Overview - ISO 16671:2015 (Ophthalmic irrigating solutions)
ISO 16671:2015 specifies safety, design and evaluation requirements for ophthalmic irrigating solutions (OIS) used during ophthalmic surgery. The standard covers intended performance, product design attributes, preclinical and clinical evaluation, sterilization, packaging, labelling and the information manufacturers must supply. ISO 16671:2015 applies to aqueous irrigation solutions that act solely by mechanical means and do not have primary immunological, pharmacological or metabolic functions.
Key technical topics and requirements
- Intended performance: Manufacturers must document functional characteristics, surgical indications and conditions of use, and demonstrate safety through risk analysis, literature, preclinical and clinical data.
- Composition and contaminants: Identify and quantify all components and potentially hazardous chemical/biological contaminants; set limits and describe analytical methods.
- Water quality: Water used in OIS must meet Water for Injections standards.
- pH and buffering: pH measured at 25 °C ± 2 °C; products should be close to aqueous humour (≈ pH 7.38). OIS are classified by buffering capacity and pH (groups range approximately from pH 6.5–8.5 to 7.2–7.6 depending on buffer strength). Annex A gives a pH/buffer test example.
- Osmolality: Finished-product osmolality must be between 200 and 400 mosm/kg, measured by vapor-pressure or cryoscopic osmometry.
- Spectral transmittance: Record transmission from 300 nm to 1100 nm and report graphically.
- Particulates: Risk-assess particulate sources; test for visible and sub‑visible particles (Annexes B–D describe test methods).
- Biological safety and sterilization: Preclinical tests include endotoxin testing and intraocular irritation assessment; clinical evaluation guidance is provided (Annex E, F). Sterility and validated sterilization processes are required.
- Packaging and labelling: Sterile barrier systems, transport protection, maintenance of sterility, and manufacturer information requirements are specified.
Practical applications - who uses this standard
- Medical device manufacturers developing or releasing ophthalmic irrigating solutions (R&D, quality, regulatory teams).
- Regulatory and compliance professionals preparing technical documentation for market approval.
- QA/QC laboratories performing release testing (pH, osmolality, particulates, sterility).
- Packaging and sterilization engineers designing sterile barrier systems and transport packaging.
- Clinical investigators and hospitals assessing product safety and suitability for ophthalmic procedures.
Related standards (normative references)
ISO 16671:2015 references several key medical-device standards commonly used together:
Using ISO 16671:2015 helps ensure OIS products meet recognized safety and performance expectations for ophthalmic surgery, supports regulatory submissions, and standardizes testing and documentation across manufacturers.
