What is ISO 14246:2018 ?

ISO 14246:2018 and EN ISO 14124:2019 are both important international standards that have a significant impact on the safety and quality of medical devices. Understanding the purpose and key components of these standards is essential for manufacturers and organizations to ensure compliance with regulatory requirements and industry best practices.

ISO 14246:2018 is an international standard that focuses on the design, conduct, recording, and reporting of clinical investigations involving medical devices. The primary objective of this standard is to ensure the ethical and scientific integrity of these investigations. ISO 14246:2018 provides guidelines for manufacturers to demonstrate compliance with regulatory requirements and industry best practices. The standard ensures that medical devices are designed and manufactured to minimize the risk of harm to human subjects and to maximize the benefits to the user.

EN ISO 14124:2019 is an international standard that provides guidelines for the installation, operation, and maintenance of safety signs. The standard aims to enhance safety awareness and reduce risks by improving the comprehension and visibility of safety signs. EN ISO 14124:2019 specifies requirements for the design, use of symbols, colors, and formats, ensuring that safety signs are easily understood regardless of language or cultural differences.

In conclusion, ISO 14246:2018 and EN ISO 14124:2019 are both important international standards that have a significant impact on the safety and quality of medical devices. Compliance with these standards is essential for manufacturers to ensure the ethical and scientific integrity of clinical investigations involving medical devices and the safety of individuals in various environments.