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Risk Analysis & Risk Assessment for CE Marking and UK Health and Safety Requirements |
One of the techniques growing in importance in meeting the CE marking requirements is Risk Analysis and Risk Assessment. An agreed process of assessing risk is an important part of determining whether equipment is safe. A Technical File is expected to contain details of any Risk Analysis or Assessment undertaken.
Atlantic Bridge can assist you to meet the requirements for Risk Analysis and Risk Assessment. As well as providing you with copies of the relevant European Standards, we can provide the necessary procedures and forms most suitable for your products.
Risk Assessment for Machinery - EN 1050:1996.
The Technical Committees involved in drafting Standards approved EN 1050 - Safety of Machinery - Principles of Risk Assessment on 22nd August 1996.
EN 1050 should be used as a basis for any risk analysis for Machinery. 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 Analysis for Medical Devices. The Risk Analysis Standard for Medical Devices is still in draft as prEN 1441. This Standard includes a generalised procedure with some detailed questions which serve as a useful guide to identify the possible hazards and estimate the risks. The draft provides a good basis for the Risk Analysis of Medical Devices but does not provide the documentation to be used.
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RISK ASSESSMENT OF EXISTING MACHINERY UNDER THE UK HEALTH AND
SAFETY REGULATIONS
Provision and Use of Work Equipment Regulations. (PUWER)
Assessment is carried out in a similar fashion to that required for "CE" Marking but additional emphasis is put onto the operational side of the equipment and the assessment must include the position and environment selected for the equipment when in use.
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