Test Report 1

The following information has been extracted from an

independent report produced by Trust Sterile Services Ltd.
Any information commercially confidential to Trust Sterile
Services has been omitted.

1.0 INTRODUCTION

Trust Sterile Services Limited (TSS LTD) was commissioned by Matrix Marking
to test their “dot peened plates” to determine the life cycle of the product. The
plates were individually identified, put through repeat steam sterilisation cycles
and plates were removed at specified stages during the process and then measured
to determine whether or not there was any degradation of the product.

Thirty one plates and a diathermy forceps with a metal tag attached, were used to
conduct the test.

1.1 Purpose of the Test

Matrix Marking requested that Trust Sterile Services Ltd carry out a test both to
assess the material stability of the marked plates and to test whether or not the dot
peen marking suffers from any degradation following exposure to repeat steam
sterilisation, and the subsequent readability.

2.0 PERFORMANCE QUALIFICATION TEST

2.1 Description of Test

The test was conducted at TSS LTD’s plant at Bellshill on 24th of January 2003.

Matrix Marking furnished TSS LTD with thirty one dot peened plates and one
plate attached to a diathermy forcep. Each plate had eight individual codes marked
with a computer controlled carbide tipped stylus. Each individual code was read
by a Matrix Marking code reader before the test began to ensure readability. Plates
were also read at intervals to ensure the mark stability translated into readability.

The tests were carried out in accordance with the protocol set between Matrix
Marking and Trust Sterile Services Ltd. The sterilisation tests were carried out on
a porous load extra drying cycle.

All tests were conducted with general hospital product that was available at the
time of the test cycle; this was to represent a typical sterilisation situation.
 The loading cradle containing a mixed load was introduced to the steriliser.

For the test, the packs containing the peened plates were evenly distributed around
the shelves of the carriage trolley for the steriliser (top, middle and bottom). Each
of the plates was removed at specified intervals and then measured to ascertain any
difference in peen size.

5.0 CONCLUSIONS

After the first cycle, all of the dot peened markings measured, increased in
diameter. However after the first cycle there was no increase in size, even after
300 cycles. The initial increase in diameter can be attributed to stress relieving of
the metal.

The test was stopped after 300 cycles in the steriliser, as there was not any further
noted degradation of the pinned dots apart from the initial stress relieving of the
metal (caused by the increase in temperature during the sterilisation cycle).

The code remained readable for 300 cycles with the Matrix Marking reader.

From the results Trust Sterile Services Ltd has concluded that dot peen marking
has shown the ability to last the life of a normal medical instrument.

The test was run alongside other instruments marked by different methods for
example: chemical etching, laser marking, laser bonding. One source of laser
marked instruments showed noticeable visible deterioration after only five process
cycles. Other sources lasted much longer. The chemically etched method did
show deterioration and became more difficult to read, although it should be noted
that some of this was due to technical problems with the handheld data matrix
reader. Therefore Trust Sterile Services Ltd has deemed the other results open to
interpretation.

REPORT WRITTEN BY: Amanda Renfrew, BSC, Quality Assurance. Trust Sterile
Services Ltd

DATE: 17th July 2003