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IEC 60601-1-2 4th Edition: Manufacturers Responsibilities


Description

The medical device industry is the most heavily regulated in manufacturing, for good reason. Devices that do not meet the highest quality and safety standards present a risk of injury, recalls, embargos, bans and liability.

The transition from IEC 60601-1-2:2007 to IEC 60601-1-2:2014 introduced the concept and application of risk management (carried over from the IEC 60601-1:2005+A1:2012) and shifts the testing requirements to the manufacturer.  The change in responsibility forces the manufacturer to play a more active role in the EMC evaluation.  The role of risk management is provided to allow for the modification of testing dependent on the intended use location.  With the addition of risk management, the test house conducting the testing will be looking at the manufacturer to provide clear direction not only on the tests to conduct, voltage to run the unit, what to look for during/after testing and locations to run the tests.  With the change in edition, the accompanying document requirements have changed which will require modifications to the documentation.  

In order to prevent delays in your IEC 60601-1-2:2014 evaluation, a understanding of the requirements is critical.  During this ½ day class, we will discuss the addition of Risk Management, Test Plan and Accompanying Document Requirement.

Objectives

Upon completion of this seminar, participants should be able to:

  • Understand the role of Risk Management in standard
  • Determine the correct tests
  • Generate a test plan for IEC 60601-1-2:2014
  • Understand the required wording for the Accompanying Documents

Target Audience

  • Product safety engineers
  • Compliance engineers
  • Product designers
  • Regulatory approval staff
  • Production support engineers
  • Quality assurance staff
  • Technical marketing professions
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Media

Time Requirement

Cost

Instructor-Led 4 hours $400.00

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