Answer: Yes. The legal requirements of the Machinery Regulation (EU) 2023/1230 explicitly demand that safety-related parts of control systems (SRP/CS) are designed and constructed to be sufficiently reliable. Every safety function must provide a defined level of fail-safe performance to prevent dangerous malfunctions. While customers often include specific safety levels in their procurement specifications, the actual required Performance Level (PLr) is derived solely from the formal risk assessment or applicable C-type standards. It is a methodically determined value necessary to fulfill legal health and safety requirements and is therefore not subject to negotiation.

Our Service: We support you in the precise determination of the required Performance Level (PLr). We derive this value methodically from your risk assessment or relevant product-specific standards. By providing this professional classification, we protect you from technically unnecessary and expensive "blanket demands" from customers that exceed legal requirements. Alternatively, we work out these safety objectives together with your engineering team in workshops. This approach ensures full legal certainty, while creating a lasting learning effect and deeper safety expertise within your company.

Answer: Functional safety becomes relevant as soon as you mitigate identified risks through control-based safety measures. During your risk assessment, you determine which specific hazards must be covered by safety functions (e.g., an emergency stop, a light curtain, or a safely limited speed). For each of these functions, you must determine a required Performance Level (PLr) in accordance with EN ISO 13849-1. This value describes the necessary reliability of the safety function based on the severity of potential injury and the frequency of exposure. You are then legally required to provide technical evidence that your hardware, logic, and software actually achieve this level.

Our Service: We derive the required Performance Level directly from your risk assessment. If a detailed analysis is not yet available, we work with you to define the safety requirements for your machinery. We offer complete flexibility: we can either design the safety control architecture together with your team from the start or provide the mathematical proof of reliability for an already planned system. In both cases, we ensure that the required safety level is met precisely. This approach allows us to avoid "over-engineering" and unnecessary hardware costs, while maintaining absolute compliance and safety.

Answer: The proof of reliability is based on a detailed mathematical analysis of several key factors defined by EN ISO 13849-1. To determine the achieved Performance Level (PL), four fundamental pillars must be evaluated: the architecture (Category), the Mean Time to Dangerous Failure (MTTFd), the Diagnostic Coverage (DC), and the measures against Common Cause Failures (CCF).

The Institute for Occupational Safety and Health (IFA) provides the established SISTEMA software for this purpose. However, correct modeling within the software requires in-depth knowledge of the standard and significant experience in handling specific component parameters. Only a correctly modeled safety function provides the legal certainty needed for a valid EU Declaration of Conformity.

Our Service: We take full responsibility for the modeling of your safety functions within SISTEMA. Our team identifies and verifies the necessary reliability values for your installed components and maps the entire safety chain from the sensor and logic to the actuator in strict accordance with the standard. You receive a precise and error-free calculation report proving that your control system achieves the required safety level for all defined functions. In addition to the comprehensive PDF documentation, we provide you with the editable SISTEMA project file for your permanent internal records.

Answer: No. A calculation in a tool like SISTEMA represents only the theoretical verification of your safety concept. To achieve full compliance, the safety-related control system must also be validated in accordance with Section 10 of EN ISO 13849-1. Through a combination of functional tests and analytical methods, you must prove that the safety functions perform exactly as intended in real-world conditions.
This process explicitly includes fault simulation. You must demonstrate how the machinery reacts to critical errors, such as a wire break, a welded contactor, or a cross-circuit. Only the combination of theoretical verification and successful practical validation results in a compliant and safe machine.

Our Service: We develop a comprehensive validation plan for your specific machinery. This document defines the exact functional tests and fault simulations required to confirm the reliability of your safety systems. Your team receives clear, step-by-step instructions on how to perform the validation independently and correctly. Furthermore, we provide you with standardized templates for the validation protocol. This ensures that your practical tests meet all legal requirements and that the results are documented in an audit-proof manner for your technical documentation.

Answer: When using programmable safety controllers (SPLC), the focus shifts significantly toward software quality and integrity. The program code for safety functions must not be unstructured or developed without a formal plan. The standard EN ISO 13849-1 requires a strict development process based on the V-Model.
This process includes the creation of a comprehensive Software Specification (SRS) before coding begins, followed by a formal Code Review. During this review, the program is verified for readability, modular structure, and logical accuracy to prevent systematic failures. Every change to the safety software must be fully documented and traceable throughout the entire lifecycle of the machinery.

Our Service: We act as the professional interface between your mechanical design and electrical programming departments. We create the necessary Safety Requirement Specifications as clear, actionable instructions for your software developers. Once your team has implemented the logic, we perform independent Code Reviews and verify the Safety Matrix for plausibility. We provide you with legally compliant planning and verification of the software structure to ensure that your SRASW (Safety-Related Application Software) meets all regulatory standards.