Test procedures for WDs according EN ISO 15883-1 - Sterivita.lv

Validation procedure
of cleaning and disinfection
processes
according to EN ISO 15883 series
5.20-27 538 Dr. U. Kaiser 01/2011

„Accepted guidelines of technology“
EN ISO 15883-1 to -4
(2009)
Addition:
Guideline of DGKH,
DGSV and AKI for
Germany (2008)
Requirements and test procedures of washer/disinfectors with
• Thermal disinfection for surgical instruments, anesthesia
devices, bins, utensils, glass devices etc.
• Thermal disinfection for bedpans
• Chemical disinfection for thermolabile endoscopes
German recommendation for the validation and routine
monitoring of cleaning and disinfection processes for medical
devices (MDs) and recommendation for the selection of
machines
5.21-27 540 Dr. U. Kaiser 01/2011

Test procedures for WDs according EN ISO 15883-1 (1)
1. Type test/test during production
2. Validation during installation with
1. Installation qualification (IQ)
2. Operational Qualification (OQ)
3. Perfomance Qualification (PQ)
3. Routine monitoring (ROUT) and annually requalification (RQ)
5.22-27 541 Dr. U. Kaiser 01/2011

Test procedures for WDs according EN ISO 15883-1 (2)
Test OQ PQ Rout. Requirement Measurement
Cleaning
Test type 1
Cleaning
Test type 2
X
X
X
(daily)
Spray system X X X
X
Clean test of the load or
PCD with test soil
according EN ISO
15883-5 according to
country recommendation
Clean test of real
contaminated load
(3 measurements!)
See cleaning
(Test type 1)
According
EN ISO 15883-5
(mostly visual test)
Visual test and
remaining proteine test
• Ninhydrin-Method
• Biuret/BCA-Method
• OPA-Method
See cleaning.
Good: additional
measurement of the
flushing pressure
5.23-27 542 Dr. U. Kaiser 01/2011

Test procedures for WDs according EN ISO 15883-1 (3)
Test OQ PQ Rout. Requirement Measurement
Temperature profile X X X
Thermal disinfection
reservior
Only for chemical
disinfection
X
X
X
Confirmation of
machine settings
and keeping of
tolerances, e.g.:
Cleaning: +/- 5°C
Disinfection -
0/+5°C
Temperature band
≤ 4°C
Confirmation of
machine settings
and achieving
drinking water
quality
Confirmation of
machine settings
(Temperature
profile and dosage)
Temperature
sensor/ data logger
on load carrier,
chamber wall and
load
Temperature
sensor/ data logger/
micro-biological test
Temperature
sensor/ data logger/
Measurement
dosage see below
5.24-27 543 Dr. U. Kaiser 01/2011

Test OQ PQ Rout. Requirement Measurement
Dosage of cleaning
agent
Failure indication
lack of cleaning
agent
Test procedures for WDs according EN ISO 15883-1 (4)
Process residuals
Quality of flushing
water
X
X
X
X
X
X
Accuracy of the
dosage according to
the manufacturer‘s
instructions
Failure indication,
if the remaining
amount is not
sufficient for a cycle
Defined by the
manufacturer of the
chemicals
According to the
instructions of the
WD manufacturer
Dryness of the load X No remaining water
Volumetric or gravimetric
metering
Test for failure
indication because
of empty reservoir
Ususally by
measurement of pH
and conductivity of
the last flushing
Conductivity, pH,
salts, bioburden
Visual test using
crepe paper or
weight comparison
before and after the
process
5.25-27 544 Dr. U. Kaiser 01/2011

Test procedures for WDs according EN ISO 15883-1 (5)
Test OQ PQ Rout. Requirement Measurement
Leak tightness of
the chamber
Door locking X X
Reproducibility
Failure indication
X
X
X
No leaks in full
chamber
Not allowed:
• process start with
open door
• Opening the door
during the process
• Opening both
doors
In the last 3 of 4
test cycles the
temperature profile
must be the same
within 2,5°C
Failure indication, if
a sensor is out of
order
Visual test
Check during
operation, if
requirements are
fulfilled
Cooling the WD,
then 4 x recording
temperature profile
with sensors/ data
loggers
Switch off the
sensors separately
and check failure
indication
5.26-27 545 Dr. U. Kaiser 01/2011

Test procedures for WDs according EN ISO 15883-1 (6)
Additions
Source
Requirement
EN ISO 15883-2 • Definition of dosing accuracy of chemicals of minimum 5 %
Guideline DGKH,
DGSV and AKI for
Germany
EN ISO 15883-4
(WDs for thermolabile
endoscopes)
• Determination to test devices not complying the standards
• Definition reference PCD (Crile-clamps with
blood contamination in the joint)
• Definition of the test load
• Definition of proteine limit value and test of it
• Restatement routine monitoring
• Definition of dosing accuracy of chemicals of minimum 5 %
• Extension and specialization of the scope covering the
requirements for endoscope WDs (WD-E), e.g.:
• Requirements on the leak tightness of endoscopes
• Requirements on the failure indication of blockage or
missing connection of canals
• Cleaning and flushing of canals
• Chemical disinfection at average temperature
• Self-disinfection of WD-E without endoscopes
using disinfectants or thermal disinfection
5.27-27 546 Dr. U. Kaiser 01/2011