ISO 14971 is a risk management standard for
medical devices. Since ISO 14971 introduces its
risk management requirements in sections 3 to 9,
the following material begins with section 3.
3. Establish your risk management
Part 3 of ISO 14971 introduces the
standard and discusses general
These general requirements are
discussed in greater detail in Parts 4 to 9. It asks you to
a process that you can use to manage and control the risks
associated with your organizationís medical
Part 3 also asks you to assign
responsibility for risk management
and to ensure that all risk management personnel are competent.
addition, it asks you to define a policy that governs and
risk acceptability criteria are established and then asks you to
policy to establish risk acceptability criteria for each medical
Finally, it asks you to establish a risk management plan and to
maintain a risk
management file for each medical device.
4. Perform a risk analysis for each
Part 4 expects you to use your risk
management file to document
the intended use
of your medical device and to identify the product
characteristics that could affect safety. It then expects you to
out a risk
analysis for each medical device by identifying hazards
and by estimating the risk for each hazardous
5. Evaluate risk for each
identified hazardous situation
Part 5 then wants you to evaluate
risk for each hazardous situation.
It wants you to use your risk acceptability criteria to decide
reduction is required.
6. Develop risk control measures
when risk must be reduced
Part 6 then expects you to identify
control measures that can reduce
your risk to an acceptable level and then to implement these
and to verify that they were in fact implemented. Once youíve
Part 6 wants you to use your risk acceptability criteria to
whether or not your residual
risk is acceptable.
Whenever your residual risk is
unacceptable and further risk control is
impractical, it wants you to
determine whether or not the
outweigh the residual risk (it wants you to do a
Part 6 also wants you to review your risk control measures to
see if they
inadvertently introduce new hazards. It wants you to make sure
hazards and all identified hazardous situations have been
7. Evaluate the overall residual
risk posed by each device
Now that youíve implemented and
verified all risk control measures,
Part 7 expects you to evaluate the acceptability of your
overall residual risk. If your
overall residual risk is unacceptable, Part 7
expects you to use evidence to decide whether
or not the medical benefits
actually outweigh the overall
residual risks. If your overall residual risk is
unacceptable and if your overall residual risk outweighs the
benefits, then your medical device is not ready for the
8. Review risk management process
and prepare report
Part 8 asks you to carry out a risk
management review and to
prepare a risk management report before you release your
device for commercial distribution. Part 8 wants you to review
management plan, your overall residual risk, and both your
information gathering methods and plans.
9. Monitor device during
production and post-production
Lastly, Part 9 wants you to
establish a system that you can use to
monitor your medical devices during production and
phases. It then wants you to use your system to monitor your
devices and all similar devices.
Also check out our more
detailed version of ISO 14971.
summarizes the ISO 14971 2007 standard.
the main points. It does not
present detail. To get the complete
plain English standard, please consider purchasing our
Title 48: ISO 14971
2007 Translated into Plain English.
Title 48 is detailed, accurate, and complete. It
that is clear, precise, and easy to understand.
We guarantee it!
Title 48 can be delivered to you on CD
or as an email attachment.
Title 48 is 60 pages long and comes in pdf and MS doc file
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Updated on May
16, 2016. First published on February 28, 2011.
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