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PD CLC IEC/TS 63394:2024 Safety of machinery. Guidelines on functional safety of safety-related control system, 2024
- undefined
- Annex ZA (normative)Normative references to international publicationswith their corresponding European publications [Go to Page]
- CONTENTS
- FOREWORD
- INTRODUCTION
- 1 Scope
- 2 Normative references
- 3 Terms and definitions [Go to Page]
- 3.1 Terms and definitions
- 3.2 Alphabetical list of terms, definitions and abbreviated terms
- Tables [Go to Page]
- Table 1 – Terms used in this document
- 4 Typical classification of safety functions in safety of machinery [Go to Page]
- 4.1 General [Go to Page]
- 4.1.1 Overview
- 4.1.2 Risk assessment and risk reduction according to ISO 12100
- 4.1.3 Risk reduction and interconnection to SCS and SRP/CS
- 4.1.4 Basic assumptions for risk reduction in machinery
- Figures [Go to Page]
- Figure 1 – Integration within the risk reduction process of ISO 12100
- 4.3 Safety functions [Go to Page]
- 4.3.1 General
- 4.3.2 Risk reduction process by safety functions
- Figure 2 – Decomposition of an SCS or SRP/CS [Go to Page]
- 4.3.3 Typical classification of safety functions
- Figure 3 – Risk reduction process by safety functions
- 4.4 Interrelation between ISO 12100 and IEC 62061 or ISO 13849-1 [Go to Page]
- 4.4.1 General
- 4.4.2 Input information in accordance with IEC 62061 or ISO 13849-1
- 4.4.3 Output information from IEC 62061 or ISO 13849-1
- Table 2 – Input information for the safety requirements specification (SRS)
- Table 3 – Output information from SCS or SRP/CS design on overall risk assessment
- 4.5 Safety functions for protection of persons [Go to Page]
- 4.5.1 General
- 4.5.2 Safety functions for protection of persons based on guards and protective devices
- Table 4 – Safety functions for protection of persons
- 4.6 Other safety functions to prevent hazardous situations [Go to Page]
- 4.6.1 General
- 4.6.2 Other safety functions
- Table 5 – Other safety functions
- 4.7 Safety functions for protection of the integrity of the machine [Go to Page]
- 4.7.1 General
- 4.7.2 Safety functions for the protection of integrity of the machine
- 4.8 Safety functions and Type-C standards
- Table 6 – Safety functions for the protection of integrity of the machine
- 5 Demand mode of operation related to safety functions [Go to Page]
- 5.1 General
- 5.2 High demand or continuous mode of operation [Go to Page]
- 5.2.1 General
- 5.2.2 Approach of IEC 62061 and ISO 13849-1
- 5.2.3 Rarely activated safety functions
- Figure 4 – High demand mode of operation
- 5.3 Low demand mode of operation [Go to Page]
- 5.3.1 General
- Figure 5 – Process for determining high demand mode of operation [Go to Page]
- 5.3.2 Approach of IEC 62061 and ISO 13849-1
- 6 Design process of safety functions [Go to Page]
- 6.1 General
- 6.2 Design procedure
- Figure 6 – Low demand mode of operation
- 6.3 Evaluation of required safety integrity
- 6.4 Decomposition of a safety function
- 6.5 Subsystem design [Go to Page]
- 6.5.1 Architectural constraints
- Table 7 – Architectural constraints for high demand mode of operation [Go to Page]
- 6.5.2 Fault accumulation and undetected faults
- 6.5.3 Evaluation of PFH
- 6.6 Examples of safety functions
- 7 Verification procedures for safety functions [Go to Page]
- 7.1 General
- 7.2 Verification of the test interval of a safety function
- 7.3 Verification procedures
- 7.4 Initial verification
- 7.5 Periodic verification [Go to Page]
- 7.5.1 General
- 7.5.2 Frequency of periodic verification
- 7.6 Verification reporting
- Annex A (informative)Risk assessment and risk reduction according to ISO 12100 [Go to Page]
- A.1 General
- A.2 Risk assessment principles [Go to Page]
