BS EN 285 & BS EN ISO 17665: Clinical Large Porous Load Test Schedule

BS EN 285 & BS EN ISO 17665: Clinical Large Porous Load Steam Steriliser
Installation, Commissioning and Periodic Test Schedule.

Below is the BS EN 285 and BS EN ISO 17665 installation, commissioning and periodic test schedule for clinical large porous load steam sterilisers.

Manufacturer schedules take precedent over the schedule from BS EN 285 and BS EN ISO 17665. 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 Engineer.

Periodic testing is carried out routinely by the User (or by delegation to the Operator), and also a qualified 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
BS EN 285
TT/WT/IQ
BS EN ISO 17665
OQ/PQ/DWQY
Safety Tests and Checks 1 Clause 11
(BS EN 285)
       
1: The manufacturer should specify tests and frequency of tests - Ref: Table A.3 (BS EN ISO 17665).
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Steam Quality

Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
BS EN 285
TT/WT/IQ
BS EN ISO 17665
OQ/PQ/DWQY
Non-Condensable
Gases
22.1
(BS EN 285)
A.11
(BS EN ISO 17665
:2)
         
BS EN 285
TT/WT/IQ
BS EN ISO 17665
OQ/PQ/DWQY
Dryness Value 22.2
(BS EN 285)
A.11
(BS EN ISO 17665
:2)
         
BS EN 285
TT/WT/IQ
BS EN ISO 17665
OQ/PQ/DWQY
Superheat 22.3
(BS EN 285)
A.11
(BS EN ISO 17665
:2)
         
BS EN 285
TT/WT/IQ
BS EN ISO 17665
OQ/PQ/DWQY
Contaminants Table E.2
(BS EN 285)
A.11
(BS EN ISO 17665
:2)
           
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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
BS EN 285
TT/WT/IQ
BS EN ISO 17665
OQ/PQ/DWQY
Air Leakage Flow Rate
18
(BS EN 285)
A.6
(BS EN ISO 17665:2)
       
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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
BS EN 285
TT/WT/IQ
BS EN ISO 17665
OQ/PQ/DWQY
Automatic Control 1 10.3 (C)
(BS EN ISO 17665:1)
         
BS EN 285
TT/WT/IQ
BS EN ISO 17665
OQ/PQ/DWQY
Verification of Calibration D.9.1 (a)
(BS EN ISO 17665:1)
               
1: This test is not scheduled in either document with the only comment being that the test is performed 'routinely' - Ref: 10.3 (c) (17665:1).
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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
BS EN 285
TT/WT/IQ
BS EN ISO 17665
OQ/PQ/DWQY
Thermometric Tests Small Load
16.1
(BS EN 285)
A.4.1
(BS EN ISO 17665:2)
         
BS EN 285
TT/WT/IQ
BS EN ISO 17665
OQ/PQ/DWQY
Thermometric Tests Full Load
16.2
(BS EN 285)
A.4.2
(BS EN ISO 17665:2)
           
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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
BS EN 285
TT/WT/IQ
BS EN ISO 17665
OQ/PQ/DWQY
Air Detector
Function

19.4
(BS EN 285)
A.7
(BS EN ISO 17665:2)
         
BS EN 285
TT/WT/IQ
BS EN ISO 17665
OQ/PQ/DWQY
Air Detector
Small Load

19.2
(BS EN 285)
A.7
(BS EN ISO 17665:2)
         
BS EN 285
TT/WT/IQ
BS EN ISO 17665
OQ/PQ/DWQY
Air Detector
Full Load

19.3
(BS EN 285)
A.7
(BS EN ISO 17665:2)
           
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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
BS EN 285
TT/WT/IQ
BS EN ISO 17665
OQ/PQ/DWQY
Load Dryness - Small Load, Textiles
20.1
(BS EN 285)
A.8
(BS EN ISO 17665:2)
             
BS EN 285
TT/WT/IQ
BS EN ISO 17665
OQ/PQ/DWQY
Load Dryness - Full Load, Textiles
20.2
(BS EN 285)
A.8
(BS EN ISO 17665:2)
             
BS EN 285
TT/WT/IQ
BS EN ISO 17665
OQ/PQ/DWQY
Load Dryness - Metal 20.3
(BS EN 285)
A.8
(BS EN ISO 17665:2)
             
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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
BS EN 285
TT/WT/IQ
BS EN ISO 17665
OQ/PQ/DWQY
Bowie and Dick Test 17
(BS EN 285)
A.5
(BS EN ISO 17665:2)
 
BS EN 285
TT/WT/IQ
BS EN ISO 17665
OQ/PQ/DWQY
Hollow Load Test
15
(BS EN 285)
A.2
(BS EN ISO 17665:2)
           
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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
BS EN 285
TT/WT/IQ
BS EN ISO 17665
OQ/PQ/DWQY
Dynamic Pressure Test 1 23
(BS EN 285)
A.10
(BS EN ISO 17665:2)
             
1: The manufacturer should be contacted for frequency of periodic test - Ref Table A.3 (BS EN ISO 17665:2).
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Table Key

Validation Test Abbreviations
TT Type Test By the manufacturer during the machine design stage. BS EN 285
Ref: 3.40
WT Works Test By the manufacturer prior to releasing the machine. BS EN 285
Ref: 3.43
IQ Installation Qualification By the manufacturer, contractor or supplier upon delivery. BS EN 285
Ref: 3.16
OQ Operational Qualification By the Engineer after IQ. BS EN 285
Ref: 3.21
PQ Performance Qualification By the Engineer after IQ and OQ. BS EN ISO 17665:1
Ref: 3.31
D Daily Periodic By the User or by delegation to the Operator. BS EN ISO 17665:2
Ref: D.2.2 (n)
W Weekly Periodic By the User (or Operator) or Engineer. BS EN ISO 17665:2
Ref: D.2.2 (n)
Q Quarterly Periodic By the Engineer. BS EN ISO 17665:2
Ref: D.2.2 (n)
Y Yearly Periodic By the Engineer. BS EN ISO 17665:2
Ref: D.2.2 (n)
Validation Contacts, Personnel & Miscellaneous Abbreviations 
MAN Manufacturer The manufacturer of the machine. Common abbreviation, no specific reference.
SUP Supplier The supplier of the machine.
Often also the manufacturer.
Common abbreviation, no specific reference.
CON Contractor Hired to perform IQ.
Often also the manufacturer.
Common abbreviation, no specific reference.
USER User Has final responsibility for machine performance/operation. Common abbreviation, no specific reference.
ENG Engineer A qualified engineer and test person in decontamination. Common abbreviation, no specific reference.
OPT Optional Test     The standard states that this is an optional test requirement. N/A
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