alphabetical list of definitions
Tables
Table 1 – Terms used in IEC 62061
25 3.2 Terms and definitions
38 3.3 Abbreviations
4 Design process of an SCS and management of functional safety
4.1 Objective
Table 2 – Abbreviations used in IEC 62061
39 4.2 Design process
Figure 2 – Integration within the risk reduction process of ISO 12100 (extract)
40 Figure 3 – Iterative process for design of the safety-related control system
41 4.3 Management of functional safety using a functional safety plan
Figure 4 – Example of a combination of subsystems as one SCS
43 4.4 Configuration management
4.5 Modification
44 5 Specification of a safety function
5.1 Objective
5.2 Safety requirements specification (SRS)
5.2.1 General
5.2.2 Information to be available
45 5.2.3 Functional requirements specification
5.2.4 Estimation of demand mode of operation
46 5.2.5 Safety integrity requirements specification
Figure 5 – By activating a low demand safety function at least once per year it can be assumed to be high demand
Table 3 – SIL and limits of PFH values
47 6 Design of an SCS
6.1 General
6.2 Subsystem architecture based on top down decomposition
6.3 Basic methodology – Use of subsystem
6.3.1 General
48 6.3.2 SCS decomposition
49 6.3.3 Sub-function allocation
6.3.4 Use of a pre-designed subsystem
Figure 6 – Examples of typical decomposition of a safety function into sub-functions and its allocation to subsystems
50 6.4 Determination of safety integrity of the SCS
6.4.1 General
6.4.2 PFH
Figure 7 – Example of safety integrity of a safety function based on allocated subsystems as one SCS
Table 4 – Required SIL and PFH of pre-designed subsystem
51 6.5 Requirements for systematic safety integrity of the SCS
6.5.1 Requirements for the avoidance of systematic hardware failures
52 6.5.2 Requirements for the control of systematic faults
53 6.6 Electromagnetic immunity
6.7 Software based manual parameterization
6.7.1 General
6.7.2 Influences on safety-related parameters
54 6.7.3 Requirements for software based manual parameterization
55 6.7.4 Verification of the parameterization tool
6.7.5 Performance of software based manual parameterization
6.8 Security aspects
56 6.9 Aspects of periodic testing
7 Design and development of a subsystem
7.1 General
57 7.2 Subsystem architecture design
Table 5 – Relevant information for each subsystem
58 7.3 Requirements for the selection and design of subsystem and subsystem elements
7.3.1 General
7.3.2 Systematic integrity
61 7.3.3 Fault consideration and fault exclusion
62 7.3.4 Failure rate of subsystem element
65 7.4 Architectural constraints of a subsystem
7.4.1 General
66 7.4.2 Estimation of safe failure fraction (SFF)
Table 6 – Architectural constraints on a subsystem: maximum SIL that can be claimed for an SCS using the subsystem
68 7.4.3 Behaviour (of the SCS) on detection of a fault in a subsystem
69 7.4.4 Realization of diagnostic functions
7.5 Subsystem design architectures
7.5.1 General
70 7.5.2 Basic subsystem architectures
Figure 8 – Basic subsystem architecture A logical representation
Figure 9 – Basic subsystem architecture B logical representation
Figure 10 – Basic subsystem architecture C logical representation
71 7.5.3 Basic requirements
Figure 11 – Basic subsystem architecture D logical representation
Table 7 – Overview of basic requirements and interrelation to basic subsystem architectures
72 7.6 PFH of subsystems
7.6.1 General
7.6.2 Methods to estimate the PFH of a subsystem
7.6.3 Simplified approach to estimation of contribution of common cause failure (CCF)
8 Software
8.1 General
73 8.2 Definition of software levels
Table 8 – Different levels of application software
74 8.3 Software – Level 1
8.3.1 Software safety lifecycle – SW level 1
Figure 12 – V-model for SW level 1
Figure 13 – V-model for software modules customized by the designer for SW level 1
75 8.3.2 Software design – SW level 1
77 8.3.3 Module design – SW level 1