- A.2.1 General
- A.2.2 Basic information to be available (as input to risk assessment)
- A.2.3 Risk analysis
- Table A.1 – Basic information for risk assessment according to ISO 12100
- Table A.2 – Determination of limits of machinery according to ISO 12100
- Table A.3 – Principles of hazard identification according to ISO 12100
- Table A.4 – Risk estimation according to ISO 12100
- Table A.5 – Additional considered aspects during risk estimationaccording to ISO 12100
- A.3 Risk reduction by means of safeguarding and complementary protective measures [Go to Page]
- A.3.1 General
- A.3.2 Inherently safe design measures
- A.3.3 Selection of safeguarding and complementary protective measures
- A.4 Other protective measures (procedure based) [Go to Page]
- A.4.1 General
- A.4.2 Procedures for maintenance
- A.4.3 Organizational work procedures
- A.5 Guards and protective devices according to ISO 12100 [Go to Page]
- A.5.1 General
- A.5.2 Interlocking guard with a start function, with manual reset function
- Table A.6 – Guards according to ISO 12100 [Go to Page]
- A.5.3 Protective device according to ISO 12100
- A.5.4 Manual local control device (and procedure)
- Table A.7 – Examples of protective devices according to ISO 12100 [Go to Page]
- A.5.5 Manual parameter selection device (and procedure)
- A.5.6 Manual operating mode selection device (and procedure)
- A.5.7 Energy control device (and procedure)
- A.6 Matrix assignment approach [Go to Page]
- A.6.1 Overview
- A.6.2 General
- A.6.3 Methodology of IEC 62061:2021, Annex A
- A.7 Risk graph approach [Go to Page]
- A.7.1 General
- A.7.2 Methodology of ISO 13849-1:2015, Annex A with assigned SIL
- Figure A.1 – SIL assignment approach
- Figure A.2 – Risk graph approach of ISO 13849-1:2015, Figure A.1 with assigned SIL
- Annex B (informative)Methodology of SCS or SRP/CS design [Go to Page]
- B.1 General
- B.2 Functional safety plan
- Table B.1 – Overview functional safety plan
- B.3 Safety requirements specification [Go to Page]
- B.3.1 General
- B.3.2 Functional requirements
- B.3.3 Safety integrity requirements
- Table B.2 – Overview of basic functional requirements
- B.4 Protection against unexpected start-up
- B.5 Decomposition of the safety function [Go to Page]
- B.5.1 General
- B.5.2 Subsystem architecture based on top-down decomposition
- B.6 Design of the SCS by using subsystems
- Table B.3 – SIL and limits of PFH values
- B.7 Requirements for systematic safety integrity [Go to Page]
- B.7.1 General
- B.7.2 SCS level
- Figure B.1 – Example of decomposition of a safety function
- Table B.4 – Avoidance of systematic failures (SCS or SRP/CS level)
- Table B.5 – Control of systematic failures (SCS or SRP/CS level) [Go to Page]
- B.7.3 Subsystem level
- Table B.6 – Avoidance of systematic failures (subsystem level)
- B.8 Electromagnetic immunity
- B.9 Software-based manual parameterization
- Table B.7 – Control of systematic failures (subsystem level)
- Table B.8 – Software-based manual parameterization
- B.10 Security aspects
- B.11 Aspects of testing
- Figure B.2 – Possible effects of security risk(s) to a SCS (IEC TR 63074:2019, Figure 2)
- B.12 Design and development of a subsystem [Go to Page]
- B.12.1 General
- B.12.2 Subsystem architecture design
- B.12.3 Fault consideration and fault exclusion
- B.12.4 Architectural constraints of a subsystem
- Figure B.3 – Rarely activated safety functions and mode of operation of subsystems
- Table B.9 – Cause and effects of rarely activated safety functions
- Table B.10 – Architectural constraints and basic requirements on a subsystem [Go to Page]
- B.12.5 Subsystem design architectures
- B.12.6 PFH value of subsystems
- B.13 Validation
