WHTM 01-05: Clinical Transportable Non-Vacuum Test Schedule

WHTM 01-05: Clinical Transportable Non-Vacuum Steam Steriliser
Installation, Commissioning and Periodic Test Schedule.

Below is the WHTM 01-05 installation, commissioning and periodic test schedule for clinical transportable non-vacuum steam sterilisers.

Manufacturer schedules take precedent over the schedule from WHTM 01-05. 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
01-05
Weekly Safety Checks 15.14            
WHTM
01-05
Yearly Safety Checks 15.16                
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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
01-05
Automatic Control
Test

15.3          
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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
WHTM
01-05
Thermometric Tests
Small Load
Table
Page 64
Refers
EN 13060
       
WHTM
01-05
Thermometric Tests
Large Load
Table
Page 64
Refers
EN 13060
         
WHTM
01-05
Steam Generator Overheat Cut-Out Test Table
Page 64
Refers
EN 13060
         
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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
01-05
Dynamic Chamber Pressure Table
Page 63
Refers
EN 13060
             
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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
WHTM
01-05
Empty Chamber Table
Page 63
Refers
EN 13060
         
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Table Key

Validation Test Abbreviations
TT Type Test By the manufacturer during the machine design stage. WHTM 01-05
Ref: 12.3
WT Works Test By the manufacturer prior to releasing the machine. WHTM 01-05
Ref: 12.3
IQ Installation Qualification By the manufacturer, contractor or supplier upon delivery. WHTM 01-05
Ref: 14.2
OQ Operational Qualification By the Competent Person (Decontamination) after IQ. WHTM 01-05
Ref: 14.2
PQ Performance Qualification By the CP(D) after IQ and OQ. WHTM 01-05
Ref: 14.2
D Daily Periodic By the User or by delegation to the Operator. WHTM 01-05
Ref: 14.4
W Weekly Periodic By the User (or Operator) or CP(D). WHTM 01-05
Ref: 14.4
Q Quarterly Periodic By the CP(D). WHTM 01-05
Ref: 14.4
Y Yearly Periodic By the CP(D). HTM 01-05
Ref: 14.3
Validation Contacts, Personnel & Miscellaneous Abbreviations 
MAN Manufacturer The manufacturer of the machine. WHTM 01-05
Ref: 9.3
SUP Supplier The supplier of the machine.
Often also the manufacturer.
WHTM 01-05
Ref: 9.3
CON Contractor Hired to perform IQ.
Often also the manufacturer.
WHTM 01-05
Ref: 9.3
USER User Has final responsibility for machine performance/operation. WHTM 01-05
Ref: 9.3
CP(D) Competent Person (Decontamination)     A qualified engineer and test person in decontamination. WHTM 01-05
Ref: 9.3
OPT Optional Test     The standard states that this is an optional test requirement. N/A
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