ISO 10993-17-2023 PDF

Full title and description

ISO 10993-17:2023 — Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents. This international standard specifies the process, methods and criteria for performing a toxicological risk assessment (TRA) of chemical constituents present in medical devices, as part of the biological evaluation of the finished device.

Edition: 2 (2023). The document replaces the previous 2002 edition and introduces revised terminology and approaches for assessing tolerable intake and exposure for device constituents.

Abstract

This standard describes a systematic process to determine whether patient or user exposure to identified chemical constituents in a medical device is without appreciable harm. It sets out when a TRA is required, how to use compositional and analytical chemistry data (including extractables and leachables generated in line with ISO 10993-18), and the decision criteria for deeming risks negligible or tolerable. The document also lists situations where TRA is not applicable (for example, constituents below reporting thresholds, established equivalence to clinically accepted devices, non-body-contact items, certain device–drug/biologic combinations, and exposures originating from non-device sources).

General information

• Status: Published.
• Publication date: September 2023 (second edition published 2023‑09; corrected language version issued November 2023 in some records).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.100.20 (Biological evaluation of medical devices).
• Edition / version: Edition 2 (2023).
• Number of pages: 65 (official ISO published pagination).

Scope

ISO 10993-17:2023 defines the scope and procedure for toxicological risk assessment of chemical constituents of medical devices when chemical characterization information is available in accordance with ISO 10993-18. It applies to compositional information and analytical chemistry outputs (e.g., extractables/leachables) used to estimate worst-case exposure and compare that exposure with toxicologically based tolerable intake or contact levels. The scope also clarifies exclusions and special cases (e.g., non‑body‑contact devices, active pharmaceutical or biologic components of combination products, exposures from non-device sources, and situations where other equivalence or reporting-threshold rules apply).

Key topics and requirements

• Framework and stepwise process for performing a toxicological risk assessment of device constituents, integrated with ISO 10993-1 biological evaluation workflows.
• Calculation of worst‑case estimated exposure (EEDmax) based on compositional and analytical chemistry data, including guidance on using extractables and leachables data from ISO 10993-18.
• Definition and use of tolerable intake/tolerable contact levels and decision criteria to determine whether exposure is negligible, tolerable, or requires mitigation.
• Introduction of the toxicological screening limit (TSL) concept to screen-out low‑risk constituents when total exposure is below a defined micrograms-per-day threshold (with specified exceptions and caveats for cohorts of concern, neonates, irritation endpoints, unknowns, VOCs in gas-pathway devices, etc.).
• Identification of when TRA is not required (e.g., constituents below reporting thresholds, established chemical/biological equivalence, and other situations described by ISO 10993-18 and ISO/TS 21726).
• Technical updates and removal of prior terminology such as “allowable limit,” with clarified definitions and updated toxicological approaches.

Typical use and users

Primary users include medical device manufacturers, biocompatibility/toxicology specialists, regulatory affairs professionals, notified bodies and conformity assessment organizations, contract testing and consulting laboratories, and clinicians involved in device safety review. The standard is applied when chemical characterization data are available and a toxicological assessment is needed to support product safety, regulatory submissions, or design changes.

Related standards

ISO 10993-17 is part of the ISO 10993 series on biological evaluation of medical devices and is intended to be used alongside related documents such as ISO 10993-1 (evaluation and testing within a risk management process), ISO 10993-18 (chemical characterization — identification and quantification of constituents, extractables/leachables), and ISO/TS 21726 (requirements for reporting); other parts of ISO 10993 (e.g., test methods and specific endpoints) are relevant depending on device type and contact conditions.

Keywords

toxicological risk assessment; tolerable intake; tolerable contact level; toxicological screening limit; extractables and leachables; chemical characterization; biocompatibility; ISO 10993; medical device constituents; worst-case exposure.

FAQ

Q: What is this standard?

A: ISO 10993-17:2023 is the ISO standard that defines how to perform a toxicological risk assessment of chemical constituents found in medical devices, including decision criteria for when exposure is negligible or tolerable.

Q: What does it cover?

A: It covers the TRA process, how to use compositional and analytical chemistry data (including extractables/leachables per ISO 10993-18), calculation of worst-case exposures, application of tolerable intake/contact levels and screening limits, and the situations where TRA is not applicable or can be omitted.

Q: Who typically uses it?

A: Biocompatibility and toxicology experts, medical device manufacturers, regulatory affairs teams, testing laboratories, and conformity assessment bodies use it to demonstrate or evaluate chemical safety of devices during development, change control, and regulatory submissions.

Q: Is it current or superseded?

A: ISO 10993-17:2023 is the current edition published in 2023 and technically replaces the 2002 edition; subsequent amendments (where issued) should be checked for updates relevant to specific projects or regulatory submissions.

Q: Is it part of a series?

A: Yes — it is Part 17 of the ISO 10993 series on biological evaluation of medical devices and is intended to be used in concert with other parts (notably ISO 10993-1 and ISO 10993-18) to perform a complete biological evaluation.

Q: What are the key keywords?

A: Toxicological risk assessment, tolerable intake/contact, toxicological screening limit (TSL), extractables and leachables, chemical characterization, biocompatibility, ISO 10993 series.