What is EN ISO 13142-2:2019?

An of the Standard

EN ISO 13142-2:2019 is a technical standard developed by the International Organization for Standardization (ISO) and the European Committee for Standardization (CEN). It provides guidelines and requirements for the safety and performance of medical devices. Specifically, it focuses on the validation of instructions for use (IFU) and the process of translating them into different languages.

The Importance of Validating IFUs

Instructions for use play a vital role in ensuring the safe and effective use of medical devices. They provide important information on how to correctly handle, operate, and maintain these devices. However, if the instructions are not properly validated, they can lead to misunderstandings or errors, potentially risking patient safety.

EN ISO 13142-2:2019 emphasizes the need for manufacturers to validate their IFUs through rigorous testing and evaluation. This includes assessing the content, design, and usability of the instructions.

Translating IFUs for Global Markets

With medical devices being used in various countries around the world, it is crucial to ensure that the instructions are accurately translated into different languages. Incorrect translations can result in misinterpretations that may compromise patient care.

The standard provides guidance on best practices for translation processes, including the selection of qualified translators, establishing efficient review procedures, and incorporating user feedback. It also encourages the use of appropriate linguistic resources and tools to ensure accuracy and consistency across translations.

Compliance and Benefits

Adhering to EN ISO 13142-2:2019 brings several benefits to both medical device manufacturers and end-users. By validating instructions for use and implementing proper translation processes, manufacturers can enhance the safety and usability of their products. This, in turn, leads to improved user satisfaction and reduced risks associated with device misuse or mishandling.

Furthermore, compliance with this standard demonstrates the manufacturer's commitment to quality and regulatory requirements. It instills confidence in regulatory agencies, healthcare professionals, and patients, who rely on accurate instructions for proper device use.

In conclusion, EN ISO 13142-2:2019 plays a crucial role in ensuring the safety, efficacy, and global usability of medical devices. By setting guidelines for validating instructions for use and ensuring accurate translations, it contributes to enhanced patient care and improved regulatory compliance.