WHTM 01-01: SIWD Test Schedule

WHTM 01-01 Part D: Surgical Instrument Washer Disinfector
Installation, Commissioning and Periodic Test Schedule.

Below is the WHTM 01-01 installation, commissioning and periodic test schedule for surgical instrument washer disinfectors.

Manufacturer schedules take precedent over the schedule from WHTM 01-01 Part D. 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 Competent Person (Decontamination).

Periodic testing is carried out routinely by the User (or by delegation to the Operator), and also a qualified Competent Person (Decontamination).

Testing Categories

Tests, References and Schedules

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

Housekeeping and Safety Checks

Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
WHTM
01-01
Part D
Remove and Clean Strainers and Filters Etc. Section 2
Table 3
             
WHTM
01-01
Part D
Weekly Safety Checks 2.66          
WHTM
01-01
Part D
Yearly Safety Checks 2.68                
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Cleaning Efficacy

Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
WHTM
01-01
Part D
Cleaning Efficacy by Residual Soil 2.263                
WHTM
01-01
Part D
Cleaning Efficacy Test: Chamber Walls & Load Carriers 1 2.237        
WHTM
01-01
Part D
Cleaning Efficacy Test: Reference Load 1 2.242        
1: Cleaning efficacy test on Reference Load is performed directly after a successful cleaning efficacy test on Walls and Load Carriers - Ref: 2.247
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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
WHTM
01-01
Part D
Automatic Control Test 1 2.299      
WHTM
01-01
Part D
Verification of Calibration 1 2.176    
1: These tests can be performed at the same time - Ref: Section 2.177
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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
WHTM
01-01
Part D
Chemical Dosing: Reproducibility of Volume Admitted
 2.154        
WHTM
01-01
Part D
Indication of insufficient chemical additives 1  2 2.163        
WHTM
01-01
Part D
Residual Chemical Additives 3 2.206          
1: Only required for SIWD with automatic dosing of process chemicals - Ref: Table 1 (Footnote No.1)
2: Also referred to as 'Chemical Additive Dosing Tests: Low Level Detection' - Ref: Table 3
3: Also referred to as 'Process Residue Test'
 - Ref: Table 1 and Table 3
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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
WHTM
01-01
Part D
Free Draining (Chamber & Load Carriers) 2.85                  
WHTM
01-01
Part D
Free Draining (Tanks) 2.86
       
