Benchtop Steriliser

HTM 01-05 has a structured test schedule for checking, testing and validating benchtop sterilisers which should be adhered to if no manufacturer guidelines have been provided.

HTM 01-05

Benchtop Steriliser Validation Test Schedule

Below is the HTM01-05 Periodic Test Schedule for benchtop sterilisers.

The schedule shows the requirements dependent on steriliser type, vacuum (Type B and Type S) and non-vacuum (Type N).

This should be followed if manufacturer recommendations are not available.

It is a generic schedule created from the methods within the various legislative guidelines used to create HTM 01-05.

For a testing and validation schedule specific to your benchtop steriliser which takes into consideration HTM 01-05 and manufacturer recommendations, click on the link to the Isopharm validation test schedule creator.

 D = Day | W =Weekly | Q = Quarterly | Y = Yearly | CP(D) = Competent Person (Decontamination) | ENG = Engineer
 * Check with the machine manufacturer whether this test should be performed with either a Helix or Bowie Dick Pack.
 ** Check with the machine manufacturer if quarterly engineer validation is required as some require only yearly.

When is it Performed, and by Who?

The table below shows the full periodic schedule for the tests associated with the benchtop Steriliser CP(D) or Engineer Validation.

This is so that the User can see when they perform the test on a daily or weekly basis in relation to when the qualified validation engineer carries out the tests quarterly and annually.

The methods for the User during Daily and Weekly testing can be found in the relevant sections on the Isopharm website.

Document Specific Title Reference Installation & Commission Periodic Testing
D W Q Y
HTM 01-05 Automatic Control Test
15.3 
SUPPLIER
or
ENGINEER

USER   

USER   

CP(D)
or
ENG 

CP(D)
or
ENG 
MDA DB
2002 (06)
Appendix 4
Section 1.1 
HTM 01-05

Steam Penetration Test

Type B & Type S vacuum only

Table on page
56 Refers to
MDA DB 2002(06) 

SUPPLIER
or
ENGINEER

USER 

USER  

CP(D)
or
ENG 

CP(D)
or
ENG 
HTM 01-05 Weekly Safety Checks 15.14 
SUPPLIER
or
ENGINEER
 
USER  

CP(D)
or
ENG 

CP(D)
or
ENG 
HTM 01-05

Air Leakage Test

Type B & Type S vacuum only

Table on page
56 Refers to
MDA DB 2002(06) 

SUPPLIER
or
ENGINEER
 
USER  

CP(D)
or
ENG 

CP(D)
or
ENG 
HTM 01-05

Residual Air Test

Type S vacuum & Type N non-vacuum only

Table on page
56 Refers to
MDA DB 2002(06) 

SUPPLIER
or
ENGINEER
 
USER 

CP(D)
or
ENG 

CP(D)
or
ENG 
HTM 01-05 Steam Generator Overheat Cut-Out Test Table on page
56 Refers to
MDA DB 9804 

SUPPLIER
or
ENGINEER
   
CP(D)
or
ENG 

CP(D)
or
ENG 
HTM 01-05 Thermometric Test for Sterilisation Table on page
56 Refers to
EN 13060

SUPPLIER
or
ENGINEER
   
CP(D)
or
ENG 

CP(D)
or
ENG 
HTM 01-05

Load Dryness Test

Type B & Type S vacuum only

Table on page
56 Refers to
EN 13060 

SUPPLIER
or
ENGINEER
   
CP(D)
or
ENG 

CP(D)
or
ENG 
HTM 01-05 Yearly Safety Checks 15.16 
SUPPLIER
or
ENGINEER
     
CP(D)
or
ENG