International Standard
ISO 15883-7:2025
Washer-disinfectors — Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-critical thermolabile medical devices and health care equipment
Reference number
ISO 15883-7:2025
Edition 2
2025-03
© ISO 2025
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Опубликовано (Версия 2, 2025)

ISO 15883-7:2025

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Тезис

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.

Общая информация

  • Текущий статус
     : Опубликовано
    Дата публикации
     : 2025-03
    Этап
    : Опубликование международного стандарта [60.60]
  • Версия
     : 2
  • Технический комитет :
    ISO/TC 198
    ICS :
    11.080.10 
  • RSS обновления

Жизненный цикл

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Данный стандарт разработан для достижения следующих Цель устойчивого развития

3
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