The last version of this document was published in 2019. Manufacturers and medical equipment industry activists who intend to implement and obtain ISO 13485 certification can use this standard to identify and evaluate the risks of medical equipment.
In ISO 14971 standard document terms, principles and process for risk management of medical equipment including:In ISO 14971 standard document terms, principles and process for risk management of medical equipment including: The software is provided as a medical equipment and laboratory diagnostic medical equipment.
The process described in this document aims to help medical equipment manufacturers for the following:
- Identify risks related to medical equipment
- Estimate and evaluate the relevant risks
- Control these risks
- Monitor the effectiveness of controls
The requirements of this document are applicable to all stages of the life cycle of a medical device.
The process described in this document applies to risks related to medical equipment, these risks include the following:
Biocompatibility, data and systems security, electricity, moving parts, radiation therapy and usability
Also, the process described in this document can be applied to products that in some medical fields are not necessarily medical equipment and can be used by other people in the life cycle of the medical equipment.
The ISO 14971 standard does not apply in the following cases:
- Deciding on the use of medical equipment in any specific clinical procedure
- Business risk management
This document requires manufacturers to set objective criteria for risk acceptability, but does not specify acceptable risk levels.
Risk management can be an integral part of the quality management system. However, there is no need for a manufacturer to implement a quality management system.
To download the latest version of the ISO 14971 standard, risk management in the medical equipment industry, click on the button below.
