BS EN ISO 18562-2:2020

Overview of BS EN ISO 18562-2:2020

The BS EN ISO 18562-2:2020 standard is a crucial document within the field of health care technology, specifically focusing on the assessment of biocompatibility for the components of medical devices that come in contact with the respiratory system. An integral part of the ISO 18562 series, this standard outlines the requirements and methodologies for measuring and evaluating the potential risks associated with emissions from breathing gas pathways in medical devices.

Purpose and Importance

This standard aims to ensure the safety and efficacy of medical devices intended for ventilatory support, anesthesia, and other respiratory functions. As innovations in health care technology continue to progress, the importance of a structured approach to assessing biocompatibility and safety cannot be overstated. BS EN ISO 18562-2:2020 plays a pivotal role in establishing a common framework that manufacturers, regulatory bodies, and practitioners can rely on, fostering a safer environment for patients.

Key Features

• Identical Nature to ISO 18562-2:2017: BS EN ISO 18562-2:2020 mirrors the international standard ISO 18562-2:2017, ensuring global consistency in the evaluation of respiratory medical devices.
• Comprehensive Testing Methods: The standard provides detailed guidelines on the testing for chemical emissions from medical device materials, facilitating accurate risk assessments.
• Risk Management Focus: By identifying and quantifying potential emissions that could affect patients, the standard promotes effective risk management strategies throughout the medical device lifecycle.
• Enforcement of Quality Control: The standard sets forth rigorous quality control measures that bolster the reliability and safety of respiratory devices, boosting confidence among users and stakeholders alike.

Application

Manufacturers of medical devices, particularly those that interface with the respiratory system, will find BS EN ISO 18562-2:2020 invaluable. Compliance with this standard not only enhances product safety but also streamlines the regulatory approval process in various global markets. Additionally, healthcare providers benefit from standardized benchmarks that ensure their equipment is safe for patient use, ultimately leading to improved health outcomes.

Purchase and Access

The BS EN ISO 18562-2:2020 standard is available for purchase at £220.00, and is offered in both PDF and hardcopy formats for your convenience. This document provides a robust reference for anyone involved in the design, manufacturing, and evaluation of medical devices for the respiratory system.