ISO 14971 is an international standard for medical device risk management that defines requirements for establishing a risk management process. It aims to help manufacturers identify hazards, estimate risks, implement risk control measures, and monitor their effectiveness throughout the entire product lifecycle. The standard was developed because no risk management standard previously existed and regulators wanted manufacturers to apply risk management practices. ISO 14971 provides a step-by-step process for medical device manufacturers to assess and manage risks, from initial concept through final disposal of a product. Compliance with ISO 14971 is expected by regulators in most major markets.
2. 1of 1
• ISO 13485 is an international risk
management standard for medical
devices (including in vitro diagnostic
medical devices).
3. It defines a set of medical device risk management
requirements.
• The purpose of ISO 14971 is to help
manufacturers to establish a medical
device risk management process that can
be used to identify hazards, to estimate
and evaluate risks, and to implement and
monitor the effectiveness of risk control
measures.
4. ISO 14971 was first published in 2000. This
second edition was officially published on
March 1, 2007. It cancels and replaces the first
edition. ISO 14971 was developed because no
standard existed at the time and because
regulators throughout the world wanted
manufacturers to apply risk management to
their medical devices.
5. Definitions
• When the standard development
process began it soon became
obvious that “absolute safety” was
not achievable.
6. In addition, it became clear that product safety standards
cannot deal with all possible risks. There are just too many
products and applications for a product oriented approach
to work effectively. Because of this, and because there was
a great need to manage risks throughout the entire
product life-cycle, the standards development committee
decided to prepare ISO 14971.
7. SCOPE
• ISO 14971 applies to all medical
device manufacturers and all
medical devices and should be
used to manage risk throughout
• All stages of the product life-cycle
from initial concept right through
to final disposal..
8. Since risks can be introduced throughout
the product life-cycle and since risks that
emerge at one point can often be controlled at a
completely different point, ISO 14971 must be
used throughout the product’s entire existence.
9. However, ISO 14971 does not apply to clinical
decision making. Whether or not a medical
device should be used in the context of a
particular clinical procedure is a matter of
judgment. Such judgments are usually made
by qualified health care professionals and are
not regulated by this international standard.
10. REGULATORY ENVIRONMENT
• ISO 14971 is widely recognized as
the official standard for medical
device risk management.
Regulators in most major markets
expect medical device
manufacturers to use this standard
to manage risk.
11. ISO 14971 has been officially recognized by the
U.S. FDA and by Health Canada. In addition, the
European Union has adopted it as a harmonized
standard and Australia and Japan have accepted it
as the official standard for medical device risk
management.
12. Medical device risk management is now mandatory
in most countries and regions of the world. Every
regulated medical device manufacturer now needs
to be able to prove to regulators that they use risk
management methods to control risk and to ensure
that their products are safe.
14. ISO 14971 does not expect medical device
manufacturers to become certified.
You can simply use the standard to manage
risk and then declare that you are in compliance
(if you can demonstrate that this is in fact true).
15. However, regulators may require certification
and your customers may be more impressed if an
independent registrar (certification body) has
confirmed that you use the standard to manage
risk and that you actually are in compliance.
16. While ISO 14971 does not expect you to
become certified, several major registrars
now offer certification services. Some of these
include BSI, Underwriters Laboratories,
INTERINTERTEK, and SGS
18. 3. Establish your risk management framework.
4. Perform a RISK ANALYSIS for each medical device.
5. Evaluate risk for each identified Hazardous
situation.
6. Develop risk control measures when risk must be
reduced.
7. Evaluate the overall residual risk posed by each
device.
8. Review risk management process and prepare
report.
9. Monitor device during production and post-
production.
20. The following diagram summarizes the
ISO 14971-2007risk management process.
It describes the main steps that define
this process, including the sequence that
should be followed, and it highlights key
decision points
21.
22. Thank you
Prepared & implemented by
Dr. krupasankar,Joint director,
Council of Quality standards India
Tamil Nadu region
