PD ISO/TS 37137-1:2021: Biological Evaluation of Absorbable Medical Devices - General Requirements

Standard Number: PD ISO/TS 37137-1:2021

Pages: 22

Released: March 15, 2021

ISBN: 978 0 539 02157 8

Status: Standard

Overview

The PD ISO/TS 37137-1:2021 is a pivotal standard that outlines the general requirements for the biological evaluation of absorbable medical devices. This standard is essential for manufacturers, researchers, and healthcare professionals involved in the development and assessment of medical devices that are designed to be absorbed by the body over time. With the increasing demand for biocompatible and absorbable materials in medical applications, this standard provides a comprehensive framework to ensure safety and efficacy.

Key Features

• Comprehensive Guidelines: This standard provides detailed guidelines for the biological evaluation of absorbable medical devices, ensuring that they meet the necessary safety and performance criteria.
• Up-to-Date Information: Released in March 2021, this standard reflects the latest advancements and research in the field of absorbable medical devices.
• International Recognition: As an ISO/TS standard, it is recognized globally, making it a valuable resource for international compliance and market access.

Importance of Biological Evaluation

Biological evaluation is a critical component in the development of medical devices, particularly those that are absorbable. These devices are designed to perform their function and then be safely absorbed by the body, minimizing the need for surgical removal. The evaluation process ensures that the materials used are biocompatible, non-toxic, and effective in their intended use. The PD ISO/TS 37137-1:2021 standard provides a structured approach to assess these factors, helping to mitigate risks and enhance patient safety.

Who Should Use This Standard?

This standard is indispensable for a wide range of professionals in the medical device industry, including:

• Manufacturers: To ensure that their products comply with international safety and performance standards.
• Regulatory Bodies: To evaluate and approve new absorbable medical devices entering the market.
• Researchers: To guide the development of new materials and technologies in the field of absorbable medical devices.
• Healthcare Professionals: To understand the safety and efficacy of the devices they use in clinical settings.

Benefits of Compliance

Adhering to the PD ISO/TS 37137-1:2021 standard offers numerous benefits, including:

• Enhanced Safety: By following the guidelines, manufacturers can ensure that their devices are safe for patient use.
• Market Access: Compliance with international standards facilitates entry into global markets, expanding business opportunities.
• Innovation Support: The standard provides a framework that supports innovation while maintaining safety and efficacy.

Conclusion

The PD ISO/TS 37137-1:2021 standard is an essential resource for anyone involved in the development, evaluation, or use of absorbable medical devices. By providing a comprehensive set of guidelines, it ensures that these devices are safe, effective, and compliant with international standards. Whether you are a manufacturer, researcher, or healthcare professional, this standard is a valuable tool in advancing the field of absorbable medical devices and improving patient outcomes.

PD ISO/TS 37137-1:2021

This standard PD ISO/TS 37137-1:2021 Biological evaluation of absorbable medical devices is classified in these ICS categories:

• 11.040.40 Implants for surgery, prosthetics and orthotics

This document specifies the requirements for the evaluation of absorbable medical devices during a biological risk assessment based on ISO 10993-1, including a clarification of the terms "absorb", "degrade" and other related terms (see Annex A).