WHTM 01-01 Part C: Clinical Large Porous Load Test Schedule

WHTM 01-01 Part C: Clinical Large Porous Load Steam Steriliser
Installation, Commissioning and Periodic Test Schedule.

Below is the WHTM 01-01 installation, commissioning and periodic test schedule for clinical large porous load steam sterilisers.

Manufacturer schedules take precedent over the schedule from WHTM 01-01 Part C. 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 C
Weekly Safety Checks 2.104              
WHTM
01-01
Part C
Yearly Safety Checks 2.105                
1: Also referred to as 'Annual Safety Checks' - Ref: Table 4
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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
WHTM
01-01
Part C
Non-Condensable
Gas Test
 1
3.207            
WHTM
01-01
Part C
Steam Dryness
Test
 1
3.33            
WHTM
01-01
Part C
Steam Superheat
Test
 1
3.223            
WHTM
01-01
Part C
Steam Chemical Purity Tests Table 5              
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
WHTM
01-01
Part C
Air Leakage Test 1  2  3 2.69      
1: The test is performed once for the weekly periodic requirement - Ref: Table 4 (WHTM 01-01 Part C).
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 3 and Table 4 (WHTM 01-01 Part C).
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
WHTM
01-01
Part C
Automatic Control
Test
 1  2  3
 2.60        
WHTM
01-01
Part C
Verification of Calibration of Steriliser Instruments 1 2.62              
1: These tests can be performed at the same time - Ref: 2.62 (WHTM 01-01 Part C).
2: This test can be performed at the same time as the thermometric test (small load) - Ref: Table 3 (WHTM 01-01 Part C).
3: During the quarterly and yearly periodic test the temperature and pressure sensors used for thermometric testing should be attached - Ref: 2.62
 (WHTM 01-01 Part C).
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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 C
Thermometric Test
for a Small Load
 1
2.73        
WHTM
01-01
Part C
Thermometric Test
for a Full Load
 1
2.74          
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
WHTM
01-01
Part C
Air Detector Function Test 1 2.71      
WHTM
01-01
Part C
Air Detector Performance Test for a Small Load 1 2.71          
WHTM
01-01
Part C
Air Detector Performance Test for a Full Load 1 2.71            
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
WHTM
01-01
Part C
Load Dryness - Small Load Textiles 2 2.82                
WHTM
01-01
Part C
Load Dryness - Full Load Textiles 2 2.82                
WHTM
01-01
Part C
Load Dryness Test for a Metal Load 1  2 2.82            
WHTM
01-01
Part C
Production Load Dryness Test 2.83                
1: Where required by the AE(D) - Ref: Table 4 (WHTM 01-01 Part C).
2: 
Type Test requirement as stated in BS EN 285:2006 - Ref: Table 4 (BS EN 285:2006).
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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
WHTM
01-01
Part C
Bowie and Dick Steam Penetration Test 1 2.85  
WHTM
01-01
Part C
Hollow Load Test 1  2 2.86            
1: Type Test and Works Test requirement as stated in BS EN 285:2006 - Ref: Table 4 (BS EN 285:2006).
2: This test is optional and should be performed if specific lumen are to be processed - Ref: Section 2.87 Note (WHTM 01-01 Part C).
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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
WHTM
01-01
Part C
Dynamic Pressure Test 1 2.88                
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
WHTM
01-01
Part C
Sound Power
Test 1
2.15                
1: Type Test requirement as stated in BS EN 285:2006 - Ref: Table 4 (BS EN 285:2006).
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Table Key

Validation Test Abbreviations
TT Type Test By the manufacturer during the machine design stage. WHTM 01-01 Ref: 5.56 Part A
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 Manufacturer 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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