ISO 15798:2022

Overview

ISO 15798:2022 - fourth edition - specifies safety and performance requirements for ophthalmic viscosurgical devices (OVDs), a class of surgical invasive medical devices with viscous and/or viscoelastic properties used in the anterior segment of the human eye. OVDs are intended to create and maintain space, protect intraocular tissues and assist tissue manipulation during surgery. The standard covers design attributes, preclinical and clinical evaluation, sterilization, packaging, labelling and information supplied by the manufacturer.

Note: while OVDs are not implants by intended use, the standard recognizes they can share some risks associated with non‑active implants.

Key topics and technical requirements

• Intended performance and design attributes: requirements for device function, usability and delivery system integrity.
• Characterization of components and finished product, including:
  • Absolute complex viscosity, shear viscosity and elasticity
  • Concentration, molecular mass distribution (where applicable), osmolality, pH, refractive index and spectral transmittance
  • Particulates and chemical/biological contaminants
• Design evaluation and biological safety:
  • Requirements for preclinical testing (biocompatibility per ISO 10993 series)
  • Bacterial endotoxin testing and evaluation of degradation, toxicokinetics and clearance of residual OVD
  • Assessments of inflammation and intraocular pressure effects
• Clinical evaluation:
  • Clinical investigation design, outcome reporting and standardized endpoints such as corneal endothelial cell density, postoperative inflammation, intraocular pressure changes and adverse events
• Sterilization and residuals:
  • Sterilization validation (EO, radiation, moist heat) and acceptable residuals (reference to ISO 10993‑7)
• Packaging and stability:
  • Sterile barrier, packaging integrity, protection during storage/transport and labelling (including “Do not use if sterile barrier is breached” guidance)
• Information to be supplied: manufacturer labelling, instructions for use and required technical information.

Applications - who uses ISO 15798:2022

• Medical device manufacturers developing OVDs for cataract, anterior segment and other intraocular surgeries
• Regulatory and quality affairs teams preparing technical files and conformity evidence
• Clinical researchers and trial designers planning OVD clinical investigations
• Sterilization and packaging engineers validating processes and sterile barrier systems
• Ophthalmic surgeons and hospitals referencing safety and labelling expectations

Related standards

ISO 15798:2022 references and aligns with key standards, including:

• ISO 10993 series (biocompatibility)
• ISO 14155 (clinical investigation)
• ISO 14971 (risk management)
• ISO 11135 / ISO 11137 / ISO 17665 (sterilization)
• ISO 11607 (packaging)

Keywords: ISO 15798:2022, ophthalmic viscosurgical devices, OVD, ophthalmic implants, sterilization, biocompatibility, clinical evaluation, viscosity, packaging integrity.