Overview
EN ISO 10993-14:2009 (identical to ISO 10993-14:2001) is part of the ISO 10993 series on the biological evaluation of medical devices. It defines procedures to identify and quantify degradation products from ceramics (including glasses) by in vitro chemical dissolution. The standard provides two complementary test methods - an extreme solution test (low pH, worst‑case screen) and a simulation solution test (representative of commonly encountered in vivo pH) - and guidance on analysing the resulting solutions (filtrate) to support risk assessment and subsequent biological safety evaluations under ISO 10993-1.
Key topics and requirements
- Scope
- Applies to ceramics used in medical devices (bulk, granular, blank discs) and to degradation produced by chemical dissociation in aqueous in vitro tests.
- Excludes degradation induced by mechanical stress, external energy, or biological agents (enzymes/proteins).
- Two test approaches
- Extreme solution test: low‑pH, worst‑case screening to reveal likely dissolution products.
- Simulation solution test: mimics more typical in vivo aqueous conditions to produce realistic degradation profiles.
- Sample handling & outputs
- Distinguishes filtrate (solution passing the filter) and retentate (undissolved solids).
- Guidance on what chemicals/elements to analyse and on method sensitivity; no single analytical technique is mandated.
- Analytical guidance
- The standard does not prescribe specific instruments or detection limits - laboratories select appropriate methods based on the ceramic type and required accuracy/precision.
- Reporting
- Specifies content to include in the test report to support traceability and risk assessment.
- Regulatory linkage
- Adopted as a CEN standard and intended to support Essential Requirements of EU Directive 93/42/EEC for medical devices (see informative Annex ZA).
Applications and who uses it
- Medical device manufacturers developing ceramic/dental/implantable components who need to characterise potential leachables and degradation products.
- Biocompatibility engineers and toxicologists conducting chemical characterisation and preparing safety dossiers.
- Analytical laboratories selecting dissolution protocols and analytical methods (e.g., ICP, AAS, chromatography) appropriate to the material.
- Regulatory affairs specialists using standardised test data to demonstrate conformity with ISO 10993 series and EU medical device requirements.
- Risk assessors who use identified/quantified degradation products as inputs to biological safety and allowable‑limit evaluations.
Related standards
- ISO 10993-1 (general biological evaluation)
- ISO 10993-9 (framework for identification/quantification of potential degradation products)
- Other ISO 10993 parts addressing polymers, metals and toxicokinetics (for complementary testing and risk assessment)
Keywords: EN ISO 10993-14, ISO 10993-14, biological evaluation, degradation products from ceramics, ceramic degradation testing, extreme solution test, simulation solution test, medical device biocompatibility, leachables, 93/42/EEC.
