Test and Inspection Protocols
Details
Last Updated: 20 January 2017
Article courtesy of Eastwood Park (http://www.eastwoodparktraining.co.uk)
7.1 When to test
As discussed at paragraphs under 5.6 above, user organisations should design and implement
electrical safety inspection and test regimes on the basis of risk assessments.
In practice, most user organisations have found it necessary to carry out electrical inspection and
safety testing on medical electrical equipment on the following occasions.
a. On newly acquired equipment prior to being accepted for use
b. During routine planned preventative maintenance,
c. After repairs have been carried out on equipment.
A patient should never be connected to a piece of equipment that has not been checked.
The testing regime used in the case of acceptance testing will be slightly different to that used on
other occasions particularly as regards checks on the condition of packaging, presence of relevant
documentation and accessories. However it is useful to use the acceptance testing procedure to
lay down baseline data for comparison when the equipment is tested on future scheduled services
and after repairs,
7.2 Example inspection and test protocol
Annex 3 contains a test record sheet that is used to record inspection and test results produced by
a simple electrical safety protocol. It is not intended to be in any way prescriptive, but is included
here simply to illustrate many of the important features of an effective protocol
Details of the equipment under test are recorded at the top of the form including the device serial
number and a plant number ascribed by the user organisation. This ensures that the record can be
linked to the particular item of equipment. The class and type/s of the equipment under test are
also recorded here to ensure that appropriate test limits are applied.
The details of the test equipment used are also recorded at the top of the form together with thecalibration date. This information is important for traceability since test results can only be proved
to be accurate if it can be demonstrated that the test equipment was in calibration.
The visual inspection checklist provides a record that the relevant parts of the equipment have
been inspected. This is very important since, in practice, the visual inspection is likely to flag up
problems far more often than the electrical safety tests themselves. It is also important that a
record of visual inspection is kept. Where user organisations use electronic means to record data
downloaded from electrical safety testers, it is important to add information on visual inspection
‘to the record.
The electrical safety tests that are used in this particular protocol are few in number and are the
same tests, derived from IEC60601-1, that were selected for HEI 95. The earth continuity test is
obviously important for all class | equipment. The insulation test is intended to look at the
insulation between the mains part and the earth of the equipment under test, and may be regarded
as a pretest to verify that it is safe to apply mains power in order to measure leakage currents.
Earth leakage current here is only measured under normal condition (NC). Note that “normal” and
“reverse” here mean that the leakage current is measured with L1 and L2 the right way round and
the wrong way round. Both of these conditions are defined as "normal condition’. This test will not
usually produce as high a reading as if the test is conducted with under single fault condition,
neutral open circuit. However, in most cases, if there is no problem with earth leakage current
under normal condition, there is unlikely to be one under the single fault condition.
Enclosure leakage and patient leakage currents are both recommended under this protocol to
measured under single fault condition, earth open circuit (EOC). The rationale behind this is that
any problems are likely to be evident under this condition and it is not improbable that the fault
condition may arise when the equipment is in use.
At the foot of the form, it is recorded whether the equipment has passed or failed in the light of the
visual inspection and the electrical safety test results. The date of the test and the identity of the
person who performed the test must also be recorded.
The comments field below the table is a useful feature of any recording system. It allows any
observations to be recorded, for example, of peculiarities of the equipment under test or concerns
about test results. The record should be referred to by the person performing the next test and
inspection on the equipment prior to carrying out the inspection and test.
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