• 99/124125 DC : DRAFT NOV 1999

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    BS EN ISO 15883-1 - WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, DEFINITIONS AND TESTS

    Available format(s): 

    Superseded date:  31-05-2006

    Language(s): 

    Published date:  23-11-2012

    Publisher:  British Standards Institution

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    Table of Contents - (Show below) - (Hide below)

    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
    Bibliography

    General Product Information - (Show below) - (Hide below)

    Comment Closes On
    Committee LBI/35/7
    Document Type Draft
    Publisher British Standards Institution
    Status Superseded
    Superseded By

    Standards Referencing This Book - (Show below) - (Hide below)

    BS 2745-3:1993 Washer-disinfectors for medical purposes Specification for washer-disinfectors except those used for processing human-waste containers and laundry
    IEC 60416:1988 General principles for the formulation of graphical symbols
    EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
    IEC 60073:2002 Basic and safety principles for man-machine interface, marking and identification - Coding principles for indicators and actuators
    EN 1441 : 1997 MEDICAL DEVICES - RISK ANALYSIS
    EN 46001 : 1996 QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9001
    PREN ISO 14644-2 : DRAFT 2010 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 2: SPECIFICATIONS FOR MONITORING AND PERIODIC TESTING TO PROVE CONTINUED COMPLIANCE WITH ISO 14644-1
    EN 1174-1 : 1996 STERILIZATION OF MEDICAL DEVICES - ESTIMATION OF THE POPULATION OF MICRO-ORGANISMS ON PRODUCT - REQUIREMENTS
    EN 866-1 : 1997 BIOLOGICAL SYSTEMS FOR TESTING STERILIZERS AND STERILIZATION PROCESSES - GENERAL REQUIREMENTS
    EN ISO 9001:2015 Quality management systems - Requirements (ISO 9001:2015)
    IEC 61010-2-045:2000 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-045: Particular requirements for washer disinfectors used in medical, pharmaceutical, veterinary and laboratory fields
    BS 2745-2:1993 Washer-disinfectors for medical purposes Specification for human waste container washer-disinfectors
    ISO 14644-1:2015 Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration
    IEC 60751:2008 Industrial platinum resistance thermometers and platinum temperature sensors
    ISO 9001:2015 Quality management systems — Requirements
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    IEC 60584-1:2013 Thermocouples - Part 1: EMF specifications and tolerances
    ISO 10012-1:1992 Quality assurance requirements for measuring equipment Part 1: Metrological confirmation system for measuring equipment
    ISO 228-1:2000 Pipe threads where pressure-tight joints are not made on the threads Part 1: Dimensions, tolerances and designation
    EN 554 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT
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