Bioparhom technologies benefit from different certifications:
- CE marking under the Medical Devices Directive 93/42 /EEC
- 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
The instructions for use are available below and include all the information required by the applicable regulations. For products under directive 93/42/CE :
For Z-Métrix,
Instructions in French SC007-D (11.05.2022)
Instructions In English SC008-D (11.05.2022)
For Z-Hydra,
Instructions in French SC007-D (11.05.2022)
For Starvac DIAG,
Instructions in French SC029-A (11.05.2022)
Products in transfert to regulation MDR 2017/745 :
For Z-Métrix,
Instructions in French SC008 V3 Draft
Instructions in English SC007 V2 Draft
For Z-Hydra,
Instructions in French SC008 V3 Draft
For Starvac DIAG,