PD ISO/TS 21726:2019 - Biological Evaluation of Medical Devices

Standard Number: PD ISO/TS 21726:2019

Pages: 14

Released: February 5, 2019

ISBN: 978 0 580 99738 9

Status: Standard

Overview

The PD ISO/TS 21726:2019 is a pivotal standard that provides comprehensive guidelines for the biological evaluation of medical devices. This document is essential for manufacturers, researchers, and regulatory bodies involved in the development and assessment of medical devices. It focuses on the application of the threshold of toxicological concern (TTC) for assessing the biocompatibility of medical device constituents, ensuring that these devices are safe for human use.

Key Features

• Comprehensive Guidelines: This standard offers detailed instructions on how to apply the TTC approach in the evaluation of medical devices, ensuring a thorough assessment of potential toxicological risks.
• Focus on Biocompatibility: It emphasizes the importance of biocompatibility, which is crucial for the safety and effectiveness of medical devices.
• Up-to-Date Information: Released in 2019, this standard reflects the latest advancements and methodologies in the field of medical device evaluation.
• Internationally Recognized: As part of the ISO standards, it is recognized globally, facilitating international trade and regulatory compliance.

Why Choose PD ISO/TS 21726:2019?

In the rapidly evolving field of medical technology, ensuring the safety and efficacy of medical devices is paramount. The PD ISO/TS 21726:2019 standard provides a robust framework for evaluating the biocompatibility of medical device constituents. By applying the TTC approach, it helps identify potential toxicological risks at an early stage, thereby enhancing the safety profile of medical devices.

This standard is particularly beneficial for:

• Manufacturers: It aids in the design and development of safer medical devices, reducing the risk of adverse effects and enhancing patient safety.
• Regulatory Bodies: Provides a reliable basis for regulatory assessments, ensuring that medical devices meet the necessary safety standards.
• Researchers: Offers a scientific approach to evaluating the biocompatibility of new materials and technologies used in medical devices.

Application of the Threshold of Toxicological Concern (TTC)

The TTC approach is a scientifically validated method used to assess the potential risk of chemical substances present in medical devices. By establishing a threshold level below which there is no significant risk to human health, the TTC approach provides a pragmatic and efficient means of evaluating the safety of medical device constituents.

This approach is particularly useful in situations where there is limited toxicological data available, allowing for a risk-based assessment that prioritizes patient safety without the need for extensive testing.

Conclusion

The PD ISO/TS 21726:2019 standard is an indispensable resource for anyone involved in the development, evaluation, or regulation of medical devices. By providing clear guidelines on the application of the TTC approach, it ensures that medical devices are thoroughly assessed for biocompatibility, ultimately safeguarding patient health and well-being.

Whether you are a manufacturer looking to enhance the safety of your products, a regulatory body seeking to ensure compliance, or a researcher exploring new materials, this standard offers the guidance and assurance you need to succeed in the field of medical device evaluation.

PD ISO/TS 21726:2019

This standard PD ISO/TS 21726:2019 Biological evaluation of medical devices. Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents is classified in these ICS categories:

• 11.100.20 Biological evaluation of medical devices

This document describes the basis for, selection of, and general applicability of a threshold of toxicological concern (TTC) value for a constituent present in/on a medical device or released from a medical device. The TTC values in this document can be used for:

• comparing to a maximum concentration of an identified or unidentified constituent in an extract (see ISO 10993‑18);

• supporting toxicological equivalence;

• comparing to a maximum exposure dose estimate of an identified constituent (see ISO 10993‑17).

NOTE Constituent is defined in 3.1.

ISO 10993‑18 specifies how to convert TTC (µg/d) into a concentration (µg/ml).

TTC is not applicable to constituents with adequate toxicity data for deriving a tolerable intake (TI) value (see ISO 10993‑17).

The TTC values established in this document are protective for carcinogens, systemic toxicants, and reproductive toxicants (see Clause 5). This document does not include TTC values for other biological endpoints assessed as part of the biological evaluation of a medical device, per ISO 10993‑1, for example:

• cytotoxicity;

• irritation;

• sensitization;

• hemocompatibility;

• material mediated pyrogenicity;

• local effects that occur in tissues at the site of contact between a medical device and the body (e.g. the observations from implantation studies).

The TTC values in this document do not apply to potential exposure via gas pathways of medical devices. For application of TTC for constituents present/released from these devices, see the ISO 18562 series.

The TTC values presented in this document are not applicable for the safety assessment of cohort of concern (see 5.3).