This document specifies the requirements for washer-disinfectors (WD) intended to be used for the cleaning and chemical disinfection, in a single operating cycle, of reusable items such as:
a) bed frames;
b) bedside tables;
c) transport carts;
d) containers;
e) surgical tables;
f) sterilization containers;
g) surgical clogs;
h) wheelchairs;
i) aids for persons with disabilities.
This document also specifies the performance requirements for the cleaning and disinfection of the WD and its components and accessories.
Devices identified within the scopes of ISO 15883-2, ISO 15883-3, ISO 15883-4, and ISO 15883-6 do not fall within the scope of this document.
In addition, this document specifies the methods for type testing, works testing, validation (installation, operation, and performance qualification on first installation), routine control, and monitoring, as well as requalifications to be carried out periodically and after essential repairs.
NOTE 1 WD covered by this document can also be used for cleaning and chemical disinfection of other thermolabile and reusable devices as recommended in the instructions for use (IFU) for those devices.
NOTE 2 The performance requirements specified in this document cannot ensure the inactivation or removal of the causative agent(s) (prion proteins) of transmissible spongiform encephalopathies.
Directives related to this standards.
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
PUBLISHED
SSH EN ISO 15883-7:2016
IN_DEVELOPMENT
prSSH EN ISO 15883-7:2025
40.20
DIS ballot initiated: 12 weeks
Feb 9, 2026
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