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(as of Jan 26,2025 11:31:31 UTC – Details)
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This book gives a step-by-step approach to CE marking of electrical and electronic equipment including risk assessment. It covers, in detail, five important directives viz. low voltage directive (LVD), electromagnetic compatibility (EMC) directive, ce marking for medical devices directive (MDD), radio equipment directive (RED) and the RoHS directive. It provides insights into product design and test methodologies especially EMC and product SAFETY so that the product meets the technical requirements of the applicable standards. It also seeks to clarify the many doubts and misconceptions about ce marking for medical devices.
The book begins with a chapter that introduces the reader to the nuances of the ce marking for medical devices process, the conformity assessment modules and to compile supporting documents that illustrate the process. Ee marking for medical devices
This is followed by the chapter on product safety which describes the principles of safety as found in the international IEC and European harmonized safety standards. It provides ways and means to improve product design so as to ensure reasonable compliance when a product is subject to safety evaluation by a test laboratory.
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