8.3.4 Coding – SW level 1
78 8.3.5 Module test – SW level 1
8.3.6 Software testing – SW level 1
79 8.3.7 Documentation – SW level 1
8.3.8 Configuration and modification management process – SW level 1
80 8.4 Software level 2
8.4.1 Software safety lifecycle – SW level 2
Figure 14 – V-model of software safety lifecycle for SW level 2
81 8.4.2 Software design – SW level 2
83 8.4.3 Software system design – SW level 2
8.4.4 Module design – SW level 2
84 8.4.5 Coding – SW level 2
85 8.4.6 Module test – SW level 2
8.4.7 Software integration testing SW level 2
8.4.8 Software testing SW level 2
86 8.4.9 Documentation – SW level 2
87 8.4.10 Configuration and modification management process – SW level 2
9 Validation
9.1 Validation principles
89 Figure 15 – Overview of the validation process
90 9.1.1 Validation plan
9.1.2 Use of generic fault lists
9.1.3 Specific fault lists
91 9.1.4 Information for validation
9.1.5 Validation record
92 9.2 Analysis as part of validation
9.2.1 General
9.2.2 Analysis techniques
9.2.3 Verification of safety requirements specification (SRS)
93 9.3 Testing as part of validation
9.3.1 General
9.3.2 Measurement accuracy
94 9.3.3 More stringent requirements
9.3.4 Test samples
9.4 Validation of the safety function
9.4.1 General
95 9.4.2 Analysis and testing
9.5 Validation of the safety integrity of the SCS
9.5.1 General
9.5.2 Validation of subsystem(s)
96 9.5.3 Validation of measures against systematic failures
9.5.4 Validation of safety-related software
97 9.5.5 Validation of combination of subsystems
10 Documentation
10.1 General
10.2 Technical documentation
98 Table 9 – Documentation of an SCS
99 10.3 Information for use of the SCS
10.3.1 General
10.3.2 Information for use given by the manufacturer of subsystems
100 10.3.3 Information for use given by the SCS integrator
102 Annexes
Annex A (informative) Determination of required safety integrity
A.1 General
A.2 Matrix assignment for the required SIL
A.2.1 Hazard identification/indication
A.2.2 Risk estimation
Figure A.1 – Parameters used in risk estimation
103 A.2.3 Severity (Se)
A.2.4 Probability of occurrence of harm
A.2.4.1 General
A.2.4.2 Frequency and duration of exposure
Table A.1 – Severity (Se) classification
104 A.2.4.3 Probability of occurrence of a hazardous event
Table A.2 – Frequency and duration of exposure (Fr) classification
105 A.2.4.4 Probability of avoiding or limiting harm (Av)
Table A.3 – Probability (Pr) classification
106 A.2.5 Class of probability of harm (Cl)
A.2.6 SIL assignment
Table A.4 – Probability of avoiding or limiting harm (Av) classification
Table A.5 – Parameters used to determine class of probability of harm (Cl)
107 Table A.6 – Matrix assignment for determining the required SIL (or PLr)for a safety function
108 A.3 Overlapping hazards
Figure A.2 – Example proforma for SIL assignment process
109 Annex B (informative) Example of SCS design methodology
B.1 General
B.2 Safety requirements specification
B.3 Decomposition of the safety function
Table B.1 – Safety requirements specification – example of overview
110 B.4 Design of the SCS by using subsystems
B.4.1 General
B.4.2 Subsystem 1 design – “guard door monitoring”
B.4.2.1 Architectural constraints
Figure B.1 – Decomposition of the safety function
Figure B.2 – Overview of design of the subsystems of the SCS
111 B.4.2.2 Evaluation of SFF
112 B.4.2.3 Evaluation of DCI1 and DCI2
B.4.2.4 Evaluation of PFH
B.4.3 Subsystem 2 design – “evaluation logic”
113 B.4.4 Subsystem 3 design – “motor control”
B.4.4.1 Architectural constraints
B.4.4.2 Evaluation of PFH
B.4.5 Evaluation of the SCS
B.4.5.1 Target
114 B.4.5.2 Systematic integrity and CCF
B.4.5.3 Architectural constraints
B.4.6 PFH
B.5 Verification
B.5.1 General
B.5.2 Analysis
Table B.2 – Systematic integrity – example of overview
115 B.5.3 Tests
Table B.3 – Verification by tests
116 Annex C (informative) Examples of MTTFD values for single components
