NI/CFPP/03: EWD Test Schedule

NI/CFPP/03: Endoscope Washer Disinfector
Installation, Commissioning and Periodic Test Schedule.

Below is the NI/CFPP/03 installation, commissioning and periodic test schedule for endoscope washer disinfectors.

Manufacturer schedules take precedent over the schedule from NI/CFPP/03. 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
NI/CFPP/03 Check Spray Arm Rotation for Free Movement MAN              
NI/CFPP/03 Check Spray Arm Nozzles for Blockage MAN              
NI/CFPP/03 Remove and Clean Strainers and Filters MAN
             
NI/CFPP/03 Weekly Safety Checks 4.55
CFPP 01-06 Validation & Verification
       
CFPP
01-06

Validation & Verification
Yearly Safety Checks 4.56                
Back to Testing Categories | Table Key
Cleaning Efficacy

Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
NI/CFPP/03 Cleaning Efficacy by Residual Soil Detection 16.33
CFPP 01-06 Testing Methods
               
NI/CFPP/03 Cleaning Efficacy Test: Chamber Walls & Load Carriers 1 16.22
CFPP 01-06 Testing Methods
       
NI/CFPP/03 Cleaning Efficacy Test: Reference Load 1 16.28
CFPP 01-06 Testing Methods
       
1: Cleaning efficacy test on Reference Load is performed directly after a successful cleaning efficacy test on Walls and Load Carriers - Ref: 16.28 (Testing Methods).
 Back to Testing Categories | Table Key
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
NI/CFPP/03 Automatic Control Test 1 9.1
CFPP 01-06 Testing Methods
   
NI/CFPP/03 Verification of Calibration 1 3.1
CFPP 01-06 Testing Methods
   
CFPP
01-06

Validation & Verification
Instrumentation: Legibility Section 3
Table 1
               
1: These tests can be performed at the same time - Ref: Section 9.2 (Testing Methods).
Back to Testing Categories | Table Key
Chemical Additives,
Reproducibility & Residues
Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
NI/CFPP/03 Chemical Dosing: Reproducibility of Volume Admitted 1  8.1
CFPP 01-06 Testing Methods
     
NI/CFPP/03 Chemical Dosing: Indication of Insufficient Chemical Additives 2 8.8
CFPP 01-06 Testing Methods
         
NI/CFPP/03 Chemical Additive Residual Levels 3 13.2
CFPP 01-06 Testing Methods
           
NI/CFPP/03 Disinfection Tests: Disinfectant Concentration Test 19.1
CFPP 01-06 Testing Methods
           
1: Also referred to as 'Chemical Dosing: Accuracy and Repeatability' - Ref: Table 1 (Validation & Verification).
2: Also referred to as 'Chemical Dosing: Low Ievel Indicator'
 - Ref: Table 1 (Validation & Verification).
3: 
Also referred to as 'Process Residuals' - Ref: Table 1 (Validation & Verification).
Back to Testing Categories | Table Key
Free Drainage

Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
NI/CFPP/03 Free Draining of Tanks 1 4.15
CFPP 01-06 Testing Methods
               
NI/CFPP/03 Free Draining of Chamber and Load Carriers 1 4.15
CFPP 01-06 Testing Methods
         
NI/CFPP/03 Free Draining of Pipework 1 4.15
CFPP 01-06 Testing Methods
         
NI/CFPP/03 Efficacy of Discharge Through the Trap 4.17
CFPP 01-06 Testing Methods
           
CFPP
01-06

Testing Methods
Estimation of Dead Volume of Pipework 4.23            
1: Also collectively referred to as 'Pipework: Free Draining' - Ref: Table 1 (Validation & Verification), and 'Drainage: Free Draining' - Ref: Table 3 (Validation & Verification).
Back to Testing Categories | Table Key
Doors, Interlocks
& Fault Indications
Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
NI/CFPP/03 Fault Codes MAN                
NI/CFPP/03 Cycle Start Interlock 1 7.1
CFPP 01-06 Testing Methods
       
NI/CFPP/03 In-Cycle Interlock 2 7.5
CFPP 01-06 Testing Methods
       
NI/CFPP/03 Double-Ended EWDs 7.8
CFPP 01-06 Testing Methods
           
NI/CFPP/03 On Sensor Failure 7.12
CFPP 01-06 Testing Methods
         
CFPP
01-06

Testing Methods
Door Opening Force 7.14
           
CFPP
01-06

Testing Methods
Failed Cycle Interlock 3 7.20               
NI/CFPP/03 Fault Indication on Sensor Failure 7.23
CFPP 01-06 Testing Methods
         
