What is ISO 15883-4:2018? Understanding the Standard
SN EN ISO 15883-4:2019
Reinigungs-Desinfektionsgeräte - Teil 4: Anforderungen und Prüfverfahren für Reinigungs-Desinfektionsgeräte mit chemischer Desinfektion für thermolabile Endoskope (ISO 15883-4:2018)
Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2018)
This document specifies the particular requirements, including performance criteria for washer-disinfectors (WD) that are intended to be used for cleaning and chemical disinfection of thermolabile endoscopes. This document 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. The methods, instrumentation and instructions required for type testing, works testing, validation (installation, operational and performance qualification on first installation), routine control and monitoring, and requalification of WD periodically and after essential repairs, are also specified. NOTE 1 In addition, Annex A gives guidance on an appropriate division of responsibility for the range of activities covered by this document. NOTE 2 WD complying with this document can also be used for cleaning and chemical disinfection of other thermolabile re-usable medical devices for which the device manufacturer has recommended and validated this method of disinfection. WD complying with the requirements of this document are 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). The specified performance requirements of this document do not ensure the inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies. NOTE 3 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. NOTE 4 This document can be used by prospective purchasers and manufacturers as the basis of agreement on the specification of the WD, manufacturers of endoscopes, cleaning products, and disinfecting products.
About SN EN ISO 15883-4:2019 at a glance
The SN EN ISO 15883-4:2019 standard outlines the performance criteria and testing methods for washer-disinfectors (WD) specifically designed for the chemical disinfection of thermolabile endoscopes. Published by the International Organization for Standardization (ISO) and the European Committee for Standardization (CEN), this standard provides critical guidance for manufacturers and purchasers in ensuring compliance and safety in medical environments. This FAQ addresses the most common inquiries regarding ISO 15883-4:2018, including its requirements and the certification process.
Related topics
For those interested in ISO 15883-4:2018, consider exploring the following related topics:
- Other clauses from SN EN ISO 15883 series that cover various aspects of disinfection processes.
- Sister standards that provide additional guidance on washer-disinfectors and their validation.
- Training resources for compliance with ISO standards in medical device processing.
Get the standard or training
To ensure your organization meets the requirements of ISO 15883-4:2018, consider purchasing the standard or enrolling in relevant training programs. This will provide you with the tools necessary for effective implementation and compliance.