ISO 10993-23:2021

Name: ISO 10993-23:2021 — Biological evaluation of medical devices — Part 23: Tests for irritation
SKU: ISO 10993-23:2021
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Biological evaluation of medical devices — Part 23: Tests for irritation

Название (английский):

ISO 10993-23:2021

Biological evaluation of medical devices — Part 23: Tests for irritation

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 60
Дата публикации:: 20 января 2021 г.
Издание:: ISO IS 10993 edition 1 version 1
ICS:: 11.100.20

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Описание (английский):

This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation. The tests are designed to predict and classify the irritation potential of medical devices, materials or their extracts according to ISO 10993‑1 and ISO 10993‑2. This document includes: — pre-test considerations for irritation, including in silico and in vitro methods for dermal exposure; — details of in vitro and in vivo irritation test procedures; — key factors for the interpretation of the results.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview - ISO 10993-23:2021 (Tests for irritation)

ISO 10993-23:2021 is part of the ISO 10993 series on the biological evaluation of medical devices. It specifies procedures to assess the potential of medical devices, constituent materials or extracts to cause irritation of skin or mucosal tissues. The standard defines a step-wise evaluation framework that includes pre-test considerations, validated in vitro methods (including reconstructed human epidermis models) and, when necessary, in vivo animal tests and human skin tests. It also covers result interpretation, test acceptance criteria and reporting requirements.

Key topics and technical requirements

Step-wise approach: Guidance to select appropriate testing (in silico → in vitro → in vivo → human), consistent with ISO 10993‑1 risk-based evaluation.

Pre-test considerations: Material type, chemical composition, existing data sources, and decision criteria for testing route (dermal, mucosal).

In vitro irritation tests: Use of reconstructed human epidermis (RhE) models, test system description, sample preparation, exposure procedures, and viability assessment (e.g., MTT assay) for prediction of irritation potential.

In vivo irritation tests: Protocols for skin exposure and intracutaneous (intradermal) administration in animals, observation schedules, evaluation and reporting.

Human skin irritation test: When appropriate, controlled human patch testing and associated ethical/consent considerations are described (see Annex E).

Data interpretation and documentation: Prediction models, acceptance criteria, method documentation sheets and required test report elements.

Supporting material: Annexes covering preparation of materials, checklists, special irritation test methods and background information.

Practical applications - who uses ISO 10993-23

Medical device manufacturers: To evaluate irritation risk during product development, material selection and design validation.

Regulatory and compliance teams: To assemble biocompatibility data for regulatory submissions and to meet regional requirements.

Biocompatibility and safety engineers: To plan testing strategies that minimize animal use while ensuring human safety.

Contract testing laboratories and CROs: To implement standardized in vitro and in vivo irritation assays and produce compliant reports.

Notified bodies and auditors: To assess conformity of biocompatibility evidence with international expectations.

Related standards and context

ISO 10993‑1 (biological evaluation framework and risk management) - defines the overall process and how irritation testing fits into device evaluation.

ISO 10993‑2 (animal welfare and ethical considerations) - provides guidance on animal testing and the 3Rs (replacement, reduction, refinement).

ISO 10993 series and relevant test method guidance used together to support regulatory submissions and risk assessments.

ISO 10993-23 helps organizations implement robust, reproducible irritation testing strategies-prioritizing validated in vitro alternatives where possible-to demonstrate the safety of medical device materials and products.

ISO 10993-23:2021

Abstract

Похожие стандарты

Overview - ISO 10993-23:2021 (Tests for irritation)

Key topics and technical requirements

Practical applications - who uses ISO 10993-23

Related standards and context

Технические детали

BS EN ISO 10993-9:2021

Biological evaluation of medical devices. Framework for identification and quantification of potential degrad…

BS EN ISO 10993-14:2009

Biological evaluation of medical devices. Identification and quantification of degradation products from cera…

BS EN ISO 10993-23:2021+A1:2025

Biological evaluation of medical devices. Tests for irritation.

BS EN ISO 10993-2:2006

Biological evaluation of medical devices - Animal welfare requirements