PD ISO/TS 10993-19:2020 - Biological Evaluation of Medical Devices

Standard Number: PD ISO/TS 10993-19:2020

Pages: 24

Released: March 16, 2020

ISBN: 978 0 580 99755 6

Status: Standard

Overview

The PD ISO/TS 10993-19:2020 is a pivotal standard in the realm of medical device evaluation, focusing on the physico-chemical, morphological, and topographical characterization of materials. This standard is an essential tool for professionals in the medical device industry, providing comprehensive guidelines to ensure the safety and efficacy of medical devices through detailed material analysis.

Key Features

• Comprehensive Evaluation: This standard offers a thorough framework for the biological evaluation of medical devices, emphasizing the importance of understanding the physical and chemical properties of materials used in medical devices.
• Material Characterization: It provides detailed methodologies for the morphological and topographical characterization of materials, ensuring that every aspect of the material's surface and structure is analyzed for potential biological interactions.
• Up-to-Date Guidelines: Released in March 2020, this standard reflects the latest advancements and research in the field, ensuring that your evaluations are based on the most current scientific knowledge.

Why Choose PD ISO/TS 10993-19:2020?

In the highly regulated field of medical devices, ensuring the safety and compatibility of materials is paramount. The PD ISO/TS 10993-19:2020 standard is designed to assist manufacturers, researchers, and regulatory bodies in conducting rigorous evaluations of medical device materials. By adhering to this standard, you can:

• Enhance Safety: By thoroughly understanding the physico-chemical properties of materials, you can predict and mitigate potential adverse biological reactions.
• Ensure Compliance: Align your evaluations with international standards to meet regulatory requirements and facilitate market access.
• Improve Product Development: Gain insights into material properties that can inform design decisions and lead to the development of safer, more effective medical devices.

Applications

This standard is applicable to a wide range of medical devices, from implants and prosthetics to diagnostic equipment and surgical instruments. It is particularly valuable for:

• Material Scientists: Who need to understand the detailed properties of materials used in medical devices.
• Regulatory Affairs Professionals: Who are responsible for ensuring that products meet all necessary safety and efficacy standards.
• Product Developers: Who are involved in the design and testing of new medical devices.

Detailed Content

The PD ISO/TS 10993-19:2020 standard spans 24 pages, offering a detailed exploration of the methodologies and considerations necessary for the effective evaluation of medical device materials. Key sections include:

• Introduction to Material Characterization: An overview of the importance of material characterization in the context of biological evaluation.
• Physico-Chemical Analysis: Guidelines for assessing the chemical composition and physical properties of materials.
• Morphological and Topographical Analysis: Techniques for examining the surface structure and morphology of materials.
• Interpretation of Results: Strategies for analyzing and interpreting data to make informed decisions about material suitability.

Conclusion

The PD ISO/TS 10993-19:2020 standard is an indispensable resource for anyone involved in the development, evaluation, or regulation of medical devices. By providing a comprehensive framework for the physico-chemical, morphological, and topographical characterization of materials, it ensures that medical devices are safe, effective, and compliant with international standards. Whether you are a material scientist, regulatory professional, or product developer, this standard will equip you with the knowledge and tools necessary to excel in your field.

PD ISO/TS 10993-19:2020

This standard PD ISO/TS 10993-19:2020 Biological evaluation of medical devices is classified in these ICS categories:

• 11.100.20 Biological evaluation of medical devices

This document provides a compilation of parameters and test methods that can be useful for the identification and evaluation of the physical, i.e. physico?chemical, morphological and topographical (PMT) properties of materials in finished medical devices. Such an assessment is limited to those properties that are relevant to biological evaluation and the medical device’s intended use (clinical application and duration of use) even if such properties overlap with clinical effectiveness.

This document does neither address the identification or quantification of degradation products nor the evaluation of the physico-chemical properties of the degraded materials, which are covered in ISO 10993-9, ISO 10993-13, ISO 10993-14 and ISO 10993-15.

Chemical characterization of materials is covered by ISO 10993-18.

The ISO 10993 series is not applicable when the material or device is not in contact with the body directly or indirectly.