WHTM
01-01
Part D
Free Draining (Flow to Discharge Point) 2.87        
WHTM
01-01
Part D
Drainage: Efficacy of Discharge
2.88                
WHTM
01-01
Part D
Estimation of Dead Volume of Pipework
2.94                  
WHTM
01-01
Part D
Drainage: Drain Seal Integrity 2.75                  
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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
WHTM
01-01
Part D
Cycle Start Interlock 2.128            
WHTM
01-01
Part D
In-Cycle interlock 2.132        
WHTM
01-01
Part D
Double Door Washer Disinfectors 2.135          
WHTM
01-01
Part D
On Sensor Failure 2.139            
WHTM
01-01
Part D
Fault Indication on Sensor Failure 2.149          
WHTM
01-01
Part D
Failed Cycle interlock 2.146          
WHTM
01-01
Part D
Opening Force 2.141              
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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
WHTM
01-01
Part D
Load Carriers  2.178          
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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
WHTM
01-01
Part D
Load Dryness Test 2.204        
1: Only required if the SIWD has a drying stage - Ref: Table 1 (Footnote No.3)
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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
WHTM
01-01
Part D
Chamber Wall
Temperature
 1 2
2.182          
WHTM
01-01
Part D
Load Carrier
Temperature
 1 2
2.188          
WHTM
01-01
Part D
Over-Temperature Cut-Out 1 2.197        
WHTM
01-01
Part D
Thermometric Test for Disinfection 1 2.287      
1: Thermometric testing is only required if the SIWD has a thermal disinfection stage - Ref: Table 1 (Footnote No.2)
2: These tests may be performed at the same time - Ref: Section 2.200
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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
WHTM
01-01
Part D
Venting System: Load Contamination from Ductwork 2.102                
WHTM
01-01
Part D
Water Vapour Emissions 1 2.168                
1: Also referred to as 'Water Vapour Emissions Test' and 'Water Vapour Discharge Test' - Table 1 and Table 3
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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
WHTM
01-01
Part D
Water System: Appearance 3.93            
WHTM
01-01
Part D
pH 1 3.99          
WHTM
01-01
Part D
Electrical Conductivity 1  2 3.105        
WHTM
01-01
Part D
Water Hardness 1  3 3.117        
WHTM
01-01
Part D
Total Viable Count 1 3.145          
WHTM
01-01
Part D
Water Supply Temperature  3.81              
WHTM
01-01
Part D
Water Supply Pressure 3.87              
WHTM
01-01
Part D
Volume of Water Used per Stage 2.120            
WHTM
01-01
Part D
Total Dissolved Solids 4 A.1    
WHTM
01-01
Part D
Chloride 1 3.130          
WHTM
01-01
Part D
Heavy Metals 4 A.18    
WHTM
01-01
Part D
Iron 4 A.21    
WHTM
01-01
Part D
Phosphate 4 A.30    
WHTM
01-01
Part D
Silicate 4 A.41    
WHTM
01-01
Part D
Water System: Bacterial Endotoxins 3.141          
WHTM
01-01
Part D
Water System: Overflow Test 2.112            
1: These tests are collectively known as 'Water System: Chemical Purity' Ref - Table 1 and Table 3.
2: 
Also referred to as 'Water Conductivity (Final Rinse Stage)' - Table 1 and Table 3.
3: Also referred to as 'Water Hardness (All Process Stages)' - Table 1 and Table 3.
4: This test is generally deemed unnecessary periodically unless a specific process requires it to be performed in order to validate decontamination - Ref: Appendix 1, WHTM 01-01 Part D.
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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
WHTM
01-01
Part D
Air Quality 2.212          
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Electromagnetic Interference

Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
WHTM
01-01
Part D
Electromagnetic Compatibility 2.222                
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Sound Pressure

Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
WHTM
01-01
Part D
Sound Pressure Test 2.216                
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Table Key

Validation Test Abbreviations
TT Type Test By the manufacturer during the machine design stage. WHTM 01-01 Ref: 2.9
Part D
WT Works Test By the manufacturer prior to releasing the machine. WHTM 01-01 Ref: 4.12
Part B
IQ Installation Qualification By the manufacturer, contractor or supplier upon delivery. WHTM 01-01 Ref: 4.15
Part B
OQ Operational Qualification By the Competent Person (Decontamination) after IQ. WHTM 01-01 Ref: 4.22
Part B
PQ Performance Qualification By the CP(D) after IQ and OQ. WHTM 01-01 Ref: 4.25
Part B
D Daily Periodic By the User or by delegation to the Operator. WHTM 01-01 Ref: 4.48
Part B
W Weekly Periodic By the User (or Operator) or CP(D). WHTM 01-01 Ref: 4.48
Part B
Q Quarterly Periodic By the CP(D). WHTM 01-01 Ref: 4.48
Part B
Y Yearly Periodic By the CP(D). WHTM 01-01 Ref: 4.48
Part B
Validation Contacts, Personnel & Miscellaneous Abbreviations 
MAN Manufacture The manufacturer of the machine. WHTM 01-01 Ref: 4.11 (e) Part B
SUP Supplier The supplier of the machine.
Often also the manufacturer.
WHTM 01-01 Ref: 4.11 (e) Part B
CON Contractor Hired to perform IQ.
Often also the manufacturer.
WHTM 01-01 Ref: 4.11 (f) Part B
USER User Has final responsibility for machine performance/operation. WHTM 01-01 Ref: 4.11 (j) Part B
CP(D) Competent Person (Decontamination)     A qualified engineer and test person in decontamination. WHTM 01-01 Ref: 4.11 (d) Part B
OPT Optional Test     The standard states that this is an optional test requirement. N/A
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