C.1 General
C.2 Good engineering practices method
C.3 Hydraulic components
117 C.4 MTTFD of pneumatic, mechanical and electromechanical components
Table C.1 – Standards references and MTTFD or B10D values for components
119 Annex D (informative) Examples for diagnostic coverage (DC)
Table D.1 – Estimates for diagnostic coverage (DC) (1 of 2)
121 Annex E (informative) Methodology for the estimation of susceptibility to common cause failures (CCF)
E.1 General
E.2 Methodology
E.2.1 Requirements for CCF
E.2.2 Estimation of effect of CCF
122 Table E.1 – Estimation of CCF factor (β)
123 Table E.2 – Criteria for estimation of CCF
124 Annex F (informative) Guideline for software level 1
F.1 Software safety requirements
Table F.1 – Example of relevant documents related to the simplified V-model
125 F.2 Coding guidelines
Table F.2 – Examples of coding guidelines
126 F.3 Specification of safety functions
Figure F.1 – Plant sketch
127 F.4 Specification of hardware design
Table F.3 – Specified safety functions
128 Table F.4 – Relevant list of input and output signals
129 F.5 Software system design specification
Figure F.2 – Principal module architecture design
130 Figure F.3 – Principal design approach of logical evaluation
131 F.6 Protocols
Figure F.4 – Example of logical representation (program sketch)
Table F.5 – Example of simplified cause and effect matrix
132 Table F.6 – Verification of software system design specification
Table F.7 – Software code review
133 Table F.8 – Software validation
134 Annex G (informative) Examples of safety functions
Table G.1 – Examples of typical safety functions
135 Annex H (informative) Simplified approaches to evaluate the PFH value of a subsystem
H.1 Table allocation approach
136 Table H.1 – Allocation of PFH value of a subsystem
137 H.2 Simplified formulas for the estimation of PFH
H.2.1 General
H.2.2 Basic subsystem architecture A: single channel without a diagnostic function
Figure H.1 – Basic subsystem architecture A logical representation
Table H.2 – Relationship between B10D, operations and MTTFD
138 H.2.3 Basic subsystem architecture B: dual channel without a diagnostic function
H.2.4 Basic subsystem architecture C: single channel with a diagnostic function
H.2.4.1 General
Figure H.2 – Basic subsystem architecture B logical representation
Figure H.3 – Basic subsystem architecture C logical representation
139 H.2.4.2 External fault handling function
Figure H.4 – Correlation of basic subsystem architecture C and the pertinent fault handling function
140 H.2.4.3 Fault handling partially or completely done within the subsystem
Figure H.5 – Basic subsystem architecture C with external fault handling function
141 Figure H.6 – Basic subsystem architecture C with external fault diagnostics
Figure H.7 – Basic subsystem architecture C with external fault reaction
Figure H.8 – Basic subsystem architecture C with internal fault diagnostics and internal fault reaction
142 Table H.3 – Minimum value of 1/λD FH for the applicability of PFH equation (H.3)
143 H.2.5 Basic subsystem architecture D: dual channel with a diagnostic function(s)
Figure H.9 – Basic subsystem architecture D logical representation
144 H.3 Parts count method
145 Annex I (informative) The functional safety plan and design activities
I.1 General
I.2 Example of a machine design plan including a safety plan
I.3 Example of activities, documents and roles
Figure I.1 – Example of a machine design plan including a safety plan
146 Figure I.2 – Example of activities, documents and roles (1 of 2)
148 Annex J (informative) Independence for reviews and testing/verification/validation activities
J.1 Software design
J.2 Validation
Table J.1 – Minimum levels of independence for review, testing and verification activities
Table J.2 – Minimum levels of independence for validation activities
150 Bibliography
BS EN IEC 62061:2021+A1:2024
$215.11