Overview
EN ISO 16672:2021 (adoption of ISO 16672:2020) defines safety and performance requirements for ocular endotamponades - non‑solid ophthalmic implants introduced into the vitreous cavity to flatten or tamponade the retina. The standard covers intended performance, design attributes, pre‑clinical and clinical evaluation, sterilization, packaging, labelling and the information manufacturers must supply. It is the third edition, superseding EN ISO 16672:2015.
Key topics and technical requirements
- Intended performance & risk management: requirements that link device function to safety and clinical claims (useful for design control and regulatory dossiers).
- Design attributes: measurable properties such as density, gaseous expansion, interfacial tension, kinematic/dynamic viscosity, molecular mass distribution, particulates, refractive index, spectral transmittance, surface tension and vapour pressure.
- Chemical description & contaminants: specific guidance for perfluorocarbon liquids and methods for quantifying incompletely fluorinated contaminants (Annex C).
- Biological and pre‑clinical evaluation: references ISO 10993 series; includes bacterial endotoxin testing (limit revised to 0.2 EU/ml) and intraocular implantation testing (Annex A).
- Sterilization: sterilization validation and limits for ethylene oxide residuals (≤ 1.25 µg/dose EO and ≤ 5.0 µg/dose ethylene chlorohydrin (ECH)).
- Product stability, delivery system integrity and packaging: requirements per ISO 11607-1 to protect sterility in storage/transport.
- Clinical investigation: expectations for clinical data to support safety and performance (Annex B), aligned with ISO 14155.
- Manufacturer information & labelling: mandatory labels and instructions including minimum utilization pressure, storage, sterilization method and risk information.
Practical applications - who uses this standard
- Medical device manufacturers (R&D, formulation and process engineers) to design and characterise ocular endotamponades.
- Regulatory affairs and quality teams preparing technical files and CE marking/market submissions.
- Clinical investigators and hospitals assessing product claims and designing clinical studies.
- Notified bodies / auditors evaluating conformity to harmonized European requirements.
- Contract testing and sterilization labs performing endotoxin, residual EO/ECH and fluid property testing.
Related standards
EN ISO 16672:2021 is essential for safe development, testing and regulatory compliance of ophthalmic endotamponade products (including perfluorocarbon liquids), and should be used alongside the referenced ISO and European standards.