ISO 11980-2025 PDF

Full title and description

Ophthalmic optics — Contact lenses and contact lens care products — Requirements and guidance for clinical investigations (ISO 11980:2025, 4th edition). This document specifies requirements and gives guidance for planning, conducting, monitoring and reporting clinical investigations that establish the safety and performance of contact lenses and contact-lens care products.

Abstract

ISO 11980:2025 provides requirements and guidance for clinical investigations (CIs) intended to demonstrate the safety and performance of contact lenses and contact-lens care products. The standard seeks alignment with internationally recognised regulatory requirements while noting that national regulations take precedence; it also requires additional CI considerations where intended indications go beyond correction of refractive error.

General information

• Status: Published.
• Publication date: June 2025 (published June 20, 2025 — edition information lists 2025-06).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.70 (Ophthalmic equipment / ophthalmic optics).
• Edition / version: Edition 4 (2025).
• Number of pages: 30 pages (official ISO listing).

Key bibliographic and lifecycle data from the ISO record.

Scope

The standard applies to clinical investigations intended to establish and document the safety and performance of contact lenses and contact-lens care products for their intended uses. It covers design and conduct of CIs, clinical investigation plans (CIPs), endpoints and outcome measures, safety monitoring and reporting, statistical considerations, ethical and regulatory requirements, and documentation needed to support marketing and labelling claims. National or regional legal/regulatory requirements remain authoritative where they differ from guidance in this document.

Key topics and requirements

• Clinical investigation planning: clinical investigation plan (CIP) content, objectives and defined endpoints.
• Study design considerations: choice of trial design, comparator(s), blinding and inclusion/exclusion criteria.
• Safety monitoring and adverse event reporting specific to ophthalmic devices and care products.
• Statistical methods: sample size, statistical analysis plans and handling of missing data.
• Ethics, informed consent, and protection of human subjects (alignment with general GCP principles).
• Data recording, monitoring, quality assurance and reporting requirements for regulatory submissions.
• Special considerations for claims beyond refractive correction and for post-market clinical follow-up.

Items summarise the principal technical and procedural requirements set out in the standard.

Typical use and users

Primary users include contact-lens and contact-lens-care-product manufacturers, clinical investigators, contract research organisations (CROs), regulatory affairs professionals, notified/competent bodies and clinical research ethics committees. The standard is used to develop CI protocols, prepare regulatory clinical evidence packages, and to design post-market clinical follow-up studies supporting labelling and safety surveillance.

Related standards

Relevant complementary and frequently referenced standards include ISO 14155 (Good clinical practice for clinical investigation of medical devices) for general CI/GCP requirements, and the ISO 18369 series (contact-lens product specifications, labelling and material/testing methods) for product-specific technical and labelling standards. ISO 11980:2025 replaces the previous ISO 11980:2012 edition.

Keywords

contact lenses; contact-lens care products; clinical investigation; clinical investigation plan (CIP); safety; performance; ophthalmic optics; good clinical practice; regulatory evidence; post-market clinical follow-up.

FAQ

Q: What is this standard?

A: ISO 11980:2025 is an international standard giving requirements and guidance for clinical investigations to demonstrate the safety and performance of contact lenses and contact-lens care products.

Q: What does it cover?

A: It covers planning, design, conduct, monitoring, analysis and reporting of clinical investigations; CIP content; safety monitoring and reporting; statistical and ethical considerations; and how clinical evidence supports marketing and labelling claims. It also notes that national regulations take precedence where differences exist.

Q: Who typically uses it?

A: Manufacturers, clinical investigators, CROs, regulatory affairs teams, notified/competent bodies and ethics committees use it to design trials and assemble clinical evidence for regulatory submissions and labelling.

Q: Is it current or superseded?

A: ISO 11980:2025 is the current published edition (4th edition, published June 2025) and supersedes ISO 11980:2012.

Q: Is it part of a series?

A: While ISO 11980 is focused on clinical investigations, it is commonly used alongside other ophthalmic standards (notably the ISO 18369 series for contact-lens specifications) and general clinical-investigation standards such as ISO 14155.

Q: What are the key keywords?

A: contact lenses; contact-lens care; clinical investigation; clinical evidence; safety; performance; clinical investigation plan; ophthalmic optics.