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    Copyright 2009 Rockwell Automation, Inc. All rights reserved.

    Machine SafetyStandards

    Dr Raymond Wright

    EN954 | ISO13849 | IEC62061

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    Philosophy

    Machine Safety is about the reduction of r isk.

    In the real world there is no such thing as zero risk in technology. So the aim

    is to reduce risk to a tolerable level.

    If safety depends on control systems, these must be designed for a low

    probability of functional failure. If this is not possible then errors that occur

    shall not lead to the loss of the safety function.

    To help meet this requirement harmonised standards have been created, and

    complying with these standards is the simplest way to demonstrate risk

    reduction so far as reasonably practicable.

    2

    IEC 62061ISO 13849-1

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    Scope of Machine SafetyStandards

    EN954-1 has been the dominant standard in Machine Safety

    EN 954-1 employs a deterministic approach which uses an estimate of risk in terms of Categories, which

    determine a Class of control to achieve an appropriate system behaviour and performance.

    With the advent of more complex controls, especially programmable controls, safety can no longer be

    adequately measured in the simple Category system found in EN 954-1.

    The probability of failure (failure modes and failure rates) of the more complex safety controls is not addressed

    in EN 954-1, and requires a probabilistic approach to evaluating performance.

    3

    Update Jan 2010: EN 954-1 validity to be extended to 31 Dec 2011

    EN 954-1 will be succeeded by ISO 13849-1 on 29 Dec 2009.

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    Scope of Machine SafetyStandards

    ISO 13849-1 will take the place of EN 954-1

    The standard is applied to Safety-Related Parts of Control Systems (SRP/CS) and all types of machinery

    regardless of the technology and energy employed (electrical, hydraulic, mechanical, pneumatic).

    There are also special requirements within ISO 13849-1 for SRP/CS using programmable electronic systems.

    IEC 62061 is a competing standard derived from IEC 61508

    The standard defines the requirements and gives recommendations for the design, integration and validation of

    Safety-Related Electrical, Electronic, and Programmable Electronic control systems (SRECS) for machinery.

    It does not define requirements for the performance of non-electrical (e.g. hydraulic, mechanical, pneumatic)

    safety-related control elements for machinery.

    4

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    Relationship

    Relationship of Current Standards

    5

    Process Machines

    Safety of Systems and Equipment

    IEC 61508

    Functional safety of Electrical/Electronic/ProgrammableElectronic safety-related systems

    EN 954-1

    Safety related parts of controlsystems

    Software

    IEC 61511 IEC 61508-3 IEC 62061 ISO 13849-1:2006

    Process(Electrical, Electronic

    and ProgrammableTechnology)

    Machinery(Electrical, Electronic and

    ProgrammableTechnology)

    Machinery(All Technologies)

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    Overview of ISO 13849-1

    Overview of ISO 13849-1

    Builds on the familiar Categories from EN 954-1

    Goes beyond the qualitative approach of EN 954-1 to include a quantitative assessment of the safety function.

    It examines complete safety functions, including all the components involved in their design.

    A (qualitative) risk assessment process produces a performance requirement, called the Performance Levelrequirement (PLr) for each safety function. This builds on the requirements of Categories, and is based on thedesignated architecture and designated mission time.

    Each safety function is divided into subsystems and subsystem elements for a quantitative analysis of safety

    performance

    The Performance Level of each safety function must be verified, and examples of calculation are provided in

    the standard.

    6

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    Overview of IEC 62061

    Overview of IEC 62061

    Represents a sector-specific standard under IEC 61508.

    It is based on a Lifecycle concept, and covers only electric, electronic and programmable electronic control

    systems on machinery .

    A (qualitative) risk assessment process produces a performance level requirement, called the Safety Integri tyLevel (SIL) for each safety function.

    Each safety function is divided into subsystems and subsystem elements for a quantitative analysis of safety

    performance

    The Performance Level of each safety function must be verified, and examples of calculation are provided in

    the standard.

    7

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    Choice of Standard

    Which Standard should I follow?

    In general terms, if you are familiar with the use of the Categories from EN 954-1 and use relatively

    straightforward conventional safety functions then ISO 13849-1 is probably the best choice.

