International Organization for Standardization

Washer-disinfectors - Part 7: Requirements and tests for washerdisinfectors employing chemical disinfection for non-invasive, noncritical thermolabile medical devices and healthcare equipment - First Edition
 N 15883-7

Annotation

This part of ISO 15883 specifies the particular requirements for washer-disinfectors (WD) intended to be used for the cleaning and chemical disinfection, in a single operating cycle, of re-usable items such as:

a) bedframes;

b) bedside tables;

c) transport carts;

d) containers;

e) surgical tables;

f) sterilization containers;

g) surgical clogs;

h) wheelchairs, aids for the disabled.

This Part of ISO 15883 also specifies the performance requirements for the cleaning and disinfection of the washer-disinfector and its components and accessories which may be necessary in order to achieve the required performance.

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 part of ISO 15883.

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 re-validations required to be carried out periodically and after essential repairs.