What is DD CEN/TS 15260 - Classification of safety risks from health informatics products about?
DD CEN/TS 15260 is concerned with the safety of patients and gives guidance on the analysis and categorization of hazards and risks to patients from health informatics products, to allow any product to be assigned to one of five risk classes. DD CEN/TS 15260 applies to hazards and risks which could cause harm to a patient. Other risks such as financial or organizational are out of scope unless they have the potential to harm a patient.
Note 1: DD CEN/TS 15260 applies to any health informatics product whether or not it is placed on the market and whether or not it is for sale or free of charge. Examples of the application of the classification scheme are given.
Note 2: DD CEN/TS 15260 does not apply to any software which is encompassed within EU Medical Devices Directives.
Who is DD CEN/TS 15260 - Classification of safety risks from health informatics products for?
DD CEN/TS 15260 on health informatics is useful for:
- Large Hospitals
- Health care organizations
- Managers dealing with health care services
- Clinical informatics
- Nursing informatics
- The chief medical information officer
- Public health informatics
Why should you use DD CEN/TS 15260 - Classification of safety risks from health informatics products?
Health informatics product is software proffered for use in the health sector for health-related purposes but excluding software necessary for the proper application of a medical device
DD CEN/TS 15260 covers commercial products as well as, for example, open-source health informatics software and software created for, and used in, only one health organization such as a hospital. DD CEN/TS 15260 specifies categories for consequences arising from hazards, and categories for the likelihood of such consequences being realized, in the context of health informatics products.
DD CEN/TS 15260 benefits you to classify devices with classes based on the perceived potential risk to patients (typically four classes with sub-divisions) and to apply controls on matters such as design, production, quality systems, labelling, etc where the extent of the controls, and the rigor of their application, depends on the class: the higher the risk class the stronger the controls.