HTM 2030: SIWD Test Schedule

HTM 2030: Testing Surgical Instrument Washer Disinfectors
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 & Clean Strainers & Filters Etc. 7.0
Table 5b
           
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 10.50          
HTM 2030
Validation & Verification
Cleaning Efficacy by Residual Soil Detection 10.37            
HTM 2030
Validation & Verification
Cleaning Efficacy Test: Chamber Walls & Load Carriers 1 10.16        
HTM 2030
Validation & Verification
Cleaning Efficacy Test: Reference Load 1 10.20        
1: Cleaning efficacy test on Reference Load is performed directly after a successful cleaning efficacy test on Walls and Load Carriers - Ref: 10.20.
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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
HTM 2030
Validation & Verification
Automatic Control Test 1 12.4    
HTM 2030
Validation & Verification
Verification of Calibration of WD Instruments 1 9.311    
HTM 2030
Validation & Verification
Instrumentation: Legibility Section 3.0
Table 1
               
1: These tests can be performed at the same time - Ref: 9.312.
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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              
1: Also referred to as 'Additive Dosing Tests: Reproducibility' - Ref: Table 2b (No.11), and 'Chemical Dosing: Accuracy & Repeatability' - Ref: Table 1 (No.10).
2: 
Also referred to as 'Chemical Dosing: Low Level indicator' - Ref: Table 1 (No.10), and 'Chemical Additive Dosing Tests: Low Level Detection' - Ref: Table 2b (No.11).
3: 
Also referred to as 'Process Residuals- Ref: Table 1 (No.9), and 'Process Residues: Chemical Additives' - Ref: Table 4g (No.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
HTM 2030
Validation & Verification
Free Draining of Chamber & Load Carriers 9.38          
HTM 2030
Validation & Verification
Free Draining of Tanks 9.38          
HTM 2030
Validation & Verification
Pipework Flow to Discharge Point 9.38          
HTM 2030
Validation & Verification
Drainage: Efficacy of Discharge 9.40            
HTM 2030
Validation & Verification
Estimation of Dead Volume of Pipework 1 9.49            
HTM 2030
Validation & Verification
Drainage: Drain Seal Integrity 9.17            
1: Also referred to as 'Drainage: Pipework Residual Volume' - Ref: Table 2b (No.5)
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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
HTM 2030
Validation & Verification
Doors & Door Interlocks: Cycle Start Interlock 9.253        
HTM 2030
Validation & Verification
Doors & Door Interlocks: In-Cycle Interlock 1 9.257        
HTM 2030
Validation & Verification
Doors & Door Interlocks: Double Ended WDs 9.260          
HTM 2030
Validation & Verification
On Sensor Failure 9.264          
HTM 2030
Validation & Verification
Doors & Door Interlocks: Door Opening Force 9.266          
HTM 2030
Validation & Verification
Fault Indication on Sensor Failure 2 9.274          
HTM 2030
Validation & Verification
Failed Cycle Interlock 3 9.271          
HTM 2030
Validation & Verification
Drainage: Blocked Drain Protection 9.25            
HTM 2030
Validation & Verification
Doors & Interlocks: With Services Section 3.0
Table 1
               
1: Also referred to as 'Doors & Interlocks: Loading/Unloading' - Ref: Table 1 (No.8).
2: Also referred to as 'Fault Interlock' - Ref: Table 2b (No.8) and Table 5b (No.7).
3: 
Also referred to as 'On Fault Condition' - Ref: Table 1 (No.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
HTM 2030
Validation & Verification
Load Carriers: Fitting, Stability, Alignment, Force to Move, Effect in Cycle.  9.313            
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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
HTM 2030
Validation & Verification
Load Dryness Test 9.336          
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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
HTM 2030
Validation & Verification
Chamber Wall Temperature Test 1 9.317        
HTM 2030
Validation & Verification
Load Carrier Temperature Test 1 9.323        
HTM 2030
Validation & Verification
Over-Temperature Cut-Out Test 9.330          
HTM 2030
Validation & Verification
Thermometric Test for Thermal Disinfection
11.4      
1: These tests may be performed at the same time - Ref: 9.328.
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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
Appearance 1 9.100            
HTM 2030
Validation & Verification
pH 1 9.106           
HTM 2030
Validation & Verification
Electrical Conductivity 1  2 9.112      
HTM 2030
Validation & Verification
Total Dissolved Solids 1 9.123           
HTM 2030
Validation & Verification
Hardness 1  3 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
Volume of Water Used per Stage 9.245            
HTM 2030
Validation & Verification
Supply Temperature 9.89              
HTM 2030
Validation & Verification
Supply Pressure 9.94              
HTM 2030
Validation & Verification
Overflow Test 2.237              
1: Collectively known as 'Water System: Chemical Purity' - Ref: Table 2b (No.4). 
2: Also referred to as 'Water Conductivity (Final Rinse Stage)' - Ref: Table 5b (No.4).
3: 
Also referred to as 'Water Hardness (All Process Stages)' - Ref: Table 5b (No.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 2.290          
HTM 2030
Validation & Verification
Aerosol Discharge Test 9.298            
HTM 2030
Validation & Verification
Venting System: Steam Venting 1 9.57            
HTM 2030
Validation & Verification
Fluid Emission: Chamber Leak Proof Section 3.0
Table 1
             
1: Also referred to as 'Doors & Interlocks: Loading/Unloading' - Ref: Table 1 (No.13).
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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
Test for Air Quality 9.349          
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Electromagnetic Compatibility

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 1 9.360                
1: Also referred to as 'Electromagnetic Interference' - Ref: Table 1 (No.7).
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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 1  2 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 (No.6).
 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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