PREN ISO 15883-1 : DRAFT 1999

Foreword
Introduction
1 Scope
2 Normative References
3 Terms and Definitions
   3.1 A[0]
   3.2 automatic controller
   3.3 bed pan washer-disinfector
4 Performance Requirements
   4.1 General
   4.2 Cleaning
   4.3 Disinfection
   4.4 Rinsing
   4.5 Drying
5 Mechanical and process requirements
   5.1 Materials, design and manufacture/construction
   5.2 Safety
   5.3 Calorifiers and tanks
   5.4 Loading and unloading doors and their controls
   5.5 Pipework and fittings
   5.6 Spray systems
   5.7 Dosing systems
   5.8 Over-temperature cut-outs
   5.9 Switches, gauges and indicating devices
   5.10 Instrumentation and controls
   5.11 Temperature indicating systems
   5.12 Pressure indicating systems
   5.13 Timing equipment
   5.14 Operating cycle indicating equipment
   5.15 Recording instruments (if fitted)
   5.16 Control systems
   5.17 Override of automatic control
   5.18 Microprocessor control systems
   5.19 Access to software
   5.20 Fault indication systems
   5.21 Water supply
   5.22 Venting and drainage systems
   5.23 Drainage
   5.24 Air filters installed within the washer-disinfector
   5.25 Load handling and supports for use within the
        washer-disinfector
   5.26 External load handling systems
   5.27 Environment
   5.28 Table top machines
6 Testing for conformity
   6.1 General
   6.2 Test equipment
   6.3 Tests on doors, interlocks and fault indications
   6.4 Tests on water quality
   6.5 Tests on pipework
   6.6 Tests on instrumentation fitted to the washer-disinfector
   6.7 Tests on load carriers
   6.8 Thermometric tests
   6.9 Chemical dosing tests
   6.10 Tests of cleaning efficacy
   6.11 Microbiological testing
   6.12 Tests of air quality
   6.13 Load dryness test
   6.14 Automatic control test
7 Documentation and inspection
8 Information to be supplied by the manufacturer
9 Marking, labelling, packaging
10 Information to be requested from the purchaser by the manufacturer
Annex A (informative) A[0] concept; comparative lethality of
                       moist heat processes
Annex B (informative) Test soils currently in use
Annex ZA (informative) Clauses of this European Standard addressing
                       essential requirements or other provisions
                       of EU Directives

Specifies general performance requirements for washer-disinfectors 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. Specifies performance requirements for cleaning and disinfection as well as the accessories which may be required to achieve the necessary performance. Also specifies the methods and instrumentation required for validation, routine control and monitoring and re-validation, periodically and after essential repairs. Specifies the requirements for washer-disinfectors intended to process specific loads. Applicable to washer-disinfectors intended to process loads of two or more different types.