MDA DB 9804 & 2002: Clinical Transportable Vacuum Test Schedule

MDA DB 9804 & MDA DB 2002(06): Clinical Transportable Vacuum Steam Steriliser
Installation, Commissioning and Periodic Test Schedule.

Below is the MDA DB 9804 and MDA DB 2002(06) installation, commissioning and periodic test schedule for clinical transportable vacuum steam sterilisers.

Manufacturer schedules take precedent over the schedule from MDA DB 9804 and MDA DB 2002(06). 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
MDA DB
9804
MDA DB
2002(06)
Weekly/Quarterly Safety Checks 5.2
MDA DB 9804
5.3.2
MDA DB 2002(06)
           
MDA DB
9804
MDA DB
2002(06)
Yearly Safety Checks 5.3
MDA DB 9804
               
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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
MDA DB
9804
MDA DB
2002(06)
Air Leakage 1 A.3
MDA DB 9804
         
1: The User should perform the test using the automatic method (Ref: A.3.1 MDA DB 9804) and the TP(S) should perform the test using the manual method (Ref: A.3.2 MDA DB 9804).
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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
MDA DB
9804
MDA DB
2002(06)
Automatic Control
Test

A.2
MDA DB 9804
Appendix 4
MDA DB 2002(06)
     
MDA DB
9804
MDA DB
2002(06)
Verification of Calibration Table 5
MDA DB 9804
Refers to HTM 2010:3 12.2
         
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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
MDA DB
9804
MDA DB
2002(06)
Thermometric Tests
Small Load
A.5
MDA DB 9804
           
MDA DB
9804
MDA DB
2002(06)
Thermometric Tests
Full Load
A.5
MDA DB 9804
             
MDA DB
9804
MDA DB
2002(06)
Thermometric Tests
Solid Load
A.5
MDA DB 9804
             
MDA DB
9804
MDA DB
2002(06)
Steam Generator Overheat Cut-Out Table 6
MDA DB 9804
Refers to HTM 2010:3 15.3
             
MDA DB
9804
MDA DB
2002(06)
Chamber Wall Temperature Test A.4
MDA DB 9804
             
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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
MDA DB
9804
MDA DB
2002(06)
Air Detector Function Test 5.1
MDA DB 9804
         
MDA DB
9804
MDA DB
2002(06)
Air Detector Test Small Load 5.1
MDA DB 9804
             
MDA DB
9804
MDA DB
2002(06)
Air Detector Test Small Load 5.1
MDA DB 9804
             
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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
MDA DB
9804
MDA DB
2002(06)
Porous Load Dryness Test A.6.1
MDA DB 9804
             
MDA DB
9804
MDA DB
2002(06)
Solid Load Dryness Test A.6.2
MDA DB 9804
             
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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
MDA DB
9804
MDA DB
2002(06)
Steam Penetration Test A.1
MDA DB 9804
Appendix 4
MDA DB 2002(06)
     
MDA DB
9804
MDA DB
2002(06)
Yearly Safety Checks 5.3
MDA DB 9804
               
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Empty Chamber

Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
MDA DB
9804
MDA DB
2002(06)
Functional Checks
Empty Chamber
4.6.5
MDA DB 9804
               
Table Key

Validation Test Abbreviations
TT Type Test By the manufacturer during the machine design stage. Not referenced in either document
WT Works Test By the manufacturer prior to releasing the machine. Not referenced in either document
IQ Installation Qualification By the manufacturer, contractor or supplier upon delivery. MDA DB 9804
Ref: 4.6.7
OQ Operational Qualification By the Competent Person (Decontamination) after IQ. MDA DB 9804
Ref: 4.6.8
PQ Performance Qualification By the CP(D) after IQ and OQ. MDA DB 9804
Ref: 4.6.8
D Daily Periodic By the User or by delegation to the Operator. MDA DB 9804
Ref: 5.1
W Weekly Periodic By the User (or Operator) or CP(D). MDA DB 9804
Ref: 5.1
Q Quarterly Periodic By the CP(D). MDA DB 9804
Ref: 5.1
Y Yearly Periodic By the CP(D). MDA DB 9804
Ref: 5.1
Validation Contacts, Personnel & Miscellaneous Abbreviations 
MAN Manufacturer The manufacturer of the machine. MDA DB 9804
Ref: 1.1
SUP Supplier The supplier of the machine.
Often also the manufacturer.
MDA DB 9804
Ref: 1.1
CON Contractor Hired to perform IQ.
Often also the manufacturer.
MDA DB 9804
Ref: 1.1
USER User Has final responsibility for machine performance/operation. MDA DB 9804
Ref: 1.1
TP(S) Test Person (Sterilisers)     A qualified engineer and test person in decontamination. MDA DB 9804
Ref: 1.1
OPT Optional Test     The standard states that this is an optional test requirement. N/A
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