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ISO 15883-7:2016

Washer-disinfectors -- Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment

Üldinfo
Kehtiv alates 02.02.2016
Tegevusala (ICS grupid)
11.080.10 Steriliseerimisvahendid
Direktiivid või määrused
puuduvad
Standardi ajalugu
Staatus
Kuupäev
Tüüp
Nimetus
02.02.2016
Põhitekst
ISO 15883-7:2016 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: 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. ISO 15883-7:2016 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.
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ISO 15883-1:2006

Washer-disinfectors -- Part 1: General requirements, terms and definitions and tests
Uusim versioon Kehtiv alates 06.04.2006
Põhitekst

ISO 15883-2:2006

Washer-disinfectors -- Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.
Uusim versioon Kehtiv alates 06.04.2006
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ISO 15883-3:2006

Washer-disinfectors -- Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers
Uusim versioon Kehtiv alates 06.04.2006
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ISO/TS 15883-5:2005

Washer-disinfectors -- Part 5: Test soils and methods for demonstrating cleaning efficacy
Uusim versioon Kehtiv alates 23.11.2005