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

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

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

Manufacturer schedules take precedent over the schedule from HTM 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
HTM 01-05 Weekly Safety Checks 15.14            
HTM 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
HTM 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
HTM 01-05 Thermometric Tests
Small Load
12.3        
HTM 01-05 Thermometric Tests
Large Load
12.3          
HTM 01-05 Steam Generator Overheat Cut-Out Test 12.3          
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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 01-05 Dynamic Chamber Pressure Table
Page 55
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
HTM 01-05 Empty Chamber Table
Page 55
Refers
EN 13060
         
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Table Key

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