PD ISO/TS 21560:2020 - General Requirements of Tissue-Engineered Medical Products

Standard Number: PD ISO/TS 21560:2020

Pages: 20

Released: 2020-10-02

ISBN: 978 0 580 95816 8

Status: Standard

Overview

The PD ISO/TS 21560:2020 is a pivotal standard that outlines the general requirements for tissue-engineered medical products. As the field of tissue engineering continues to evolve, this standard provides a comprehensive framework to ensure the quality, safety, and efficacy of these innovative medical products. Released on October 2, 2020, this standard is an essential resource for professionals involved in the development, manufacturing, and regulation of tissue-engineered products.

Key Features

• Comprehensive Guidelines: This standard offers detailed guidelines that cover various aspects of tissue-engineered medical products, ensuring that they meet the necessary quality and safety standards.
• Internationally Recognized: As an ISO/TS standard, it is recognized globally, making it a valuable resource for international companies and organizations involved in tissue engineering.
• Up-to-Date Information: Released in 2020, this standard reflects the latest advancements and best practices in the field of tissue engineering.

Importance of Tissue-Engineered Medical Products

Tissue-engineered medical products are at the forefront of medical innovation, offering new solutions for repairing, replacing, or regenerating damaged tissues and organs. These products have the potential to revolutionize healthcare by providing more effective treatments for a wide range of conditions, from burns and wounds to organ failure.

As the demand for these products grows, it is crucial to have standardized guidelines that ensure their safety and effectiveness. The PD ISO/TS 21560:2020 standard plays a vital role in this regard, providing a robust framework that supports the development of high-quality tissue-engineered products.

Who Should Use This Standard?

This standard is designed for a wide range of stakeholders in the tissue engineering field, including:

• Manufacturers: Companies involved in the production of tissue-engineered medical products can use this standard to ensure their products meet international quality and safety requirements.
• Regulatory Bodies: Regulatory agencies can refer to this standard when evaluating the compliance of tissue-engineered products with safety and efficacy standards.
• Researchers and Developers: Professionals involved in the research and development of new tissue-engineered products can use this standard as a guideline to align their innovations with industry best practices.

Benefits of Adhering to PD ISO/TS 21560:2020

Adhering to the PD ISO/TS 21560:2020 standard offers numerous benefits, including:

• Enhanced Product Quality: By following the guidelines outlined in this standard, manufacturers can ensure that their products are of the highest quality, meeting the expectations of both regulators and consumers.
• Increased Market Access: Compliance with an internationally recognized standard can facilitate market access, allowing companies to expand their reach and compete in global markets.
• Improved Patient Safety: By adhering to stringent safety requirements, companies can minimize the risk of adverse effects, ensuring that patients receive safe and effective treatments.

Conclusion

The PD ISO/TS 21560:2020 standard is an indispensable resource for anyone involved in the field of tissue engineering. By providing a comprehensive set of guidelines, it helps ensure that tissue-engineered medical products are safe, effective, and of the highest quality. Whether you are a manufacturer, regulator, or researcher, this standard is a valuable tool that can support your efforts to innovate and excel in the rapidly evolving field of tissue engineering.

PD ISO/TS 21560:2020

This standard PD ISO/TS 21560:2020 General requirements of tissue-engineered medical products is classified in these ICS categories:

• 11.040.40 Implants for surgery, prosthetics and orthotics

This document specifies general requirements for tissue-engineered medical products (TEMPs), which are used in regenerative medicine. With regard to safety, this document outlines requirements for materials, manufacture, quality control, and unintentional biological effects elicited by TEMPs. This document does not address requirements for clinical trials and efficacy.

This document is not applicable to tissue-engineered products used for diagnosis, ex-vivo testing or extracorporeal treatments of patients (e.g. dialysis with TEMP components). TEMPs containing viable xenogenic cells, genetically modified cells, or cells derived from abnormal cells or tissues (e.g. cancerous tissues) are also excluded from the scope. The combination of TEMPs with medical devices, with the exception of scaffolds comprised of synthetic and/or naturally-derived (e.g. animal sourced) materials, is also excluded from the scope.