Even though the ISO 14971 defines the terms hazard and hazardous situation, it is still often not so easy for medical products manufacturers to differentiate these two terms. This article will help understand these terms clearly.
The ISO 14971 defines both terms
„potential source of harm“
Source: ISO 14971:2012
„circumstance in which people, property, or the environment are exposed to one or more hazard(s)“
The ISO 14971 gives as examples of hazards:
As already mentioned, hazards are defined as potential sources of harm. There is no doubt that ionizing radiation (electromagnetic energy), voltage (electric energy), hot surfaces (thermal energy) and moving parts (mechanical energy) are potential sources of harms i.e. hazards.
But an instruction manual? An inadequate specification of the intended use? Are these hazards as well?What's about a wrong display of a drug or a drug dose at a drug management systems?
All these latter examples eventually might lead to a harm, but not directly.
Any element of a casual chain meets the definition of "potential source of harm" e.g.
It is important to have a common understanding of hazard within an organization. Otherwise the risk management file might become inconsistent and probabilities of hazards and harms and thereby risks are inappropriately assessed.
We recommend to chose one of the following complementary definitions of hazard:
„Option 1: Hazard is the 'misbehavior of the system at its output (e.g. too hot surface, display of wrong information“
„Option 2: The hazard is the last element in a causal chain previous to the hazardous situation.“
The Auditgarant can help you with more than a dozen step by step training videos sessions
Do you know the publication "TOP 10 HEALTH TECHNOLOGY HAZARDS FOR 2013 '?
Almost every other hazard has to do more or less directly with software.
If you read the whole article, you will notice that the above listed hazards and causes for hazards are mixed with each other.