ISO 10993-14:2001

Overview

ISO 10993-14:2001 is part of the ISO 10993 series on the biological evaluation of medical devices. It specifies in vitro methods to obtain, identify and quantify degradation products from ceramics (including glasses and ceramic coatings). The standard defines two complementary test approaches - an extreme solution test (worst-case, low pH) and a simulation solution test (near in vivo pH) - and provides guidance on specimen preparation, testing conditions and analysis of the resulting solutions (filtrate) for risk assessment and further biological evaluation.

Key topics and technical requirements

• Test scope: Covers degradation by chemical dissociation in aqueous in vitro environments only; mechanical or enzyme/protein‑mediated degradation is excluded.
• Two test methods:
  • Extreme solution test: Uses a citric acid buffer at pH 3.0 ± 0.2 (37 ± 1 °C) as a worst‑case environment; intended as a screening method for most ceramics.
  • Simulation solution test: Designed to simulate more common in vivo pH conditions (details and decision flow outlined in the standard).
• Specimen preparation:
  • Bulk, granular and coatings are covered; coatings may be removed and tested separately.
  • Granulation by tungsten carbide mortar and pestle; target particle sizing to pass a 400 µm screen and be retained on 315 µm.
  • Mass loading guidance: typically 5.00 ± 0.05 g for low‑solubility material and 10.00 ± 0.05 g for high‑solubility material (or scaled tests with justification).
• Test controls and equipment:
  • Use 250 ml polypropylene or high‑density polyethylene containers (avoid glass).
  • Filtration using a Büchner funnel to separate filtrate and retentate.
  • Mass determination with balances accurate to 0.0005 g and six replicates; drying at 100 ± 2 °C until mass change ≤ 0.1%.
• Analysis of filtrate: Guidance on selecting which chemicals/elements to analyze and on required analytical sensitivity, but no prescriptive analytical techniques or acceptance limits - laboratories choose validated methods appropriate to required detection limits.

Applications and users

• Intended for medical device manufacturers, materials scientists, analytical testing laboratories and regulatory bodies assessing the chemical safety of ceramic implants, prosthetics, dental implants (note: dental ceramics exposed to the oral cavity should follow ISO 6872 for extreme tests), and ceramic coatings.
• Used to identify and quantify leachable ions and degradation products that form the basis for toxicological risk assessment and any subsequent biological safety testing under ISO 10993-1.

Related standards

• ISO 10993 series (notably ISO 10993-1, ISO 10993-9, ISO 10993-13, ISO 10993-15)
• ISO 6872 (dental ceramics) and reference standards for sieves, water and density (ISO 3310-1, ISO 3696, ISO 5017, ISO 6474)

Keywords: ISO 10993-14, biological evaluation, medical devices, ceramics, degradation products, extreme solution test, simulation solution test, filtrate analysis, in vitro testing, ceramic coatings.