Medical device manufacturers need to identify the hazards associated with their products in order to estimate, evaluate and control the associated risks and monitor the effectiveness of the controls. ISO 14971 provides guidance for the application of risk management for medical devices.

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. Read more…

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