What is EN ISO 31235:2018?

EN ISO 31235:2018 is a professional technical standard that provides guidelines and requirements for the validation of cleaning processes in medical device manufacturing. This standard applies to both manual and automated cleaning processes used to remove contaminants from medical devices.

Scope and Purpose

The scope of EN ISO 31235:2018 covers all types of medical devices, including reusable surgical instruments, implants, and diagnostic equipment. The standard aims to ensure that medical device manufacturers have reliable and consistent cleaning processes in place to minimize the risk of contamination and infection.

Key Requirements

EN ISO 31235:2018 outlines several key requirements that manufacturers must meet to validate their cleaning processes. These include:

Defining acceptable levels of cleanliness based on the device's intended use and potential risk to patients.

Developing and implementing a documented cleaning validation plan and procedures.

Performing validation studies to demonstrate the effectiveness of the cleaning process.

Monitoring and documenting cleaning process parameters, such as temperature, time, detergent concentration, and mechanical action.

Establishing appropriate acceptance criteria for cleanliness verification.

Ensuring proper maintenance and calibration of cleaning equipment and monitoring devices.

Benefits and Importance

Complying with EN ISO 31235:2018 offers several benefits to both medical device manufacturers and end-users. By following standardized cleaning processes, manufacturers can enhance product safety and reduce the risk of device-associated infections. For healthcare providers and patients, this means more reliable and safer medical devices, resulting in improved patient outcomes and reduced healthcare-associated costs.

In conclusion, EN ISO 31235:2018 provides crucial guidelines for the validation of cleaning processes in medical device manufacturing. Adhering to this standard helps ensure the safety and effectiveness of medical devices, benefiting both manufacturers and end-users.