ISO 10993-15:2019

Overview

ISO 10993-15:2019 - part of the ISO 10993 biological evaluation series - specifies general requirements for the design of in vitro tests to identify and quantify chemical degradation products from metals and alloys used in medical devices. It applies to final metallic devices or material samples prepared as ready for clinical use and covers materials intended to degrade in the body as well as non‑degrading materials. The standard focuses on chemical (electrochemical and immersion) generation of degradation products for subsequent analysis and biological assessment.

Key technical topics and requirements

• Scope and exclusions
  • Applies to degradation products generated by chemical alteration in in vitro tests.
  • Excludes purely mechanical degradation (particulate wear), trace-element identification below ~10 w/w, and direct biological activity assessment (see ISO 10993‑1, ISO 10993‑17).
• Degradation test methods
  • Two main procedures: a combined potentiodynamic + potentiostatic electrochemical approach, and an immersion test.
  • Potentiodynamic testing determines electrochemical behaviour and key potentials (e.g., passive limit, breakdown potential).
  • Potentiostatic testing degrades material at a constant potential (usually above breakdown) to generate analytes.
  • Immersion tests chemically degrade materials under defined conditions to produce degradation products.
• Test design and preparation
  • Requirements for sample documentation, sample shape, surface condition, and sampling.
  • Specification of test solutions/electrolytes and apparatus for electrochemical measurements.
  • Emphasis that electrochemical degradation rates are sensitive to small variations - tests should be performed in appropriately equipped laboratories by qualified personnel.
• Analysis and reporting
  • Identification and quantification methods are not prescriptive; laboratories choose appropriate analytical chemistry techniques.
  • Test reports must document conditions, results and support downstream biological and toxicokinetic evaluation.

Practical applications - who uses ISO 10993-15

• Medical device manufacturers evaluating metallic implants and components for biocompatibility risk assessment.
• Analytical and electrochemical testing laboratories developing degradation protocols for regulatory submissions.
• Materials scientists and product development teams assessing corrosion behavior and degradation profiles.
• Regulatory reviewers and toxicologists using degradation-product data to inform biological testing and toxicokinetic studies.

Related standards

• ISO 10993‑1 (biological evaluation framework)
• ISO 10993‑9, ‑12, ‑13, ‑14, ‑16 (related degradation, sample prep, polymers, ceramics, toxicokinetics)
• ISO/TR 10993‑22 (nanomaterials guidance)
• ISO 8044, ISO 3696, ISO 3585 (supporting references)

Keywords: ISO 10993-15, biological evaluation of medical devices, degradation products, metals and alloys, electrochemical tests, potentiodynamic, potentiostatic, immersion test, biocompatibility, toxicokinetic.