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You are here:» Applications» Medical/Pharma» Washer Disinfector» Guidelines
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Guidelines

 

All washer disinfectors require validation as a regulatory requirement. The requirement for testing or validating a washer disinfector unit is covered by the EN15883 standard. According to ISO 15883 a washer disinfector must undergo a validation process in connection with the purchase and installation, which verifies that it operates within preset limits when being used in accordance with the manual. The unit will also need to be revalidated on an annual basis, or when a critical component is replaced.

Tests are performed in an empty chamber and on a standardized load.


In an empty chamber:
 

 

One sensor in each corner => 8 sensors
One sensor on each side walls => 2 sensors
One sensor on centre of roof
One sensor at automatic control temperature sensor
 
Conclusion: minimum of 12 sensors is required

 


The amount of measuring points is volume dependent - the more load carriers the more measurement points. 


On standardized load:
 
3 temperature sensors on each load carrier - at two diagonally opposite corners and in geometric centre
One on each load carrier level to a maximum of 3 temperature sensors per carrier
One on slowest and fastest responding region overall.
One sensor at automatic control temperature sensor and one at process recorder (if fitted)
 
Conclusion: minimum of 9 (10) is required having only two load carriers.


Qualifying the washer disinfector the A0 value is an important parameter. The definition of A0 is;


Time in seconds at 80 C with a Z value of 10 to produce a given disinfection effect


A0=600 for bacteria,mycobacteria,fungi and heat sensitive virus
6000 sec / 100 minutes @ 70 C
600 sec / 10 minutes @ 80 C
60 sec / 1 minute @ 90C
 

A0=3000 for heat resistant virusses e.g. in surgical instruments