“Security is freedom from unacceptable risks that cause bodily harm or damage to the health of humans, either directly or indirectly as a result of the destruction of the direct environment or the environment.”
– Working draft of IEC TR 61508-0
Based on this “philosophical” viewpoint we see our task in the implementation of an overall safety for humans and the environment. The European guidelines which are implemented in the Member States as law provide a basis for this claim. We, as a consultancy firm, company offers independent consulting services for the holistic implementation of these legal and ethical claims. Over this range of functional safety addition, we offer consulting services in the field of radiation protection, fire protection and electrical safety.
MACHINE SAFETY AND CONFORMITY
Safe machines conform to European legislation
RISK ASSESSMENT UNDER MACHINERY DIRECTIVE
We create practical risk assessment based on the harmonized standard EN 12100: 2010 according to the Machinery Directive, to which every manufacturer (distributor) is required. The way we work is also based on the methodology of EN 14121-1 / -2 and ISO 31000. We use the software CSafe in practical risk assessment
Risk assessment in accordance with EN 12100:2010
RISK MANAGEMENT UNDER MEDICAL TECHNOLOGY POLICY OR In-Vitro DIAGNOSTICS
We support you in risk management according to EN ISO 14971: 2012 – “Application of risk management to medical devices” to the Beherschung this specific risks to enable. In particular, the definition of the mechanical aspects of such a system is practically allows to generate next patient safety and optimum legal certainty.
SECURITY PRODUCTS, FEATURES
We will assist you in choosing your vendor independent safety-oriented oriented components for the best possible security concept to achieve optimized price image, particularly for mass production plants.
VERIFICATION, VALIDATION, CE-DECLARATION
The verification and validation (acc. To EN 13849 / EN 62061) is the ultimate demonstration of safety and legal certainty. The following CE Declaration of Conformance.