BS EN ISO 10993-16:2017 - Health Care Technology

The BS EN ISO 10993-16:2017 standard provides essential guidelines for the assessment of biological risks associated with medical devices. As a pivotal part of the ISO 10993 family, this standard focuses specifically on the evaluation of the effects of chemicals leaching from medical devices, ensuring that they achieve the required safety levels for patient use.

Developed to facilitate the safe introduction of new medical technologies into healthcare systems, this standard recognizes the complexities surrounding human exposure to medical device materials. The BS EN ISO 10993-16:2017 standard provides a rigorous framework for identifying and testing the potential adverse effects caused by harmful substances that may migrate from medical products into the human body.

With a publication date of January 9, 2018, the standard is intended for manufacturers, regulatory bodies, and healthcare professionals involved in the design, development, and assessment of medical devices. By adhering to the guidelines set forth in this document, manufacturers can ensure that their products meet both safety and performance requirements and remain compliant with regulatory mandates.

This standard is particularly pertinent given the increasing scrutiny of medical devices by regulatory agencies. Not only does it enhance the safety and efficacy of these products, but it also fortifies manufacturers’ reputations and minimizes liability risks associated with device failures and adverse events.

The document serves as a comprehensive resource, detailing test methods, evaluation procedures, and data interpretation techniques relevant to chemical leachables. It also addresses the need for thorough analytical methodologies to quantify and assess the potential risks posed by these leachables, thereby ensuring a systematic and informed approach to biological safety evaluation.

A key feature of the BS EN ISO 10993-16:2017 is its emphasis on harmonization with international standards, allowing for a streamlined approach to product development that can benefit companies operating in a global market. This alignment aids in expediting the approval process across different jurisdictions, allowing for quicker access to the marketplace for those medical devices conforming to these safety standards.

Priced at £220.00, the BS EN ISO 10993-16:2017 is an invaluable investment for any organization involved in health care technology. With the ever-evolving landscape of medical device regulations, ensuring compliance with this standard is not just about regulatory adherence; it is a commitment to patient safety and device integrity.

Ensure your products meet the highest safety standards and contribute to innovative healthcare solutions by securing your copy of the BS EN ISO 10993-16:2017 today. Available in both PDF and hardcopy formats, this essential document will support your organization’s commitment to excellence in health care technology.