ISO 15883-1:2024 Standard Overview
SN EN ISO 15883-1:2025
Reinigungs-Desinfektionsgeräte - Teil 1: Allgemeine Anforderungen, Begriffe und Prüfverfahren (ISO 15883-1:2024)
Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2024)
This document specifies general performance requirements for washer-disinfectors (WD) and washer-disinfector accessories that are intended to be used for cleaning and disinfection of reusable medical devices. It specifies performance requirements for cleaning and disinfection as well as for the accessories that can be required to achieve the necessary performance. The methods and instrumentation required for validation, routine control and monitoring and requalification, periodically and after essential repairs, are also specified. NOTE 1 The requirements can be applied to WD intended for use with other articles used in the context of medical, dental, pharmaceutical and veterinary practice. The requirements for WD intended to process specific loads are specified in ISO 15883-2, ISO 15883-3, ISO 15883-4, ISO 15883-6 and ISO 15883-7. For WD intended to process loads of two or more different types, the requirements of the applicable parts of ISO 15883-2, ISO 15883-3, ISO 15883-4, ISO 15883-6 and ISO 15883-7 apply. This document does not specify requirements intended for machines for use for laundry or general catering purposes. This document does not include requirements for machines which are intended to sterilize the load, or which are designated as “sterilizers” and addressed in other standards. 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 2 Chemicals in some cleaning agents and disinfectants can react with prion protein in a manner that can inhibit its removal or inactivation. If the presence of prion protein is considered a possibility, then this can influence the choice of cleaning agent and disinfectant. NOTE 3 This document can be used by prospective purchasers and manufacturers as the basis of agreement on the specification of a WD. The test methods for demonstration of conformity with the requirements of this document can also be employed by users to demonstrate continued conformity of the installed WD throughout its service life. Guidance on a routine test programme is given in Annex A.
SN EN ISO 15883-1:2025 provides essential guidelines for washer-disinfectors used in the cleaning and disinfection of reusable medical devices, ensuring compliance with international standards.
Purpose and objectives
The primary purpose of the ISO 15883-1:2024 standard is to establish a comprehensive framework for the performance, testing, and validation of washer-disinfectors. This standard aims to ensure that these devices effectively clean and disinfect reusable medical products, thus maintaining high standards of patient safety and infection control. Furthermore, it seeks to clarify the terms and definitions used within the industry, facilitating better communication among manufacturers, regulators, and healthcare providers. By adhering to these guidelines, healthcare facilities can enhance their practices in cleaning and disinfecting medical devices, ultimately improving patient outcomes.
Scope: who must comply
ISO 15883-1:2024 applies primarily to manufacturers of washer-disinfectors, healthcare facilities, and regulatory bodies involved in the cleaning and disinfection of reusable medical devices. This standard is crucial for organizations in the healthcare technology sector, including hospitals, clinics, and other medical facilities that utilize washer-disinfectors for infection prevention. Compliance is also essential for suppliers of parts and accessories related to these devices, ensuring that all components meet established safety and performance criteria. By adhering to this standard, stakeholders can enhance their operational effectiveness and regulatory compliance.
How SN EN ISO 15883-1:2025 relates to other standards
The ISO 15883-1:2024 standard is part of a broader set of standards focused on medical device sterilization and disinfection. Related standards include:
- ISO 15883-2: This standard provides specific requirements for testing the effectiveness of washer-disinfectors.
- ISO 14937: This standard outlines the general requirements for sterilization of medical devices, complementing the cleaning processes defined in ISO 15883-1.
- EN 556: This standard focuses on the sterility of medical devices, ensuring that the cleaning and disinfection processes align with sterilization practices.
Revision history and current status
The current revision of the SN EN ISO 15883-1 is from 2025, which reflects the latest updates and enhancements made to the standard since its previous iteration. Key changes include updated performance requirements based on recent technological advancements and improved validation procedures to ensure greater reliability in cleaning processes. The standard is published by the International Organization for Standardization (ISO) with contributions from the European Committee for Standardization (CEN) and is aligned with the regulations outlined in the EU Regulation 2017/745.