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99/124125 DC : DRAFT NOV 1999

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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

Superseded date

31-05-2006

Published date

23-11-2012

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

BS EN ISO 15883-1.

Committee
LBI/35/7
DocumentType
Draft
PublisherName
British Standards Institution
Status
Superseded
SupersededBy

Standards Relationship
PREN ISO 15883-1 : DRAFT 1999 Identical

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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