Overview
SIST EN ISO 10993-23:2021 - "Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)" defines procedures to assess a medical device’s potential to cause irritation. The standard is part of the ISO 10993 series on biological evaluation and is used to predict and classify irritation potential of devices, constituent materials or extracts in accordance with ISO 10993‑1 and ISO 10993‑2. It covers pre-test considerations, both non-animal and animal-based test methods, and guidance for interpreting results.
Key Topics and Technical Requirements
- Scope and purpose: Procedures to assess irritation potential for contact routes (notably dermal exposure) and to support risk management decisions.
- Pre-test considerations: Emphasis on a tiered approach that includes in silico (computational) and in vitro methods where appropriate to minimize animal testing.
- In vitro and in vivo test procedures: Describes standardized test workflows for laboratory testing of materials and extracts to evaluate irritation reactions. (The standard specifies detailed methods; laboratories should consult the full text.)
- Classification and prediction: Framework to classify irritation potential and to align results with the biological evaluation strategy in ISO 10993‑1 and ISO 10993‑2.
- Result interpretation: Key factors and contextual information to interpret outcomes, including exposure conditions, device function, duration of contact and clinical relevance.
Practical Applications and Who Uses This Standard
SIST EN ISO 10993-23 is designed for stakeholders involved in medical device safety and regulatory compliance:
- Medical device manufacturers - to design biocompatibility testing plans, select appropriate irritation tests, and document safety for regulatory submissions.
- Biocompatibility assessors & toxicologists - to interpret test data and integrate irritation findings into risk assessments.
- Testing laboratories (GLP/GMP) - to implement validated in vitro/in vivo test procedures for irritation testing.
- Regulatory and quality professionals / Notified bodies - to assess conformity with biological safety requirements and support claims under EU Regulation (EU) 2017/745 and related directives.
- R&D teams - to screen materials and formulations early in development for potential irritation hazards.
Related Standards and Regulatory Context
- Closely linked to ISO 10993‑1 (biological evaluation framework) and ISO 10993‑2 (animal welfare considerations).
- Cross-references other ISO 10993 parts (e.g., ISO 10993‑12 for sample preparation, ISO 10993‑18 for chemical characterization).
- Includes informative annexes mapping the standard to EU Directives and Regulation (EU) 2017/745 (MDR) to support conformity assessment.
This standard is essential for robust irritation testing, reducing animal use through alternative methods, and documenting compliance for safe medical device launch and post‑market surveillance.