EN ISO 15798:2022 PDF

Overview

EN ISO 15798:2022 - Ophthalmic implants: Ophthalmic viscosurgical devices (OVDs) - is a CEN-endorsed international standard that defines safety and performance requirements for OVDs used during anterior-segment eye surgery. Applicable to viscous and viscoelastic surgical invasive medical devices, the standard covers design attributes, preclinical and clinical evaluation, sterilization, packaging, labelling and manufacturer information to ensure safe intended performance and risk management.

Key topics and technical requirements

The standard organizes technical requirements into clear sections. Major topics include:

• Intended performance: purpose, functional claims and recommended removal procedures to enable near-complete clearance of OVDs from the eye.
• Design attributes and characterization:
  • Rheological properties: absolute complex viscosity, shear viscosity, elasticity.
  • Physicochemical properties: pH, osmolality, refractive index, concentration and spectral transmittance.
  • Purity and safety: particulates, chemical and biological contaminants, bacterial endotoxin testing.
  • Molecular attributes: molecular mass distribution (referenced for characterization).
• Usability and delivery system: integrity and performance of syringes, cannulas and other delivery devices.
• Design evaluation:
  • Biological safety: in vitro and in vivo tests, clearance, degradation/toxicokinetics and inflammation/intraocular pressure assessments.
  • Clinical evaluation: clinical investigation design, corneal endothelial cell density monitoring, postoperative inflammation and IOP changes, adverse event reporting.
• Sterilization and residuals: sterilization validation and limits for ethylene oxide residues (reference to ISO 10993-7).
• Product stability and packaging: shelf life, sterile barrier integrity and transport protection.
• Labeling and manufacturer information: mandatory information to be supplied with the device (aligns with ISO 15223-1 wording).

The standard includes normative Annex A (intraocular implantation test) and informative Annexes B and C on clinical investigation sizing and data analysis.

Applications and who uses it

EN ISO 15798:2022 is essential for:

• OVD manufacturers - product design, characterization, risk management, regulatory submissions and labelling.
• Regulatory affairs and notified bodies - conformity assessment and premarket review.
• Quality and testing laboratories - defining test methods for viscosity, endotoxins, particulates and sterilization residuals.
• Clinicians and clinical investigators - designing clinical trials and interpreting safety endpoints (corneal endothelial cell density, IOP).
• Procurement and hospital sterile services - evaluating packaging, shelf life and instructions for safe use.

Related standards

• ISO 10993-7 (ethylene oxide residues)
• ISO 15223-1 (device labelling symbols)
• ISO 14971 (risk management)
• ISO 14630 (general non-active surgical devices - referenced sections incorporated)

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