ISO 15883-1:2006 - $209.00   BUY NOW

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

ISO 15883-1:2006 Publication Description:

ISO 15883-1:2006 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 ISO 15883. For washer-disinfectors intended to process loads of two or more different types the requirements of all relevant parts of this standard apply.

ISO 15883-1:2006 does not specify requirements intended for machines for use for laundry or general catering purposes.

ISO 15883-1:2006 does not include requirements for machines which are intended to sterilize the load, or which are designated as "sterilizers", these are specified in other standards e.g. EN 285.

The specified performance requirements of this standard may not ensure the inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies.

ISO 15883-1:2006 may be used by prospective purchasers and manufacturers as the basis of agreement on the specification of a WD. The test methods for demonstration of compliance with the requirements of ISO 15883-1:2006 may also be employed by users to demonstrate continued compliance of the installed WD throughout its working life. Guidance on a routine test programme also is given.

International Classification for Standards (ICS)

ICS Classification Field ICS Field Sub-Group and Number
ICS-11-Health ICS Sterilizing Equipment (11.080.10)

ICS Related Standards

Cart Document Number Document Title
$19.00 ISO 15883-1:2006/Amd1:2014 - Amendment 1
$68.00 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.
$68.00 ISO 15883-3:2006 Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers
$185.00 ISO 15883-4:2008 Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
$209.00 ISO/TS 15883-5:2005 Washer-disinfectors - Part 5: Test soils and methods for demonstrating cleaning efficacy
$68.00 ISO 15883-6:2011 Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment
$162.00 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
$49.00 JIS K 3824:2012 Testing methods for determining endotoxin rejection of ultrafiltration modules