IEC 62366-1:2015 pdf free download

IEC 62366-1:2015 pdf free download
IEC 62366-1:2015 pdf free download.Medical devices
EFFICIENCY is included in the definition of USABILITY , and is itself defined as EFFECTIVENESS in relation to resources expended. EFFICIENCY is always desirable, and it is sometimes, though not always, important for SAFETY . Lack of EFFICIENCY can contribute to RISKS or increase existing RISKS , while efficient MEDICAL DEVICES can mitigate certain kinds of RISKS .
With respect to MEDICAL DEVICES , some of the instances in which EFFICIENCY is most related to SAFETY are those in which TASK performance time has important consequences for the PATIENT . One example of a MEDICAL DEVICE for which performance EFFICIENCY is important for SAFETY is an automatic external defibrillator (AED). These MEDICAL DEVICES are used in a context in which every second counts in saving someone’s life. An AED that cannot be used efficiently decreases the survival probability of the PATIENT . Similarly, PATIENTS undergoing invasive surgery are exposed to RISKS of infection and anaesthesia during these PROCEDURES . Minimizing the time vital organs are exposed and the time the PATIENT is anaesthetized are important for SAFETY . Therefore, MEDICAL DEVICES used during surgery – surgical tools need to be as efficient as possible so as not to contribute further to the existing RISKS of infection and anaesthesia.
NORMAL USE encompasses all foreseeable USER actions when a USER is operating a MEDICAL DEVICE according to the MANUFACTURER ’ S INTENDED USE for that MEDICAL DEVICE . It specifically excludes ABNORMAL USE . See also Figure B.1 . NORMAL USE is simply what is expected from a USER under normal conditions of use, which includes actions that are either correct or in error, but not contrary to the design intentions of the MANUFACTURER .
There are MEDICAL DEVICES that can be used safely without instructions for use, e.g. forceps, scalpel. For such MEDICAL DEVICES , NORMAL USE is established by use in accordance with generally accepted practice.