What is BS EN ISO 11299-2:2010 and EN ISO 27294:2011?
BS EN ISO 11299-2:2010 and EN ISO 27294:2011 are both international standards that provide guidelines for the implementation and operation of quality management systems.
BS EN ISO 11299-2:2010 is a technical standard that provides guidance on the use of symbols and labels for medical devices. It specifically focuses on symbols that can be used to convey important information to users, such as the presence of a hazardous substance or the need for special storage conditions.
EN ISO 27294:2011 is an international standard that provides guidelines for the implementation and operation of a quality management system for technical product documentation. This standard outlines the requirements for creating, organizing, and delivering product information throughout its entire lifecycle.
The main purpose of EN ISO 11299-2:2010 and EN ISO 27294:2011 is to ensure that organizations are able to effectively manage their product information and provide clear and consistent communication to healthcare professionals, patients, and end-users. By implementing standardized symbols, labels, and quality management systems, organizations can enhance the understanding of crucial information related to the use, handling, and disposal of medical devices.
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