Why is machine safety so critical?

A machine carries numerous risks from its design phase to its market launch and maintenance throughout its lifespan: mechanical crushing and cutting, electric shock, noise, vibration, control system failures, and unpredictable behavior. Machine safety is the discipline of systematically identifying and reducing these hazards to acceptable levels, starting from the design phase.

Safety is not limited solely to user safety; it is also directly related to the manufacturer's legal responsibility, right to place the product on the market, and position in product liability lawsuits. A machine placed on the market without meeting compliance requirements may face recalls, sales bans, and administrative sanctions during market surveillance inspections.

Therefore, safety is not a layer added after the product is created; it is an approach that must be embedded in engineering decisions from the very beginning of the design.

• Hazards originating from mechanical, electrical, thermal, noise, and vibration sources.
• Reliability of control and safety functions
• Predictable misuse scenarios
• Risks during use, maintenance, and decommissioning phases.

Transition to the Machinery Safety Regulation and the EU Machinery Regulation (2023/1230)

In Türkiye, the placing of machinery on the market is regulated under the Machinery Safety Regulation (2006/42/EC). This regulation mandates that the machinery meets essential health and safety requirements, that a risk assessment be carried out, that a technical file be prepared, and that a declaration of conformity and CE mark be affixed.

On the EU side, the Machinery Directive 2006/42/EC will be replaced by the new Machinery Regulation (EU) 2023/1230. This regulation will become binding on 20 January 2027, at which time 2006/42/EC will cease to be in effect. Which legislation applies is determined by the date the machine is placed on the market; therefore, it is important for manufacturers to plan the transition schedule on a product-by-product basis.

The new regulation introduces updated obligations on issues such as allowing digital user manuals, the impact of cybersecurity and software updates on security, security functions involving artificial intelligence, and the reassessment of substantially modified machines. Türkiye's process of harmonizing this regulation with national legislation should also be monitored.

This page focuses on product and market suitability; periodic inspection of machinery in businesses (periodic inspection of work equipment) is a separate topic and is not covered here.

• 2006/42/EC: still in force reference legislation.
• (EU) 2023/1230: Binding on 20 January 2027; repeals 2006/42/EC.
• The transition is determined according to the machine's market release date.
• Türkiye's harmonization timetable should also be monitored.

Steps of the CE conformity process

The CE mark on machinery is based on a self-declaration (internal production control) process carried out by the manufacturer under their own responsibility in most product categories. The involvement of a Notified Body only comes into play for certain high-risk machines specifically listed in the Machinery Regulation; otherwise, the conformity assessment and affixing of the CE mark are the manufacturer's responsibility.

The process generally follows these steps, and it is essential that each step is documented in a traceable manner.

• Classification of the product in terms of relevant legislation and scope.
• Identifying applicable harmonized standards.
• Risk assessment (TS EN ISO 12100)
• Implementation and verification of risk mitigation measures in design.
• Preparation and updating of the technical file.
• Creation of user manual and safety instructions
• Issuance of the EU/EC Declaration of Conformity (by the manufacturer)
• The CE mark is affixed by the manufacturer.

Risk assessment: Based on TS EN ISO 12100.

Risk assessment is the core of the entire machine safety process. TS EN ISO 12100 provides an iterative method for identifying hazards, estimating, assessing, and mitigating risks. It begins with defining machine limits (operation, space, time limits); then, hazards at each life cycle are systematically listed.

A three-step approach to risk mitigation is essential: first, inherently safe design; then, preventive measures and supplementary safety precautions; and finally, user information for the remaining risks. The goal is to resolve the risk through design to the highest possible degree, using warnings and instructions only for the remaining risks.

A well-conducted risk assessment forms the backbone of the technical file and provides the rationale for all subsequent design and verification decisions.

• Defining machine limits
• Hazard identification and risk estimation.
• Three-step risk reduction method
• Documenting the remaining risk and communicating it to the user.

Control system safety: EN ISO 13849-1 and IEC/EN 62061

The safety of a machine often depends on the reliability of its control system. Safety functions such as emergency stop, protective door interlocking, light curtain, and two-hand control must be sufficiently reliable. This reliability is defined by measurable performance targets.

EN ISO 13849-1 defines the required Performance Level (PLr) for safety-related control components and verifies it with parameters such as architectural category, MTTFd, and diagnostic scope. IEC/EN 62061 addresses functional safety within the framework of Safety Integrity Level (SIL); it is particularly suitable for complex electrical/electronic/programmable control systems.

Correctly defining safety functions, identifying the necessary PLr/SIL targets, and demonstrating that the selected architecture meets these targets are critical from both the design and technical documentation perspectives. The functional requirements for emergency stop devices are addressed by EN ISO 13850, while the machine's electrical equipment is covered by EN 60204-1.

• EN ISO 13849-1: Performance Level (PL/PLr) approach
• IEC/EN 62061: SIL-based functional safety
• EN ISO 13850: Emergency stop function requirements
• EN 60204-1: electrical equipment for machinery

Contents of the technical file (technical documentation)

A technical file is a collection of documents demonstrating how a machine meets the essential health and safety requirements of the relevant legislation. It must be prepared in a way that can be presented upon request by the market surveillance authority and is generally kept for a specified period after the final machine is placed on the market. An incomplete or disorganized technical file is one of the most common reasons for non-conformity during inspections.

