Certifications & Instructions

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,

Instructions in French SC029 V2 Draft