Overview
ISO 10993-11:2017 - "Biological evaluation of medical devices - Part 11: Tests for systemic toxicity" provides requirements and guidance for evaluating the potential of medical device materials to cause adverse systemic reactions. Part of the ISO 10993 biocompatibility series, this standard addresses systemic toxicity from absorbed leachables and breakdown products rather than local effects. It supports preclinical risk assessment, test selection, study design and reporting for acute and repeated‑exposure systemic toxicity testing.
Key topics and requirements
- Scope and purpose: Evaluation of generalized systemic toxicity resulting from device materials, with emphasis on study design tailored to the device and its intended use.
- Study types covered: Acute systemic toxicity and repeated‑exposure systemic toxicity (subacute, subchronic, chronic).
- General considerations: Selection of animal species, animal care and husbandry, group size and number, treatment controls, route of exposure and sample preparation.
- Dosing and administration: Guidance on dosage volumes, frequency and administration routes (informative annex on routes of administration).
- Observations and measurements: Clinical observations, body weight, food/water consumption, clinical pathology (haematology, clinical chemistry, urinalysis) and anatomic/histopathology (annexes list suggested organs and measurements).
- Study design and quality: Emphasis on scientifically sound, tailored designs, use of pilot studies, statistical methods, and adherence to good laboratory practices (GLP).
- Evaluation and reporting: Criteria for result interpretation, final report content requirements and data quality to support risk management decisions.
- Informative annexes: Practical material on dosage volumes, common clinical signs, organ lists for histopathology, material‑mediated pyrogens, and dual‑route administration options.
Applications
- Preclinical biocompatibility testing of medical devices and materials.
- Supporting regulatory submissions and safety dossiers demonstrating absence (or characterization) of systemic toxicity.
- Input to risk management processes (per ISO 10993‑1), chemical characterization and selection of further biological testing.
- Design and execution guidance for contract laboratories performing in vivo systemic toxicity studies under GLP.
Who uses this standard
- Medical device manufacturers and R&D teams
- Biocompatibility engineers and toxicologists
- Regulatory affairs professionals preparing submission packages
- Contract testing laboratories and CROs conducting in vivo studies
- Quality and compliance teams integrating ISO 10993 requirements into device risk management
Related standards
Keywords: ISO 10993-11, systemic toxicity, biological evaluation, medical devices, biocompatibility testing, in vivo testing, toxicology, risk management, GLP.
