BS ISO 15471:2016 - Comprehensive Overview

BS ISO 15471:2016 is an essential British Standard that provides a framework for evaluating the performance of medical devices in contact with blood. This standard is crucial for manufacturers, regulatory bodies, and researchers in the field of medical technology and chemical safety.

Published on September 30, 2016, BS ISO 15471:2016 is a pivotal document adopted from the International Organization for Standardization (ISO). It sets forth the requirements for the assessment of biologically hazardous substances and their interaction with medical devices. This helps ensure that devices are safe for use and compliant with international safety regulations. As the landscape of medical technology continues to evolve, adherence to such standards becomes increasingly vital for maintaining the integrity and safety of healthcare solutions.

With an ISBN of 978 0 580 94111 5, the standard is accessible in both pdf and hardcopy formats, providing flexibility for organizations and professionals seeking to integrate this knowledge into their quality management systems and operational protocols. The investment in this standard, priced at £222.00, represents a significant step towards fostering innovation while adhering to rigorous safety standards.

This document specifically addresses the determination of specified hazardous substances, enabling manufacturers to adopt appropriate measures in the design and production of devices that minimize risk to patient health. Furthermore, it includes methodologies for evaluating toxicological effects, thus ensuring comprehensive risk assessments are conducted in alignment with international best practices.

BS ISO 15471:2016 is not merely a guideline; it is a framework that professionals in medical device manufacturing, regulatory affairs, and health safety must incorporate into their operations. By aligning with this standard, organizations can enhance their credibility, improve product development cycles, and ultimately ensure the delivery of safer medical technologies to healthcare providers and patients alike.

In summary, BS ISO 15471:2016 stands as a critical resource in the realm of chemical technology and medical device safety. It underscores the commitment to upholding the highest standards of public health safety and advancing the medical technology industry.