Overview

At the suggestion of the DIN Working Committee, a new standardization project on the EN ISO 15883 series of standards "Washer-disinfectors" was launched under the auspices of CEN. The basis for the project is the DIN 58955 series of standards "Decontamination equipment for medical use". The EN ISO 15883-7 standard specifies requirements and test methods for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and accessories (for example, bedframes, sterilization containers, surgical clogs) in healthcare. The standard includes performance requirements for the cleaning and disinfection of the washer-disinfector and its components and accessories. Procedures, equipment and instructions are also specified. The washer-disinfectors specified in this standard shall not be used for products falling within the scope of DIN EN ISO 15883-2, DIN EN ISO 15883-3, DIN EN ISO 15883-4 and DIN EN ISO 15883-6. The relationship between clauses of the standard and the essential requirements of EC Directive 93/42/EEC on medical devices is shown in an informative annex. The International Standard has been prepared by ISO/TC 198 "Sterilization of health care products" in collaboration with CEN/TC 102 "Sterilizers for medical puroses" (secretariat: DIN, Germany). The responsible German committee is Working Committee NA 063-04-09 AA "Reinigungs-Desinfektionsgeräte" ("Washers-disinfectors") at DIN Standards Committee Medicine, which prepared the project in collaboration with Working Committee NA 063-04-03 AA "Desinfektionsapparate" ("Disinfection apparatus") at NAMed.

Document: references other documents

Document: referenced in other documents

Responsible national committee

NA 176-03-01 AA - Washer-disinfectors  

Responsible european committee

CEN/TC 102/WG 8 - Washer-disinfectors