ISO 12100:2010
Safety of machinery — General principles for design — Risk assessment and risk reduction
ISO 12100:2010 specifies basic terminology, principles and a methodology for achieving safety in the design of machinery. It specifies principles of risk assessment and risk reduction to help designers in achieving this objective. These principles are based on knowledge and experience of the design, use, incidents, accidents and risks associated with machinery. Procedures are described for identifying hazards and estimating and evaluating risks during relevant phases of the machine life cycle, and for the elimination of hazards or sufficient risk reduction. Guidance is given on the documentation and verification of the risk assessment and risk reduction process.
ISO 12100:2010 is also intended to be used as a basis for the preparation of type-B or type-C safety standards.
It does not deal with risk and/or damage to domestic animals, property or the environment.
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1 Scope
2 Normative references
3 Terms and definitions
4 Strategy for risk assessment and risk reduction
5 Risk assessment
5.1 General
5.2 Information for risk assessment
5.3 Determination of limits of machinery
5.3.1 General
5.3.2 Use limits
5.3.3 Space limits
5.3.4 Time limits
5.3.5 Other limits
5.4 Hazard identification
5.5 Risk estimation
5.5.1 General
5.5.2 Elements of risk
5.5.2.1 General
5.5.2.2 Severity of harm
5.5.2.3 Probability of occurrence of harm
5.5.2.3.1 Exposure of persons to the hazard
5.5.2.3.2 Occurrence of a hazardous event
5.5.2.3.3 Possibility of avoiding or limiting harm
5.5.3 Aspects to be considered during risk estimation
5.5.3.1 Persons exposed
5.5.3.2 Type, frequency and duration of exposure
5.5.3.3 Relationship between exposure and effects
5.5.3.4 Human factors
5.5.3.5 Suitability of protective measures
5.5.3.6 Possibility of defeating or circumventing protective measures
5.5.3.7 Ability to maintain protective measures
5.5.3.8 Information for use
5.6 Risk evaluation
5.6.1 General
5.6.2 Adequate risk reduction
5.6.3 Comparison of risks
6 Risk reduction
6.1 General
6.2 Inherently safe design measures
6.2.1 General
6.2.2 Consideration of geometrical factors and physical aspects
6.2.2.1 Geometrical factors
6.2.2.2 Physical aspects
6.2.3 Taking into account general technical knowledge of machine design
6.2.4 Choice of appropriate technology
6.2.5 Applying principle of positive mechanical action
6.2.6 Provisions for stability
6.2.7 Provisions for maintainability
6.2.8 Observing ergonomic principles
6.2.9 Electrical hazards
6.2.10 Pneumatic and hydraulic hazards
6.2.11 Applying inherently safe design measures to control systems
6.2.11.1 General
6.2.11.2 Starting of an internal power source/switching on an external power supply
6.2.11.3 Starting/stopping of a mechanism
6.2.11.4 Restart after power interruption
6.2.11.5 Interruption of power supply
6.2.11.6 Use of automatic monitoring
6.2.11.7 Safety functions implemented by programmable electronic control systems
6.2.11.7.1 General
6.2.11.7.2 Hardware aspects
6.2.11.7.3 Software aspects
6.2.11.8 Principles relating to manual control
6.2.11.9 Control mode for setting, teaching, process changeover, fault-finding, cleaning or maintenance
6.2.11.10 Selection of control and operating modes
6.2.11.11 Applying measures to achieve electromagnetic compatibility (EMC)
6.2.11.12 Provision of diagnostic systems to aid fault-finding
6.2.12 Minimizing probability of failure of safety functions
6.2.12.1 General
6.2.12.2 Use of reliable components
6.2.12.3 Use of “oriented failure mode” components
6.2.12.4 Duplication (or redundancy) of components or subsystems
6.2.13 Limiting exposure to hazards through reliability of equipment
