Overview
ISO 16672:2020 - Ophthalmic implants - Ocular endotamponades defines safety and performance requirements for ocular endotamponades (OE): non‑solid, surgically invasive medical devices introduced into the vitreous cavity to flatten or tamponade a detached retina. The standard covers intended performance, design attributes, pre‑clinical and clinical evaluation, sterilization, packaging, labelling and the information manufacturers must supply.
Key topics and technical requirements
- Scope and device types: Includes perfluorocarbon liquids (used intra‑operatively and removed), silicone oils (longer‑term intraocular tamponade) and gaseous OE (absorbed over time).
- Intended performance: Manufacturers must document functional characteristics, surgical indications, conditions of use and maximum contact duration with ocular tissues.
- Design attributes: Chemical composition and contaminants; density, gaseous expansion, interfacial and surface tension, kinematic/dynamic viscosity, molecular mass distribution, particulates, refractive index, spectral transmittance and vapour pressure are specified as design considerations. Testing is required on finished, sterilized product and analytical methods must be validated.
- Biological and pre‑clinical evaluation: Risk analysis for chemical/biological contaminants, bacterial endotoxin testing (limit revised to 0.2 EU/ml), intraocular implantation tests and other ISO 10993 biological evaluations where applicable.
- Sterilization and residues: Requirements for sterilization processes and limits on ethylene oxide (EO) residues (≤ 1.25 µg/dose EO and ≤ 5.0 µg/dose ethylene chlorohydrin (ECH) as revised).
- Packaging and delivery system: Protection during storage/transport, maintenance of sterile barrier per ISO 11607, and integrity/performance of the delivery system.
- Clinical investigation: Guidance and annex material (informative) for clinical study variables and design.
- Annexes: Normative intraocular implantation test, informative clinical investigation guidance, and Annex C method for quantifying incompletely fluorinated contaminants in perfluorocarbon liquids.
Applications and practical value
- Helps manufacturers of ophthalmic implants demonstrate safety, efficacy and regulatory readiness for ocular endotamponades.
- Guides formulation scientists and QA/QC labs on material properties and contaminant limits.
- Informs sterilization and packaging engineers on sterility assurance and EO residue control.
- Supports regulatory affairs and clinical teams preparing pre‑clinical and clinical evidence for market clearance.
Who should use this standard
- Medical device manufacturers (R&D, regulatory, quality) producing silicone oil, perfluorocarbon liquids or gas tamponades
- Test laboratories performing biocompatibility, endotoxin, and physicochemical assays
- Clinical researchers and ophthalmic surgeons designing trials or evaluating device performance
- Regulatory bodies and notified bodies assessing conformity
Related standards
ISO 10993 series (biological evaluation), ISO 14971 (risk management), ISO 11607 (packaging for sterilized devices), ISO 14155 (clinical investigations), ISO 14630 (non‑active surgical implants).
Keywords: ISO 16672, ocular endotamponades, ophthalmic implants, silicone oil, perfluorocarbon liquids, sterilization, biocompatibility, clinical evaluation, packaging, endotoxin.