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EVS-EN ISO 15883-1:2009

Washer-disinfectors - Part 1: General requirements, terms and definitions and tests

General information
Valid from 03.12.2009
Base Documents
ISO 15883-1:2006; EN ISO 15883-1:2009
Directives or regulations
93/42/EEC Medical devices (MDD)
Standard history
Status
Date
Type
Name
This part of ISO 15883 specifies general performance requirements for washer-disinfectors (WD) and their accessories that are intended to be used for cleaning and disinfection of re-usable medical devices and other articles used in the context of medical, dental, pharmaceutical and veterinary practice. It specifies performance requirements for cleaning and disinfection as well as for the accessories which can be required to achieve the necessary performance. The methods and instrumentation required for validation, routine control and monitoring and re-validation, periodically and after essential repairs, are also specified. The requirements for washer-disinfectors intended to process specific loads are specified in subsequent parts of this standard. For washer-disinfectors intended to process loads of two or more different types the requirements of all relevant parts of this standard apply.
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Amendment

EVS-EN ISO 15883-1:2009/A1:2014

Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006/Amd 1:2014)
Newest version Valid from 04.08.2014
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EVS-EN ISO 15883-2:2009

Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.
Newest version Valid from 03.12.2009
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EVS-EN ISO 15883-4:2009

Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
Withdrawn from 03.01.2019
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CEN ISO/TS 15883-5:2005

Washer-disinfectors - Part 5: Test soils and methods for demonstrating cleaning efficacy
Newest version Valid from 01.02.2006