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Safety Studio · Control Soft & Automation

Machinery Safety Engineering and CE documentation

Risk assessment, design and validation of safety functions for new, modernized or integrated industrial machinery.

Prepare before 2027

20 January 2027 is the key date for machinery safety

Regulation (EU) 2023/1230 on machinery becomes applicable from 20 January 2027. Early preparation reduces the risk of costly changes, commissioning delays and incomplete technical documentation.

Machinery Safety services

From hazard identification to demonstrated safety performance

Our approach brings mechanical, electrical and automation analysis into one documented engineering workflow.

01

Risk assessment

Hazard identification, risk estimation and evaluation, definition of risk-reduction measures and traceability of technical decisions.

02

Safety functions

Definition of emergency stops, interlocks, two-hand controls, light curtains and safe operating modes.

03

Safety engineering

Control architectures, safety relays and safety PLCs, sensors, actuators and integration of safety circuits into the machine electrical design.

04

PL calculation and SISTEMA

Determination of PLr, subsystem modelling, verification of MTTFd, DCavg and CCF, and documentation of the result in SISTEMA.

05

Validation and testing

Validation plans, functional tests, fault scenarios, measurable results and evidence for technical acceptance.

06

CE technical documentation

Preparation of the technical documentation required for conformity assessment: risk assessment, schematics, calculations, validation records and relevant instructions.

Safety Studio software package for Machinery Safety Engineering

Safety Studio

Also available as a software package for machinery-safety engineering

Safety Studio supports structured management of machine data, hazards, safety functions, calculations, validation activities and resulting documents.

Project information remains structured and traceable so that each risk-reduction measure can be followed through verification and documentation.

  • Machine inventory and limits of use
  • Risk assessment and risk reduction
  • Safety-function definition
  • SISTEMA calculation and documentation
  • Validation plans and results
  • CE technical-file structure
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TÜV NORD Functional Safety Certified Engineer Machinery A031_02428/23

TÜV NORD certified professional competence

Functional Safety Certified Engineer – Machinery

Machinery Safety projects are technically coordinated using individually certified professional competence in machinery functional safety.

Certificate A031_02428/23

Frequently asked questions

Preparing a Machinery Safety project

When does Regulation (EU) 2023/1230 apply?

The Regulation becomes applicable from 20 January 2027.

What machinery can be assessed?

New machinery, modernized machines, robotic cells and equipment integrated into production lines.

What documentation is produced?

Risk assessment, safety-function definition, SISTEMA calculations and reports, validation plans and the technical documentation defined for the project.

TECHNICAL REFERENCE

Technical preparation for a machinery-safety project

Risk reduction should be linked to identified hazards, safety functions and evidence that the implemented measures perform as intended.

What should a machinery risk assessment contain?

The assessment defines machine limits, identifies hazards, estimates risk and documents the selected risk-reduction measures. The result must remain linked to the real machine configuration, operating modes and foreseeable interventions.

How are PLr, PL and SISTEMA used?

The required performance level is established for each safety function. The implemented architecture is then evaluated using component data, MTTFd, DCavg and CCF as applicable. SISTEMA supports calculation and documentation but does not replace engineering judgement or validation.

What does validation add after design?

Validation verifies that the safety function behaves as specified, including fault scenarios and reset or restart conditions. Records should identify the test, result, responsible person and any corrective action.

Technical reference

Prepare your machinery before the 2027 deadline.

Request an application assessment