Reducing and managing the risks associated with medical devices is the goal of an important industry standard , ISO 14971 . Detailed guidelines for optimizing the use of this standard have been recently updated.
ISO 24971: 2020 is a guide to assist manufacturers in developing, implementing and maintaining a risk management process for medical devices, with the aim of meeting the requirements of ISO 14971: 2019, (medical devices – application of risk management on the device). Medical) is. The ISO 14971 standard, updated in December 2019, defines the so-called principles and process of risk management related to medical devices, as a medical device (SaMD) and diagnostic laboratory medical products (IVD).
ISO 24971 describes the approaches that manufacturers can use to develop, implement and maintain a risk management process in accordance with ISO 14971: 2019.
Recent Technical Report ISO / TR 24971 – Provides detailed guidance on how to use the standard, clarifies the requirements of the standard and contains practical advice and examples on how to comply with those requirements. To facilitate its use, it follows the same structure and the same paragraph number ISO 14971: 2019.
ISO 14971 and ISO / TR 24971, intended for use by commonly read and used medical device manufacturers, and information on how to identify hazards associated with medical devices and measure and manage Offer related risks.
Both documents have been jointly prepared by the International Electrotechnical Commission (IEC) by the ISO / TC 210 Technical Committees, Quality Management and General Aspects for Medical Devices and IEC / TC 62, Electrical Equipment in Medicine.
domain of usage
ISO 24971: 2020 provides guidance on the development, implementation and maintenance of a risk management system for medical devices according to ISO 14971: 2019.
The risk management process can be part of a quality management system, for example a system based on ISO 13485: 2016 . But not required by ISO 14971: 2019. Only some of the requirements in ISO 13485: 2016 (paragraph 7 on product realization and 8.2.1 on feedback during monitoring and measurement) are related to risk management and can be met using ISO 14971: 2019.
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