MDTmag.com 14 / April 2014
13 Contract Manufacturer’s
As more tasks are being pushed to manufacturing partners by OEMs, testing to industry Standards is
becoming the responsibility of outsourcing providers. While this article is written as a guide for service
partners, it also serves as a list of considerations for OEMs to keep in mind when creating the procedures
for the contract manufacturer.
By Jeff Lind, President, Compliance West
As the industry evolves and budgets hrink, quality requirements remain constant and contract manufacturers (CMs) feel the pinch. Now, OEMs are
requiring CMs to conduct electrical test
sequences to ensure product quality before
shipment. Many times, these sequences have
a basis in published Medical Standards from
the IEC, AAMI, or other Standards bodies.
In some cases, the test procedure received
from the OEM may be modified for the
production environment. The procedure
presented from the OEMs has been greatly
simplified from the presentation in the
IEC or other Standard.
Some OEM procedures are straightfor-
ward hipot or ground continuity/ground
bond testing, but there are others that are
more complex. These could include func-
tional tests to determine proper function on
a sample of production, or safety tests on
components. These more complex proce-
dures might require a CM to obtain special-
ized equipment needed to fulfill the OEM’s
The following steps offer a common-sense
checklist for review of the OEM’s test plan.
By following these basic steps, a CM can
quickly verify that the procedure is complete.
OEM Procedure Completeness Checklist
A. Test Specification and Evaluation
If the OEM has not referenced an IEC or
other published Standard as the basis for
the test, items 1 and 2 of this checklist can
1.Is the Standard the correct one for the type of equipment being tested?
2.Does the specification received for the type of test agree with the version of the test in the
latest copy of the Standard?
The adoption of IEC 60601-1:2005
and reisssuance of many IEC 60601-2-XX
Standards have caused test protocols for
many types of medical equipment to change.
However, it’s not always correct to assume
that testing to the the newest Standard
version is required. In some cases, notified
bodies are accepting construction based on
older versions of the Standards, and at least
at this point, the newer versions have not
been universally adopted worldwide. If the
Standard referenced in the procedure is
not current, consult with the OEM to see
if this is deliberate or if an update to the
plan is required.
3.Is the test specification complete regarding pass/fail criteria and disposition of failing
What exactly comprises a failure? Can the
failing part be reworked and tested again, or
is it to be disposed of?
4. Does it test the parameter in question?
The test point should reasonably test the
part. If the test seems too stringent or if the
test does not seem to apply, check with the
OEM to make sure the requirement is being
applied correctly. Does the procedure need
to be rewritten or the parameters changed
to properly test and exercise the product to
make sure it’s built to specification?
5.How will the test impact production?
Consider multiplexing or duplication of
test stations if throughput suffers.
6.Is test station infrastructure in place?
Does this area of the plant have infrastruc-
ture to support the test (personnel, power,
network connections, etc.)?
B. Production Setup and Testing
1.Does the test have a reasonable procedure and a realistic pass/fail point?
The pass/fail point has to be reasonable
for the part, the equipment, and the infrastructure of the manufacturing location. A
cleanroom-style test won’t be practical in
most manufacturing areas, and one with
complex results may have a very long
training curve for the second shift. Is there a
way to make it simpler and still have a valid
result for the OEM? If mechanical fixtures are
involved, are they supplied or do they have
to be fabricated? Is the fixture designed to
withstand test voltages and currents anticipated? Test with known good parts to know
the limits of the fixture.
Hipot, surge, and other hazardous tests should be separat-
ed from the normal workflow to protect other personnel.