What is EN ISO 13142-2:2019?

EN ISO 13142-2:2019 is a technical standard that specifies the requirements for software used in medical devices for the exchange, storage, and presentation of information. This standard is an important tool in ensuring the safety and effectiveness of medical device software.

Scope of EN ISO 13142-2:2019

The scope of EN ISO 13142-2:2019 covers various aspects of medical device software, including its development, verification, validation, installation, and maintenance. The standard addresses the specific needs related to the software used in medical devices, with the aim of minimizing risks and ensuring the quality of the software throughout its lifecycle.

Key Requirements of EN ISO 13142-2:2019

EN ISO 13142-2:2019 outlines several key requirements that software used in medical devices must meet. These requirements include:

Compliance with applicable regulations and standards

Validation of software performance and functionality

Identification and management of potential risks

Configuration management to ensure the integrity of the software

Traceability of software versions and changes

Clear documentation and instructions for use

Benefits of EN ISO 13142-2:2019

Complying with EN ISO 13142-2:2019 offers various benefits to both manufacturers and users of medical devices:

Enhanced safety: The standard helps in identifying and mitigating risks associated with medical device software. This ensures the safety of patients and healthcare professionals.

Improved quality: Following the requirements of EN ISO 13142-2:2019 helps in developing high-quality software that performs reliably and effectively.

Regulatory compliance: The standard ensures compliance with relevant regulations and standards, making it easier to obtain necessary approvals for medical devices.

Interoperability: Implementing the standard facilitates seamless exchange of information between different medical devices and systems, improving overall interoperability in healthcare settings.