What is EN ISO 13144:2011 ?

EN ISO 13144:2011 and EN ISO 14155:2011 are both international standards that provide guidelines for specific industries and fields. EN ISO 13144:2011 is a professional technical standard that focuses on the design and execution of technical drawings used in various industries, while EN ISO 14155:2011 is an international standard that focuses on the conduct and reporting of clinical investigations for medical devices.

EN ISO 13144:2011 provides a common language and format for communicating technical information between designers, manufacturers, and users. It aims to ensure consistent and accurate exchange of information by defining the elements, composition, and layout of technical drawings. The standard defines key components and requirements for the design and execution of technical drawings, including the use of symbols, notation, and other visual elements. It also provides guidelines for the creation of cross-referenced and indexed lists, as well as the use of annotations and other documentation.

EN ISO 14155:2011 is an international standard that provides guidelines on the design, conduct, and reporting of clinical investigations for medical devices. It aims to ensure the protection of patients' rights, safety, and well-being during these investigations. The standard defines key components and requirements for the conduct of clinical investigations, including the informed consent process, the recruitment and follow-up of participants, the collection and reporting of data, and the handling of confidential information. It also provides guidelines for the reporting of clinical trial results, including the presentation of data in a clear and concise manner.

In conclusion, EN ISO 13144:2011 and EN ISO 14155:2011 are both important international standards that provide guidelines for specific industries and fields. They aim to ensure the consistency, accuracy, and reliability of information, while also promoting ethical conduct and the protection of human rights.