ISO/TR 10993-22:2017

Overview

ISO/TR 10993-22:2017 - "Biological evaluation of medical devices - Part 22: Guidance on nanomaterials" is a Technical Report from ISO that provides a general framework for assessing the biological safety of medical devices that are composed of, contain, or generate nanomaterials or nano-objects. It clarifies considerations for characterization, testing, and risk assessment of nanoscale components (approximately 1–100 nm) and identifies common pitfalls when testing nanomaterials versus bulk materials or small molecules. As a TR, it summarizes current technical knowledge and does not provide detailed testing protocols.

Key technical topics and requirements

The report highlights technical topics that reviewers and test laboratories should consider when evaluating nanomaterials in medical devices:

• Characterization of nanomaterials
  • Physicochemical parameters and recommended methods
  • Use of reference materials
• Sample preparation
  • Preparation and stability of stock dispersions
  • Dose metrics and relevant dosing solutions
  • Sterilization and endotoxin considerations
• Release of nano-objects
  • Degradation, wear, and in situ processing as sources of nano-release
• Toxicokinetics
  • Factors influencing absorption, distribution, metabolism and excretion of nano-objects
  • Measurement techniques and biomolecular adsorption effects
• Toxicological evaluation
  • In vitro and in vivo testing considerations (cytotoxicity, genotoxicity, immunotoxicity, haemocompatibility, systemic toxicity, etc.)
  • Potential assay interference by nanomaterials and appropriate controls
• Presentation of results and reporting
  • How to document characterization and toxicology data
  • Structure of the biological evaluation report
• Risk assessment
  • Exposure assessment, hazard identification, risk estimation and evaluation

The TR also explicitly excludes natural/non‑engineered biological nanomaterials, intrinsic bulk nanostructures, and unintentional nanostructures formed as by-products during manufacturing (e.g., tool marks).

Practical applications

ISO/TR 10993-22:2017 is practical for:

• Preclinical safety evaluation and design validation of implants, coatings, and devices containing engineered nanomaterials
• Assessing devices that may generate nano-sized wear or degradation particles during use or processing
• Informing regulatory submissions and risk management documents where nanoscale materials are involved
• Guiding test labs on sample handling, dose metrics, and assay selection to avoid nanomaterial-specific artifacts

Who should use this standard

• Medical device manufacturers and R&D teams designing nano-enabled devices
• Biocompatibility and toxicology specialists
• Test laboratories and contract research organizations (CROs)
• Regulatory affairs professionals preparing device submissions
• Risk assessors and post-market surveillance teams

Related standards

• ISO 10993 series (biological evaluation of medical devices)
• ISO/TS 80004-1:2015 (nanotechnology - vocabulary and definitions)

Keywords: ISO/TR 10993-22:2017, biological evaluation, nanomaterials, medical devices, nano-objects, characterization, toxicokinetics, sample preparation, risk assessment.