1 Scope
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 reusable
items such as the following:
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a) bedframes;
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b) bedside tables;
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c) transport carts;
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d) containers;
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e) surgical tables;
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f) sterilization containers;
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g) surgical clogs;
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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 requalifications required to be carried out periodically and after essential
repairs.
NOTE WDs corresponding to this part of ISO 15883 can also be used for cleaning and chemical disinfection of other thermolabile and
reusable devices as recommended by the device manufacturer.
The performance requirements specified in this part of ISO 15883 may not ensure the inactivation or removal of the causative agent(s) (prion proteins)
of Transmissible Spongiform Encephalopathies.