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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BS EN ISO 15883-1 - WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, DEFINITIONS AND TESTS
31-05-2006
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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