Machinery Risk Assessment
Review machine limits, intended use, foreseeable misuse and hazards across the machine lifecycle. Identify and prioritise risk reduction measures using ISO 12100.
ISO 12100 · ISO 13849-1 · SISTEMA
Machinery Risk Assessment & Performance Level Verification
Identify machinery hazards, assess safety functions and verify Performance Levels using ISO 12100, ISO 13849-1 and SISTEMA.
- UK (Great Britain): Supply of Machinery (Safety) Regulations 2008, as amended
- EU: Machinery Directive 2006/42/EC
A clear scope for your machine
Risk Assessment & Safety Control Services
Practical machinery risk assessment, Performance Level assessment and SISTEMA calculations for manufacturers, machine builders, integrators and owners. We agree the documents, analysis and testing included before work begins.
Safety Functions & PLr
Define each safety function, its safe response and required Performance Level (PLr), using the risk assessment and applicable machine-specific type-C standards.
Safety Control System Review
Review sensors, safety relays or PLCs, drives, contactors and the relevant electrical, pneumatic or hydraulic circuits, including their interfaces.
SISTEMA Calculations
Model each safety function, check component reliability data and assumptions, and calculate its achieved PL using the matching SISTEMA version.
Verification & Validation Support
Assess specifications, calculations and safety-function behaviour through the agreed analysis and test plan, including ISO 13849-1:2023 validation requirements.
Reports & Corrective Actions
Receive traceable risk and PL findings, identified technical gaps and practical improvements that support your machinery technical file.
How Risk Assessment, Performance Level and SISTEMA Work Together
- Risk assessment
- Identifies machinery hazards and the risk reduction measures needed for safe use throughout its lifecycle.
- Required PL (PLr)
- The performance required from a particular safety function implemented by the control system.
- Achieved PL
- The performance established by evaluating the design and reliability of that safety function.
- SISTEMA
- IFA’s software tool for modelling safety-related control structures, calculating reliability and reporting results.
For each safety function: achieved PL ≥ PLr
We compare the achieved PL with the required PL for each function separately. A whole machine is not assigned a single PL. Meeting this comparison also requires the relevant design, software, systematic-failure and validation requirements to be addressed.
What goes into the calculation?
Category describes the control architecture and fault behaviour. MTTFd describes mean time to dangerous failure; DCavg describes average diagnostic coverage; and CCF addresses common-cause failures. Manufacturer data, operating cycles, mission time and documented assumptions must suit the actual application.
PLr comes from the risk assessment and applicable type-C standard. ISO 13849-1:2023 includes validation requirements in Clause 10: a numerical SISTEMA result alone is not complete validation. We use SISTEMA 3.x for ISO 13849-1:2023; existing projects are reviewed against their stated edition and software version.
Reduce Risk in the Right Order
BS EN ISO 12100:2010 prioritises design measures before safeguards and information for use.
Inherently safe design
Remove hazards or reduce risks through the machine’s design.
Safeguarding and complementary protective measures
Protect people where design measures leave risks.
Information for use
Explain residual risks, safe operation and maintenance.
A Safety Function in Context
Conceptual example only. This is not a validated circuit and does not imply a particular PL.
Guard interlock
Detects opening of a protective guard.
Safety logic
Processes the signal and requests the safe response.
Controlled actuator shutdown
Brings the relevant movement to the specified safe state.
The actual design must address stopping time, stored energy, operating modes and prevention of unintended restart as applicable.
From Machine Information to Clear Findings
Share Your Machine Information
Tell us the machine, use, market and available documents.
Assess Risks & Define Safety Functions
Identify hazards, risk reduction measures and function-specific PLr.
Review the Design & Calculate PL
Check circuits, component data and the SISTEMA model.
Verify & Validate the Agreed Scope
Complete planned analysis and testing; record remaining gaps.
Receive Reports & Improvement Actions
Obtain findings, evidence and prioritised corrective actions.
What Should You Send?
- Machine description, intended use and target market.
- Photos, model details and the machine’s location.
- Any existing risk assessment and operating instructions.
- Electrical, pneumatic and hydraulic circuit diagrams.
- Safety component details, datasheets and reliability data.
- An existing SISTEMA project, if available.
You do not need a complete technical file to start. Share what you have and we will identify the information needed for the agreed scope.
What Will You Receive?
Depending on the agreed service scope:
- Machinery risk assessment report.
- Safety-function list and PLr requirements.
- SISTEMA calculation report and agreed project files.
- Achieved PL versus required PL findings.
- Verification and validation records where included.
- Corrective actions and supporting technical-file evidence.
Risk Assessment & Performance Level Questions
What is the difference between machinery risk assessment and Performance Level assessment?
Machinery risk assessment considers hazards across the machine lifecycle and the measures needed to reduce risk. Performance Level assessment examines the safety-related control system that performs each specified safety function.
Does every safety function need the same Performance Level?
No. PLr is determined separately for each safety function from the risk assessment and any applicable type-C standard. There is no universal requirement for every machine or function to achieve PL d or PL e.
What does a SISTEMA assessment include?
The agreed scope can include reviewing safety functions, architecture, component data and assumptions; building or checking the model; calculating achieved PL; and reporting findings against PLr. Calculations to ISO 13849-1:2023 use SISTEMA 3.x.
Is a SISTEMA report enough for CE or UKCA marking?
No. It supports the control-system evidence but does not establish complete validation or whole-machine conformity. The manufacturer must complete the applicable assessment, technical documentation, instructions and Declaration of Conformity. ConformTest provides technical assessment support, not a “SISTEMA certificate”.
Can you review an existing machine or SISTEMA project?
Yes. We can review available drawings, component data, existing assessments and SISTEMA projects. We agree the applicable standard edition, software version, assumptions and any additional inspection or testing needed.
What information do you need to provide a quotation?
Send the machine type, intended use, target market and location, with photos and any available safety circuit diagrams or existing reports. A complete technical file is not needed to start the enquiry.
Standards & Official References
Technical basis: ISO 12100:2010 (including its BS EN adoption) and ISO 13849-1:2023. EN ISO 12100:2010 and EN ISO 13849-1:2023 are listed for the EU Machinery Directive and designated in Great Britain. Their application and any machine-specific requirements must match the actual machine and conformity route.
EU citation under Directive 2006/42/EC does not automatically establish harmonised status under Regulation (EU) 2023/1230. The Commission states that the new Regulation’s list is being prepared. We confirm the relevant references, restrictions and transition dates for the intended supply date. ISO 12100 alone does not establish whole-machine conformity.
European Commission: harmonised machinery standards · GOV.UK: designated machinery standards · IFA: SISTEMA and supported standard editions
Technical and official-source review: .
Tell us about your machine
Request Your Risk Assessment & Performance Level Review
Share your machine details, safety circuit information and any existing assessment. We will help define the scope for risk assessment, SISTEMA calculations and safety-function verification.
Request an AssessmentEmail: info@conformtest.com Telephone: +44 7760 682877