The ISO 14971 is an ISO standard for those companies involved in the manufacturing of medical devices. It intended for improving company processes and standardizes manufacturing procedures so that the risks associate with electronic medical devices can be mitigated. It is a set of points for risk management and adopting best practices while developing a device used in the medical industry.
There are three different versions of the ISO 14971
ISO 14971:2007- This was the first standard that was made by the world governing body for medical devices. It was replaced by the ISO 14971:2019.
ISO 14971:2019- It replaced the ISO 14971:2007 certification. It has new chapters included in it and focuses mainly on the benefit-risk ratio. It also includes information that has to be passed on to the next phases for safer use of the device.
EN ISO 14971:2012- It is intended for manufactures of medical devices in Europe only.
The ISO 14971:2019 has three main objectives
Implementing the safety standards right fro he planning phase of manufacturing
Designing medical devices is a complicated process. This feature as stated within the ISO Document Control Software is to mitigate the hazards in the medical industry by use of safe manufacturing process. It deals with removing those features that could be selected by mistake or by error.
The safety while using the medical devices can also be increased by the use of labels and displays beside each switch, plug, or socket. Also, there should be a process to automate the device functions to avoid the error. It can be used for doing the minute tasks where the chances of error are high.
Include measures to protect or contain the damage within the device itself
This point explains the need to incorporate safety measures in it and also the mechanisms in the event of wrong input. These may include safety measures such as using safety guards, shields, or manual override to contain the activity. It includes providing warning displays to warn the user while using the device such as low battery warnings on devices. This would prevent stalling a device operation midway while conducting surgery or anything similar.
Safety information
This includes users to hand a device manual which gives a thorough guide on how to use the device. It also includes providing training to the users of the device.
What are the benefits of ISO 14971:2019?
- It can avoid the wrong happenings such as injury or accident
- Optimum use of the device for improving medical infrastructure
- Develop better surgical procedures that focus on the safety of the user and the patient
- Streamlining manufacturing processes and issuing standard guidelines
Orcanos is a risk management tool designed to help medical device manufacturers. It is considered to be the best for providing an integrated solution, providing traceability, and is fully online. Visit the Orcanos website for more details: https://www.orcanos.com/compliance/
No comments:
Post a Comment