Introduction to Risk Management and CE Marking
One of the techniques growing in importance in meeting the CE marking requirements is Risk Management including the steps of Risk Analysis and Risk Assessment. A defined process of assessing and managing risk throughout all stages of the life of a product is an important part of determining whether it is safe, and remains safe, to operate. A Technical File is expected to contain details of the Risk Management undertaken.
Risk Assessment for Machinery - EN 1050:1996
EN 1050 should be used as a basis for any risk assessment of Machinery and ATEX equipment. The standard does not specify the precise method but provides detailed guidance as to what should be considered. It covers Hazard Identification providing a list in Annex A to the Standard. The elements to be considered in Risk Estimation are listed, and general advice is given on Risk Reduction. The Standard states that the documentation shall demonstrate the procedure and the results.
Risk Management for Medical Devices
The Risk Management Standard for Medical Devices is EN ISO 14971:2000. The Standard covers risk management throughout the life of a medical devices and for each phase of that life. It includes the required content of the Risk Management File and in the Annexes lists likely hazards. The standard does not provide documentation or a methodology for Risk Assessment but refers out to methodologies such as FMECA. Atlantic Bridge can provide suitable methods to conduct Risk Management to EN ISO 14971:2000.