    If you are specifically required to use SIL, or if your application uses complex multi-conditional safety

    functionality then IEC 62061 may be the most suitable.

    Keep in mind that ISO 13849-1 covers all technologies whereas IEC 62061 only covers electrical and

    electronic systems.

    Holistic Approach

    Whichever standard is chosen, a holistic Safety Strategy (risk management process) must be followed to

    ensure that the performance of the safety functions can be directly linked to the risk reduction requirementsdetermined during Hazard Identification and Risk Assessment activities.

    8

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    User Safety St rategy

    User Safety Strategy:

    Identify all Machines Determine Machine Limits (each machine)

    Identify Tasks (each machine)

    Identify Hazards (each task)

    Estimate Risk (each hazard)

    Severity of potential injury

    Probability of its occurrence

    Frequency of exposure

    Probability of injury

    Reduce Risk (each hazard)

    Eliminate or reduce

    Install protective equipment

    Procedures / training / PPE

    Determine the required performance: Cat/PLr/SIL(each safety function)

    Design Safety Functions (vendor or integrator)

    Evaluation (each safety function)

    9

    RiskAssessment

    RiskContro

    l

    EN 1050 | ISO 14121

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    Risk Assessment ISO 13849-1

    10

    ISO 13849-1 Risk Assessment

    PLr

    +Verification of Performance Level (PL) required for each safety function

    Severity of Injury

    S1 Slight (normally reversible injury)

    S2 Serious (normally irreversible) injury including death

    Frequency and/or Exposure Time to the Hazard

    F1 Seldom to less often and/or the exposure time is short

    F2 Frequent to continuous and/or the exposure time is long

    Possibility of Avoiding the Hazard or Limiting the Harm

    P1 Possible under specificconditions

    P2 Scarcely possibleRisk Graph from Annex A of EN ISO 13849-1

    START

    PLrLowRisk

    HighRisk

    S1

    S2

    F1

    F2

    F1

    F2

    P1

    P2

    P1

    P2

    P1

    P2

    P1

    P2

    a

    b

    cd

    e

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    Performance Level Verif icat ion

    ISO 13849-1

    Factors to consider when verifying performance (PL) ofeach safety function:

    11

    Severity of Injury

    S1 Slight (normally reversible injury)

    S2 Serious (normally irreversible) injury including death

    Frequency and/or Exposure Time to the Hazard

    F1 Seldom to less often and/or the exposure time is short

    F2 Frequent to continuous and/or the exposure time is long

    Possibility of Avoiding the Hazard or Limiting the Harm

    P1 Possible under specific conditions

    P2 Scarcely p ossible

    Elements for PLr Consideration

    Cat Category (Designated Architecture)

    MTTFd Mean Time To Dangerous Failure

    DC Diagnostic Coverage

    CCF () Susceptibility to Common Cause Failure

    Tm Mission Time

    B10d For elements that suffer from wear:Mean number of cycles until 10% of components fail

    dangerously.

    (Used to calculate the MTTFd of components)

    START

    PLrLowRisk

    HighRisk

    S1

    S2

    F1

    F2

    F1

    F2

    P1

    P2

    P1

    P2

    P1

    P2

    P1

    P2

    a

    b

    c

    de

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    Performance Level Verif icat ion

    PL Verification

    12

    MTTFd = low

    MTTFd = medium

    MTTFd = highe

    d

    c

    b

    a

    PerformanceL

    evel(PL)

    Category

    B

    DCavg

    = 0

    Category

    1

    DCavg

    = 0

    Category

    2

    DCavg

    = low

    Category

    2

    DCavg

    = medium

    Category

    3

    DCavg

    = low

    Category

    3

    DCavg

    = medium

    Category

    4

    DCavg

    = high

    Determination of PL from Figure 6 of ISO 13849-1

    P f L l V if i i

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    Performance Level Verif icat ion(simplified)

    PL Verification (simplified)

    13

    MTTFd = low

    MTTFd = medium

    MTTFd = highe

    d

    c

    b

    a

    PerformanceL

    evel(PL)