- Table B.11 – Overview of validation process with required information
- B.14 Documentation
- Table B.12 – Technical documentation based on the design process(Table 9 of IEC 62061:2021, modified)
- Table B.13 – Overview of documentation
- Annex C (informative)Examples of MTTFD values for single components [Go to Page]
- Table C.1 – MTTFD or B10D values for components (derived from ISO 13849-1:2015)
- Table C.2 – Relationship of λD, MTTFD and B10D
- Annex D (informative)Examples for diagnostic coverage (DC) [Go to Page]
- D.1 General
- D.2 Influence of cabling, wiring and interconnections [Go to Page]
- D.2.1 General
- D.2.2 "Serial wiring"
- Table D.1 – Measures to prevent of short circuit
- D.3 Use of manufacturing process information [Go to Page]
- D.3.1 General
- D.3.2 Use of expected timing or awaiting of signal status
- D.4 Typical DC measures
- Table D.2 – DC values and recommended measures
- Annex E (informative)Measures for the achievement of functional safetywith regards to electromagnetic phenomena [Go to Page]
- E.1 General
- E.2 Measures [Go to Page]
- E.2.1 General
- E.2.2 Recommendation for electrical/electronic items of equipment (devices or apparatus)
- E.2.3 Recommendation for the integration of an SCS or SRP/CS into the electrical equipment of the machine
- Table E.1 – Non-exhaustive list of recommendations regarding EMI measures for integration of devices or equipment into the electrical equipment of the machine
- Annex F (informative)Guidelines for software [Go to Page]
- F.1 General
- F.2 Documentation
- Table F.1 – Documents for SW level 1 and SW level 2
- Table F.2 – Coding guidelines
- F.3 Activities
- Table F.3 – Overview of protocols
- Table F.4 – SW level 1 – Overview of basic activities
- Table F.5 – SW level 2 – Overview of basic activities (1/2)
- Table F.5 – SW level 2 – Overview of basic activities (1/2) (continued)
- Table F.6 – SW level 2 – Overview of basic activities (2/2)
- Annex G (informative)Examples of safety functions [Go to Page]
- G.1 General
- G.2 Safety functions [Go to Page]
- G.2.1 Basic information
- Table G.1 – Examples of safety functions and associated safety-related devices [Go to Page]
- G.2.2 Detailed description of safety requirements
- Table G.2 – Basic information related to the safety requirements specification [Go to Page]
- G.2.3 Example of interlocking guard
- Table G.3 – Example of safety-related parameters fora safety function with required SIL 1
- Table G.4 – Example of safety-related parameters fora safety function with required SIL 3
- Annex H (informative)Evaluation of PFH value of a subsystem [Go to Page]
- H.1 General
- H.2 Table allocation approach (IEC 62061)
- H.3 Simplified formulas for the estimation of PFH value (IEC 62061)
- H.4 Approaches of IEC 61508, IEC 62061 and ISO 13849-1 [Go to Page]
- H.4.1 General
- H.4.2 Approach of IEC 61508
- H.4.3 Approach of IEC 62061
- H.4.4 Approach of ISO 13849-1:2015, Annex K
- H.5 Basic considerations regarding exponential and Weibull distributions [Go to Page]
- H.5.1 Exponential distribution
- H.5.2 Weibull distribution
- H.6 T10 and B10 [Go to Page]
- H.6.1 General
- H.6.2 T10 with exponential distribution
- H.6.3 T10 with Weibull distribution
- Figure H.1 – Cumulative distribution functions (CDF)
- H.7 Overview of PFH formulas [Go to Page]
- H.7.1 Definitions
- H.7.2 Formulas
- Table H.1 – Formulas for basic subsystem architecture A (1oo1)
- Table H.2 – Formulas for basic subsystem architecture C (1oo1D)
- Table H.3 – Formulas for basic subsystem architecture B (1oo2) [Go to Page]
- H.7.3 Examples
- Table H.4 – Formulas for basic subsystem architecture D (1oo2D)
- Table H.5 – Examples of PFH values based on B10D
- H.8 Methodology for the estimation of CCF
- Table H.6 – Examples of PFH values based on T10D and B10D
