EN ISO 15883-6:2015
Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment (ISO 15883-6:2011)

Standard No.
EN ISO 15883-6:2015
Release Date
2015
Published By
European Committee for Standardization (CEN)
Latest
EN ISO 15883-6:2015
Replace
FprEN ISO 15883-6:2011
Scope
This part of ISO 15883 specifies specific requirements for washer-disinfectors (RDGs) intended for use when the required level of disinfection safety can be achieved by cleaning and thermal disinfection (A0 not less than 60) and it is not necessary maintain an independent automated record of critical processes. It is intended to be used together with ISO 15883-1, which specifies general requirements for RGD. The range of products on which RDGs of this type can be applied is limited to products and accessories that are non-invasive and non-critical (ie, do not penetrate the skin or come into contact with mucosal surfaces). NOTE Thermal disinfection can be achieved by rinsing the load with hot water, by exposure to steam, or by a combination of both.

EN ISO 15883-6:2015 Referenced Document

  • 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. (ISO 15883-2:2006)
  • EN ISO 15883-3:2009 Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO 15883-3:2006)
  • EN ISO 15883-4:2009 Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
  • IEC 61010-2-040:2015 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
  • ISO 15883-1:2006 Washer-disinfectors - Part 1: General requirements, terms and definitions and tests
  • ISO/TS 15883-5:2005 Washer-disinfectors - Part 5: Test soils and methods for demonstrating cleaning efficacy

EN ISO 15883-6:2015 history

  • 2015 EN ISO 15883-6:2015 Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment (ISO 15883-6:2011)
  • 2011 EN 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



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