What is BS EN ISO 14460:2010 ?

Title: What is BS EN ISO 14460:2010 and How Does it Impact Medical Device Manufacturers?

Introduction

When it comes to medical devices, ensuring the safety and effectiveness of the products is of the utmost importance. This is where EN ISO 14155:2011 comes in, serving as a guide for conducting clinical investigations on medical devices. EN ISO 14155:2011 is an international standard that aims to ensure the reliability and credibility of the data collected during these investigations, while protecting the rights, safety, and well-being of patients. In this article, we will discuss the purpose of EN ISO 14155:2011, its key components and requirements, and how it impacts medical device manufacturers.

Purpose of EN ISO 14155:2011

The primary purpose of EN ISO 14155:2011 is to harmonize the requirements for conducting clinical investigations on medical devices, ensuring the reliability and credibility of the data collected. By establishing a common framework for these investigations, EN ISO 14155:2011 aims to guarantee the ethical conduct of such investigations, regardless of the country or organization involved.

Key Components and Requirements

EN ISO 14155:2011 is made up of several key components and requirements, which are designed to ensure the quality and reliability of the data collected during clinical investigations. These components include:

Introduction: This section provides an overview of the standard, including its scope, purpose, and key requirements.

Medical device clinical investigations: This section outlines the types of medical device clinical investigations that are covered by the standard, such as their design, conduct, and reporting.

Data collection: This section discusses the data collection requirements for medical devices, including the types of data that should be collected and how it should be done.

Ethical considerations: This section outlines the ethical principles that should guide the conduct of medical device clinical investigations, such as the rights and welfare of patients.

Reporting: This section discusses the reporting requirements for medical devices, including the format of the report and who is responsible for it.

Conclusion

EN ISO 14155:2011 is an essential standard for medical device manufacturers, providing them with a common framework for conducting clinical investigations on medical devices. By adhering to this standard, medical device manufacturers can gather essential data during clinical investigations, proving the reliability and functionality of their products. By ensuring the safety and effectiveness of medical devices, EN ISO 14155:2011 plays a crucial role in protecting the rights, safety, and well-being of patients.