Overview
EN ISO 10993-15:2023 (adoption of ISO 10993-15:2019) is part of the ISO 10993 series on the biological evaluation of medical devices. It provides guidance for the identification and quantification of degradation products from metals and alloys used in medical devices. The standard describes how to plan and perform degradation studies, prepare samples and reagents, run electrochemical and immersion tests, and analyze degradation products to support biological risk assessment and regulatory submissions.
Key Topics
- Scope and harmonisation: Adopted by CEN as EN ISO 10993-15:2023 and mapped to Regulation (EU) 2017/745 via Annex ZA to support presumption of conformity when cited in the Official Journal.
- Degradation test methods: Framework for designing degradation studies (electrochemical tests, potentiostatic/potentiodynamic measurements and immersion tests).
- Sample and reagent preparation: Documentation, sample shape, surface condition, sampling and electrolyte/test solution considerations.
- Analytical requirements: Identification and quantitative analysis of released metal ions and other degradation products; sample handling and analysis strategy to generate data for biological evaluation.
- Integration with risk management: Links to ISO 10993-1 and other ISO 10993 parts for overall biological evaluation and with ISO 10993-16 for toxicokinetic study design where needed.
- Documentation & reporting: Emphasis on traceable sample documentation and test record keeping to support safety assessments and regulatory audits.
Applications
EN ISO 10993-15 is intended for:
- Medical device manufacturers assessing biocompatibility and corrosion-related risks of metallic implants, instruments and components.
- Testing laboratories that perform electrochemical, immersion and chemical analyses to quantify metal release.
- Regulatory and quality teams preparing clinical evaluation reports, CE marking dossiers and demonstrating conformity with MDR (EU) 2017/745.
- Materials scientists and design engineers selecting alloys, surface treatments and coatings to minimise harmful degradation products.
Practical uses include planning degradation studies, generating quantitative release data for biological risk assessments, comparing material options, and supporting post-market surveillance and clinical evaluation.
Related standards
Key referenced standards within the ISO 10993 series and related documents:
- ISO 10993-1 - Biological evaluation framework
- ISO 10993-9 - Framework for identification/quantification of potential degradation products
- ISO 10993-12 - Sample preparation and reference materials
- ISO 10993-13 / -14 - Identification and quantification for polymers and ceramics
- ISO 10993-16 - Toxicokinetic study design for degradation products
Keywords: EN ISO 10993-15:2023, ISO 10993-15, biological evaluation of medical devices, degradation products, metals and alloys, electrochemical tests, immersion tests, biocompatibility, EU MDR.
