BS EN ISO 10993-2:2006 - Biological Evaluation of Medical Devices

The BS EN ISO 10993-2:2006 standard provides essential guidance for the biological evaluation of medical devices, particularly focusing on the testing of the effects of these devices on biological systems. Established to ensure the safe use of medical devices, this standard is crucial for manufacturers, regulatory bodies, and clinical professionals involved in the design, development, and assessment of medical equipment.

Overview

As a vital component in the broader framework of ISO 10993, BS EN ISO 10993-2:2006 specifically addresses the general requirements and methodologies for the biological evaluation process under the conditions of clinical use. This standard aids in identifying the necessary testing and assessments needed to evaluate the potential risks associated with medical devices and materials used in patient care.

Significant Features

• Identical to ISO 10993-2:2006: This British Standard is fully aligned with the international ISO 10993-2 standard, ensuring consistency and harmonization in the evaluation process on a global scale.
• Biocompatibility Testing: It provides a clear framework for determining biocompatibility through the use of various in vitro and in vivo testing protocols.
• Risk Management: Emphasizes the importance of continuous risk assessment and management throughout all phases of product development and post-market surveillance.
• Implementation Guidance: Offers practical guidance on how to implement the standard’s requirements effectively into existing quality management systems.

Who Should Use This Standard?

This document is vital for manufacturers of medical devices, including, but not limited to, those in the fields of implantable devices, diagnostic devices, and surgical instruments. Regulatory bodies and compliance professionals will find this standard essential in establishing the necessary benchmarks for safety and efficacy in medical devices.

Benefits of Compliance

By adhering to BS EN ISO 10993-2:2006, organizations can demonstrate their commitment to safety and effectiveness, facilitating regulatory approvals and providing a competitive advantage in the market. Additionally, compliance supports the mitigation of potential adverse effects, enhancing overall patient safety and confidence in medical technologies.

Purchase Information

The standard is available for purchase in both PDF and hardcopy formats at a price of £220.00. By integrating BS EN ISO 10993-2:2006 into your regulatory practices, you position your organization as a leader in the commitment to patient safety and quality health care technology.