BS EN ISO 14160:2021 - Key Standards for Medical Devices

The BS EN ISO 14160:2021 is a pivotal standard focusing on the requirements for the biocompatibility of materials utilized in manufacturing medical devices. This standard is essential for organizations involved in the development, production, and quality assurance of healthcare technology and medical equipment, ensuring that all materials adhere to high safety and performance standards.

Published on July 5, 2021, and identical to ISO 14160:2020, this standard outlines the test requirements and methodologies relevant to the evaluation of potential biological risks associated with various materials that come into contact with human tissues. This document serves as a crucial guideline for ensuring that medical devices do not compromise patient safety due to material toxicity or adverse biological reactions.

Key Features and Scope

BS EN ISO 14160:2021 encompasses a comprehensive framework that covers multiple areas of concern including:

• Material Selection: Guidance on the selection of materials appropriate for temporary and long-term use in medical devices.
• Biocompatibility Testing: Detailed testing protocols that manufacturers must follow to evaluate the safety profile of materials.
• Regulatory Compliance: Insights into compliance with relevant regulations, ensuring that manufacturers meet both national and international standards for medical devices.

Importance to Manufacturers

For manufacturers of medical technology, adherence to BS EN ISO 14160:2021 is not just a regulatory requirement; it is a commitment to patient safety and product efficacy. This standard aids in minimizing risks associated with material use in healthcare devices, ultimately contributing to better patient outcomes.

By integrating these standards into the product development life cycle, companies can enhance their marketability while assuring stakeholders of their commitment to quality. In today's healthcare environment, where patient safety is paramount, this standard provides the necessary benchmarks to help manufacturers maintain compliance and pursue continuous improvement in their processes.

Purchase Information

The document is available in both PDF and hardcopy formats. For organizations looking to invest in this critical standard, it is offered at a price of £430.00. Ensure that your organization is meeting the health technology requirements set forth in BS EN ISO 14160:2021, and reinforce your dedication to producing safe and reliable medical devices.