ISO 19979:2018

Overview

ISO 19979:2018 - Ophthalmic optics: Hygienic management of multipatient use trial contact lenses - provides guidance for manufacturers to develop instructions for eye care practitioners on cleaning, disinfection and storage of trial hydrogel, composite and rigid gas‑permeable (RGP) contact lenses intended for multipatient use. The standard is focused on mitigating cross‑infection risk when a single trial lens is used on more than one patient and does not cover labelling or prion/virus inactivation where no standardised methods exist.

Key topics and requirements

• Scope and definitions: Clarifies terms such as trial contact lens and multipatient use trial contact lens, and identifies competent personnel responsible for hygienic management.
• Disinfection methods: Presents options and requirements:
  • Moist heat (preferred for hydrogel lenses) - example process parameters given (e.g., target 134 °C for ≥3 min or 121 °C for ≥15 min) and guidance on validated sterilization claims.
  • Chemical disinfection - requires solutions with efficacy equivalent to 3% ophthalmic hydrogen peroxide for 3 hours or demonstrably equivalent systems; neutralization procedures and avoiding one‑step H2O2 systems for multipatient use are noted.
• Cleaning and inspection: Lenses must be inspected before and after each use; damaged or altered‑appearance lenses must be discarded.
• Storage and container management: Manufacturers must specify suitable container types, cleaning/closure/relabelling methods and whether wet or dry storage is applicable (hydrogel generally not stored dry).
• Traceability and documentation: Records should include lot number, lens parameters, expiry, patient reference, dates of use and hygienic management, and the person performing disinfection.
• Waste and infection control: Precautions for disposing of lenses when used on known infected patients and handling biohazardous waste are covered.

Practical applications

• Helps manufacturers create compliant hygienic management instructions for multipatient trial lenses.
• Informs eye care practitioners and clinics on safe reconditioning workflows to reduce pathogen transfer.
• Supports development of clinic procedures: selection of disinfection method (moist heat vs chemical), container protocols, reuse limits, and recordkeeping for traceability and auditability.

Who should use this standard

• Contact lens manufacturers preparing user and practitioner instruction materials
• Eye care practitioners, optometrists and ophthalmic clinics that fit trial lenses on multiple patients
• Regulatory and quality personnel developing hygienic management procedures and training for competent staff

Related standards

• ISO 18369‑1 - vocabulary, classification and labelling recommendations (referenced for terms)
• ISO/TS 17665‑2:2009 - sterilization validation guidance (cited for sterilization claims)
• Note: ISO 14729 does not cover multipatient use

Keywords: ISO 19979:2018, hygienic management, multipatient use trial contact lenses, moist heat disinfection, 3% hydrogen peroxide, RGP, hydrogel, composite lenses, eye care practitioners.