1. EU: Council Directive 93/42/EEC. Official Journal of the European Union, June 1993
2. EU: Directive 2007/47/EC of the European Parliament and of the Council. Official Journal of the European Union, September 2007
3. IEC 60601–1:2005: Medical electrical equipment Part 1: General requirements for basic safety and essential performance (2005)
4. IEC 62304:2006: Medical device software - Software life cycle processes (2006)
5. IEC 61508–3 Ed 2.0: Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 3: Software requirements (2010)