DIN EN ISO 10993-17 2024-02 PDF

Full title and description

DIN EN ISO 10993-17:2024-02 — Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents. This is the German adoption (DIN/EN) of ISO 10993-17:2023 and specifies the process and requirements for performing toxicological risk assessments of chemical constituents that may be present in or released from medical devices.

Abstract

This document defines a risk‑based process to determine whether exposure to device constituents is without appreciable harm. It describes methods and criteria for hazard identification, exposure estimation (including consideration of extractables/leachables and chemical characterization per ISO 10993‑18), dose–response evaluation and the derivation of acceptable exposure or allowable limits for constituents as part of the overall biological evaluation (ISO 10993 series).

General information

• Status: Published / Current (DIN national adoption of EN ISO 10993‑17:2023).
• Publication date: 2024-02 (DIN edition published 1 Feb 2024, listed as 2024-02).
• Publisher: Deutsches Institut für Normung (DIN) — national adoption of EN ISO 10993‑17:2023.
• ICS / categories: 11.100.20 — Biological evaluation of medical devices.
• Edition / version: Edition corresponds to ISO 10993‑17:2023 (Edition 2); DIN national edition date 2024‑02 (DIN EN ISO 10993‑17:2024‑02).
• Number of pages: 88 (DIN publication, including national foreword/translation pages).

Scope

The standard specifies the process and requirements for toxicological risk assessment of medical‑device constituents based on composition and chemical characterization data (e.g., extractables/leachables). It applies when such an assessment is needed to determine if constituent‑related risks are negligible or tolerable and is intended to be used as part of the product’s biological evaluation under ISO 10993‑1. The document is not intended to address constituents that do not contact the body and does not replace other regulatory considerations for device‑drug or device‑biologic combination products.

Key topics and requirements

• Framework and stepwise process for toxicological risk assessment of constituents (hazard identification, dose–response, exposure assessment, risk characterization).
• Use of chemical characterization and analytical data (extractables/leachables) obtained in line with ISO 10993‑18 to inform exposure estimates and constituent identification.
• Derivation of acceptable exposure values or allowable limits for individual constituents and guidance on combining exposures where relevant.
• Documentation, rationale and reporting requirements to support biocompatibility conclusions within the product risk management file (alignment with ISO 10993‑1 principles).
• Consideration of device use, patient population, route and duration of exposure, and potential background/external exposures when assessing risk.

Typical use and users

Used by medical‑device manufacturers, materials suppliers, biocompatibility and toxicology specialists, regulatory and quality teams, testing laboratories, and conformity assessment bodies (notified bodies) to assess chemical risks from device constituents and to produce justification and allowable‑limit documentation for regulatory submissions and internal risk management.

Related standards

Key related documents include ISO 10993‑1 (Biological evaluation — evaluation and testing within a risk management process) and ISO 10993‑18 (Chemical characterization of medical device materials within a risk management process). The part is one element of the ISO 10993 series that together addresses biocompatibility evaluation of medical devices.

Keywords

toxicological risk assessment; allowable limits; leachables; extractables; chemical characterization; biocompatibility; medical device constituents; ISO 10993; DIN EN ISO; exposure assessment; hazard identification.

FAQ

Q: What is this standard?

A: DIN EN ISO 10993-17:2024-02 is the German (DIN/EN) adoption of ISO 10993‑17:2023 setting requirements and a process for toxicological risk assessment of chemical constituents of medical devices.

Q: What does it cover?

A: It covers hazard identification, exposure estimation (including use of extractables/leachables data), dose–response considerations and the derivation of acceptable exposure or allowable limits for device constituents as part of the biological evaluation. It relies on chemical characterization information obtained in line with ISO 10993‑18.

Q: Who typically uses it?

A: Medical‑device manufacturers, material suppliers, biocompatibility/toxicology specialists, testing labs, regulatory affairs teams and notified bodies use this standard to support safety assessments and regulatory submissions.

Q: Is it current or superseded?

A: This DIN adoption (DIN EN ISO 10993‑17:2024‑02) implements the current ISO 10993‑17:2023 edition and replaces earlier national/adopted editions based on older ISO versions. It is the current published version at the DIN national level (published Feb 2024).

Q: Is it part of a series?

A: Yes — it is Part 17 of the ISO 10993 series (Biological evaluation of medical devices). It is intended to be used alongside other parts such as ISO 10993‑1 (general biological evaluation framework) and ISO 10993‑18 (chemical characterization).

Q: What are the key keywords?

A: Toxicological risk assessment, allowable limits, leachables/extractables, chemical characterization, biocompatibility, medical device constituents, ISO 10993, DIN EN ISO.