What is BS EN ISO 12400-4:2010 ?

EN ISO 14155:2011 is an essential standard for ensuring the quality and integrity of clinical investigations on medical devices. It provides a framework for the design, conduct, and reporting of such investigations and helps maintain ethical conduct throughout the process.

One of the key components of EN ISO 14155:2011 is the right to privacy and informed consent. The standard outlines the ethical principles and requirements for obtaining, using, and reporting on personal data related to clinical investigations. It is important to ensure that patients understand the potential risks and benefits of participating in the investigation and give informed consent before participating.

Another important component of EN ISO 14155:2011 is the need for transparency and reproducibility. The standard emphasizes the importance of providing clear and understandable explanations of the methods used, results obtained, and conclusions drawn from the investigation. This ensures that the results of the investigation can be easily understood by stakeholders, including patients, healthcare professionals, and researchers.

How to Follow EN ISO 14155:2011 in Writing Clinical Technical Articles?EN ISO 14155:2011 provides guidelines for writing clinical technical articles that are clear, concise, and easily understandable. To follow the standard, it is important to ensure that the article is structured according to the standard's requirements and includes all necessary information.

Firstly, it is important to provide a clear and concise that explains the purpose and scope of the article. This should include information about the clinical investigation, the methods used, and the results obtained.

Secondly, it is essential to use appropriate terminology and language to ensure that the article is clear and understandable to stakeholders. This includes using the same terminology throughout the article and avoiding the use of jargon or technical terms that may be difficult to understand.

Thirdly, it is important to report the results of the clinical investigation in a clear and concise manner. This includes providing information about the study design, the inclusion and exclusion criteria, the number of participants, the duration of the investigation, and the results obtained.

Finally, it is essential to include a discussion of the results and their implications for the clinical investigation and healthcare practice. This should include a discussion of any limitations or drawbacks of the study and any potential future research directions.

ConclusionEN ISO 14155:2011 is an essential standard for ensuring the quality and integrity of clinical investigations on medical devices. By following the standard's guidelines for writing clinical technical articles, healthcare professionals can help ensure that the results of these investigations are accurate, reliable, and easily understandable for stakeholders. Understanding the significance of EN ISO 14155:2011 is crucial for anyone working in the field of healthcare or medical devices.