Chemical / Physical / Biological Properties (IVDR)

BPG reference: Team-NB BPG-IVDR V2 (Chemical, physical and biological properties, approx. pp. 23–25)

Checklist

• [ ] Materials and residue risks for user/patient/specimen contact identified
• [ ] Biocompatibility planned and reported where bodily contact is reasonably foreseeable
• [ ] Chemical characterisation / extractables & residuals support RM conclusions where applicable
• [ ] Microbial status (bioburden, sterility, endotoxin) as applicable to product type
• [ ] Cross-contamination / carry-over controls verified (critical for automated systems)
• [ ] SDS/CLP information for hazardous reagents aligned with labelling
• [ ] Materials of animal/human origin: source control, viral safety and traceability where applicable

Related pages

• Device description
• Risk management
• Stability