ISO 10993-23-2021 PDF

Full title and description

ISO 10993-23:2021 — Biological evaluation of medical devices — Part 23: Tests for irritation. This International Standard specifies procedures to assess the potential of medical devices, their constituent materials or extracts to produce irritation (dermal, mucosal or other relevant contact routes) using in silico, in vitro and, where necessary, in vivo methods and guidance for interpreting results.

Abstract

This document describes pre-test considerations (including in silico and in vitro approaches for dermal exposure), details of irritation test procedures (both in vitro and in vivo where applicable) and key factors for interpreting irritation results. Tests are intended to predict and classify irritation potential in support of the biological evaluation strategy defined in ISO 10993‑1 and harmonized with other parts of the 10993 series.

General information

• Status: Published.
• Publication date: January 2021 (corrected French version February 2021).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.100.20 (Medical devices; biological evaluation).
• Edition / version: Edition 1 (2021).
• Number of pages: 60 pages.

Key bibliographic and status details above are taken from the ISO catalogue entry for ISO 10993‑23:2021.

Scope

ISO 10993‑23:2021 applies to the assessment of irritation potential of medical devices, device materials and extracts. It provides procedures and decision‑making guidance to help predict and classify irritation for devices in contact with skin or mucosal surfaces, and to support biological evaluation under the ISO 10993 family framework (notably ISO 10993‑1 and ISO 10993‑2). The standard addresses screening and definitive tests, and includes recommendations for when in vitro methods are appropriate and when in vivo testing may still be required.

Key topics and requirements

• Pre-test considerations and test selection (including use of in silico and in vitro approaches for dermal exposure).
• Details of in vitro irritation test procedures (including reconstructed human epidermis models where applicable).
• Details of in vivo irritation test procedures and humane/ethical considerations consistent with animal‑welfare guidance.
• Data interpretation principles and classification of irritation potential in the context of ISO 10993‑1 risk management.
• Guidance on applicability, limitations and when additional testing or alternative methods are required (amendments add additional validated in vitro models as available).

The list above summarizes the principal technical topics specified in the standard.

Typical use and users

Primary users are medical device manufacturers, material suppliers, biocompatibility scientists, contract testing laboratories, regulatory and quality professionals, and notified bodies reviewing biological safety data. The standard is used to design irritation testing strategies, select appropriate in vitro/in vivo assays, and interpret results as part of the overall biological evaluation and regulatory submissions (e.g., CE/UK/US filings). For regulatory context and how ISO 10993 outputs are used in submissions, see regulatory guidance that references the ISO 10993 family.

Related standards

ISO 10993‑23 is one part of the ISO 10993 family on biological evaluation of medical devices. Closely related parts include ISO 10993‑1 (general principles and evaluation strategy), ISO 10993‑2 (animal welfare requirements), ISO 10993‑9 (degradation products), ISO 10993‑10 (skin irritation and sensitization—historical context), ISO 10993‑11 (systemic toxicity) and ISO 10993‑6 (local effects after implantation). Users commonly apply ISO 10993‑23 together with ISO 10993‑1 and other 10993 parts when preparing a device’s biological evaluation.

Keywords

irritation, dermal irritation, mucosal irritation, in vitro irritation tests, reconstructed human epidermis, in vivo irritation, biological evaluation, biocompatibility, medical device testing, ISO 10993.

FAQ

Q: What is this standard?

A: ISO 10993‑23:2021 is an ISO International Standard that specifies test methods and interpretation guidance for assessing irritation potential of medical devices, materials and extracts.

Q: What does it cover?

A: It covers pre‑test considerations (including in silico and in vitro options), standardised in vitro irritation procedures (e.g., reconstructed human epidermis models), guidance on in vivo tests when necessary, and interpretation/classification of irritation potential within the ISO 10993 evaluation framework.

Q: Who typically uses it?

A: Medical device manufacturers, material suppliers, contract testing laboratories, biocompatibility/toxicology experts, regulatory affairs teams and conformity assessment bodies use this standard to plan and justify irritation testing and to interpret results for safety assessments and regulatory submissions.

Q: Is it current or superseded?

A: ISO 10993‑23 was published in January 2021 (Edition 1) and remains the current published edition. The ISO catalogue entry shows the part is under periodic review and that an amendment (ISO 10993‑23:2021/Amd 1:2025) providing additional in vitro reconstructed human epidermis models has been published as an amendment. Check the ISO catalogue for the very latest status if you need confirmation at the time of use.

Q: Is it part of a series?

A: Yes — ISO 10993‑23 is part of the ISO 10993 family (Biological evaluation of medical devices), which is a multi‑part series addressing different biological endpoints and methods; the family’s central planning and evaluation principles are given in ISO 10993‑1.

Q: What are the key keywords?

A: Irritation, skin irritation, mucosal irritation, in vitro, in vivo, reconstructed human epidermis (RHE), biocompatibility, biological evaluation, medical device safety, ISO 10993.