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ISO 14971 is an international standard for risk management of medical devices, which can be voluntary or mandatory in some countries. It aims to limit risks by assessing likelihood and severity, and requires ongoing risk management processes including analysis, evaluation, control, and information. The standard also includes requirements for adequate resources, determining acceptable risk levels, and qualified personnel.
ISO 14971 is an international standard covering the risk management system used for medical devices. While it can be used as a voluntary standard, ISO 14971 can also be used as a mandatory legal requirement in some countries. For example, all countries within the European Union are required by the Medical Device Directive to have national laws forcing device manufacturers to follow the standard.
One of the key principles of ISO 14971 is that no medical device can be completely risk-free. It therefore works on the basis of risk limitation, taking into account both the likelihood that a device will cause damage, and the severity of such damage if it occurs. It does not establish a specific acceptable level of risk, but rather covers how manufacturers can assess risk and make informed decisions.
While the standard deals primarily with risk to patients, it does cover potential risk to other people, equipment and the environment. In particular, he deals with the risk management of the producer. The standard does not address the risk management decisions of other parties, such as how medical professionals weigh the potential risk of equipment against the potential benefit to patients.
The main requirement of ISO 14971 for manufacturers is to set up a risk management process. This process must be ongoing for the lifetime of the device. This means that simply ensuring an acceptable risk at the point of manufacture and sale will not be sufficient.
The risk management process must include four elements: analysis, evaluation, control and information. The analysis involves examining the device, its safety features, its potential dangers and consequent risks. Evaluation involves taking the data from the analysis and deciding whether it is acceptable or has indicated a need for change. Risk control involves examining how risks can be mitigated and whether the actions required to accomplish mitigation will themselves lead to new risks. Information involves compiling the details of the rest of the process clearly for future reference.
ISO 14971 also includes several requirements on how the risk management process is conducted. The manufacturer’s management must ensure that adequate resources are available to carry out the process. They are also required to determine the acceptable level of risk in the device. Those who actually carry out the risk management process must be suitably qualified or experienced, which can involve both an understanding of risk management and in-depth knowledge of the device itself.
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