BS EN ISO 15883-1:2025

What is BS EN ISO 15883-1:2025 - Washer-disinfectors requirements about?

This document is the first in an international series on performance requirements for washer-disinfectors that are used to clean and disinfect reusable medical devices. BS EN ISO 15883-1:2025 specifies the general requirements for performance that apply to all washer-disinfectors.

Who is BS EN ISO 15883-1:2025 - Washer-disinfectors requirements for?

• Manufacturers of washer-disinfectors
• Specifiers and purchasers of washer-disinfectors, typically in:
• Laboratories
• Healthcare
• Veterinary practices
• Dental practices
• Pharmaceutical practices

What does BS EN ISO 15883-1:2025 - Washer-disinfectors requirements cover?

BS EN ISO 15883-1:2025 specifies general performance requirements for washer-disinfectors and their accessories that are intended to be used for the 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. 

BS EN ISO 15883-1:2025 also specifies the methods and instrumentation required for validation, routine control and monitoring, and requalification, periodically and after essential repairs.

NOTE 1: This document does not include requirements for machines intended to sterilize the load, or which are designated as “sterilizers”, these are specified in other standards, e.g. BS EN 285.

NOTE 2: The specified performance requirements of this standard do not ensure the inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies. If it is considered that prion protein can be present, particular care is needed in the choice of cleaning agents and disinfectants to ensure that the chemicals used do not react with the prion protein in a manner that can inhibit its removal or inactivation. 

Why should you use BS EN ISO 15883-1:2025 - Washer-disinfectors requirements?

• It sets internationally agreed performance standards for washer-disinfectors
• It supplies the basis for agreed specifications between prospective purchasers and manufacturers of washer-disinfectors
• Its test methods allow users to demonstrate continued conformity to performance requirements throughout the service life of a washer-disinfector
• It can help improve the efficiency of manufacture and operation of washer-disinfectors
• It can help increase confidence in the efficacy of washer-disinfectors in operation
• It can help manage risk in relation to washer-disinfectors

What’s new about BS EN ISO 15883-1:2025?

This is a revision of BS EN ISO 15883-1:2006. The main changes in BS EN ISO 15883-1:2025 are: 
a) Incorporation of ISO 15883-1:2006/Amd1:2014
b) Alignment of terms and definitions with BS EN ISO 11139:2018
c) Addition of requirements for load carrier(s)
d) Clarification of water quality requirements
e) Relocation of former Annex C, Test methods for the detection and assessment of residual proteinaceous contamination, to BS EN ISO 15883-5:2021
f) Redesignation of former Annex D, Microbiological recovery medium for estimation of bacterial contamination of water, as Annex C
g) Increase in the minimum temperature limit for thermal disinfection and calculation of A0 values from 65 °C to 70 °C
h) Revision of the Bibliography