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EN ISO 15883-2:2025 Standard

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  Keywords:

#document #requirements #specified #critical #used

  Directive

Medical devices Regulation ((EU) 2017/745)

  Last Official Journal reference

Thursday 11th of June 2026

  Description:

Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for critical and semi-critical medical devices (ISO 15883-2:2024)

  Purpose

This document specifies requirements for washer-disinfectors (WD) that are intended for use for the cleaning and thermal disinfection, in a single operating cycle, of reusable critical and semi-critical medical devices, such as surgical instruments, anaesthetic equipment, and any non-critical devices used in conjunction with critical and semi-critical medical devices, such as bowls, dishes and receivers, utensils and glassware. This document is intended to be used in conjunction with the general requirements specified in ISO 15883-1:2024, except those specified in 4.1.1. NOTE The specified performance requirements of this document cannot ensure the inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies.

  Publication

Thursday 11th of June 2026

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