[ Introduction ISO 14971:2019 ]

The risks derived from the increasing diversification of medical devices and related programs cannot be fully resolved by product safety standards, so the first edition of ISO 14971 was published in 2000 due to the need for risk management over the life cycle of medical devices to actively improving.

Since then, based on the principles of risk management developed over the years, the International Organization for Standardization (ISO) systematically applies its experience, insight and judgment to medical devices to manage and ameliorate possible or potential related risks, On December 18, 2019, the risk management application requirements for medical devices were newly revised.

ISO 14971:2019 specifies terms, principles, and processes for risk management of medical devices, including medical device software and in vitro diagnostic medical devices.

Risk referred to in risk management may be associated with damage to assets (e.g., data, other equipment) or environment, including injuries to patients as well as users and others, and is not necessarily limited to medical devices.

These requirements can be used as a possible guidance in developing and maintaining risk management processes for non-medical devices and for suppliers and various other stakeholders involved in the life cycle of medical devices and medical devices.

[ Necessity of ISO 14971:2019 ]

• •  It is easy to help the understanding of risk management of various stakeholders including health care workers, government, patients, etc.
• •  Possible to identify and control possible risks in medical device manufacturers and verify their effectiveness
• •  Identify the risks and benefits associated with the intended use of the medical device, its performance, and clinical procedures

[ ISO 14971:2019 Requirements ]

• Scope
• Reference
• Terms and definitions
• General requirements for risk management system
• Risk analysis
• Risk evaluation
• Risk control
• Evaluation of overall residual risk
• Risk management review
• Production and post-production activities

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