ISO/TS 10993-19:2020

Overview

ISO/TS 10993-19:2020, "Biological evaluation of medical devices - Part 19: Physico‑chemical, morphological and topographical characterization of materials," is a technical specification that compiles parameters and test methods useful for identifying and evaluating the physico‑chemical (PMT) properties of materials in finished medical devices. The focus is on material properties relevant to biological evaluation and the device’s intended clinical application and exposure duration. It does not cover chemical characterization (see ISO 10993‑18) or degradation product analysis (see ISO 10993‑9, ‑13, ‑14, ‑15). The ISO 10993 series is not applicable when devices do not contact the body.

Key topics and requirements

• Scope and relevance: PMT characterization limited to properties that affect biocompatibility and intended use (including overlaps with clinical effectiveness).
• Characterization procedure: Guidance on selecting analytical methods, validating/adapting literature methods, and using surrogate materials or system suitability checks to verify methods.
• Qualitative vs quantitative data:
  • Qualitative: documented descriptions of materials and finished device PMT features, supplier, batch/lot, and material specifications.
  • Quantitative: measurements sufficient to assess fitness-for-purpose and to support risk analysis.
• Material equivalence: Principles and decision-making guidance (Annex A) to judge equivalence between proposed and clinically established materials, prototypes vs final devices, and pre/post manufacturing or sterilization changes.
• Reporting: Expectations for documenting methods, validation, results and justification of selected PMT parameters.
• Cross-disciplinary approach: Encourages collaboration among material scientists, analytical scientists and risk assessors when defining the extent of characterization.

Practical applications and users

Who uses ISO/TS 10993-19:

• Medical device manufacturers performing biological evaluations and risk assessments
• Regulatory affairs professionals preparing device submissions
• Materials suppliers providing PMT data to customers
• Testing laboratories developing/validating PMT methods
• Design engineers assessing material selection and process changes

Typical uses:

• Screening and selection of materials or surface treatments for implants, catheters, meshes and other devices
• Demonstrating material equivalence after supplier, process or sterilization changes
• Supporting biocompatibility dossiers by documenting PMT characterization of the finished device
• Informing risk management and design decisions related to surface morphology, topography and physico‑chemical properties

Related standards

• ISO 10993-1 - Biological evaluation framework
• ISO 10993-18 - Chemical characterization of medical device materials
• ISO 10993-9, -13, -14, -15 - Degradation and degradation products
• ISO/TR 10993-22 - Guidance on nanomaterials
• ISO 14971 - Risk management for medical devices

ISO/TS 10993-19:2020 is a practical reference for integrating material surface and morphological data into the biological evaluation and risk assessment of medical devices.