ISO TR 10993-22-2017 PDF

Full title and description

ISO/TR 10993-22:2017 — Biological evaluation of medical devices — Part 22: Guidance on nanomaterials. This Technical Report provides guidance and considerations for the biological evaluation of medical devices that are composed of, contain, or can generate nanomaterials (nano‑objects) during manufacture, wear, degradation or processing.

Abstract

ISO/TR 10993-22:2017 summarizes current technical knowledge relevant to assessing the biological safety of medical devices involving nanomaterials. Topics include nanomaterial characterization, sample preparation, potential release of nano‑objects, toxicokinetics, biological testing considerations, presentation of results, risk assessment in the context of ISO 10993 and reporting of findings. As a Technical Report, it gives guidance and highlights important considerations rather than prescribing detailed test protocols.

General information

• Status: Published.
• Publication date: 14 July 2017 (edition 1).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.100.20 — Biological evaluation of medical devices (ISO/TC 194).
• Edition / version: Edition 1 (2017).
• Number of pages: 61 pages (PDF/print).

Scope

The document provides a general framework to support the biological evaluation of medical devices that contain, are composed of, or can generate nano‑objects (typically defined as structures with dimensions on the order of 1 nm to 100 nm). It addresses characterization of nanomaterials, sample preparation for biological testing, mechanisms and likelihood of release of nano‑objects, toxicokinetic considerations, interpretation and presentation of results, and integration of these elements into device risk assessment and the biological evaluation report. Exclusions include unengineered natural/biological nanomaterials, intrinsic nanostructures within bulk materials, and surface nanostructures unintentionally produced as manufacturing artifacts. The guidance is non‑prescriptive and intended to inform risk‑based testing strategies.

Key topics and requirements

• Definitions and applicability: use of ISO/TS definitions for nanomaterials and note that regulatory definitions may vary by region.
• Physicochemical characterization: size, morphology, surface area, surface chemistry, aggregation/agglomeration and relevant analytical methods.
• Sample preparation and representative test articles: preparing materials and suspensions while minimizing artefacts that alter nanoparticle behaviour.
• Release assessment: evaluation of whether nano‑objects can be released during manufacture, use, wear or degradation and quantification/qualification of released species.
• Toxicokinetics and fate: considerations for absorption, distribution, metabolism, elimination and potential persistence of nano‑objects.
• Biological evaluation strategy: adapting ISO 10993‑1 risk‑based approach to nanomaterials, including use of existing data and equivalence demonstrations where appropriate.
• Reporting and interpretation: recommended content of biological evaluation reports and key data presentation issues specific to nanomaterials.
• Known limitations and pitfalls: highlights of common testing and interpretation challenges unique to nanoscale materials.

Typical use and users

Primary users are medical device manufacturers (R&D, materials & regulatory teams), contract testing laboratories, toxicologists, risk assessors, notified bodies and regulatory reviewers who need to evaluate devices incorporating or producing nano‑objects. The report is also used by material scientists and quality engineers designing devices with intentional nanoscale features. It informs test planning, selection of characterization techniques and risk‑management decisions within the ISO 10993 framework.

Related standards

ISO/TR 10993-22:2017 sits within the ISO 10993 biological evaluation series and is typically used alongside ISO 10993‑1 (biological evaluation and risk management) and other parts of ISO 10993. It is also connected to ISO 14971 (medical device risk management) and to ISO/TS and ISO standards for nanomaterial terminology and characterization (for example ISO/TS 80004 series). Users should consult applicable regional regulatory guidance on nanomaterials where definitions or expectations differ.

Keywords

nanomaterials; nano‑objects; biological evaluation; medical devices; ISO 10993; toxicokinetics; material characterization; release assessment; risk assessment; technical report.

FAQ

Q: What is this standard?

A: ISO/TR 10993-22:2017 is a Technical Report providing guidance for the biological evaluation of medical devices that contain, are composed of, or can generate nanomaterials (nano‑objects). It is guidance rather than a prescriptive test method.

Q: What does it cover?

A: It covers nanomaterial characterization, sample preparation, potential release of nano‑objects, toxicokinetics, how to adapt biological evaluation and risk assessment for nanomaterials, and how to present and report relevant data. It also notes exclusions such as unengineered natural nanomaterials and unintentional manufacturing artefacts.

Q: Who typically uses it?

A: Medical device manufacturers, regulatory reviewers, testing laboratories, toxicologists, and risk assessment professionals use this guidance to plan characterization, testing and risk‑management activities for devices involving nanoscale materials.

Q: Is it current or superseded?

A: As published, ISO/TR 10993-22:2017 is the Technical Report edition from 14 July 2017. Users should check for any updates, amendments or newer related documents in the ISO 10993 series or regional regulatory guidance that may have been published after that date.

Q: Is it part of a series?

A: Yes — it is Part 22 of the ISO 10993 series (Biological evaluation of medical devices) and is intended to be used in the context of ISO 10993‑1 and other relevant parts of the series.

Q: What are the key keywords?

A: Nanomaterials, nano‑objects, biological evaluation, characterization, release assessment, toxicokinetics, risk assessment, ISO 10993.