What is BS EN ISO 13961:2010 ?

What is BS EN ISO 13961:2010 and EN ISO 14155:2011?

BS EN ISO 13961:2010 and EN ISO 14155:2011 are both international standards that focus on the conduct of clinical investigations for medical devices. These standards were developed to ensure the protection of patients' rights, safety, and well-being during these investigations.

EN ISO 13961:2010 is an international standard that provides guidelines for the design, conduct, and reporting of clinical investigations for medical devices. It aims to establish a common framework for the ethical conduct of such investigations, regardless of the country or organization involved.

EN ISO 14155:2011 is an international standard that further develops the requirements for conducting clinical investigations on medical devices. It is designed to harmonize the requirements for conducting clinical investigations on medical devices in order to guarantee the reliability and credibility of the data collected.

The primary purpose of EN ISO 14155:2011 is to establish a common framework for the ethical conduct of clinical investigations on medical devices, ensuring that medical device manufacturers gather essential data during these investigations and prove the safety and functionality of their products.

Key Components and Requirements of EN ISO 14155:2011

EN ISO 14155:2011 provides several key components and requirements that medical device manufacturers must adhere to in order to conduct ethical clinical investigations. These components and requirements include:

Ethical Conduct of Clinical Investigations

Medical device manufacturers must ensure that their clinical investigations are conducted in accordance with ethical principles. This includes the protection of human rights, the safety of patients, and the promotion of public health.

Data Collection and Reporting

Medical device manufacturers must ensure that they collect and report data from clinical investigations in a standardized and systematic manner. This includes the collection of data on the safety and effectiveness of their products, as well as any adverse events that occur.

Documentation

Medical device manufacturers must ensure that they document their clinical investigations in a comprehensive and transparent manner. This includes the documentation of the methods used to conduct the investigation, the data collected, and any findings or conclusions that were drawn from the investigation.

Quality Management

Medical device manufacturers must ensure that they have a quality management system in place to ensure the quality and reliability of their clinical investigations. This includes the establishment of procedures for conducting investigations, as well as the assurance that the investigation was conducted in accordance with the requirements of EN ISO 14155:2011.

Conclusion

EN ISO 14155:2011 is an essential standard for medical device manufacturers who conduct clinical investigations on their products. By adhering to the key components and requirements outlined in this standard, medical device manufacturers can ensure the safety and effectiveness of their products, while also ensuring the ethical conduct of their clinical investigations.