NI/CFPP/03 Blocked Drain Protection 4.2
CFPP 01-06 Testing Methods
           
NI/CFPP/03 Doors and Interlocks: With Services 4 Page 10
NI/CFPP/03
             
1: Also referred to as 'Doors and Interlocks: Cycle Start' - Ref: Table 1 (Validation & Verification).
2: 
Also referred to as 'Doors and Interlocks: Loading/Unloading' - Ref: Table 1 (Validation & Verification).
3: 
Also referred to as 'On Fault Condition' - Ref: Table 1 (Validation & Verification).
4: Services tested should include if applicable Cold Water, Hot Water, RO Water, Electricity - Ref: Page 10 (NI/CFPP/03).
Back to Testing Categories | Table Key
Leak, Disconnection
& Channel Patency
Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
NI/CFPP/03 Leak Test 17.1
CFPP 01-06 Testing Methods
     
NI/CFPP/03 Lumen Patency Detection Test 1 17.9
CFPP 01-06 Testing Methods
     
NI/CFPP/03 Lumen Disconnection Detection Test 17.14
CFPP 01-06 Testing Methods
     
1: Includes testing for both partial blockage and total blockage - Ref: Page 5 (NI/CFPP/03).
Back to Testing Categories | Table Key
Load Carriers

Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference   TT WT  IQ OQ PQ D W Q Y
NI/CFPP/03 Load Carriers 1 10.1
CFPP 01-06 Testing Methods
             
1: Also referred to as 'Load Carriers: Fitting, Stability, Alignment, Force to Move, Effect in Cycle' - Ref: Table 1 (Validation & Verification).
Back to Testing Categories | Table Key
Load Dryness

Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
CFPP
01-06

Testing Methods
Load Dryness 12.1          
Back to Testing Categories | Table Key
Disinfection During Routine Cycle

Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
NI/CFPP/03 Temperature During Routine Cycle 1 11.25
CFPP 01-06 Testing Methods
     
NI/CFPP/03 Microbiological: Disinfection Efficacy Part 4
ISO EN 15883:4
             
1: Only required if heat is used during the process - Ref: 11.1 (Testing Methods).
Back to Testing Categories | Table Key
Thermometric Self-Disinfection Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
NI/CFPP/03 Chamber Wall Temperature for the Self-Disinfection Cycle (if applicable) 1  2 11.4
CFPP 01-06 Testing Methods
     
CFPP
01-06

Testing Methods
Load Carrier Temperature During Self-Decontamination (if temperature used) 1  2 11.10          
NI/CFPP/03 Over-Temperature Cut-Out (when temperature is used for self-disinfection) 1 11.18
CFPP 01-06 Testing Methods
         
1: Only required if heat is used during the process - Ref: 11.1 (Testing Methods).
2: Also referred to as 'EWD Self-Disinfection Test - Thermal Disinfection' - Ref: 18.4 (Testing Methods).
Back to Testing Categories | Table Key
Chemical Self-Disinfection Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
NI/CFPP/03 EWD Self-Disinfection Test - Chemical Disinfection 18.4 
CFPP 01-06 Testing Methods
             
Back to Testing Categories | Table Key
Venting & Process Emissions Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
NI/CFPP/03 Load Contamination from Ductwork 5.1
CFPP 01-06 Testing Methods
         
NI/CFPP/03 Droplet Emission 5.2
CFPP 01-06 Testing Methods
         
NI/CFPP/03 Chemical Vapour Emission 5.8
CFPP 01-06 Testing Methods
         
CFPP
01-06

Validation & Verification
Fluid Emission: Chamber Leak-Proof Table 1              
CFPP
01-06

Validation & Verification
Pipework: Venting System Table 1                
Back to Testing Categories | Table Key
Water Quality & Supply

Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
NI/CFPP/01 Final Rinse Water System: TOC 1  2 Table 5
CFPP 01-06 Testing Methods
         
CFPP
01-06

Testing Methods
Water Supply Temperature 6.15              
CFPP
01-06

Testing Methods
Water Supply Pressure 6.22              
NI/CFPP/01 Appearance 3 6.28
CFPP 01-06 Testing Methods
         
