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STANDARD

Current

ÖNORM EN ISO 15883-1

Issue date: 2025 07 01

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. 2 Normative references The following
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General information on ÖNORM EN ISO 15883-1

Format
Paper | 100 Pages
Language
German | English | Download GER/ENG
Publisher
Austrian Standards International
Committee 215 Sterilization and disinfection of medical devices

Timeline

An overview of the development of ÖNORM EN ISO 15883-1 from 2006 til today.

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Normative References

Here you will find an extract of the normative references. Please refer to the document itself for the full list.

Dokumentnummer Titel Ausgabedatum Art
Dokumentnummer
ISO 10012:2003
Titel
Measurement management systems — Requirements for measurement processes and measuring equipment
Ausgabedatum
2003 04 14
Art
Standard
Zur Produktseite
Dokumentnummer
ISO 14644-3:2019
Titel
Cleanrooms and associated controlled environments — Part 3: Test methods (Corrected version 2020-06)
Ausgabedatum
2019 08 30
Art
Standard
Zur Produktseite
Dokumentnummer
ISO 14971:2019
Titel
Medical devices — Application of risk management to medical devices
Ausgabedatum
2019 12 10
Art
Standard
Zur Produktseite
Dokumentnummer
ISO 15883-2:2006
Titel
Washer-disinfectors — Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.
Ausgabedatum
2006 04 06
Art
Standard
Zur Produktseite
Dokumentnummer
ISO 15883-3:2006
Titel
Washer-disinfectors — Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers
Ausgabedatum
2006 04 06
Art
Standard
Zur Produktseite
Dokumentnummer
ISO 15883-4:2018
Titel
Washer-disinfectors — Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
Ausgabedatum
2018 11 12
Art
Standard
Zur Produktseite
Dokumentnummer
ISO 15883-5:2021
Titel
Washer-disinfectors — Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy
Ausgabedatum
2021 07 30
Art
Standard
Zur Produktseite
Dokumentnummer
ISO 15883-6:2011
Titel
Washer-disinfectors — Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment
Ausgabedatum
2011 04 12
Art
Standard
Zur Produktseite
Dokumentnummer
ISO 15883-7:2016
Titel
Washer-disinfectors — Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment
Ausgabedatum
2016 02 02
Art
Standard
Zur Produktseite
Dokumentnummer
ISO 7000:2019
Titel
Graphical symbols for use on equipment — Registered symbols
Ausgabedatum
2019 07 12
Art
Standard
Zur Produktseite

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