CEN EN ISO 15883-6 Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for noninvasive, non-critical medical devices and healthcare equipment
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European Committee for Standardization
Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for noninvasive, non-critical medical devices and healthcare equipment
N EN ISO 15883-6
Annotation
This part of ISO 15883 specifies particular requirements for washer-disinfectors (WDs) intended for use when the level of assurance of disinfection that is necessary can be achieved by cleaning and thermal disinfection (A0 not less than 60) and does not require an independent automated record of critical processes to be kept. It is intended to be used in conjunction with ISO 15883-1, which gives general requirements for WDs.
The range of products on which WDs of this particular type can be used is restricted to devices and equipment which are non-invasive and non-critical (i.e. not penetrating skin or contacting mucosal surfaces).
NOTE Thermal disinfection can be achieved by rinsing the load with hot water, exposure to steam or combination of the two.
Автоматический перевод:
Дезинфекционные аппараты моечной машины - Часть 6: Требования и испытания на дезинфекционные аппараты моечной машины, использующие тепловую дезинфекцию для неразрушающих, некритических медицинских устройств и оборудования для здравоохранения
Эта часть ISO 15883 определяет конкретные требования для дезинфекционных аппаратов моечной машины (WDs), предназначенный для использования, когда уровень гарантии дезинфекции, которая необходима, может быть достигнут путем очистки и тепловая дезинфекция (A0 не меньше чем 60) и не требует, чтобы независимый автоматизированный учет критических процессов был сохранен. Это предназначается, чтобы использоваться в сочетании с ISO 15883-1, дающей общие требования для WDs.



