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Hi,
I feel a little inconvenient when thinking the safety classification. According to IEC 62304 the safety classification may be reduced (C->B, B->A) only by a hardware risk control measure.
In case of really huge standalone software systems (where medical device is the software) there really are no way or point to isolate hazardous software units. For example if the software uses database, every function can be used to manipulate database. "You can code what ever you want where ever you want". The whole software is hazardous because of chance of programming errors.
Using ISO 14971 becomes inconsequential because there is no way to reduce the safety classification. It's good to perform risk analysis but impossible to do risk control. Doing risk control to software by software only increase the amount of software. So there is a point in 62304 that safety classification may be reduced only by a hardware risk control measure. Of course it's important to keep in mind the possible hazards relating to software system..
Safety classification is anyway one of the most important aspects of 62304 and hence affects software development process. Also 5.5.4 specify lots of documentation for each software unit.
Does anyone have some experience concerning standalone software and safety classification?
I feel a little inconvenient when thinking the safety classification. According to IEC 62304 the safety classification may be reduced (C->B, B->A) only by a hardware risk control measure.
In case of really huge standalone software systems (where medical device is the software) there really are no way or point to isolate hazardous software units. For example if the software uses database, every function can be used to manipulate database. "You can code what ever you want where ever you want". The whole software is hazardous because of chance of programming errors.
Using ISO 14971 becomes inconsequential because there is no way to reduce the safety classification. It's good to perform risk analysis but impossible to do risk control. Doing risk control to software by software only increase the amount of software. So there is a point in 62304 that safety classification may be reduced only by a hardware risk control measure. Of course it's important to keep in mind the possible hazards relating to software system..
Safety classification is anyway one of the most important aspects of 62304 and hence affects software development process. Also 5.5.4 specify lots of documentation for each software unit.
Does anyone have some experience concerning standalone software and safety classification?