A typical technical file covers everything from a general description of the machine and risk assessment to the standards used, test and calculation reports.

• General description of the machine, drawings and circuit diagrams.
• Risk assessment and implemented risk mitigation measures
• List of harmonized standards applied
• Design calculations, test and verification reports.
• User manual and safety instructions
• EU/EC Declaration of Conformity Sample

AES's role: independent advice and review (Not a Notified Body)

AES Innovation provides independent consulting and technical review support to the manufacturer throughout this process. It works alongside the manufacturer's own team on issues such as structuring the risk assessment, conducting compliance gap analysis, identifying applicable standards, and structuring the technical file.

It is important to clearly understand the scope: AES is NOT a Notified Body and does not issue CE certificates or affix CE marks for machinery. For most machinery covered by the Machinery Directive, conformity assessment is based on self-declaration; it is legally the manufacturer's responsibility to assess conformity, issue the EU/EC Declaration of Conformity, and affix the CE mark.

AES's contribution is methodological support, independent review, and standards compliance consulting to ensure that the manufacturer fulfills this responsibility correctly, completely, and defensibly.

• Risk assessment methodology and content support.
• Compliance gap analysis
• Establishing applicable standards and providing compliance support.
• Structuring and independent review of the technical file.
• It does not issue CE certificates/certifications; it does not provide NB services.

The synergy of accredited electrical expertise and machine safety.

AES is a Type A Inspection Body accredited by TÜRKAK under TS EN ISO/IEC 17020; its accreditation covers the area of 6.1 Electrical Installations. This accredited electrical expertise provides a strong technical infrastructure that directly contributes to machine safety consulting.

Machine safety relies significantly on electrical equipment and control systems. In-depth expertise in electrical equipment requirements, protective measures, and grounding, as outlined in EN 60204-1, enhances the quality of machine safety assessments.

At this point, the distinction in scope is maintained: electrical installation inspection is within the scope of accredited services, while machinery CE conformity is a consultancy and independent review activity. The two competencies complement each other; however, the scope of accreditation applies only to the field of electrical installations.

• TURKAK accredited Type A Inspection Body (TS EN ISO/IEC 17020)
• Accreditation scope: 6.1 Electrical Installations
• EN 60204-1 strong expertise in electrical equipment.
• A combination of electrical and mechanical safety expertise.

How do you start?

Whether you are designing a new machine or preparing an existing product for the (EU) 2023/1230 transition, planning the process early offers advantages in terms of both cost and time. The first step is usually a compliance gap analysis: the current state of your product is assessed against relevant legislation and standards, and priority actions are identified.

The AES team supports manufacturers in correctly fulfilling their compliance responsibilities throughout the entire process, from risk assessment to technical documentation, through methodological and independent review support.

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Frequently Asked Questions

Will AES issue a CE certificate for my machine?

No. AES is not a Notified Body and does not issue CE certificates or affix CE marks for machinery. For most machinery covered by the Machinery Directive, conformity is based on self-declaration; assessing conformity, issuing the EU/EC Declaration of Conformity, and affixing the CE mark are legally the manufacturer's responsibility. AES provides consultancy support to this process through risk assessment, technical file preparation, conformity gap analysis, and independent review.

When will the Machinery Regulation (EU) 2023/1230 become mandatory?

The regulation will become binding on 20 January 2027 and will repeal the existing Machinery Directive 2006/42/EC. Which legislation applies is determined by the date the machine is placed on the market. Türkiye's national legislation harmonization schedule should also be monitored.

Which standard is used for risk assessment?

The basic standard is TS EN ISO 12100. This standard provides a systematic framework covering the definition of machine limits, identification of hazards, estimation and assessment of risk, and a three-step risk mitigation method. For control system safety, EN ISO 13849-1 and IEC/EN 62061 also come into play.

What should a technical file (technical documentation) include?

The technical file includes a general description and drawings of the machine, risk assessment and measures taken, a list of harmonized standards applied, design calculations and test/verification reports, the user manual, and a sample EU/EC Declaration of Conformity. It is prepared in a way that can be presented to the market surveillance authority upon request and is kept for the period stipulated by legislation.

Does AES's TÜRKAK accreditation cover the machinery CE process?

AES is a Type A Inspection Body accredited by TÜRKAK under TS EN ISO/IEC 17020; its accreditation scope is limited to area 6.1 Electrical Installations. Machine CE conformity is a consultancy and independent review activity carried out outside the scope of this accreditation. Expertise in the electrical field provides a strong technical contribution to machine safety assessments; however, the accreditation is only valid for electrical installations.

Why is control system security also evaluated?

Safety functions such as emergency stop, protective door interlocking, and light curtain must be sufficiently reliable. This reliability is defined as measurable targets in EN ISO 13849-1 with Performance Level (PL/PLr) and in IEC/EN 62061 with Safety Integrity Level (SIL). Demonstrating that the safety functions meet the correct requirement level is an indispensable part of both the design and the technical file.