HTM 2030: EWD Test Schedule

HTM 2030: Endoscope Washer Disinfector
Installation, Commissioning and Periodic Test Schedule.

Below is the HTM 2030 installation, commissioning and periodic test schedule for surgical instrument washer disinfectors.

Manufacturer schedules take precedent over the schedule from HTM 2030. 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 Test Person (Sterilisers)*.

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

* Please Note: Although HTM 2030 does not cover sterilisers, Test Person (Sterilisers) is still the term used by the standard to describe a qualified test engineer - Ref: HTM 2030: Validation & Verification Section 1.28.

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
HTM 2030
Validation & Verification
Remove and Clean Strainers and Filters etc. 7.0
Table 5e
               
HTM 2030
Validation & Verification
Weekly Safety Checks 7.8        
HTM 2030
Validation & Verification
Yearly Safety Checks 7.10                
Back to Testing Categories | Table Key
Cleaning Efficacy

Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
HTM 2030
Validation & Verification
Residual Soil Detection: Visual Inspection 1 10.50          
HTM 2030
Validation & Verification
Cleaning Efficacy Test by Residual Soil Detection 10.37            
HTM 2030
Validation & Verification
Cleaning Efficacy Test: Chamber Walls & Load Carriers 2 10.16        
HTM 2030
Validation & Verification
Cleaning Efficacy Test: Reference Load 2 10.20        
1: This test is not scheduled within the document.
2: Cleaning efficacy test on Reference Load is performed directly after a successful cleaning efficacy test on Walls and Load Carriers - Ref: 10.20 (Validation & Verification).
 Back to Testing Categories | Table Key
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
HTM 2030
Validation & Verification
Automatic Control Test 1 12.4      
HTM 2030
Validation & Verification
Verification of Calibration 1 9.311    
HTM 2030
Validation & Verification
Instrumentation: Legibility Section 3
Table 1
               
1: These tests can be performed at the same time - Ref: Section 9.312 (Validation & Verification).
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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
HTM 2030
Validation & Verification
Chemical Dosing: Reproducibility of Volume Admitted 1  9.279        
HTM 2030
Validation & Verification
Chemical Dosing: Indication of Insufficient Chemical Additives 2 9.285          
HTM 2030
Validation & Verification
Residual Chemical Additives 3 9.343              
HTM 2030
Validation & Verification
Disinfectant Concentration Test 17.23            
1: Also referred to as 'Chemical Dosing: Accuracy and Repeatability' - Ref: Table 1 (Validation & Verification).
2: Also referred to as 'Chemical Dosing: Low Ievel Indicator'
 - Ref: Table 1 (Validation & Verification).
3: 
Also referred to as 'Process Residuals' - Ref: Table 1 (Validation & Verification).
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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
HTM 2030
Validation & Verification
Free Draining (Tanks) 1 9.38          
HTM 2030
Validation & Verification
Free Draining (Chamber and Load Carriers) 1 9.38          
HTM 2030
Validation & Verification
Free Draining (Pipework) 1 9.38          
HTM 2030
Validation & Verification
Estimation of Dead Volume of Pipework 2 9.49          
1: Also collectively referred to as 'Pipework: Free Draining' - Ref: Table 1 (Validation & Verification), and 'Drainage: Free Draining' - Ref: Table 2e and Table 5e (Validation & Verification).
2: Also referred to as 'Pipework: Residual Volume' - Ref: Table 1 (Validation & Verification), and 'Drainage: Pipework Residual Volume' - Ref: Table 2e and Table 5e (Validation & Verification).
Back to Testing Categories | Table Key
Doors, Interlocks
& Fault Indications
Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
HTM 2030
Validation & Verification
Blocked Drain Protection 9.25            
HTM 2030
Validation & Verification
Cycle Start Interlock 1 9.253        
HTM 2030
Validation & Verification
In-Cycle Interlock 2 9.257        
HTM 2030
Validation & Verification
On Sensor Failure 9.264          
HTM 2030
Validation & Verification
Door Opening Force 9.266          
HTM 2030
Validation & Verification
Failed Cycle Interlock 3 9.271            
HTM 2030
Validation & Verification
Fault Indication on Sensor Failure 9.274          
HTM 2030
Validation & Verification
Doors and Door Interlocks: With Services Section 3
Table 1
               
1: Also referred to as 'Doors and Interlocks: Cycle Start' - Ref: Table 1 (Validation & Verification).
2: 
Also referred to as 'Doors and Interlocks: Loading/Unloading' - Ref: Table 1 (Validation & Verification).
3: 
Also referred to as 'On Fault Condition' - Ref: Table 1 (Validation & Verification).
Back to Testing Categories | Table Key
Leak, Disconnection
& Channel Patency
Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
HTM 2030
Validation & Verification
Channel Patency Test 17.19      
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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
HTM 2030
Validation & Verification
Load Carriers 1 9.313            
1: Also referred to as 'Load Carriers: Fitting, Stability, Alignment, Force to Move, Effect in Cycle' - Ref: Table 1 (Validation & Verification).
Back to Testing Categories | Table Key
Load Dryness

Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
HTM 2030
Validation & Verification
Load Dryness 9.336          
Back to Testing Categories | Table Key
Disinfection During Routine Cycle

Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
HTM 2030
Validation & Verification
Thermometric Test for Disinfection 11.4      
HTM 2030
Validation & Verification
Microbiological Test of Disinfection Efficacy 1  2 17.41          
1: Microbiological testing should not be performed until a successful test of the self-disinfection cycle has been carried out - Ref: 17.41 (Validation & Verification).
2: 
Microbiological testing should not be performed until a successful thermometric test of the disinfection cycle has been carried out - Ref: 17.42 (Validation & Verification).
Back to Testing Categories | Table Key
Thermometric Self-Disinfection Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
HTM 2030
Validation & Verification
Chamber Wall Temperature 1 9.317        
HTM 2030
Validation & Verification
Load Carrier Temperature 1 9.232        
HTM 2030
Validation & Verification
Over-Temperature Cut-Out 9.330          
1: These tests may be performed at the same time - Ref: 9.328 (Validation & Verification).
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Chemical Self-Disinfection Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
HTM 2030
Validation & Verification
WD Self-Disinfection Test (Chemical) 17.3          
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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
HTM 2030
Validation & Verification
Load Contamination from Ductwork 9.61          
HTM 2030
Validation & Verification
Water Vapour Emission 9.290                
HTM 2030
Validation & Verification
Chemical Vapour Emission 9.308          
HTM 2030
Validation & Verification
Fluid Emission: Chamber Leak-Proof Section 3
Table 1
             
HTM 2030
Validation & Verification
Pipework: Venting System Section 3
Table 1
               
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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
HTM 2030
Validation & Verification
Water Supply Temperature 9.89              
HTM 2030
Validation & Verification
Water Supply Pressure 9.94              
HTM 2030
Validation & Verification
Appearance 1 9.100            
HTM 2030
Validation & Verification
pH 1 9.106          
HTM 2030
Validation & Verification
Electrical Conductivity 1 9.112      
HTM 2030
Validation & Verification
Total Dissolved Solids 1 9.123          
HTM 2030
Validation & Verification
Hardness 1 9.140    
HTM 2030
Validation & Verification
Chloride 1 9.153          
HTM 2030
Validation & Verification
Heavy Metals 1 9.164          
HTM 2030
Validation & Verification
Iron 1 9.167          
HTM 2030
Validation & Verification
Phosphate 1 9.176          
HTM 2030
Validation & Verification
Silicate 1 9.188          
HTM 2030
Validation & Verification
Bacterial Endotoxins 9.201          
HTM 2030
Validation & Verification
Total Viable Count 9.213      
HTM 2030
Validation & Verification
Environmental Mycobacteria 9.227          
HTM 2030
Validation & Verification
Overflow Test 9.237              
HTM 2030
Validation & Verification
Volume of Water used per Stage 9.245            
HTM 2030
Validation & Verification
Final Rinse Decontamination Test 17.16          
1: Known collectively as 'Water System: Chemical Purity' - Ref: Table 2e and Table 5e (Validation & Verification).
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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
HTM 2030
Validation & Verification
Air Quality 9.349          
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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
HTM 2030
Validation & Verification
Electromagnetic Compatibility 9.360                
1: Also referred to as 'Electromagnetic Interference' - Ref: Table 1 (Validation & Verification).
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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
HTM 2030
Validation & Verification
Sound Pressure Test 1 9.353            
1: Please Note: Although the standard lists this as an OQ by the Test Person, the standard also states that this test is only performed by the manufacturer to BS 4196 Part 6 during Type Tests (Ref HTM 2030 Validation & Verification Section 9.353 and 9.357). Therefore it is unlikely to be required at installation, commissioning or periodically. If in doubt, manufacturer instructions should be obtained.
2: 
Also referred to as 'Sound Power' - Ref: Table 1 (Validation & Verification).
 Back to Testing Categories | Table Key
Table Key

Validation Test Abbreviations
TT Type Test By the manufacturer during the machine design stage. HTM 2030 Ref: 3.1
Validation & Verification
WT Works Test By the manufacturer prior to releasing the machine. HTM 2030 Ref: 2.21
Validation & Verification
IQ Installation Qualification By the manufacturer, contractor or supplier on delivery. HTM 2030 Ref: 2.26
Validation & Verification
OQ Operational Qualification By the TP(S) after IQ. HTM 2030 Ref: 2.31
Validation & Verification
PQ Performance Qualification By the TP(S) after IQ and OQ. HTM 2030 Ref: 2.33
Validation & Verification
D Daily Periodic By the User or by delegation to the Operator. HTM 2030 Ref: 2.46
Validation & Verification
W Weekly Periodic By the User (or Operator) or TP(S). HTM 2030 Ref: 2.46
Validation & Verification
Q Quarterly Periodic By the TP(S). HTM 2030 Ref: 2.46
Validation & Verification
Y Yearly Periodic By the TP(S). HTM 2030 Ref: 2.46
Validation & Verification
Validation Contacts, Personnel & Miscellaneous Abbreviations
MAN Manufacturer The manufacturer of the machine. HTM 2030 Ref: 1.36
Validation & Verification
SUP Supplier The supplier of the machine.
Often also the manufacturer.
HTM 2030 Ref: 1.37
Validation & Verification
CON Contractor Hired to perform IQ.
Often also the manufacturer.
HTM 2030 Ref: 1.37
Validation & Verification
USER User Has final responsibility for machine performance/operation. HTM 2030 Ref: 1.24
Validation & Verification
TP(S) Test Person (Sterilisers) A qualified engineer and test person in decontamination. HTM 2030 Ref: 1.28
Validation & Verification
OPT Optional Test The standard states that this is an optional test requirement. N/A
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