HTM 2010: Clinical Large Porous Load Test Schedule

HTM 2010: Clinical Large Porous Load Steam Steriliser
Installation, Commissioning and Periodic Test Schedule.

Below is the HTM 2010 installation, commissioning and periodic test schedule for clinical large porous load steam sterilisers.

Manufacturer schedules take precedent over the schedule from HTM 2010. 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).

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 2010
Part 3: Validation & Verification
Weekly Safety Checks 5.7              
HTM 2010
Part 3: Validation & Verification
Yearly Safety Checks 5.8                
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Steam Quality

Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
HTM 2010
Part 3: Validation & Verification
Steam Non-Condensable
Gas Test
 1
9.4            
HTM 2010
Part 3: Validation & Verification
Steam Dryness
Test
 1
9.30            
HTM 2010
Part 3: Validation & Verification
Steam Superheat
Test
 1
9.20            
1: Type Test requirement as stated in BS EN 285:2006 - Ref: Table 4 (BS EN 285:2006).
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Air Leakage Test

Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
HTM 2010
Part 3: Validation & Verification
Vacuum Leak
Test
 1  2  3
11.2    
1: The test is performed once for the IQ and weekly periodic requirement - Ref: Table 2 (HTM 2010 Part 3).
2: The test is performed three times for OQ and the quarterly and yearly periodic requirement. The first as the weekly method (to ensure air leakage value is acceptable under normal conditions), the second with all sensors in place for thermometric testing (to ensure air leakage value is acceptable with sensors placed), the third as the weekly method (to ensure air leakage value is acceptable after thermometric testing and the sensors have been removed)
 - Ref: Table 2 and Table 4 (HTM 2010 Part 3).
3: 
Type Test and Works Test requirement as stated in BS EN 285:2006 - Ref: Table 4 (BS EN 285:2006).
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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 2010
Part 3: Validation & Verification
Automatic Control
Test
 1  2  3
12.1        
HTM 2010
Part 3: Validation & Verification
Verification of Calibration of Steriliser Instruments 1 12.2        
1: These tests can be performed at the same time - Ref: Table 4 (HTM 2010 Part 3).
2: This test can be performed at the same time as the thermometric test (small load) - Ref: Table 4 (HTM 2010 Part 3).
3: During the quarterly and yearly periodic test the temperature and pressure sensors used for thermometric testing should be attached - Ref: 12.2
 (HTM 2010 Part 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
HTM 2010
Part 3: Validation & Verification
Chamber Wall Temperature Test 13.3              
HTM 2010
Part 3: Validation & Verification
Thermometric Test
for a Small Load
 1
13.7        
HTM 2010
Part 3: Validation & Verification
Thermometric Test
for a Full Load
 1
13.15          
1: Type Test requirement as stated in BS EN 285:2006 - Ref: Table 4 (BS EN 285:2006).
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Air Detector Tests

Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
HTM 2010
Part 3: Validation & Verification
Air Detector Function Test 1 11.53      
HTM 2010
Part 3: Validation & Verification
Air Detector Performance Test for a Small Load 1 11.45          
HTM 2010
Part 3: Validation & Verification
Air Detector Performance Test for a Full Load 1 11.53            
1: Type Test and Works Test requirement as stated in BS EN 285:2006 - Ref: Table 4 (BS EN 285:2006).
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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 2010
Part 3: Validation & Verification
Load Dryness Test (Small Load) 1  3  4 13.25              
HTM 2010
Part 3: Validation & Verification
Load Dryness Test (Full Load) 2  3  4 13.25              
HTM 2010
Part 3: Validation & Verification
Hospital Load Dryness Check 13.25                
1: This test may be performed at the same time as thermometric test (small load) - Ref: Table 2 (HTM 2010 Part 3).
2: This test may be performed at the same time as thermometric test (full load) - Ref: Table 2 (HTM 2010 Part 3).
3: 
Type Test requirement as stated in BS EN 285:2006 - Ref: Table 4 (BS EN 285:2006).
4: Optional test as required by the User - Ref: Table 2 
(HTM 2010 Part 3).
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Steam Penetration

Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
HTM 2010
Part 3: Validation & Verification
Bowie-Dick Test for Steam Penetration 1 13.39  
1: Type Test and Works Test requirement as stated in BS EN 285:2006 - Ref: Table 4 (BS EN 285:2006).
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Dynamic Pressure

Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
HTM 2010
Part 3: Validation & Verification
Dynamic Pressure Test 1 N/A                
1: Type Test requirement as stated in BS EN 285:2006 - Ref: Table 4 (BS EN 285:2006).
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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 2010
Part 3: Validation & Verification
Sound Pressure
Test 1  2
10.1              
1: Type Test requirement as stated in BS EN 285:2006 - Ref: Table 4 (BS EN 285:2006).
2: Please Note: Although the standard lists this as an optional OQ requirement, the standard also states that this test is only performed in a specially designed and equipped test room (Ref: 10.1 HTM 2010 Part 3). Therefore it is unlikely to be required at installation, commissioning or periodically. If in doubt, manufacturer instructions should be obtained.
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Table Key

Validation Test Abbreviations
TT Type Test By the manufacturer during the machine design stage. HTM 2010: Part 3
Ref: Page 136
WT Works Test By the manufacturer prior to releasing the machine. HTM 2010: Part 3
Ref: Page 136
IQ Installation Qualification By the manufacturer, contractor or supplier upon delivery. Also known as Commissioning. HTM 2010: Part 3
Ref: Page 133
OQ Operational Qualification By the Test Person (Sterilisers) after IQ. Also known as Commissioning. HTM 2010: Part 3
Ref: Page 131
PQ Performance Qualification By the TP(S) after IQ and OQ. HTM 2010: Part 3
Ref: Page 134
D Daily Periodic By the User or by delegation to the Operator. HTM 2010: Part 3
Ref: 2.36
W Weekly Periodic By the User (or Operator) or TP(S). HTM 2010: Part 3
Ref: 2.36
Q Quarterly Periodic By the TP(S). HTM 2010: Part 3
Ref: 2.36
Y Yearly Periodic By the TP(S). HTM 2010: Part 3
Ref: 2.37
Validation Contacts, Personnel & Miscellaneous Abbreviations 
MAN Manufacturer The manufacturer of the machine. HTM 2010: Part 3
Ref: 2.11
SUP Supplier The supplier of the machine.
Often also the manufacturer.
HTM 2010: Part 3
Ref: 2.11
CON Contractor Hired to perform IQ.
Often also the manufacturer.
HTM 2010: Part 3
Ref: 2.12
USER User Has final responsibility for machine performance/operation. HTM 2010: Part 3
Ref: 1.12
TP(S) Test Person (Sterilisers)     A qualified engineer and test person in decontamination. HTM 2010: Part 3
Ref: 1.17
OPT Optional Test     The standard states that this is an optional test requirement. N/A
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