Part 2: Amendment 2 of IEC 60601-1:2005

This is a continuation of our article last month titled, Amendment 2 of IEC 60601-1. Last month, we covered the history of Amendment 2. This month, we will be discussing key points in ISO 14971:2019 (Third edition) as well as information on regulatory compliance timelines.

Understanding the ISO 14971:2019 (Third edition)

Compliance with the requirements of ISO 14971:2019 will be required by the newly published IEC 60601-1:2005/AMD 2: 2020. Additionally, the U.S. Food and Drug Administration (FDA) has previously granted Recognized Consensus Standard status to the 2019 edition of the ISO 14971. The FDA will accept declarations of conformity to the ISO 14971:2007 (Second edition) included in premarket submissions until December 25th, 2020. From that point on, it will be required to provide declarations of conformity to the standard’s 2019 edition.

Manufacturers of medical devices need to identify the hazards associated with medical devices in order to estimate and evaluate the associated risks, control these risks, and to monitor the effectiveness of the controls. The ISO 14971 standard provides guidance for the application of risk management for medical devices.

The road to compliance

In order to comply with standard IEC 60601-1 Edition 3.1 2012-08 (Medical electrical equipment – Part 1: General requirements for basic safety and essential performance), manufacturers are obliged to prepare and maintain the risk management documentation according to ISO 14971. Historically, ISO 14971 originates from norms EN 1441 (1997) and ISO 14971-1 (1998). The first edition of ISO 14971 was published in 2000 while the second edition, which is currently referenced by most of the standards, was published in 2007. To follow up, the ISO 14971 third edition was released in 2019.

The six most important changes brought by ISO 14971:2019 (third edition) were: 

• Addition of system security to the scope of the risk management — The medical electrical equipment manufacturer shall now consider risks related to cybersecurity also.
• Wider harm definition — The word “physical” was removed from the definition. ISO 14971 third edition does not consider physical injury or damage as the only kind of harm. With the newest edition, manufacturers shall also consider other forms of harm like mental discomfort due to false positive diagnoses, leakage of medical records, etc.
• The edition enforced risk control priority order — Inherently safe design in manufacturing remains the first and most important feature of the risk control option analysis. If it is not practicable to achieve an accessible risk level by inherently safe design, manufacturers are allowed to apply protective measures such as barriers or alarms. The third and the least preferred option is to provide information for safety such as a written warning or contra-indication.
• Economic advantage cannot be taken under consideration for risk-benefit analysis — This comment was already in the second edition of the EN version of ISO 14971. ISO 14971 third edition in clause 7.4 states now clearly that risk-benefit analysis cannot be used to weigh residual risks against economic advantages.
• The manufacturer shall now inform users of significant residual risks — ISO 14971 third edition in clause 8 states that for an overall residual risk that is judged acceptable, the manufacturer shall decide which information is necessary to include in the accompanying documents in order to disclose the overall residual risk to the users.
• Additional guidance document ISO 24971 — The new document provides guidance on the application of ISO 14971. In the document, you can find interesting information, like an additional explanation for each clause from ISO 14971, guidance on the identification of hazards and characteristics related to safety, and other guidance that will help you prepare proper risk management documentation for your products.

When comparing the third edition ISO 14971 to the second edition, the newer edition is an evolution of the norm and not a revolution in the requirements. The manufacturer who prepared their documentation according to requirements from ISO 14971 second edition and truly focused on proper application of the requirements would not need to invest much effort to comply with the third edition.