ISO 15883-1:2006
Washer-disinfectors - Part 1: General requirements, terms and definitions and tests

Standard No.

ISO 15883-1:2006

Release Date

2006

Published By

International Organization for Standardization (ISO)

Status

Be replaced

Replace By

ISO 15883-1:2006/Amd 1:2014

Latest

ISO 15883-1:2006/Amd 1:2014

Scope

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. This part of ISO 15883 does not specify requirements intended for machines for use for laundry or general catering purposes. This part of ISO 15883 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. This part of ISO 15883 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 this part of ISO 15883 may also be employed by users to demonstrate continued compliance of the installed WD throughout its working life. Guidance on a routine test programme is given in Annex A.

ISO 15883-1:2006 Referenced Document

• IEC 60417-DB Graphical symbols for use on equipment
• IEC 60584-1:1995 Thermocouples - Part 1: Reference tables
• IEC 60751:1983 Industrial platinium resistance thermometer sensors
• IEC 80416-1 Basic principles for graphical symbols for use on equipment - Part 1: Creation of graphical symbols for registration*， 2008-11-01 Update
• ISO 10012 Measurement management systems - Requirements for measurement processes and measuring equipment
• ISO 14644-3:2005 Cleanrooms and associated controlled environments - Part 3: Test methods
• ISO 14971 Medical devices - Application of risk management to medical devices*， 2019-12-01 Update
• ISO 228-1 Pipe threads where pressure-tight joints are not made on the threads - Part 1: Dimensions, tolerances and designation
• ISO 7000 Graphical symbols for use on equipment — Index and synopsis*， 2019-07-12 Update
• ISO/TS 15883-5:2005 Washer-disinfectors - Part 5: Test soils and methods for demonstrating cleaning efficacy

ISO 15883-1:2006 history

• 2014 ISO 15883-1:2006/Amd 1:2014 Washer-disinfectors - Part 1: General requirements, terms and definitions and tests; Amendment 1
• 2006 ISO 15883-1:2006 Washer-disinfectors - Part 1: General requirements, terms and definitions and tests