Bioparhom technologies benefit from different certifications:
- CE marking under the Medical Devices Directive 93/42 /EEC and Regulatory 2017/745
- Quality Management System ISO 13485: 2016
They also comply with the standards:
- NF EN 60601-1 2007 Electrical equipment – Part 1: General requirements for basic safety and essential performance
- NF EN 60601-1-2 2007 Electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Standard collateral: Electromagnetic compatibility – Requirements and tests
- NF EN 62304 2006 Medical device software – Software Process Lifecycle
- NF EN 60601-1-6 2010 Electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Standard collateral: usability
