Overview
EN ISO 19979:2023 (ISO 19979:2018) - Ophthalmic optics - Contact lenses - Hygienic management of multipatient use trial contact lenses - provides guidance for manufacturers to create instructions for eye care practitioners on hygienic handling, disinfection and storage of trial contact lenses intended for use on more than one patient. The standard covers hydrogel, composite and rigid gas-permeable (RGP) trial lenses and is intended to mitigate pathogen transfer between patients while supporting safe clinical fitting workflows.
Key topics and requirements
- Scope and purpose: Guidance for manufacturers to develop hygienic management information for multipatient use trial contact lenses.
- Exclusions: Does not cover labelling requirements or methods for inactivating prions and viruses (no standardized methods available).
- Preferred methods: Moist heat management is preferred whenever applicable; chemical disinfection (e.g., ophthalmic hydrogen peroxide) is an alternative. The document references a disinfection option using a 3% ophthalmic hydrogen peroxide treatment (3 h or equivalent) and includes an example procedure in Annex A.
- Process elements: Cleaning (same as end‑user cleaning), disinfection, and storage procedures are described. Manufacturer instructions must specify applicable methods, container choice and closure, and how to maintain processed lenses.
- Operational controls: Recommendations on hand washing, workbench surface disinfection, use and disposal of gloves, biohazardous waste treatment, and monitoring for patients with known infections (e.g., herpes simplex cornea, hepatitis, HIV, adenovirus).
- Reuse limits: Manufacturers must define the allowable number of re-uses or maximum time in use (discard criteria) and provide guidance if lenses become damaged or altered.
- Supporting material: The standard provides tables of hygienic management processes and a flowchart to describe multipatient trial-lens use.
Applications and who uses it
- Primary users: Contact lens manufacturers preparing instructions for multipatient trial lenses; eye care practitioners, optometrists and ophthalmic clinics implementing safe fitting procedures.
- Other stakeholders: Regulatory bodies, clinical protocol developers, standards committees and training organizations focused on infection control in ophthalmic optics.
- Practical uses: Developing clinic SOPs for trial-lens handling, staff training on disinfecting and storage procedures, designing packaging/containers suitable for reconditioned lenses, and reducing cross‑infection risks during patient fittings.
Related standards
- ISO 18369‑1 - referenced for vocabulary and classification.
- ISO 14729 - covers disinfection for individual-use lenses but does not address multipatient use; ISO 19979 complements this gap.
Keywords: EN ISO 19979:2023, ISO 19979:2018, hygienic management, multipatient use trial contact lenses, contact lens disinfection, moist heat, hydrogen peroxide, ophthalmic optics.