BS EN ISO 10993-10-2023 PDF

Full title and description

STB BS EN ISO 10993-10:2023 — Biological evaluation of medical devices — Part 10: Tests for skin sensitization (tests for irritation and skin sensitization). This is the British (BS) / European (EN) adoption of the ISO 10993‑10 technical part that specifies procedures and interpretation criteria for assessing the potential of medical devices and their constituent materials to cause skin sensitization and local irritation.

Abstract

This document specifies the procedures for assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization. It includes details of in vivo skin sensitization test procedures, pretest considerations and key factors for interpretation of test results; Annex A gives instructions for preparation of materials for testing.

General information

• Status: Current / Definitive (BS adoption of EN ISO 10993‑10:2023).
• Publication date: 08 February 2023 (BS publication / EN release in early 2023).
• Publisher: British Standards Institution (BSI) — published as BS EN ISO 10993‑10:2023.
• ICS / categories: 11.100.20 (Biological evaluation of medical devices).
• Edition / version: 2023 (UK/EN adoption of ISO 10993‑10; identical in content to ISO 10993‑10:2021 as adopted by EN/BSI).
• Number of pages: 64 pages (BS published English text — typical national-format page count).

Scope

Gives the standardised, step‑wise approach and test methods for evaluating the potential of medical devices and their materials to cause skin irritation and sensitization. The scope covers selection of appropriate tests (including in vivo procedures), preparations of test materials, pretest considerations and factors to consider when interpreting results in a biological evaluation within a risk‑management framework.

Key topics and requirements

• Stepwise approach to biocompatibility testing for dermal endpoints (irritation and skin sensitization).
• Details of in vivo skin sensitization test procedures and recommended experimental designs.
• Pretest considerations: material preparation, extraction methods and choice of route/exposure.
• Key factors and decision criteria for interpretation of test outcomes in the context of device risk assessment.
• Normative Annex A: instructions for preparation of materials specifically for irritation/sensitization testing.

Typical use and users

Used by medical device manufacturers, biocompatibility/toxicology laboratories, notified bodies, regulatory authorities and quality/clinical teams to plan, perform and interpret biological testing for skin sensitization and irritation as part of device safety documentation and regulatory submissions. It is applied during product development, preclinical testing and regulatory filing.

Related standards

Part of the ISO 10993 series on biological evaluation of medical devices (see related parts such as ISO 10993‑1, ISO 10993‑5, ISO 10993‑12, ISO 10993‑17 and ISO 10993‑18). BS EN ISO 10993‑10:2023 replaces the earlier BS EN ISO 10993‑10:2013 adoption. Users commonly apply this part alongside ISO 10993‑1 (overall strategy) and ISO 10993‑12 (sample preparation).

Keywords

biological evaluation; medical devices; skin sensitization; irritation; biocompatibility; ISO 10993; BSI; test methods; in vivo testing; sample preparation.

FAQ

Q: What is this standard?

A: It is the British/European adoption (BS EN) of ISO 10993‑10, the part of the ISO 10993 series that specifies tests and interpretation criteria for skin sensitization and irritation of medical devices.

Q: What does it cover?

A: Procedures and guidance for selection, conduct and interpretation of tests (primarily in vivo methods), pretest material preparation and key factors for interpreting results when assessing skin sensitization and irritation potential. Annex A covers material preparation.

Q: Who typically uses it?

A: Medical device manufacturers, biocompatibility and toxicology testing laboratories, regulatory reviewers, notified bodies and product safety or quality teams involved in device development and regulatory submissions.

Q: Is it current or superseded?

A: Current. BS EN ISO 10993‑10:2023 is the active (definitive) UK/EN adoption published in early 2023 and replaces the prior BS EN ISO 10993‑10:2013 adoption. The core ISO document is ISO 10993‑10 (the ISO edition referenced is ISO 10993‑10:2021 as adopted by EN/BSI).

Q: Is it part of a series?

A: Yes — it is Part 10 of the ISO 10993 family (Biological evaluation of medical devices). It is intended to be used together with other parts of ISO 10993 (for example Part 1, Part 5, Part 12, Part 17 and Part 18) as part of an overall biocompatibility/risk‑management approach.

Q: What are the key keywords?

A: Skin sensitization, irritation, biological evaluation, biocompatibility, medical devices, in vivo test procedures, sample preparation, ISO 10993.