What is EN ISO 15883-6:2019?

EN ISO 15883-6:2019 is an international standard that specifies the requirements and test methods for washer-disinfectors used in healthcare facilities. This standard sets out the guidelines for the design, performance, safety, and efficacy of washer-disinfectors to ensure that they effectively clean and disinfect medical devices.

The Purpose of EN ISO 15883-6:2019

The primary purpose of EN ISO 15883-6:2019 is to ensure the cleanliness and decontamination of reusable medical devices. Washer-disinfectors are critical in the healthcare setting as they play a vital role in reducing the risk of healthcare-associated infections.

This standard provides detailed instructions on the proper use, installation, maintenance, and testing of washer-disinfectors. It covers various aspects, including cleaning effectiveness, temperature monitoring, chemical dosing, and validation protocols.

Key Requirements of EN ISO 15883-6:2019

EN ISO 15883-6:2019 outlines specific requirements that washer-disinfectors must meet to comply with the standard. These requirements include:

Construction and Materials: The standard defines the materials that should be used for construction, ensuring durability and compatibility with cleaning agents.

Process Parameters: Washer-disinfectors must maintain specific parameters such as temperature, pressure, and time during the cleaning and disinfection cycles to achieve optimal results.

Chemical Dosing: The standard lays down guidelines for the correct dosing and use of cleaning and disinfection chemicals to ensure effective decontamination.

Monitoring and Validation: Regular monitoring, validation, and maintenance of washer-disinfectors are necessary to ensure consistent performance and adherence to the standard.

The Benefits of EN ISO 15883-6:2019 Compliance

Compliance with EN ISO 15883-6:2019 brings several benefits to healthcare facilities. Firstly, it ensures patient safety by reducing the risk of cross-contamination and healthcare-associated infections. Properly cleaned and disinfected medical devices protect patients from potential harm.

This standard also improves operational efficiency by providing clear guidelines for the use and maintenance of washer-disinfectors. Healthcare professionals can rely on standardized protocols, resulting in consistent and reliable outcomes.

Lastly, compliance with EN ISO 15883-6:2019 enhances the reputation of healthcare facilities. It demonstrates a commitment to quality care and adherence to international standards, which can inspire confidence and trust among patients and stakeholders.