SIST EN ISO 11979-5:2020 PDF

Name: SIST EN ISO 11979-5:2020 — Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2020)
SKU: SIST EN ISO 11979-5:2020
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Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2020)

Название (английский):

SIST EN ISO 11979-5:2020

Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2020)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 36
Дата публикации:: 12 ноября 2020 г.
ICS:: 11.040.70
Технический комитет:: VAZ - Healthcare

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Описание (английский):

This document specifies particular requirements for the biocompatibility evaluation of materials for intraocular lenses (IOLs) including the processing conditions to produce them. These requirements include evaluation of physicochemical properties that are relevant to biocompatibility. It also gives guidance on conducting an ocular implantation test.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

EN ISO 11979-5:2020 - "Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility" (CEN adoption of ISO 11979-5:2020) specifies requirements and guidance for the biological evaluation of materials and processing conditions used to manufacture intraocular lenses (IOLs). The standard focuses on physicochemical characterization relevant to biocompatibility and provides guidance on conducting ocular implantation tests within a risk-based framework consistent with ISO 10993 principles.

Key topics and requirements

Scope and risk-based approach

Applies to biocompatibility evaluation of IOL materials and production processes; aligns with ISO 10993 series and ISO 14971 risk management.

Physicochemical tests

Requirements for physical/chemical description, contaminants, exhaustive extraction, leachables testing, hydrolytic stability, photostability, Nd:YAG laser exposure and evaluation of insoluble inorganics.
Emphasis on using state-of-the-art analytical methods.

Biological tests

Guidance for cytotoxicity, sensitization, genotoxicity, and local effects testing.
Specifies sample preparation ratios and test sequencing aligned to ISO 10993.

Ocular implantation test

Normative guidance for in vivo ocular implantation tests (e.g., rabbit model) and supplemental conditions for implantation studies.

Documentation

Requirement for a biological evaluation plan and explicit reporting of physicochemical and biological test results.

Updates from previous edition

Clarified use of analytical methods, added risk-based guidance, revised test orders and durations for implantation studies, and strengthened photostability and extraction procedures.

Applications and who uses this standard

IOL manufacturers and R&D teams - to design and validate biocompatible lens materials and document safety for regulatory submissions.

Quality assurance and regulatory affairs - to prepare biological evaluation plans and compliance evidence for CE marking and other market clearances.

Test laboratories and contract research organizations (CROs) - to execute physicochemical and biological test protocols (leachables, cytotoxicity, genotoxicity, ocular implantation).

Notified bodies and regulatory authorities - to assess conformity of ophthalmic implants against biocompatibility requirements.

Clinicians and clinical investigators - to understand safety evaluation expectations when assessing new or modified IOL designs.

Related standards

ISO 10993 series (biological evaluation of medical devices)

ISO 11979 series (other parts covering optics, mechanical tests, vocabulary)

ISO 14971 (risk management)

ISO/TR 22979 (guidance on clinical investigation needs for IOL modifications)

This standard is an authoritative reference for ensuring the biocompatibility and safety of intraocular lenses through physicochemical characterization, biological testing, and documented risk-based evaluation.

SIST EN ISO 11979-5:2020 PDF

Abstract

Похожие стандарты

Overview

Key topics and requirements

Applications and who uses this standard

Related standards

Технические детали

ISO 11979-5:2020

Ophthalmic implants — Intraocular lenses — Part 5: Biocompatibility

BS EN ISO 10993-11:2018

Biological evaluation of medical devices. Tests for systemic toxicity.

BS/AAMI 34971:2023

Application of ISO 14971 to machine learning in artificial intelligence. Guide.

BS EN ISO 11979-4:2026

Ophthalmic implants — Intraocular lenses. Labelling and information.

ISO/TR 22979:2006

Ophthalmic implants — Intraocular lenses — Guidance on assessment of the need for clinical investigation of i…