PD ISO/TR 10993-22:2017 - Biological Evaluation of Medical Devices: Guidance on Nanomaterials

Standard Number: PD ISO/TR 10993-22:2017

Pages: 72

Released: July 19, 2017

ISBN: 978 0 580 94682 0

Status: Standard

Overview

The PD ISO/TR 10993-22:2017 is an essential standard for professionals involved in the development and evaluation of medical devices, particularly those incorporating nanomaterials. This comprehensive document provides detailed guidance on the biological evaluation of medical devices, focusing on the unique considerations and challenges presented by nanomaterials.

Why Choose This Standard?

In the rapidly evolving field of medical technology, the integration of nanomaterials into medical devices offers unprecedented opportunities for innovation and improvement in patient care. However, with these advancements come new challenges in ensuring the safety and efficacy of these devices. The PD ISO/TR 10993-22:2017 standard addresses these challenges by offering a structured approach to the biological evaluation of nanomaterials used in medical devices.

Key Features

• Comprehensive Guidance: This standard provides a thorough framework for evaluating the biological safety of nanomaterials, ensuring that all potential risks are identified and mitigated.
• Expert Insights: Developed by leading experts in the field, the guidance reflects the latest scientific understanding and regulatory requirements.
• Global Relevance: As a part of the ISO 10993 series, this standard is recognized and utilized worldwide, making it an invaluable resource for international compliance.

Understanding Nanomaterials in Medical Devices

Nanomaterials are materials with structural components smaller than 100 nanometers. Their unique properties, such as increased surface area and reactivity, make them highly desirable for use in medical devices. However, these same properties can also pose potential risks to human health, necessitating rigorous evaluation and testing.

Applications of Nanomaterials

Nanomaterials are used in a variety of medical applications, including:

• Drug Delivery Systems: Enhancing the delivery and efficacy of therapeutic agents.
• Diagnostic Tools: Improving the sensitivity and accuracy of diagnostic tests.
• Implants and Prosthetics: Offering improved integration and functionality.

Guidance on Biological Evaluation

The PD ISO/TR 10993-22:2017 provides a detailed approach to the biological evaluation of nanomaterials, covering key areas such as:

• Risk Assessment: Identifying potential biological hazards associated with nanomaterials.
• Testing Strategies: Outlining appropriate in vitro and in vivo testing methods to assess biocompatibility.
• Data Interpretation: Providing guidance on the interpretation of test results to ensure accurate risk characterization.

Benefits of Compliance

Adhering to the PD ISO/TR 10993-22:2017 standard offers numerous benefits, including:

• Enhanced Safety: Ensuring that medical devices incorporating nanomaterials are safe for patient use.
• Regulatory Approval: Facilitating compliance with international regulatory requirements, streamlining the approval process.
• Market Confidence: Building trust with healthcare providers and patients by demonstrating a commitment to safety and quality.

Conclusion

The PD ISO/TR 10993-22:2017 is an indispensable resource for anyone involved in the development, testing, or regulation of medical devices that incorporate nanomaterials. By providing comprehensive guidance on the biological evaluation of these materials, this standard helps ensure that innovative medical technologies are both safe and effective for patient use. Embrace the future of medical device innovation with confidence by integrating the principles of this standard into your development processes.

PD ISO/TR 10993-22:2017

This standard PD ISO/TR 10993-22:2017 Biological evaluation of medical devices is classified in these ICS categories:

• 11.100.20 Biological evaluation of medical devices

This document describes considerations for the biological evaluation of medical devices that are composed of or contain nanomaterials. In addition, this guidance can also be used for the evaluation of nano-objects generated as products of degradation, wear, or from mechanical treatment processes (e.g. in situ grinding, polishing of medical devices) from (components of) medical devices that are manufactured not using nanomaterials.

This document includes considerations on the:

• characterization of nanomaterials;

• sample preparation for testing of nanomaterials;

• release of nano-objects from medical devices;

• toxicokinetics of nano-objects;

• biological evaluation of nanomaterials;

• presentation of results;

• risk assessment of nanomaterials in the context of medical device evaluation;

• biological evaluation report;

• nanostructures on the surface of a medical device, intentionally generated during the engineering, manufacturing or processing of a medical device.

The following are excluded from this document:

• natural and biological nanomaterials, as long as they have not been engineered, manufactured or processed for use in a medical device;

• intrinsic nanostructures in a bulk material;

• nanostructures on the surface of a medical device, generated as an unintentional by-product during the engineering, manufacturing or processing of a medical device.

NOTE Examples of unintentional nanostructures on the surface of a medical device are extrusion draw lines and machining/tool marks.

This document is intended to provide a general framework and highlights important aspects which need to be considered when assessing the safety of medical devices composed of, containing and/or generating nano-objects. Additionally, the document identifies several common pitfalls and obstacles which have been identified when testing nanomaterials compared to bulk materials or small molecule chemical species. As a technical report (TR), this document represents the current technical knowledge related to nanomaterials. No detailed testing protocols are outlined or provided. This document can serve as a basis for future documents containing detailed protocols with a focus on nanomaterial testing.