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4 Putting the sterilizer into service
4.1
Tests
Type testing
Type testing consists of a series of tests for confirming the functional data for a
specific type of sterilizer (DIN EN 285:1997).
Type testing was performed by the manufacturer on a representative 65 TC steam
sterilizer following the guidelines laid out in DIN EN 285 (February 1997). The
requisite tests ensure that the values for the physical sterilization parameters are
within the prescribed range, using an independent and calibrated measuring
system. All sterilizing programs are tested without load and with partial and full
loads (see Tables 2, 3 and 4). The unit is also tested for air leaks (vacuum test),
and a Bowie & Dick test is performed.
Factory testing
Factory testing includes a series of tests performed at the manufacturer's site in
order to demonstrate for each sterilizer that the unit performs in accordance with
applicable specifications (DIN EN 285:1997).
Within the framework of pre-acceptance testing at the factory, each sterilizer is
factory tested. This means that an independent, calibrated measuring system is
used to determine whether or not the sterilization process uses the predetermined
parameters. The Bowie & Dick test program is also tested. A test for air leaks
(vacuum test) is performed as well.
Acceptance test
Acceptance testing consists of a series of checks and tests performed on-site after
deployment of the sterilizer (DIN EN 285:1997). The owner or operator usually lets
the manufacturer or an authorized service agency perform this test.
Any additional tests (such as installation checks and microbiological testing) will
also be agreed between the operator and the manufacturer.
Within the framework of commissioning, each sterilizer is subjected to acceptance
testing. This means that an independent, calibrated measuring system is used to
determine whether or not the sterilization process uses the predetermined
parameters. The Bowie & Dick and Textiles programs are tested with different
loads as representative of the other programs. A test for air leaks (vacuum test) is
performed as well.
Validation
Validation is a documented procedure for obtaining, recording and interpreting data
required to show that a process will consistently comply with predetermined
specifications (see EN 554).
Validation of sterilization processes pursuant to Section 4, paragraph 2 of the
German Regulation for Operators of Medical Devices (MPBetriebV) has to be
applied for by the owner and can only be performed by the operator. Suitable
validating aids are available from Thermo Electron on request.
20
Thermo Scientific
50112712_082007_GB
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