BS ISO 10936-1:2017 - Healthcare Technology Standard

The BS ISO 10936-1:2017 standard provides essential guidelines for the performance evaluation of medical devices intended for respiratory use. Aimed at healthcare technology professionals, this document outlines the test methods necessary for determining the efficiency of respiratory support equipment. The standard emphasizes the importance of ensuring that such devices function adequately under clinical conditions, safeguarding patient wellbeing while optimizing therapeutic outcomes.

This standard serves as an identical adoption of the ISO 10936-1:2017, which was published on September 19, 2017. Consequently, compliance with this standard assures stakeholders of a consistent framework that adheres to international best practices.

Health care technology is rapidly evolving, and the need for verified safety and performance metrics has never been more critical. BS ISO 10936-1:2017 stipulates rigorous testing protocols that manufacturers must follow to assess respiratory medical devices. It includes clear definitions of parameters such as device leakage, inspiratory and expiratory resistance, and flow performance, which are crucial for delivering effective respiratory therapy.

The implications of this standard extend to various stakeholders—including manufacturers, regulators, and healthcare providers—who rely on these evaluative methods to ensure high-quality patient care. By adhering to BS ISO 10936-1:2017, manufacturers can enhance their credibility in the market, providing clinicians with the assurance that the respiratory devices they employ meet stringent performance criteria.

For those seeking to comply with or implement this standard, comprehensive documentation is available in two formats: PDF and hardcopy. This publication not only enriches the repository of healthcare technology standards but also reaffirms the commitment of stakeholders to uphold regulatory compliance, ethical responsibility, and operational excellence in the healthcare sector.

The price for BS ISO 10936-1:2017 is set at £188.00, representing a valuable investment in the quality assurance processes of medical respiratory devices. By adopting this standard, organizations can effectively navigate the complexities of medical device regulations while facilitating superior patient outcomes.