HTM 01-05: SIWD Test Schedule

HTM 01-05: Surgical Instrument Washer Disinfector
Installation, Commissioning and Periodic Test Schedule.

Below is the HTM 01-05 installation, commissioning and periodic test schedule for surgical instrument washer disinfectors.

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, a qualified Competent Person (Decontamination) or Service Engineer.

Periodic testing is carried out routinely by the User (or by delegation to the Operator), a qualified Competent Person (Decontamination) or Service Engineer.

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
Remove & Clean Strainers & Filters 13.3          
HTM
01-05
Weekly Safety Checks 15.14            
HTM
01-05
Yearly Safety Checks 15.16                
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Cleaning Efficacy

Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
HTM
01-05
Cleaning Efficacy (Visual Inspection) 13.3
Refers to
ISO 15883
         
HTM
01-05
Protein Residue Test 13.3
Refers to
ISO 15883
           
HTM
01-05
Cleaning Efficacy Test 13.3
Refers to
ISO 15883
           
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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            
HTM
01-05
Verification of Calibration
13.2
Refers to
ISO 15883
             
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Chemical Additives,
Reproducibility & Residues
Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
HTM
01-05
Chemical Dosing 1 13.3
Refers to
ISO 15883
             
1: Also referred to as 'Detergent Dosing Test' - Ref: 13.2 (Table)
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Free Drainage

Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
HTM
01-05
Pipework Free Flowing Drainage 13.2
Refers to
ISO 15883
             
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Doors, Interlocks
& Fault Indications
Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
HTM
01-05
Doors and Door Interlocks 13.2
Refers to
ISO 15883
             
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Load Carriers

Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
HTM
01-05
Load Carriers 13.2
Refers to
ISO 15883
               
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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 Test (Chamber Walls)
13.2
Refers to
ISO 15883
             
HTM
01-05
Thermometric Test
(Load Carrier)

13.2
Refers to
ISO 15883
             
HTM
01-05
Thermometric Test
(Load) 1
13.2
Refers to
ISO 15883
           
1: Also referred to as 'Thermometric Disinfection Test' - Ref: 13.3 (Table)
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Venting & Process Emissions

Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
HTM
01-05
Fluid Emission 13.2
Refers to
ISO 15883
             
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Water Quality & Supply Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
HTM
01-05
Rinse Water Quality Test (pH) 1 13.2
Refers to
ISO 15883
             
HTM
01-05
Rinse Water Quality Test (Conductivity) 1 13.2
Refers to
ISO 15883
             
HTM
01-05
Rinse Water Quality Test (Hardness) 1 13.2
Refers to
ISO 15883
             
HTM
01-05
Rinse Water Quality Test (Total Dissolved Solids) 1 13.2
Refers to
ISO 15883
             
HTM
01-05
Rinse Water Quality Test (Chloride) 1 13.2
Refers to
ISO 15883
             
HTM
01-05
Rinse Water Quality Test (Inorganic Phosphate) 1 13.2
Refers to
ISO 15883
 
                 
1: The standard states 'Rinse Water Quality Test' (Ref - Section 13.2 Table) and refers to ISO 15883. Therefore the tests listed and bracketed above are those stated as required according to ISO 15883:1 and 15883:2.
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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
(Mentioned in testing sterilisers)
WT Works Test     By the manufacturer prior to releasing the machine. HTM 01-05 Ref: 12.3
(Mentioned in testing sterilisers)
IQ Installation Qualification     By the manufacturer / contractor / supplier or CP(D) upon delivery. HTM 01-05 Ref: 14.2
OQ Operational Qualification     By the CP(D) or Service Engineer after IQ. HTM 01-05 Ref: 14.2
PQ Performance Qualification     By the CP(D) or Service Engineer 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) or Service Engineer. HTM 01-05 Ref: 14.3
Y Yearly Periodic     By the CP(D) or Service Engineer. 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
ENG Service Engineer     Engineer certified by the service provider or manufacturer. 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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