Overview
ISO 10993-10:2021 - Biological evaluation of medical devices, Part 10: Tests for skin sensitization - defines procedures and interpretative criteria for assessing the potential of medical devices and their constituent materials to cause skin sensitization. The fourth edition (2021) focuses specifically on skin sensitization testing, describes a step-wise evaluation approach, and includes details for in vivo assays plus guidance on preparing test materials (Annex A). The document also outlines the role of non‑animal (in chemico and in vitro) methods and their current status for device evaluation.
Key technical topics and requirements
- Scope and objective: Assess contact hazards from chemicals released by devices and determine sensitization potential prior to clinical use or marketing.
- Step-wise approach: Encourages preliminary review of chemical data, use of in vitro screening where appropriate, and tiered use of in vivo tests to reduce animal use and refine testing decisions.
- In vivo test methods described:
- Murine Local Lymph Node Assay (LLNA) - principle, sample prep, animal care, test procedure, data interpretation and reporting.
- Guinea pig assays - including the Maximization Test and Closed‑Patch (Buehler) test - with guidance on induction, challenge, observation and evaluation.
- Preparation and extraction: Annex A (normative) and Annex B (informative) provide instructions on preparing device materials and polymeric extracts for testing.
- Non‑animal methods: Annex C summarizes validated in chemico and in vitro assays (currently validated for neat chemicals) and discusses integration through IATA (Integrated Approaches to Testing and Assessment).
- Interpretation and reporting: Key factors affecting outcomes, statistical analyses, and essential report elements are covered to support regulatory submissions.
- Quality and compliance: Recommends GLP or ISO/IEC 17025 where applicable and adherence to animal welfare standards (ISO 10993-2).
Practical applications and users
ISO 10993-10:2021 is used by:
- Medical device manufacturers (R&D, biocompatibility teams) to design safety testing programs.
- Regulatory and quality professionals preparing submissions and conformity documentation.
- Toxicologists and contract testing laboratories executing skin sensitization studies.
- Clinical and compliance specialists integrating chemical characterization with biological testing.
The standard helps organizations determine whether materials or device extracts pose a risk of allergic contact dermatitis and supports safe product development and regulatory compliance.
Related standards
Keywords: ISO 10993-10:2021, skin sensitization, medical devices, LLNA, guinea pig maximization test, Buehler test, in vitro, IATA, OECD guidelines, GLP, biocompatibility.
