DIN EN ISO 10993-23 2021-10 PDF

Full title and description

STB DIN EN ISO 10993-23:2021-10 — Biological evaluation of medical devices — Part 23: Tests for irritation. German adoption of EN ISO 10993-23:2021 (ISO 10993-23:2021). Specifies procedures to assess the potential of medical devices, constituent materials and extracts to produce irritation, with guidance on pre-test considerations, in vitro and in vivo test methods and interpretation for classification of irritation potential.

Abstract

This part of the ISO 10993 series provides test methods and decision-making guidance for evaluating irritation potential associated with medical devices and their materials or extracts. It covers pre-test planning (including in silico and in vitro approaches for dermal exposure), details of applicable in vitro and in vivo irritation procedures, and key factors for interpreting results and assigning irritation classifications in the context of ISO 10993-1 risk management.

General information

• Status: Published (ISO: international publication; German version adopted as DIN EN ISO).
• Publication date: ISO original published 20 January 2021; German adoption published October 2021 (designation DIN EN ISO 10993-23:2021-10).
• Publisher: International Organization for Standardization (ISO); German national adoption/translation distributed via DIN / Beuth Verlag (Deutsche Fassung of EN ISO 10993-23:2021).
• ICS / categories: 11.100.20 — Biological evaluation of medical devices.
• Edition / version: Edition 1 (ISO 10993-23:2021); national adoption corresponds to EN/ISO 10993-23:2021 (German text published 2021-10).
• Number of pages: 60 pages (ISO edition).

Scope

Provides procedures to assess and classify irritation potential (primarily dermal irritation, including mucosal/skin contact relevant to medical device use) of medical devices, their components and extracts. The standard supports selection and interpretation of appropriate in silico, in vitro and, where necessary, in vivo tests in the framework of ISO 10993-1 biological evaluation and device risk management.

Key topics and requirements

• Pre-test considerations and test selection aligned with ISO 10993-1 (risk-based approach, exposure assessment and rationale for chosen tests).
• Use of in silico and in vitro methods (including reconstructed human epidermis models) for dermal irritation screening and reduction of animal testing where appropriate.
• Standardized in vitro irritation test procedures and criteria for acceptance, controls and interpretation of results.
• Guidance on in vivo irritation testing when in vitro methods are not applicable or are inconclusive, including considerations for animal welfare and justification.
• Factors affecting result interpretation: exposure route, contact time, dose, test material form (device, material, extract), and clinical relevance.
• Classification and reporting of irritation potential to support regulatory and conformity assessment requirements.

Typical use and users

Used by medical device manufacturers, component suppliers, biological testing laboratories, regulatory and compliance teams, notified bodies and quality/regulatory affairs professionals to plan and perform irritation testing and to interpret results for technical files, CE marking/registration and risk management. Also used by clinical researchers and contract research organizations (CROs) conducting biocompatibility evaluations.

Related standards

Closely linked to other parts of the ISO 10993 series and supporting documents, notably ISO 10993-1 (biological evaluation and test selection), ISO 10993-12 (sample preparation and reference materials), ISO 10993-10 (sensitization and other skin tests), ISO 10993-5 (cytotoxicity), ISO 10993-18 (chemical characterization) and relevant national/regional adaptations (EN ISO/DIN EN ISO versions) and applicable regulatory guidance for biocompatibility and device submission.

Keywords

biological evaluation, irritation testing, skin irritation, reconstructed human epidermis, in vitro methods, in vivo methods, medical devices, biocompatibility, ISO 10993, risk assessment, DIN EN ISO

FAQ

Q: What is this standard?

A: ISO 10993-23:2021 (adopted nationally as DIN EN ISO 10993-23:2021-10) is the part of the ISO 10993 series that specifies tests and interpretive guidance for assessing irritation potential of medical devices, materials and extracts.

Q: What does it cover?

A: It covers pre-test considerations, recommended in silico and in vitro approaches (including reconstructed epidermis models) for dermal exposure, details of in vitro and in vivo irritation test procedures when needed, and guidance for interpreting and classifying irritation outcomes in the context of overall biological safety.

Q: Who typically uses it?

A: Medical device manufacturers, material suppliers, testing laboratories, contract research organizations, regulatory and quality professionals, and notified bodies use it to design testing strategies and to support regulatory submissions and conformity assessments.

Q: Is it current or superseded?

A: The ISO edition was published in January 2021 and adopted nationally in Germany in October 2021 as DIN EN ISO 10993-23:2021-10. Users should check national standards bodies and the ISO catalogue for any later amendments or corrigenda (amendments to the ISO text have been issued subsequently).

Q: Is it part of a series?

A: Yes — it is Part 23 of the ISO 10993 series (Biological evaluation of medical devices). It is intended to be used together with ISO 10993-1 and other relevant parts of the series that cover cytotoxicity, sensitization, chemical characterization and sample preparation.

Q: What are the key keywords?

A: Irritation testing, biocompatibility, skin irritation, in vitro methods, reconstructed human epidermis, medical device testing, ISO 10993, DIN EN ISO, biological evaluation.