6.2.14 Limiting exposure to hazards through mechanization or automation of loading (feeding)/ unloading (removal) operations
6.2.15 Limiting exposure to hazards through location of setting and maintenance points outside danger zones
6.3 Safeguarding and complementary protective measures
6.3.1 General
6.3.2 Selection and implementation of guards and protective devices
6.3.2.1 General
6.3.2.2 Where access to the hazard zone is not required during normal operation
6.3.2.3 Where access to the hazard zone is required during normal operation
6.3.2.4 Where access to the hazard zone is required for machine setting, teaching, process changeover, faultfinding, cleaning or maintenance
6.3.2.5 Selection and implementation of sensitive protective equipment)
6.3.2.5.1 Selection
6.3.2.5.2 Implementation
6.3.2.5.3 Additional requirements for sensitive protective equipment when used for cycle initiation
6.3.2.6 Protective measures for stability
6.3.2.7 Other protective devices
6.3.3 Requirements for design of guards and protective devices
6.3.3.1 General requirements
6.3.3.2 Requirements for guards
6.3.3.2.1 Functions of guards
6.3.3.2.2 Requirements for fixed guards
6.3.3.2.3 Requirements for movable guards
6.3.3.2.4 Requirements for adjustable guards
6.3.3.2.5 Requirements for interlocking guards with a start function (control guards)
6.3.3.2.6 Hazards from guards
6.3.3.3 Technical characteristics of protective devices
6.3.3.4 Provisions for alternative types of safeguards
6.3.4 Safeguarding to reduce emissions
6.3.4.1 General
6.3.4.2 Noise
6.3.4.3 Vibration
6.3.4.4 Hazardous substances
6.3.4.5 Radiation
6.3.5 Complementary protective measures
6.3.5.1 General
6.3.5.2 Components and elements to achieve emergency stop function
6.3.5.3 Measures for the escape and rescue of trapped persons
6.3.5.4 Measures for isolation and energy dissipation
6.3.5.5 Provisions for easy and safe handling of machines and their heavy component parts
6.3.5.6 Measures for safe access to machinery
6.4 Information for use
6.4.1 General requirements
6.4.2 Location and nature of information for use
6.4.3 Signals and warning devices
6.4.4 Markings, signs (pictograms) and written warnings
6.4.5 Accompanying documents (in particular — instruction handbook)
6.4.5.1 Contents
6.4.5.2 Production of instruction handbook
6.4.5.3 Drafting and editing information for use
7 Documentation of risk assessment and risk reduction
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1 Scope
2 Normative references
3 Terms and definitions
4 Strategy for risk assessment and risk reduction
5 Risk assessment
5.1 General
5.2 Information for risk assessment
5.3 Determination of limits of machinery
5.3.1 General
5.3.2 Use limits
5.3.3 Space limits
5.3.4 Time limits
5.3.5 Other limits
5.4 Hazard identification
5.5 Risk estimation
5.5.1 General
5.5.2 Elements of risk
5.5.2.1 General
5.5.2.2 Severity of harm
5.5.2.3 Probability of occurrence of harm
5.5.2.3.1 Exposure of persons to the hazard
5.5.2.3.2 Occurrence of a hazardous event
5.5.2.3.3 Possibility of avoiding or limiting harm
5.5.3 Aspects to be considered during risk estimation
5.5.3.1 Persons exposed
5.5.3.2 Type, frequency and duration of exposure
5.5.3.3 Relationship between exposure and effects
5.5.3.4 Human factors
5.5.3.5 Suitability of protective measures
5.5.3.6 Possibility of defeating or circumventing protective measures
5.5.3.7 Ability to maintain protective measures
5.5.3.8 Information for use
5.6 Risk evaluation
5.6.1 General
5.6.2 Adequate risk reduction
5.6.3 Comparison of risks
6 Risk reduction
6.1 General
6.2 Inherently safe design measures
6.2.1 General
6.2.2 Consideration of geometrical factors and physical aspects
6.2.2.1 Geometrical factors
6.2.2.2 Physical aspects
6.2.3 Taking into account general technical knowledge of machine design
