BS EN ISO 15883: SIWD Test Schedule

BS EN ISO 15883: Surgical Instrument Washer Disinfector
Installation, Commissioning and Periodic Test Schedule.

Below is the BS EN ISO 15883 installation, commissioning and periodic test schedule for surgical instrument washer disinfectors.

Manufacturer schedules take precedent over the schedule from BS EN ISO 15883. If no information is available from the manufacturer then the schedule below should be followed.

Type Tests and Works Tests are carried out by the Manufacturer.

Installation and commissioning (IQ OQ PQ) is carried out by either the equipment Supplier or a qualified Service Engineer.

Periodic testing is carried out routinely by the User or qualified Service Engineer.

Testing Categories

Tests, References and Schedules

A key to the various abbreviations used can be found at the bottom of this page.

Cleaning Efficacy

Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
BS EN ISO 15883
Part 1
Cleaning Efficacy
Test 2: Visual
6.10.3        
BS EN ISO 15883
Part 1
Cleaning Efficacy
Test 2: Annex C
6.10.3
See Annex C
     
BS EN ISO 15883
Part 1
Cleaning Efficacy
Test 1: Chamber, Load Carrier, Load
6.10.2          
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Automatic Control Test
& Verification of Calibration
Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
BS EN ISO 15883
Part 1

Automatic Control
Test
 1

6.13                
BS EN ISO 15883
Part 1
Verification of Calibration
6.6.1        
BS EN ISO 15883
Part 1
Tests on instrumentation fitted to the WD:
Legibility
6.6.2                
1: Test method described but no test schedule provided within the document.
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Chemical Additives,
Reproducibility & Residues
Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
BS EN ISO 15883
Part 1
Chemical Dosing:
Accuracy and Repeatability
6.9.1        
BS EN ISO 15883
Part 1
Indication of Insufficient Process Chemical for a Cycle 1 6.9.2        
BS EN ISO 15883
Part 1
Process Residuals 6.10.4              
1: Also referred to as 'Chemical Dosing: Low Level Indicator' - Ref: Table A1 Section 7.2
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Free Drainage

Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
BS EN ISO 15883
Part 1
Free Draining of Chamber and Load Carriers 6.5.4.2          
BS EN ISO 15883
Part 1
Free Draining of Tanks 6.5.4.3            
BS EN ISO 15883
Part 1
Pipework Flow to Discharge Point 6.5.5            
BS EN ISO 15883
Part 1
Estimation of Dead Volume of Pipework 6.5.1               
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Doors, Interlocks
& Fault Indications
Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
BS EN ISO 15883
Part 1
Doors and Interlocks: Cycle Start Interlock 6.3.1        
BS EN ISO 15883
Part 1
Doors and Interlocks: Door Locking During Cycle  6.3.2        
BS EN ISO 15883
Part 1
Doors and Interlocks: Cycle Complete Door Interlocks 6.3.4        
BS EN ISO 15883
Part 1
Doors and Interlocks: Door Interlocks on Double-Ended WDs 6.3.3        
BS EN ISO 15883
Part 1
Doors and Interlocks: Fault Indication on Sensor Failure 6.3.5    
BS EN ISO 15883
Part 1
Doors and Interlocks: Fault Indication on Service Failure 6.3.6    
BS EN ISO 15883
Part 1
Doors and Interlocks: Failed Cycle Interlock 6.3.7    
BS EN ISO 15883
Part 1
Doors and Interlocks: Blocked Drain Protection 6.3.8                
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Load Carriers

Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
BS EN ISO 15883
Part 1
Load Carriers: Internal - Stability, Alignment, Fitting, Force to Move 6.7.1                
BS EN ISO 15883
Part 1
Trolleys 6.7.2                
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Load Dryness Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
BS EN ISO 15883
Part 1
Load Dryness 6.12  
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Thermometric Tests

Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
BS EN ISO 15883
Part 1
Thermometric:
Chamber Walls

6.8.3  
BS EN ISO 15883
Part 1
Thermometric:
Load Carrier
6.8.2    
BS EN ISO 15883
Part 1
Thermometric:
Load
6.8.2            
BS EN ISO 15883
Part 1
Load Temperature Protection 1 6.8.5      
1: Also referred to as 'Over-Temperature Cut-Out' - Ref: Table A1 Section 2.3
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Venting & Process Emissions

Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
BS EN ISO 15883
Part 1
Chamber Leak Tightness 1 6.5.3            
BS EN ISO 15883
Part 1
Venting 6.5.6                
BS EN ISO 15883
Part 1
Tests on Pipework:
Load Contamination from Ductwork of WD
 2
6.5.7                  
1: Also referred to as 'Fluid Emission: Chamber Leak Proof' - Table A1 Section 4
2: Test method described but no test schedule provided within the document
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Water Quality & Supply Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
BS EN ISO 15883
Part 1
Oxidizable Substances 6.4.2.2      
BS EN ISO 15883
Part 1
pH 6.4.2.2      
BS EN ISO 15883
Part 1
Conductivity 6.4.2.2      
BS EN ISO 15883
Part 1
Total Hardness
6.4.2.2       
BS EN ISO 15883
Part 1
Microbial Quality 6.4.2.4      
BS EN ISO 15883
Part 1
Total Dissolved Solids
6.4.2.2    
BS EN ISO 15883
Part 1
Chloride 6.4.2.2    
BS EN ISO 15883
Part 1
Inorganic Phosphate 6.4.2.2    
BS EN ISO 15883
Part 1
Bacterial Endotoxins 6.4.2.3    
BS EN ISO 15883
Part 1
Volume of Water used per Stage 1 6.4.4                  
1: Test method described but no test schedule provided within the document.
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Air Quality  Factory
Testing
 Installation
& Commissioning
Periodic
Testing 
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
BS EN ISO 15883
Part 1
Air Quality 6.11  
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Table Key

Validation Test Abbreviations
TT Type Test By the manufacturer during the machine design stage. BS EN ISO 15883
Part 1 Section 3.56
WT Works Test By the manufacturer prior to releasing the machine. BS EN ISO 15883
Part 1 Section 3.64
IQ Installation Qualification By the manufacturer/contractor/supplier or Service Engineer on delivery. BS EN ISO 15883
Part 1 Section 3.31
OQ Operational Qualification By the Service Engineer after IQ. BS EN ISO 15883
Part 1 Section 3.41
PQ Performance Qualification By the Service Engineer after IQ and OQ. BS EN ISO 15883
Part 1 Section 3.43
D Daily Periodic By the User or by delegation to the Operator. BS EN ISO 15883
Part 1 Table A1 Footnotes
W Weekly Periodic By the User (or Operator) or Service Engineer. BS EN ISO 15883
Part 1 Table A1 Footnotes
Q Quarterly Periodic By the Service Engineer. BS EN ISO 15883
Part 1 Table A1 Footnotes
Y Yearly Periodic By the Service Engineer. BS EN ISO 15883
Part 1 Table A1 Footnotes
Validation Contacts, Personnel & Miscellaneous Abbreviations 
MAN Manufacturer The manufacturer of the machine. Common abbreviation, no specific reference
SUP Supplier The supplier of the machine. Common abbreviation, no specific reference
CON Contractor Hired to perform IQ. Common abbreviation, no specific reference
USER User Has final responsibility for machine performance/operation. Common abbreviation, no specific reference
ENG Service Engineer Engineer certified by the service provider or manufacturer. Common abbreviation, no specific reference
OPT Optional Test The standard states that this is an optional test requirement. N/A
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