Abstract

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 the following: 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 I5883-4, and ISO 15883 6 do not fall within the scope of this document. In addition, the methods are specified, as well as instrumentation and instructions required, for type testing, works testing, validation (installation, operation, and performance qualification on first installation), routine control, and monitoring, as well as requalifications required to be carried out periodically and after essential repairs.

Begin

2021-12-21

WI

00102167

Planned document number

DIN EN ISO 15883-7

Project number

06302131

Responsible national committee

NA 176-03-01 AA - Washer-disinfectors  

Responsible european committee

CEN/TC 102/WG 8 - Washer-disinfectors  

Responsible international committee

ISO/TC 198/WG 13 - Washer-disinfectors  

draft standard

Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-critical thermolabile medical devices and health care equipment (ISO/DIS 15883-7:2024); German and English version prEN ISO 15883-7:2024
2024-03
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previous edition(s)

Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment (ISO 15883-7:2016); German version EN ISO 15883-7:2016
2016-10

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