What are the safety classification for software systems as per IEC 62304?
The IEC 62304 defines three software safety classes: Class A: If the software cannot cause any harm. Class B: If the software can cause minor harm such as injuries. Class C: If the software can cause major harm such as severe injuries or even death.
How is software safety classification determined?
Software classification is based on potential for hazard(s) that could cause injury to the user or patient. Per IEC 62304:2006, software can be divided into three separate classes: Class A: No injury or damage to health is possible. Class B: Nonserious injury is possible.
What is device classification?
Classification of Medical Devices The FDA categorizes medical devices into one of three classes – Class I, II, or III – based on their risks and the regulatory controls necessary to provide a reasonable assurance of safety and effectiveness.
What are Class II medical devices?
Class II medical devices are those devices that have a moderate to high risk to the patient and/or user. 43% of medical devices fall under this category. Most medical devices are considered Class II devices. Examples of Class II devices include powered wheelchairs and some pregnancy test kits.
Does FDA recognize IEC 62304?
“(IEC 62304) defines software lifecycle processes for medical device software. It’s recognized by the FDA as a consensus standard.”
How is FDA device classification determined?
The FDA categorizes medical devices into one of three classes – Class I, II, or III – based on their risks and the regulatory controls necessary to provide a reasonable assurance of safety and effectiveness.
What are the safety classifications in IEC 62304?
The IEC 62304 standard expects the manufacturer to assign a safety class to the software system as a whole, based on its potential to create a hazard that could result in an injury to the user, the patient, or other people. There are three software safety classifications, as follows: Class A: No injury or damage to health is possible.
When does IEC 62304 apply to medical device software development?
The processes, activities, and tasks described in clause 5 establish a common framework for medical device software life cycle processes that can be understood and shared within and between teams working on a project (see Figure 1). IEC 62304 applies to the development and maintenance of medical device software when:
Why is IEC 62304 used as a benchmark?
It is harmonized by the European Union (EU) and the United States (US), and therefore can be used as a benchmark to comply with regulatory requirements from both these markets . The IEC 62304 standard calls out certain cautions on using software, particularly SOUP ( software of unknown pedigree or provenance).
What is the class of risk of medical device software?
The class of risk of the software is the highness class of risk of any software requirements evaluated. The IEC 62304 – Medical Device Software requires the documentation of a software development plan. This provides a framework for the conduction of the activities related to the SW development lifecycle.