    Category

    B

    DCavg

    = 0

    Category

    1

    DCavg

    = 0

    Category

    2

    DCavg

    = low

    Category

    2

    DCavg

    = medium

    Category

    3

    DCavg

    = low

    Category

    3

    DCavg

    = medium

    Category

    4

    DCavg

    = high

    Simplified Determination of PL from Table 7 of ISO 13849-1

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    Risk Assessment IEC 62061

    14

    +Verification of performance required (SIL) for each safety function

    ConsequenceSeverity

    Se

    Class Cl

    3-4 5-7 8-10 11-13 14-15

    Death, losing an

    eye or arm4 SIL 2 SIL 2 SIL 2 SIL 3 SIL 3

    Permanent, losing

    fingers3 OM SIL 1 SIL 2 SIL 3

    Reversible, medical

    attention2 OM SIL 1 SIL 2

    Reversible, first aid 1 OM SIL 1

    Frequency & DurationFr

    Prob. of Hazard EventPr

    AvoidanceAv

    1 hr 5 Very High 5

    > 1 hr 1 day 5 Likely 4

    > 1 day 2 wk 4 Possible 3 Impossible 5

    > 2 wk 1 yr 3 Rarely 2 Possible 3

    > 1 yr 2 Negligible 1 Likely 1

    IEC 62061 Risk Assessment

    Tables fromAnnex A of IEC 62061

    Cl = Fr + Pr + Av

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    Risk Est imation IEC62061

    Risk Assessment Form

    15

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    Risk Est imation IEC62061

    Estimate the Frequency of Exposure

    16

    Table A.2 Frequency and duration of exposure (Fr) Classification

    Frequency and duration of exposure (Fr)

    Frequency of exposure Duration > 10min

    1 h 5

    > 1 h to 1 day 5

    > 1 day to 2 weeks 4

    > 2 weeks 1 year 3

    > 1 year 2

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    Risk Est imation IEC62061

    Estimate the Probabil ity of Occurrence

    17

    Table A.3 Probability (Pr) Classification

    Probability (Pr)

    Probability of Occurrence Probability (Pr)

    Very high 5

    Likely 4

    Possible 3

    Rarely 2

    Negligible 1

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    Risk Est imation IEC62061

    Estimate the Probability of Avoiding or Limiting Harm

    18

    Table A.4 Probability of avoiding or limiting harm (Av) Classification

    Probability of avoiding or limiting harm (Av)

    Probability of Avoidance Probability (Av)

    Impossible 5

    Rarely 3

    Probable 1

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    Risk Est imation IEC62061

    Estimate the Severity of the Consequence

    19

    Table A.1 Severity (Se) Classification

    Severity (Se)

    Consequences Severity (Se)

    Irreversible: death, losing an eye or arm 4

    Irreversible: broken limb(s), losing finger(s) 3

    Reversible: requiring attention from a medical practitioner 2

    Reversible: requiring first aid 1

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    Risk Est imation IEC62061

    Determining the SIL Requirement

    20

    1 1 CRUSHING 3 5 5 3 13 5 + 5 + 3 = 13

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    SIL Verif icat ion IEC 62061

    IEC 62061

    Factors to consider when verifying performance (SIL) ofeach safety function:

    21

    Element for SIL Consideration

    PFHd Probabili ty of Dangerous Failure per Hour

    DC Diagnostic Coverage

    Susceptibility to Common Cause Failure

    T1 Lifetime

    T2 Diagnostic Test Interval

    HFT Hardware Fault Tolerance

    SFF Safe Failure Fraction

    B10d

    Failure rate ; or

    For elements suffering from wear

    ConsequenceSeverity

    Se

    Class Cl

    3-4 5-7 8-10 11-13 14-15

    Death, losing an eye

    or arm4 SIL 2 SIL 2 SIL 2 SIL 3 SIL 3

    Permanent, losing

    fingers3 OM SIL 1 SIL 2 SIL 3

    Reversible, medicalattention

    2 OM SIL 1 SIL 2

    Reversible, first aid 1 OM SIL 1

    Frequency & DurationFr

    Prob. of Hazard EventPr

    AvoidanceAv

    1 hr 5 Very High 5

    > 1 hr 1 day 5 Likely 4

    > 1 day 2 wk 4 Possible 3 Impossible 5

    > 2 wk 1 yr 3 Rarely 2 Possible 3

    > 1 yr 2 Negligible 1 Likely 1

    Tables fromAnnex A of IEC 62061

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    SIL Verification

    SIL Verification (simplified)

