BS EN ISO 10993-9:2021 Biological Evaluation of Medical Devices

Framework for Identification and Quantification of Potential Degradation Products

Standard Number: BS EN ISO 10993-9:2021

Pages: 24

Released: 2022-05-19

ISBN: 978 0 580 97078 8

Status: Standard

Overview

The BS EN ISO 10993-9:2021 standard is an essential document for professionals in the medical device industry. This standard provides a comprehensive framework for the identification and quantification of potential degradation products that may arise from medical devices. Ensuring the safety and efficacy of medical devices is paramount, and this standard plays a crucial role in achieving that goal.

Why This Standard is Important

Medical devices are subjected to various conditions during their lifecycle, which can lead to degradation. The degradation products can potentially pose risks to patients. The BS EN ISO 10993-9:2021 standard outlines the necessary procedures to identify and quantify these degradation products, ensuring that any potential risks are thoroughly evaluated and mitigated.

Key Features

• Comprehensive Framework: Provides a detailed methodology for identifying and quantifying degradation products.
• Safety Assurance: Helps in assessing the safety of medical devices by evaluating potential degradation products.
• Regulatory Compliance: Assists manufacturers in meeting regulatory requirements for medical device safety.
• Industry Standard: Recognized globally, ensuring consistency and reliability in the evaluation process.

Detailed Content

The standard spans 24 pages and covers various aspects of the biological evaluation of medical devices. It includes detailed guidelines on the following:

• Identification of potential degradation products
• Quantification methods for degradation products
• Risk assessment procedures
• Documentation and reporting requirements

Release Information

The BS EN ISO 10993-9:2021 standard was released on May 19, 2022. It is the latest version, reflecting the most current practices and methodologies in the field of medical device evaluation.

ISBN and Identification

This standard is identified by the ISBN number 978 0 580 97078 8. This unique identifier ensures that you are referencing the correct and most up-to-date version of the standard.

Who Should Use This Standard?

The BS EN ISO 10993-9:2021 standard is indispensable for a wide range of professionals, including:

• Medical device manufacturers
• Regulatory affairs specialists
• Quality assurance professionals
• Biomedical engineers
• Research and development teams

Benefits of Using This Standard

By adhering to the guidelines set forth in the BS EN ISO 10993-9:2021 standard, organizations can achieve several benefits:

• Enhanced Safety: Thorough evaluation of degradation products ensures that medical devices are safe for patient use.
• Regulatory Approval: Compliance with this standard facilitates smoother regulatory approval processes.
• Market Confidence: Demonstrating adherence to recognized standards builds trust with healthcare providers and patients.
• Risk Mitigation: Identifying and addressing potential risks early in the product lifecycle reduces the likelihood of adverse events.

Conclusion

The BS EN ISO 10993-9:2021 standard is a critical resource for ensuring the safety and effectiveness of medical devices. By providing a robust framework for the identification and quantification of potential degradation products, this standard helps manufacturers and regulatory bodies maintain high standards of patient safety and product quality. Whether you are involved in the design, manufacturing, or regulatory approval of medical devices, this standard is an invaluable tool in your professional toolkit.

BS EN ISO 10993-9:2021

This standard BS EN ISO 10993-9:2021 Biological evaluation of medical devices is classified in these ICS categories:

• 11.100.20 Biological evaluation of medical devices

This document provides general principles for the systematic evaluation of the potential and observed degradation of medical devices through the design and performance of in vitro degradation studies. Information obtained from these studies can be used in the biological evaluation described in the ISO 10993 series.

This document is applicable to both materials designed to degrade in the body as well as materials that are not intended to degrade.

This document is not applicable to:

1. the evaluation of degradation which occurs by purely mechanical processes; methodologies for the production of this type of degradation product are described in specific product standards, where available;

   NOTE

   Purely mechanical degradation causes mostly particulate matter. Although this is excluded from the scope of this document, such degradation products can evoke a biological response and can undergo biological evaluation as described in other parts of ISO 10993 .

2. leachable components which are not degradation products;

3. medical devices or components that do not contact the patient's body directly or indirectly.