BS EN ISO 10993-12:2021 - Biological Evaluation of Medical Devices

In the ever-evolving world of medical technology, ensuring the safety and efficacy of medical devices is paramount. The BS EN ISO 10993-12:2021 standard is a crucial component in the biological evaluation of medical devices, focusing on sample preparation and reference materials. This standard is an essential tool for manufacturers, researchers, and regulatory bodies involved in the development and assessment of medical devices.

Overview of BS EN ISO 10993-12:2021

The BS EN ISO 10993-12:2021 standard provides comprehensive guidelines for the preparation of samples and the selection of reference materials used in the biological evaluation of medical devices. Released on June 21, 2021, this standard is part of the ISO 10993 series, which is dedicated to the biological evaluation of medical devices. It plays a critical role in ensuring that medical devices are safe for human use by providing standardized methods for testing and evaluation.

Key Features

• Standard Number: BS EN ISO 10993-12:2021
• Pages: 34
• ISBN: 978 0 539 00751 0
• Status: Standard

Importance of Sample Preparation and Reference Materials

Sample preparation and the use of reference materials are critical steps in the biological evaluation process. Proper sample preparation ensures that the test results are accurate and reliable, while reference materials provide a benchmark for comparison. The BS EN ISO 10993-12:2021 standard outlines the procedures and criteria for these processes, ensuring consistency and reliability in the evaluation of medical devices.

Why Choose BS EN ISO 10993-12:2021?

Adhering to the BS EN ISO 10993-12:2021 standard offers numerous benefits for manufacturers and researchers:

• Compliance: Ensures compliance with international regulations and standards, facilitating market access and acceptance.
• Quality Assurance: Provides a framework for consistent and reliable testing, enhancing the quality and safety of medical devices.
• Risk Management: Helps identify potential biological risks associated with medical devices, allowing for proactive risk management.
• Innovation Support: Supports innovation by providing clear guidelines for the evaluation of new materials and technologies.

Who Should Use This Standard?

The BS EN ISO 10993-12:2021 standard is designed for a wide range of stakeholders in the medical device industry, including:

• Manufacturers: To ensure their products meet safety and regulatory requirements.
• Researchers: To conduct accurate and reliable biological evaluations.
• Regulatory Bodies: To assess compliance with international standards.
• Quality Assurance Professionals: To implement effective quality control measures.

Detailed Content of the Standard

The BS EN ISO 10993-12:2021 standard is a comprehensive document spanning 34 pages. It covers various aspects of sample preparation and reference materials, including:

• Preparation Techniques: Detailed procedures for preparing samples for biological evaluation.
• Selection Criteria: Guidelines for selecting appropriate reference materials.
• Testing Protocols: Standardized methods for conducting biological tests.
• Data Interpretation: Criteria for analyzing and interpreting test results.

Conclusion

The BS EN ISO 10993-12:2021 standard is an indispensable resource for anyone involved in the biological evaluation of medical devices. By providing clear and standardized guidelines for sample preparation and reference materials, it ensures the safety, efficacy, and quality of medical devices. Whether you are a manufacturer, researcher, or regulatory body, this standard is essential for ensuring compliance and maintaining the highest standards of safety and quality in the medical device industry.

BS EN ISO 10993-12:2021

This standard BS EN ISO 10993-12:2021 Biological evaluation of medical devices is classified in these ICS categories:

• 11.100.20 Biological evaluation of medical devices

This document specifies requirements and gives guidance on the procedures in the preparation of samples and the selection of reference materials for medical device testing primarily in biological test systems primarily in accordance with one or more parts of the ISO 10993 series.

Specifically, this document addresses the following:

• test sample selection;

• selection of representative portions from a medical device;

• test sample preparation;

• experimental controls;

• selection of, and requirements for, reference materials;

• preparation of extracts.

This document is not applicable to live cells but can be relevant to the material or medical device components of combination products containing live cells.

Extractions for chemical characterization are covered in ISO 10993-18. Clause 7, 8, 9, 10 [with the exception of 10.3.5 and 10.3.11 b)], and 11 can apply to extractions for chemical characterization. Information given in C.1 to C.4 can also be relevant.