BS EN 13060 & BS EN ISO 17665: Clinical Transportable Non-Vacuum Test Schedule

BS EN 13060 & BS EN ISO 17665: Clinical Transportable Non-Vacuum Steam Steriliser
Installation, Commissioning and Periodic Test Schedule.

Below is the BS EN 13060 and BS EN ISO 17665 installation, commissioning and periodic test schedule for clinical transportable non-vacuum steam sterilisers.

Manufacturer schedules take precedent over the schedule from BS EN 13060 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 13060
(TT/WT/IQ)
BS EN ISO 17665
(OQ/PQ/DWQY)
Safety Tests and Checks A.3
ISO/TS 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 13060
(TT/WT/IQ)
BS EN ISO 17665
(OQ/PQ/DWQY)
Automatic Control
10.3 (c)
BS EN ISO 17665:1
   
BS EN 13060
(TT/WT/IQ)
BS EN ISO 17665
(OQ/PQ/DWQY)
Verification of Calibration 12.2
BS EN ISO 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 13060
(TT/WT/IQ)
BS EN ISO 17665
(OQ/PQ/DWQY)
Thermometric Tests - Small Load 10.5
BS EN 13060
       
BS EN 13060
(TT/WT/IQ)
BS EN ISO 17665
(OQ/PQ/DWQY)
Thermometric Tests - Full Load 10.5
BS 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
BS EN 13060
(TT/WT/IQ)
BS EN ISO 17665
(OQ/PQ/DWQY)
Dynamic Pressure Test A.10
ISO/TS 17665:2
10.3
BS 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
BS EN 13060
(TT/WT/IQ)
BS EN ISO 17665
(OQ/PQ/DWQY)
Empty Chamber 10.4
BS EN 13060
           
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Table Key

Validation Test Abbreviations
TT Type Test By the manufacturer during the machine design stage. BS EN 13060
Ref: 3.48
WT Works Test By the manufacturer prior to releasing the machine. BS EN 13060
Ref: 3.53
IQ Installation Qualification By the manufacturer, contractor or supplier upon delivery. BS EN 13060
Ref: 3.22
OQ Operational Qualification By the Competent Person (Decontamination) after IQ. BS EN ISO 17665:2
Ref: 9.3
PQ Performance Qualification By the CP(D) 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 CP(D). BS EN ISO 17665:2
Ref: D.2.2 (n)
Q Quarterly Periodic By the CP(D). BS EN ISO 17665:2
Ref: D.2.2 (n)
Y Yearly Periodic By the CP(D). 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.
CP(D) Competent Person (Decontamination)     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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