SHTM 2010: Clinical Large Porous Load Test Schedule

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

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

Manufacturer schedules take precedent over the schedule from SHTM 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
SHTM 2010
Part 3: Validation & Verification
Weekly Safety Checks 5.7              
SHTM 2010
Part 3: Validation & Verification
Yearly Safety Checks 5.8                
Back to Testing Categories | Table Key
Steam Quality

Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
SHTM 2010
Part 3: Validation & Verification
Steam Non-Condensable
Gas Test
 1
9.4            
SHTM 2010
Part 3: Validation & Verification
Steam Dryness
Test
 1
9.30            
SHTM 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).
 Back to Testing Categories | Table Key
Air Leakage Test

Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
SHTM 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 2a (SHTM 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 2a and Table 4a (SHTM 2010 Part 3).
3: 
Type Test and Works Test requirement as stated in BS EN 285:2006 - Ref: Table 4 (BS EN 285:2006).
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
SHTM 2010
Part 3: Validation & Verification
Automatic Control
Test
 1  2  3
12.1        
SHTM 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 4a (SHTM 2010 Part 3).
2: This test can be performed at the same time as the thermometric test (small load) - Ref: Table 4a (SHTM 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
 (SHTM 2010 Part 3).
Back to Testing Categories | Table Key
Thermometric Tests

Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
SHTM 2010
Part 3: Validation & Verification
Chamber Wall Temperature Test 13.3              
SHTM 2010
Part 3: Validation & Verification
Thermometric Test for a Small Load 1 2 13.7        
SHTM 2010
Part 3: Validation & Verification
Thermometric Test for a Full Load 1 3 13.15            
SHTM 2010
Part 3: Validation & Verification
Thermometric Test for PQ as required by the User 4 8.64              
1: Type Test requirement as stated in BS EN 285:2006 - Ref: Table 4 (BS EN 285:2006).
2: This test is performed twice during commissioning - Ref: Table 2a (SHTM 2010 Part 3).
3: Although this test is not included within the periodic test schedule, all other documents list this as a yearly periodic requirement.
4: Not usually required for SSD process loads - Ref: Table 2a (SHTM 2010 Part 3).
Back to Testing Categories | Table Key
Air Detector Tests

Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
SHTM 2010
Part 3: Validation & Verification
Air Detector Function Test 1 11.60      
SHTM 2010
Part 3: Validation & Verification
Air Detector Performance Test for a Small Load 1 11.45          
SHTM 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).
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
SHTM 2010
Part 3: Validation & Verification
Load Dryness Test (Small Load) 1  3  4 13.25    

         
SHTM 2010
Part 3: Validation & Verification
Load Dryness Test (Full Load) 2  3  4 13.25              
SHTM 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 2a (SHTM 2010 Part 3).
2: This test may be performed at the same time as thermometric test (full load) - Ref: Table 2a (SHTM 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 2a 
(SHTM 2010 Part 3).
Back to Testing Categories | Table Key
Steam Penetration

Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
SHTM 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).
Back to Testing Categories | Table Key
Dynamic Pressure

Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
SHTM 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).
Back to Testing Categories | Table Key
Sound Pressure

Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
SHTM 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 SHTM 2010 Part 3). Therefore it is unlikely to be required at installation, commissioning or periodically. If in doubt, manufacturer instructions should be obtained.
 Back to Testing Categories | Table Key
Table Key

Validation Test Abbreviations
TT Type Test By the manufacturer during the machine design stage. SHTM 2010: Part 3
Ref: Page 178
WT Works Test By the manufacturer prior to releasing the machine. SHTM 2010: Part 3
Ref: Page 178
IQ Installation Qualification By the manufacturer, contractor or supplier upon delivery. Also known as Commissioning. SHTM 2010: Part 3
Ref: Page 172
OQ Operational Qualification By the Test Person (Sterilisers) after IQ. Also known as Commissioning. SHTM 2010: Part 3
Ref: Page 168
PQ Performance Qualification By the TP(S) after IQ and OQ. SHTM 2010: Part 3
Ref: Page 175
D Daily Periodic By the User or by delegation to the Operator. SHTM 2010: Part 3
Ref: Page 175
W Weekly Periodic By the User (or Operator) or TP(S). SHTM 2010: Part 3
Ref: Page 175
Q Quarterly Periodic By the TP(S). SHTM 2010: Part 3
Ref: Page 175
Y Yearly Periodic By the TP(S). SHTM 2010: Part 3
Ref: Page 175
Validation Contacts, Personnel & Miscellaneous Abbreviations 
MAN Manufacturer The manufacturer of the machine. SHTM 2010: Part 3
Ref: 1.23
SUP Supplier The supplier of the machine.
Often also the manufacturer.
SHTM 2010: Part 3
Ref: 1.23
CON Contractor Hired to perform IQ.
Often also the manufacturer.
SHTM 2010: Part 3
Ref: 1.24
USER User Has final responsibility for machine performance/operation. SHTM 2010: Part 3
Ref: 1.11
TP(S) Test Person (Sterilisers)     A qualified engineer and test person in decontamination. SHTM 2010: Part 3
Ref: 1.17
OPT Optional Test     The standard states that this is an optional test requirement. N/A
Last Viewed Test Table | Back to Testing Categories