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Safety Test Procedures
Chapter 8 - Test and Inspection Matrix
The test procedures outlined in this section are to be used only for verifying the
safe installation or service of the product. "Safety checks at installation refer to
safety aspects directly related to the installation and setup activities and not to
intrinsic safety features that have already been checked during final acceptance
testing at the factory."
[FDA 97-4179 Medical Quality Systems Manual: A Small Entity Compliance
Guide (QSR manual). First Edition December 1996. Chapter 14: Storage,
Distribution and Installation. This document may be viewed at http://
www.fda.gov.
When running safety tests on the peripheral components of the system, refer to
the documentation included with those products.
When performing safety tests, you must use a standard safety tester. You can use
testers complying with IEC 601-1 internationally. You may also use testers
complying with any local standards and statutes applicable to the country of the
installation. For safety test procedures see the operation instructions of the safety
tester used.
If using the Metron safety tester use your local regulations to perform the test,
for example
• in Europe: IEC60601-1/IEC60601-1-1
• in the US: UL2601-1
The Metron Report should print results as detailed in this chapter, along with
other data.
Note—For information and ordering guides for Metron products contact:
Metron AS, Travbaneveien 1, N-7044 Trondheim, Norway
Tel. (+47) 73 82 85 00; Fax (+47) 73 91 70 09;
E-mail: sales@metron.no/support@metron.no
www: http://www.metron-biomed.com
There are two general categories of safety test:
• Ground integrity
• Electrical Leakage
Safety Testing
85
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