ISO 11979-4:2026 PDF

Name: ISO 11979-4:2026 — Ophthalmic implants — Intraocular lenses — Part 4: Labelling and information
SKU: ISO 11979-4:2026
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Ophthalmic implants — Intraocular lenses — Part 4: Labelling and information

Название (английский):

ISO 11979-4:2026

Ophthalmic implants — Intraocular lenses — Part 4: Labelling and information

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 7
Дата публикации:: 18 февраля 2026 г.
Издание:: ISO IS 11979 edition 3 version 1
ICS:: 11.040.70

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Описание (английский):

This document specifies the labelling requirements for intraocular lenses (IOLs) and the information to be provided within or on the packaging. NOTE This document attempts to harmonize the recognized labelling requirements for IOLs throughout the world. However, there can be additional national requirements.

Abstract

Overview

Key Topics

Labelling Requirements
- Mandatory information for primary and secondary packaging of IOLs
- Use of recognized symbols (per ISO 15223-1) to simplify and clarify packaging
Instructions for Use
- Minimum elements required, such as device description, technical and optical data, sterilization method, handling instructions, contraindications, adverse events, warnings, and clinical investigation summary (if available)
- Instructions may be provided electronically, subject to national regulations
Self-Adhesive Labels
- When supplied, must provide details including manufacturer, product model, batch/serial number, UDI code, and key device specifications such as dioptric power and dimensions
Patient Information Materials
- Patient information leaflets (PILs) and implant cards are required for effective communication and device traceability
- Leaflets must be written for patient comprehension, including use, warnings, and expected outcomes
- Implant cards enable traceability in cases of recall and post-implantation follow-up
Special Considerations for SVIOLs
- Simultaneous vision intraocular lenses have unique labelling needs, such as the inclusion of defocus curves and base/addition powers, reflecting ISO 11979-7 requirements

Applications

ISO 11979-4:2026 applies to stakeholders involved in the life cycle of intraocular lenses, from development and manufacture to clinical use:

Manufacturers
- Ensure labelling aligns with global regulatory expectations, improving market access
- Enhance patient safety through clear, standardized information on packaging and documentation
Healthcare Providers
- Access comprehensive and reliable IOL information for patient counseling, surgical planning, and post-operative care
- Utilize patient implant cards and leaflets for accurate record-keeping and patient education
Regulators and Auditors
- Reference a global benchmark for assessing compliance in labelling and documentation of ophthalmic implants
Patients
- Receive standardized, understandable information about implanted devices and aftercare

Digital documentation is increasingly accepted, as provided for under this standard, supporting modern supply chain and information management practices.

Related Standards

ISO 11979-1: Vocabulary for ophthalmic implants and intraocular lenses
ISO 11979-2: Optical properties and test methods for IOLs
ISO 11979-3: Mechanical properties and test methods for IOLs
ISO 11979-7: Clinical investigations of intraocular lenses for aphakia correction
ISO 13485: Quality management systems for medical devices
ISO 15223-1: Symbols to be used with medical device information supplied by the manufacturer
ISO 20417: Information to be supplied by medical device manufacturers

ISO 11979-4:2026 is a critical reference for anyone working with intraocular lenses, ensuring harmonized, high-quality labelling practices that promote safety, traceability, and regulatory compliance in global ophthalmic care.

Технические детали

Технический комитет: ISO/TC 172/SC 7 - Ophthalmic optics and instruments
SKU: ISO 11979-4:2026

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SIST EN ISO 15223-1:2021/A1:2026

Действующий

Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General re…

Overview EN ISO 15223-1:2021/A1:2025 is a CEN-adopted amendment to the international standard on medical device symbols used in manufacturer-supplied information. This Amendment 1 (ISO 15223-1:2021/A…

38 · PDF

89 €

SIST EN ISO 11979-7:2024

Действующий

Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the corr…

Overview EN ISO 11979-7:2024 (ISO 11979-7:2024) defines the particular requirements for clinical investigations of intraocular lenses (IOLs) implanted to correct aphakia. This fifth edition (publishe…

59 · PDF

109 €

SIST EN ISO 11979-1:2026

Действующий

Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary (ISO 11979-1:2026)

Overview SIST EN ISO 11979-1:2026 sets forth standardized terminology for intraocular lenses (IOLs), a crucial category of ophthalmic implants. This international standard, developed by CEN in collab…

20 · PDF

66 €

BS EN ISO 11979-2:2024

Действующий

Ophthalmic implants. Intraocular lenses. Optical properties and test methods.

32 · PDF

50 €

SIST EN ISO 11979-3:2013

Действующий

Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods (ISO 11979-3:2012)

Overview EN ISO 11979-3:2012 (Ophthalmic implants - Intraocular lenses - Part 3) defines required mechanical properties and test methods for intraocular lenses (IOLs) intended for implantation in the…

39 · PDF

89 €

SIST EN ISO 13485:2016/A11:2021

Действующий

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

Overview EN ISO 13485:2016/A11:2021 is the European amendment (A11) to the international standard ISO 13485:2016 specifying quality management system (QMS) requirements for medical devices. Prepared…

27 · PDF

82 €

EN ISO 20417:2026

Действующий

Medical devices - Information to be supplied by the manufacturer (ISO 20417:2026)

Overview EN ISO 20417:2026, titled Medical devices - Information to be supplied by the manufacturer (ISO 20417:2026), is a European and international standard developed jointly by CEN and ISO. This s…

60 · PDF

109 €

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ISO 11979-4:2026 PDF

Abstract

Overview

Похожие стандарты

Key Topics

Applications

Related Standards

Технические детали

SIST EN ISO 15223-1:2021/A1:2026

Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General re…

SIST EN ISO 11979-7:2024

Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the corr…

SIST EN ISO 11979-1:2026

Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary (ISO 11979-1:2026)

BS EN ISO 11979-2:2024

Ophthalmic implants. Intraocular lenses. Optical properties and test methods.

SIST EN ISO 11979-3:2013

Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods (ISO 11979-3:2012)

SIST EN ISO 13485:2016/A11:2021

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

EN ISO 20417:2026

Medical devices - Information to be supplied by the manufacturer (ISO 20417:2026)