ISO /IEC 62304:2006 defines the life cycle requirements for medical device software. The set of processes, activities, and tasks described in this standard establishes a common framework for medical device software life cycle processes.
Eurotech assesses the Software for medical devices with its compliance with ISO/IEC 62304:2006.
IEC 62304 is a harmonised standard for software design in medical products adopted by the European Union and the United States. Because the standard is “harmonised,” medical device manufacturers adopting it will satisfy the essential requirements contained in Medical Devices Directive 93/42/EEC (MDD) with amendment M5 (2007/47/EC) as related to software development. This is the least onerous route to ensuring compliance with the MDD. US FDA will also accept ANSI/AAMI/IEC 62304:2006 as evidence that medical device software has been designed to an acceptable standard. This standard is identical to the EN/ISO variant in all essential details.
Initially the IEC 62304 standard expects the manufacturer to assign a safety class to the software system as a whole. This class-ification is based on the potential to create a hazard that could result in an injury to the user, the patient or other people.
The software is classified into three simple classes, as follows:
- Class A: No injury or damage to health is possible
- Class B: Nonserious injury is possible
- Class C: Death or serious injury is possible