ISO 14971:2019
ISO 14971:2019-Medical devices — Application of risk management to medical devices
| Standard´s number: | ISO 14971:2019 |
| Pages: | 36 |
| Edition: | 3 |
| Released: | 2019 |
ISO 14971
This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process described in this document intends to assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The requirements of this document are applicable to all phases of the life cycle of a medical device. The process described in this document applies to risks associated with a medical device, such as risks related to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability. The process described in this document can also be applied to products that are not necessarily medical devices in some jurisdictions and can also be used by others involved in the medical device life cycle. This document does not apply to: — decisions on the use of a medical device in the context of any particular clinical procedure; or — business risk management. This document requires manufacturers to establish objective criteria for risk acceptability but does not specify acceptable risk levels. Risk management can be an integral part of a quality management system. However, this document does not require the manufacturer to have a quality management system in place.
NOTE Guidance on the application of this document can be found in ISO/TR 24971
ISO 14971 Content
| Foreword |
| Introduction |
| 1 Scope |
| 2 Normative references |
| 3 Terms and definitions |
| 4 General requirements for risk management system |
| 4.1 Risk management process |
| 4.2 Management responsibilities |
| 4.3 Competence of personnel |
| 4.4 Risk management plan |
| 4.5 Risk management file |
| 5 Risk analysis |
| 5.1 Risk analysis process |
| 5.2 Intended use and reasonably foreseeable misuse |
| 5.3 Identification of characteristics related to safety |
| 5.4 Identification of hazards and hazardous situations |
| 5.5 Risk estimation |
| 6 Risk evaluation |
| 7 Risk control |
| 7.1 Risk control option analysis |
| 7.2 Implementation of risk control measures |
| 7.3 Residual risk evaluation |
| 7.4 Benefit-risk analysis |
| 7.5 Risks arising from risk control measures |
| 7.6 Completeness of risk control |
| 8 Evaluation of overall residual risk |
| 9 Risk management review |
| 10 Production and post-production activities |
| 10.1 General |
| 10.2 Information collection |
| 10.3 Information review |
| 10.4 Actions |
| Annex A Rationale for requirements |
| A.1 General |
| A.2 Rationale for requirements in particular clauses and subclauses |
| Annex B Risk management process for medical devices |
| B.1 Correspondence between second and third editions |
| B.2 Risk management process overview |
| Annex C Fundamental risk concepts |
| C.1 General |
| C.2 Examples of hazards |
| C.3 Examples of events and circumstances |
| C.4 Examples of relationships between hazards, foreseeable sequences of events, hazardous situations and the harm that can occur |
| Bibliography |
Cleanrooms and associated controlled environments - Part 3: Test methods (ISO 14644-3:2019, Corrected version 2020-06)
Cleanrooms and associated controlled environments - Biocontamination control
ISO 13485:2016-Medical devices — Quality management systems — Requirements for regulatory purposes
Medical device software. Software life-cycle processes