6.2.4 Choice of appropriate technology
6.2.5 Applying principle of positive mechanical action
6.2.6 Provisions for stability
6.2.7 Provisions for maintainability
6.2.8 Observing ergonomic principles
6.2.9 Electrical hazards
6.2.10 Pneumatic and hydraulic hazards
6.2.11 Applying inherently safe design measures to control systems
6.2.11.1 General
6.2.11.2 Starting of an internal power source/switching on an external power supply
6.2.11.3 Starting/stopping of a mechanism
6.2.11.4 Restart after power interruption
6.2.11.5 Interruption of power supply
6.2.11.6 Use of automatic monitoring
6.2.11.7 Safety functions implemented by programmable electronic control systems
6.2.11.7.1 General
6.2.11.7.2 Hardware aspects
6.2.11.7.3 Software aspects
6.2.11.8 Principles relating to manual control
6.2.11.9 Control mode for setting, teaching, process changeover, fault-finding, cleaning or maintenance
6.2.11.10 Selection of control and operating modes
6.2.11.11 Applying measures to achieve electromagnetic compatibility (EMC)
6.2.11.12 Provision of diagnostic systems to aid fault-finding
6.2.12 Minimizing probability of failure of safety functions
6.2.12.1 General
6.2.12.2 Use of reliable components
6.2.12.3 Use of “oriented failure mode” components
6.2.12.4 Duplication (or redundancy) of components or subsystems
6.2.13 Limiting exposure to hazards through reliability of equipment
6.2.14 Limiting exposure to hazards through mechanization or automation of loading (feeding)/ unloading (removal) operations
6.2.15 Limiting exposure to hazards through location of setting and maintenance points outside danger zones
6.3 Safeguarding and complementary protective measures
6.3.1 General
6.3.2 Selection and implementation of guards and protective devices
6.3.2.1 General
6.3.2.2 Where access to the hazard zone is not required during normal operation
6.3.2.3 Where access to the hazard zone is required during normal operation
6.3.2.4 Where access to the hazard zone is required for machine setting, teaching, process changeover, faultfinding, cleaning or maintenance
6.3.2.5 Selection and implementation of sensitive protective equipment)
6.3.2.5.1 Selection
6.3.2.5.2 Implementation
6.3.2.5.3 Additional requirements for sensitive protective equipment when used for cycle initiation
6.3.2.6 Protective measures for stability
6.3.2.7 Other protective devices
6.3.3 Requirements for design of guards and protective devices
6.3.3.1 General requirements
6.3.3.2 Requirements for guards
6.3.3.2.1 Functions of guards
6.3.3.2.2 Requirements for fixed guards
6.3.3.2.3 Requirements for movable guards
6.3.3.2.4 Requirements for adjustable guards
6.3.3.2.5 Requirements for interlocking guards with a start function (control guards)
6.3.3.2.6 Hazards from guards
6.3.3.3 Technical characteristics of protective devices
6.3.3.4 Provisions for alternative types of safeguards
6.3.4 Safeguarding to reduce emissions
6.3.4.1 General
6.3.4.2 Noise
6.3.4.3 Vibration
6.3.4.4 Hazardous substances
6.3.4.5 Radiation
6.3.5 Complementary protective measures
6.3.5.1 General
6.3.5.2 Components and elements to achieve emergency stop function
6.3.5.3 Measures for the escape and rescue of trapped persons
6.3.5.4 Measures for isolation and energy dissipation
6.3.5.5 Provisions for easy and safe handling of machines and their heavy component parts
6.3.5.6 Measures for safe access to machinery
6.4 Information for use
6.4.1 General requirements
6.4.2 Location and nature of information for use
6.4.3 Signals and warning devices
6.4.4 Markings, signs (pictograms) and written warnings
6.4.5 Accompanying documents (in particular — instruction handbook)
6.4.5.1 Contents
6.4.5.2 Production of instruction handbook
6.4.5.3 Drafting and editing information for use
7 Documentation of risk assessment and risk reduction