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ISO/FDIS 15883-7

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Washer-disinfectors — Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-critical thermolabile medical devices and health care equipment

Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Superseded date

06-03-2025

Language(s)

English, French

Published date

12-12-2024

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:

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 ISO15883-2, ISO15883-3, ISO15883-4, and ISO15883-6 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.

Committee
ISO/TC 198
DocumentType
Draft
Pages
34
PublisherName
International Organization for Standardization
RevisionOf
Status
Superseded

€149.00
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