What is ISO 15883-4- Requirements and tests for washer-disinfectors about?
ISO 15883 is an international standard that discusses washer-disinfectors. ISO 15883-4 provides the best industry guidance on requirements and tests for washer-disinfectors to ensure the safety and health of its users.
ISO 15883-4 is the fourth part of a multi-part series that layouts the requirements, including performance criteria for washer-disinfectors (WD). Washer-disinfectors (WD) are intended to be used for cleaning and chemical disinfection of thermolabile endoscopes.
ISO 15883-4 also specifies the performance requirements for the cleaning and disinfection of the washer-disinfector and its components and accessories which can be required to achieve the necessary performance criteria.
ISO 15883-4 assists you to standardize the performance and ensure the safety of washer-disinfectors employing chemical disinfection for thermolabile endoscopes.
The methods, instrumentation, and instructions required for type testing, work testing, validation (installation, operational, and performance qualification on the first installation), routine control and monitoring, and requalification of WD periodically and after essential repairs, are also specified under ISO 15883-4.
Note 1: WD complying with the requirements of ISO 15883-4 is not intended for cleaning and disinfection of medical devices, including endoscopic accessories, which are heat stable and can be disinfected or sterilized by thermal methods (see ISO 15883‑1:2006+Amd 1:2014, 4.1.5).
Note 2: The specified performance requirements of ISO 15883-4 do not ensure the inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies.
Note3: If it is considered that prion protein might be present, particular care is needed in the choice of cleaning agents and disinfectants to ensure that the chemicals used do not react with the prion protein and/or other protein in a manner that can inhibit its removal or inactivation from the load or washer-disinfector.
Who is ISO 15883-4- Requirements and tests for washer-disinfectors for?
ISO 15883-4 on requirements and tests of washer-disinfectors is useful for:
- Washer-disinfectors manufacturers
- Test centers for washer-disinfectors
- Regulatory authorities
Why should you use ISO 15883-4- Requirements and tests for washer-disinfectors?
A washer-disinfector is used for the automated cleaning and disinfection of instruments in practices, clinics, dental offices, medical centers, and hospitals. The reliable monitoring and documentation of the relevant process parameters ensure standardized and reproducible decontamination procedures.
ISO 15883-4 guideline assists you with performance requirements on systems for leak testing, cleaning, disinfecting, final rinsing, purging to remove rinse water, drying, self-disinfection, and water treatment equipment for washer-disinfectors employing chemical disinfection for thermolabile endoscopes.
ISO 15883-4 provides mechanical and process requirements on materials, device channel irrigation system, venting, drainage systems, temperature control, process chemicals, process verification, and dosing systems for washer-disinfectors employing chemical disinfection for thermolabile endoscopes.
ISO 15883-4 also provides test methods on water used for final rinsing, hardness of the water used during type testing, leakage test, channels non-obstruction test, thermometric tests, tests of cleaning efficacy, and more for washer-disinfectors employing chemical disinfection for thermolabile endoscopes. In addition, assists in guiding documentation, inspection, marking, labeling, packaging, and information supplied by the manufacturer.
With compliance and obedience to ISO 15883-4, you can enhance the functionality and performance of washer-disinfectors and ensure safety, health, and environments.
What’s changed since the last update?
BS EN ISO 15883-4:2018 supersedes ISO 15883-4:2008, which is withdrawn. BS EN ISO 15883-4:2018 has additional annexes for establishing endoscope type test groups and endoscope product families included compared to ISO 15883-4:2008.