DIN EN ISO 15883-4:2009
Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2008); English version of DIN EN ISO 15883-4:2009-09

Standard No.

DIN EN ISO 15883-4:2009

Release Date

2009

Published By

German Institute for Standardization

Status

Be replaced 2016-07

Replace By

DIN EN ISO 15883-4:2016

Latest

DIN EN ISO 15883-4:2019-06

Replace

DIN EN ISO 15883-4:2008 DIN EN ISO 15883-4/A1:2009

Scope

This part of ISO 15883 specifies the particular requirements, including performance, for washer-disinfectors (WDs) that are intended to be used for cleaning and chemical disinfection of tnermolabile endoscopes. This part of ISO 15883 also specifies the performance requirements for the cleaning and disinfection of the washer-disinfector and its components and accessories which may be required to achieve the necessary performance. The methods, instrumentation and instructions required for type testing, works testing, validation (installation, operational and performance qualification on first installation), routine control and monitoring and re-validation. periodically and after essential repairs, are also specified. NOTE 1 In addition, Annex A gives guidance on an appropriate division of responsibility for the range of activities covered by this part of ISO 15883. NOTE 2 WDs complying with this part of ISO 15883 can also be used for cleaning and chemical disinfection of other thermolabile re-usable medical devices for which the device manufacturer has recommended this method of disinfection WDs complying with the requirements of this part of ISO 15883 are not intended for cleaning and disinfection of medical devices, including endoscopic accessories, which are heat stable and can be disinfected or sterilized by thermal methods (see ISO 15883-1:2006, 4.1.5). The specified performance requirements of this part of ISO 15883 may not ensure the inactivation or removal of the causative agent(s) (priori protein) of transmissible spongiform encephalopathies. NOTE 3 If it is considered that priori protein might be present, particular care is needed in the choice of disinfectants and cleaning agents to ensure that the chemicals used do not react with the prion protein in a manner that may inhibit its removal or inactivation from the load or washer-disinfector. This part of ISO 15883 can be used by prospective purchasers and manufacturers as the basis of agreement on the specification of WD manufacturers of endoscopes, cleaning products, disinfecting products, and also by users.

DIN EN ISO 15883-4:2009 Referenced Document

• ISO 11731-2 Water quality - Detection and enumeration of Legionella - Part 2: Direct membrane filtration method for waters with low bacterial counts
• ISO 15883-1:2006 Washer-disinfectors - Part 1: General requirements, terms and definitions and tests

DIN EN ISO 15883-4:2009 history

• 2019 DIN EN ISO 15883-4:2019-06 Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2018); German version EN ISO 15883-4:2018
• 2019 DIN EN ISO 15883-4:2019 Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2018)
• 2016 DIN EN ISO 15883-4:2016 Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO/DIS 15883-4:2016); German and English version prEN ISO 15883-4:2016
• 2009 DIN EN ISO 15883-4:2009 Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2008); English version of DIN EN ISO 15883-4:2009-09
• 2008 DIN EN ISO 15883-4:2008 Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2008); German version EN ISO 15883-4:2008