Skip to main content

ISO 15883-1:2024

Current Date published:

Washer-disinfectors — Part 1: General requirements, terms and definitions and tests

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.

Get this standard Prices exclude GST
PDF ( Single user document)
$386.00 NZD
HardCopy
$430.00 NZD
Networkable PDF
Price varies
Preview only close
Prev {{ page }}/ {{ numPages }} Next
Preview only close
Prev {{ page }}/ {{ numPages }} Next
Pages: 73

Previous versions

Keep me up-to-date

Sign up to receive updates when there are changes to this standard

Related Information

Similar Standards

  • BS 2646-1:2021

    Autoclaves for sterilization in laboratories, Design, construction, safety and performance. Specification

  • BS 2646-2:2023

    Autoclaves for sterilization in laboratories, Planning and installation. Code of practice

  • BS 2646-2:2023 - TC

    Tracked Changes. Autoclaves for sterilization in laboratories, Planning and installation. Code of practice

  • BS 2646-3:2023

    Autoclaves for sterilization in laboratories, Safe use and operation. Code of practice

Preview only close
Prev {{ page }}/ {{ numPages }} Next
Preview only close
Prev {{ page }}/ {{ numPages }} Next
Pages: 73

Previous versions

ISO 15883-1:2024

Get this standard Prices exclude GST
PDF ( Single user document)
$386.00 NZD
HardCopy
$430.00 NZD
Networkable PDF
Price varies

Request to add this standard to your subscription

ISO 15883-1:2024

Price varies
Online library subscription

Your organisation’s Account Administrator must approve a request to add a standard to your subscription.

You may add a comment to the administrator below.

Cancel