Need help?

EN ISO 15883-6:2026 Standard

wave
Save  

  Keywords:

#document #wd #can #specifies #particular

  Directive

Medical devices Regulation ((EU) 2017/745)

  Last Official Journal reference

Monday 9th of November 2026

  Description:

Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-critical medical devices and health care equipment (ISO 15883-6:2026)

  Purpose

This document specifies particular requirements for washer-disinfectors (WD) intended for use when the level of assurance of disinfection that is necessary can be achieved by cleaning and thermal disinfection (A0 not less than 60) and does not require an independent automated record of critical processes to be kept. It is intended to be used in conjunction with ISO 15883-1, which specifies general requirements for WD. The range of products on which WD of this particular type can be used is restricted to non-invasive and non-critical devices and equipment (i.e. not penetrating skin or contacting mucosal surfaces). NOTE Thermal disinfection can be achieved by rinsing the load with hot water, exposure to steam, or combination of the two. This document does not cover powered devices, lumened devices, and other semi-critical and critical medical devices. Devices identified within the scopes of ISO 15883-2, ISO 15883-3, ISO 15883-4, and ISO 15883-7 do not fall within the scope of this document.

  Publication

Monday 9th of November 2026

  Related Standards

EN 285:2015+A1:2021

Medical devices Regulation ((EU) 2017/745)

Sterilization - Steam sterilizers - Large sterilizers

EN ISO 10993-9:2021

Medical devices Regulation ((EU) 2017/745)

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation produc...

EN ISO 10993-12:2021

Medical devices Regulation ((EU) 2017/745)

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)

EN ISO 11135:2014

Medical devices Regulation ((EU) 2017/745)

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a ste...

EN ISO 11135:2014/A1:2019

Medical devices Regulation ((EU) 2017/745)

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a ste...

EN ISO 11737-1:2018

Medical devices Regulation ((EU) 2017/745)

Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on produ...

  Stay up to date

  ACCESS

Search for a standard
GO

Register

Already a member?
Login

  OTHER APPLICATIONS

If you are interested in DO160 tests, you can give a try to our other free of charge software:
CE-Marking assistant, Version: 1.3.0