EN ISO 15883-7:2016

European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Performance requirements
5 Mechanical requirements
6 Testing for conformity
7 Documentation
8 Information to be provided by the manufacturer
9 Marking, labelling, and packaging
10 Information to be requested from the purchaser
   by the manufacturer
Annex A (normative) - Summary of test programmes
Annex B (normative) - Methods for microbiological
        evaluation of disinfection of liquid transport system
Annex C (normative) - Tests for microbiological
        contamination of post-disinfection rinse water
Annex D (normative) - Preparation and evaluation of
        indicators for microbiological testing of the efficacy
       of chemical disinfection of the load
Annex E (informative) - Examples of test locations for the
        tests with biological indicators
Bibliography
Annex ZA (informative) - Relationship between this
         European Standard and the essential
         requirements of Directive 93/42/EEC [OJ L 169]
         aimed to be covered

ISO 15883-7:2016 specifies the particular requirements for washer-disinfectors (WD) intended to be used for the cleaning and chemical disinfection, in a single operating cycle, of reusable items such as the following:a) bedframes;b) bedside tables;c) transport carts;d) containers;e) surgical tables;f) sterilization containers;g) surgical clogs;h) wheelchairs, aids for the disabled.ISO 15883-7:2016 also specifies the performance requirements for the cleaning and disinfection of the washer-disinfector and its components and accessories which may be necessary in order to achieve the required performance.Devices identified within the scopes of ISO 15883‑2, ISO 15883‑3, ISO I5883-4, and ISO 15883‑6 do not fall within the scope of this part of ISO 15883.In addition, the methods are specified, as well as instrumentation and instructions required for type testing, works testing, validation (installation, operation, and performance qualification on first installation), routine control, and monitoring, as well as requalifications required to be carried out periodically and after essential repairs.NOTE WDs corresponding to this part of ISO 15883 can also be used for cleaning and chemical disinfection of other thermolabile and reusable devices as recommended by the device manufacturer.The performance requirements specified in this part of ISO 15883 may not ensure the inactivation or removal of the causative agent(s) (prion proteins) of Transmissible Spongiform Encephalopathies.