ISO 14971 INTRODUCTION

OVERVIEW

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• ISO 13485 is an international risk management standard for medical devices (including in vitro diagnostic medical devices).

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.

ISO 14971 was first published in 2000. This second edition was officially published on March 1, 2007. It cancels and replaces the firstedition. 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.

Definitions

• When the standard development process began it soon became obvious that “absolute safety” was not achievable.

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.

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..

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.

However, ISO 14971 does not apply to clinical decision making. Whether or not a medical device should be used in the context of aparticular 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.

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.

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.

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.

FINDS

CERTIFICATION

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).

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.

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

STEP-BY-STEP OVERVIEW

ISO 14971 describes a risk management process (Parts 3 to 9) and is organized in the following way:

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.

1.PRODUCT ORIENTED APPROACH2.ENTIRE PRODUCT LIFE-CYCLE

Where is 1&2-?

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

Thank you

Prepared & implemented by Dr. krupasankar,Joint director,

Council of Quality standards IndiaTamil Nadu region