- H.9 Basic subsystem architecture A (1oo1) [Go to Page]
- H.9.1 General
- Figure H.2 – Common cause failure
- Figure H.3 – Basic subsystem architecture A (1oo1) reliability block diagram
- Figure H.4 – Unavailability function of basic subsystem architecture A (1oo1) [Go to Page]
- H.9.2 PFH
- H.9.3 Simplified Weibull approach
- Figure H.5 – 1oo1 reliability block diagram, simplified Weibull approach
- H.10 Basic subsystem architecture C (1oo1D) [Go to Page]
- H.10.1 General
- H.10.2 Fault reaction performed by another subsystem
- Figure H.6 – Basic subsystem architecture C (1oo1D) logical viewwith safe state initiation using another subsystem
- Figure H.7 – Basic subsystem architecture C (1oo1D) reliability block diagram with safe state initiation using another subsystem [Go to Page]
- H.10.3 Fault reaction to be considered in the subsystem
- Figure H.8 – Unavailability functions of basic subsystem architecture C (1oo1D)
- Figure H.9 – Basic subsystem architecture C (1oo1D) logical view with fault reaction
- Figure H.10 – Basic subsystem architecture C (1oo1D) reliabilityblock diagram with fault reaction
- Figure H.11 – Unavailability functions of basic subsystem architecture C (1oo1D) [Go to Page]
- H.10.4 PFH
- H.10.5 Influence of CCF
- H.11 Basic subsystem architecture B (1oo2) [Go to Page]
- H.11.1 General
- Figure H.12 – Basic subsystem architecture B (1oo2) reliability block diagram
- Figure H.13 – Unavailability functions of basic subsystem architecture B (1oo2) [Go to Page]
- H.11.2 PFH
- H.11.3 Influence of CCF
- H.12 Basic subsystem architecture D (1oo2D) [Go to Page]
- H.12.1 General
- Figure H.14 – Basic subsystem architecture D (1oo2D) reliability block diagram
- Figure H.15 – Unavailability functions of basic subsystem architecture D (1oo2D) [Go to Page]
- H.12.2 PFH evaluation of Term A
- H.12.3 PFH evaluation of Term B
- H.12.4 PFH evaluation of Term C and Term D
- H.12.5 PFH
- H.12.6 Influence of CCF
- H.13 Basic subsystem architecture D (1oo2D) with two periods of time consideration [Go to Page]
- H.13.1 General
- H.13.2 PFH evaluation of Term A
- H.13.3 PFH evaluation of Term B
- H.13.4 PFH evaluation of Term C and Term D
- H.13.5 PFH
- H.13.6 Influence of CCF
- Annex I (informative)Commented examples of current regulations [Go to Page]
- I.1 General
- I.2 European Union [Go to Page]
- I.2.1 General European legislation
- I.2.2 New proposed machinery regulation (under preparation)
- I.2.3 Relevant legislation
- I.2.4 Duties of the manufacturer of the machine
- I.3 North America – USA
- I.4 North America – Canada
- I.5 South America – Brazil
- I.6 China
- I.7 Japan
- Annex J (informative)Combination of modes of operation [Go to Page]
- J.1 General
- J.2 Basic approaches with different modes of operation [Go to Page]
- J.2.1 General
- Figure J.1 – Basic approach in high demand or continuous modeof operation based on IEC 61508 (and IEC 62061) [Go to Page]
- J.2.2 Risk reduction measures on low demand mode of operation
- Figure J.2 – Basic approach in low demand mode of operation basedon IEC 61508 (and IEC 61511)
- J.3 Use of subsystems in different modes of operation [Go to Page]
- J.3.1 General
- J.3.2 Example with different modes of operation
- Figure J.3 – Functional view
- Figure J.4 – Logical view [Go to Page]
- J.3.3 Subsystem(s) used for different modes of operation
- Figure J.5 – Decomposition view
- Figure J.6 – Quantitative SIL evaluation using the approach of ratioof probability of failures of each subsystem
- Figure J.7 – Example of quantitative SIL evaluation using the approachof ratio of probability of failures of each subsystem
- Table J.1 – PFDavg max and PFHmax for respective target SIL
- Bibliography [Go to Page]