BS EN ISO 14971 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
The requirements of this International Standard are applicable to all stages of the life-cycle of a medical device.
This International Standard does not apply to clinical decision making.
This International Standard does not specify acceptable risk levels.
This International Standard does not require that the manufacturer have a quality management system in place. However, risk management can be an integral part of a quality management system.
H.2 Risk analysis
H.2.1 Identification of intended uses
H.2.1.1 General
IVD medical devices for laboratory or point of care examinations have two users: (1) an operator who performs the examination, and (2) a healthcare provider who receives, interprets and acts on the results. In the case of IVD medical devices for self-testing, the patient could be the only user.
Identification of intended uses should consider the objective intent of the manufacturer with respect to both elements of use: (1) use of the IVD medical device to produce an examination result, and (2) use of the examination result to reach a decision on the diagnosis, treatment or monitoring of a patient.
H.2.1..2 Intended use
The intended use of an IVD medical device can include the measurement system, analyte, kind-of-property, sample matrix, examination procedure (qualitative, semi-quantitative or quantitative), type of operator and site of use.
For example, quantitative examinations for beta-human chorionic gonadotropin (13-hCG) concentration can be ordered for serum, plasma or urine samples. Not every [-hCG examination procedure has performance characteristics suitable for all three types of sample matrix.
H.2.1.3 Indications for use
The indications for use include the medical applications and patient populations for which the IVD medical device is intended.
For example, -hCG results can be used for detecting pregnancy, for screening pregnant women for foetal Down’s syndrome, and for monitoring certain cancers. Each medical application may have different requirements for measurement sensitivity, specificity, precision and trueness.
BS EN ISO 14971:2009 pdf free.Medical Devices – Application Of Risk Management To Medical Devices.