SN EN ISO 15883-1 : 2009 AMD 1 2014

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Performance requirements
   4.1 General
   4.2 Cleaning
   4.3 Disinfection
   4.4 Rinsing
   4.5 Drying
   4.6 Process chemicals
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 Load temperature protection
   5.9 Process temperature control limits
   5.10 Switches, gauges and indicating devices
   5.11 Process verification
   5.12 Instrumentation and controls
   5.13 Temperature indicating systems
   5.14 Pressure indicating systems
   5.15 Timing equipment
   5.16 Operating cycle indicating equipment
   5.17 Recording instruments (if fitted)
   5.18 Control systems
   5.19 Override of automatic control
   5.20 Microprocessor control systems
   5.21 Access to software
   5.22 Fault indication systems
   5.23 Water supply
   5.24 Venting and drainage systems
   5.25 Drainage
   5.26 Air filters installed within the WD
   5.27 Load handling and supports for use within the WD
   5.28 Trolleys
   5.29 Environment
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 and water volume
   6.5 Tests on pipework
   6.6 Tests on instrumentation fitted to the WD
   6.7 Tests on load carriers
   6.8 Thermometric tests
   6.9 Chemical dosing tests
   6.10 Tests of cleaning efficacy
   6.11 Tests of air quality
   6.12 Load dryness test
   6.13 Automatic control test
7 Documentation
8 Information to be supplied by the manufacturer
   8.1 General
   8.2 Before delivery of the WD and for installation
   8.3 At delivery of the WD
9 Marking, labelling and packaging
   9.1 Marking and labelling
   9.2 Packaging
10 Information to be requested from the purchaser by the
   supplier of the WD
Annex A (informative) - Test programme
Annex B (informative) - A[0] concept - Comparative lethality of
        moist heat processes
Annex C (normative) - Test methods for the detection and
        assessment of residual proteinaceous contamination
Annex D (normative) - Microbiological recovery medium for
        estimation of bacterial contamination of water
Annex ZA (informative) - Relationship between this European
                          Standard and the Essential Requirements
                          of EU Directive 93/42/EEC on medical
                          devices
Bibliography

Describes general performance requirements for washer-disinfectors (WD) 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.