NI/CFPP/01 pH 6.35
CFPP 01-06 Testing Methods
         
NI/CFPP/01 Electrical Conductivity 4 6.41
CFPP 01-06 Testing Methods
   
NI/CFPP/01 Hardness 5 6.51
CFPP 01-06 Testing Methods
     
NI/CFPP/01 Total Viable Count 6.63
CFPP 01-06 Testing Methods
     
NI/CFPP/01 Environmental Mycobacteria 6.84
CFPP 01-06 Testing Methods
               
NI/CFPP/01 Bacterial Endotoxin Page 2
NI/CFPP/01
               
CFPP
01-06

Testing Methods
Volume of Water Used per Stage 6 6.91            
CFPP
01-06

Validation & Verification
Microbiological: Disinfection of Water Treatment System Table 1                
1: TOC abbreviation is Total Organic Carbon - Ref: Table 1 (Testing Methods).
2: 
Also referred to as 'Water System: TOC' - Ref: Table 3 (Validation & Verification).
3: 
Also referred to as 'Final Rinse-Water tests: Appearance' - Ref: Table 5 (Validation & Verification).
4: 
Also referred to as 'Final Rinse-Water Conductivity (if pure water used)' - Ref: Table 3 (Validation & Verification).
5: 
Also referred to as 'Water Hardness (all process stages)' - Ref: Table 5 (Validation & Verification).
6: 
Also referred to as 'Water Quality Used: Water Volume' - Ref: Table 1 (Validation & Verification).
Back to Testing Categories | Table Key
Drying Cabinets

Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
NI/CFPP/03 Check the air pressure within the cabinet using the in-built Manometer 6.11
CFPP 01-06 Testing Methods
         
NI/CFPP/03 Daily Checks as Required by the Manufacturer MAN                
NI/CFPP/03 Weekly Checks as Required by the Manufacturer MAN                
NI/CFPP/03 Quarterly Checks as Required by the Manufacturer MAN                
NI/CFPP/03 Yearly Checks as Required by the Manufacturer MAN                
NI/CFPP/03 Differential pressure across HEPA filter 6.12
CFPP 01-06 Testing Methods
             
NI/CFPP/03 Lumen Airflows 6.15
CFPP 01-06 Testing Methods
               
NI/CFPP/03 Microbiological Testing of Drying Cabinet Page 5
NI/CFPP/01
               
Back to Testing Categories | Table Key
Air Quality

Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
NI/CFPP/03 Air Quality 14.1
CFPP 01-06 Testing Methods
         
Back to Testing Categories | Table Key
Electromagnetic Interference

Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
CFPP
01-06

Validation & Verification
Electromagnetic Interference Table 1                
Back to Testing Categories | Table Key
Sound Pressure

Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
CFPP
01-06

Testing Methods
Sound Pressure Test 1 15.1              
1: Please Note: Although the standard lists this as an OQ by the CP(D), the standard also states that this test is only performed in a specially designed and equipped test room, and that it is not required for an installed EWD (Ref CFPP 01-06: Testing Methods Section 15.1). Therefore it is unlikely to be required at installation, commissioning or periodically. If in doubt, manufacturer instructions should be obtained.
2: 
Also referred to as 'Sound Power' - Ref: Table 1 (Validation & Verification).
 Back to Testing Categories | Table Key
Table Key

Validation Test Abbreviations
TT Type Test By the manufacturer during the machine design stage. CFPP 01-06 Ref: 3.1
Validation & Verification
WT Works Test By the manufacturer prior to releasing the machine. CFPP 01-06 Ref: 1.30
Validation & Verification
IQ Installation Qualification By the manufacturer, contractor or supplier upon delivery. CFPP 01-06 Ref: 1.35
Validation & Verification
OQ Operational Qualification By the Competent Person (Decontamination) after IQ. CFPP 01-06 Ref: 1.39
Validation & Verification
PQ Performance Qualification By the CP(D) after IQ and OQ. CFPP 01-06 Ref: 1.41
Validation & Verification
D Daily Periodic By the User or by delegation to the Operator. CFPP 01-06 Ref: 1.55
Validation & Verification
W Weekly Periodic By the User (or Operator) or CP(D). CFPP 01-06 Ref: 1.55
Validation & Verification
Q Quarterly Periodic By the CP(D). CFPP 01-06 Ref: 1.55
Validation & Verification
Y Yearly Periodic By the CP(D). CFPP 01-06 Ref: 1.55
Validation & Verification
Validation Contacts, Personnel & Miscellaneous Abbreviations 
MAN Manufacture The manufacturer of the machine. CFPP 01-06 Ref: 1.25
Validation & Verification
SUP Supplier The supplier of the machine.
Often also the manufacturer.
CFPP 01-06 Ref: 1.25
Validation & Verification
CON Contractor Hired to perform IQ.
Often also the manufacturer.
CFPP 01-06 Ref: 1.27
Validation & Verification
USER User Has final responsibility for machine performance/operation. CFPP 01-06 Ref 1.18
Operational Management
CP(D) Competent Person (Decontamination)     A qualified engineer and test person in decontamination. CFPP 01-06 Ref: 1.3
Validation & Verification
OPT Optional Test     The standard states that this is an optional test requirement. N/A
Last Viewed Test Table | Back to Testing Categories