    22

    PFHd 10-5 10-6 10-7 10-8

    na SIL 1 SIL 2 SIL 3

    Safety Instrumented Function (SIF)

    Sensor

    Subsystem

    Logic Solver

    Subsystem

    Final Element

    Subsystem

    PFHd(s) PFHd(ls) PFHd(fe)

    PFHd(sif) = PFHd(s) + PFHd(ls) + PFHd(fe)

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    PL : SIL Relationship

    Relationship between PL and SIL

    23

    Performance LevelISO 13849-1

    Probability of a dangerousfailure per hour (PFHd)

    Safety Integri ty LevelIEC 62061

    a 10-5 PFHd < 10-4 na

    b 3x10-6 PFHd < 10-5 1

    c 10-6 PFHd < 3x10-6 1

    d 10-7 PFHd < 10-6 2

    e 10-8 PFHd < 10-7 3

    PFHd 10

    -4

    10

    -5

    10

    -6

    10

    -7

    10

    -8

    SIL na SIL 1 SIL 2 SIL 3

    PL a b c d e

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    Summary

    IEC 62061

    Relatively complex methodology More flexibility

    Less constraints

    Simplified modularity via subsystems

    Only applies to electrical technology

    24

    Are there complex safety functions e.g. depending

    on logic decisions?

    or

    Will the system require complex or programmable

    electronics to a high level of integrity?

    If the answer to either question is YES, it isprobably most appropriate to use IEC 62061

    ISO 13849-1: 2006

    Simpler methodology Builds on Categories

    More constraints

    System based

    Applies to all technologies

    Can the system be designed simply using the

    designated architectures?

    or

    Will the system include technologies other than

    electrical?

    If the answer to either question is YES, it isprobably most appropriate to use ISO 13849-1:

    2006

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    Benefits of Compliance

    Compliance with Standards has Benefits:

    As a Supplier:

    Compliance with relevant machine safety legislation.

    Easier entry into overseas markets.

    As a Buyer:

    Knowledge that machine is built with an adequate level of safety.

    The required safety performance is achieved not too much (unnecessary cost), and not too little (doubt

    about safety).

    Reduce repair time, fewer unnecessary stoppages.

    As a User/Operator:

    Knowledge that machine is safe to work with, and provides a better operational work environment.

    More comfortable with the machine, higher productivity.

    Less waste material, and more consistent quality.

    25

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    Moving Ahead

    What should I do now?

    The ideal first step is to read both standards in order to understandtheir requirements and implications.

    Perhaps the most daunting aspect of both standards is the fact that they

    require calculations based on reliability data that the safety component

    manufacturers should supply.

    Help is available in the form of information booklets and software tools

    for calculations.

    The BGIA in Germany provides a comprehensive calculation tool for EN

    ISO 13849-1 called SISTEMA. It is available free from the BGIA website.

    26

    If you design and build machines and have used EN 954-1 as a guidance standard todemonstrate compliance, you wil l be required to recertify your machines safety relatedcontrol systems to new Functional Safety standards such as ISO 13849-1 or IEC 62061,

    or directly to the Machinery Directive.

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    Questions

    Defining Best Practice in Process & Machine Safety

    THANK YOUQUESTIONS?

    [email protected]

    Safety Management Systems

    Safety Management Planning

    Safety Lifecycle Templates

    Safety Compliance Audits

    Safety Case Development

    PHA / HAZOP

    Risk Assessment

    PL/SIL Determination / LOPA

    Safety Requirement Specification

    PL/SIL Verification

    ISA Certif ication Courses

    Functional Safety Courses

    Safety Lifecycle Courses

    PL/SIL Determination / LOPA

    PL/SIL Verification

    SafetyManagement

    RiskManagement

    SafetyTraining / Workshops

    The FSE Global Advantage