What is EN ISO 15883-3:2009+A2:2019?

EN ISO 15883-3:2009+A2:2019 is an international standard that specifies the requirements for washer-disinfectors used in healthcare facilities. The standard was first published in 2001 to address the need for a consistent and effective process of cleaning and disinfection of medical devices.

The Purpose and Scope of the Standard

The primary purpose of EN ISO 15883-3:2009+A2:2019 is to ensure the cleanliness and safety of medical devices. It provides guidelines for the performance, testing, and validation of washer-disinfectors, which are widely used in hospitals, clinics, and other healthcare settings. The standard covers both thermal and chemical disinfection processes.

Key Requirements of EN ISO 15883-3:2009+A2:2019

1. Cleaning Performance: The standard specifies the minimum performance requirements for the removal of contaminants from medical devices. This includes the efficiency of detergent action, removal of organic and inorganic residues, and prevention of cross-contamination.

2. Disinfection Performance: EN ISO 15883-3:2009+A2:2019 sets criteria for achieving effective microbial reduction during the disinfection process. This ensures that washer-disinfectors provide a high level of hygiene control for reusable medical equipment.

3. Validation and Testing: The standard outlines specific procedures for testing the performance of washer-disinfectors. It covers various parameters such as temperature, time, water quality, and detergent concentration to ensure reliable and reproducible results.

4. Documentation: EN ISO 15883-3:2009+A2:2019 requires manufacturers to provide comprehensive documentation on the operation, maintenance, and validation of washer-disinfectors. This includes instructions for use, routine testing procedures, and guidance on troubleshooting.

Benefits of EN ISO 15883-3:2009+A2:2019 Compliance

Compliance with EN ISO 15883-3:2009+A2:2019 offers several advantages to healthcare facilities. Firstly, it helps in achieving consistent and reliable cleaning and disinfection results, leading to reduced risks of healthcare-associated infections. Secondly, adherence to the standard ensures that medical devices are processed using validated and controlled methods, resulting in improved patient safety. Additionally, compliance enhances the overall quality management system of healthcare facilities by providing a standardized approach to washer-disinfector operations.