ISO 10993-17 — Establishment Of Allowable Limits For Leachable Substances

ISO 10993-17 provides guidance and standards for methods of determining acceptable levels of leachable substances from medical devices. As a component of ISO 10993, ISO 10993-17 is aimed at quantifying risk levels and establishing maximum limits of leachable exposure when specific standards do not exist.

BA Sciences features expertise in ISO 10993 Part 17 testing methods and establishment of standards and acceptable limits of exposure. We also offer process validation and documentation to ensure that testing is accurate, traceable, and repeatable.

Rationale for Leachable Testing and Establishment of Limits

The materials and processes involved in medical device manufacturing may include leachable substances, which can be hazardous to patients and users in the course of operation of the medical device. Leachables may be introduced into the body through a number of different routes, depending upon the device in question and the way in which it is used. Potential routes of introduction include ingestion, inhalation, skin absorption, direct administration, and more.

The limits and standards defined by ISO 10993 Part 17 are intended to quantify acceptable risk levels as compared with the potential benefits of medical devices, with the ultimate intention of preventing equipment and materials with unacceptable risk levels from interacting with end users.

Because medical devices may be placed into different categories based on their expected duration of use, each leachable substance may have a corresponding acceptable limit: a short-term limit, a prolonged-use limit, and a lifetime limit. These limits may also be used in conjunction with limits as defined by routes of exposure as defined in ISO 10993-1.

General Steps for Risk Management in Medical Devices

Based on ISO 14971, medical device risk management comprises four general steps:

Hazard identification
Hazard characterization
Exposure assessment
Risk characterization

ISO 10993-17 builds upon this framework, providing a standardized process for developing acceptable leachable limits based upon available data and research.

Method for Quantifying Risks and Limiting Exposure to Leachables

As defined by ISO 10993-17, the following process can be used to establish standardized acceptable exposure levels, and can also be used to limit exposure to remain within acceptable levels. The process steps are:

Identify the critical health endpoint (the lowest acceptable level of exposure) through literature review.
Determine a point of departure, typically the highest level of exposure at which no adverse effects occur (NOAEL).
Examine the route and duration of exposure to create a Tolerable Intake level (TI).
Calculate a Tolerable Exposure (TE) for patient subgroups.
Where feasible, calculate the TE as a function of potential benefit of device usage.
Compare the final TE with worst-case exposure levels and calculate a Margin of Safety (MOS).

Working With BA Sciences

With extensive experience and knowledge in ISO standards, laboratory testing, validation, facility commissioning and decommissioning, and certification, BA Sciences is your partner of choice for your regulatory and safety compliance needs. We feature the latest testing equipment and maintain up-to-date knowledge on the standards and guidelines that you need to meet all applicable requirements for certification and compliance.