BS EN ISO 18562-2:2024 - Biocompatibility Evaluation of Breathing Gas Pathways

Introducing the BS EN ISO 18562-2:2024, a pivotal standard in the realm of healthcare applications, specifically designed to ensure the safety and biocompatibility of breathing gas pathways. This standard is an essential resource for professionals in the healthcare industry, providing comprehensive guidelines for testing emissions of particulate matter, which is crucial for maintaining the highest standards of patient safety and care.

Overview of the Standard

The BS EN ISO 18562-2:2024 is part of a series of standards that focus on the biocompatibility evaluation of breathing gas pathways. This particular document addresses the critical aspect of particulate matter emissions, which can have significant implications for patient health if not properly managed. By adhering to this standard, healthcare providers can ensure that their equipment meets rigorous safety requirements, thereby safeguarding patients from potential harm.

Key Features

• Standard Number: BS EN ISO 18562-2:2024
• Pages: 30
• Released: 2024-10-25
• ISBN: 978 0 539 18656 7
• Status: Standard

Importance of Biocompatibility Evaluation

Biocompatibility evaluation is a critical component in the design and manufacturing of medical devices, particularly those involved in respiratory care. The presence of particulate matter in breathing gas pathways can lead to adverse health effects, including respiratory distress and other complications. The BS EN ISO 18562-2:2024 standard provides a structured approach to testing and evaluating these emissions, ensuring that medical devices are safe for patient use.

Who Should Use This Standard?

This standard is indispensable for:

• Medical device manufacturers who need to ensure their products meet international safety standards.
• Healthcare facilities that utilize respiratory equipment and need to maintain compliance with safety regulations.
• Regulatory bodies responsible for overseeing the safety and efficacy of medical devices.
• Quality assurance professionals tasked with implementing and maintaining safety protocols in healthcare settings.

Comprehensive Testing Guidelines

The BS EN ISO 18562-2:2024 standard outlines detailed testing procedures for assessing particulate matter emissions. These guidelines are designed to be thorough and precise, ensuring that all potential risks are identified and mitigated. By following these procedures, manufacturers and healthcare providers can demonstrate their commitment to patient safety and regulatory compliance.

Benefits of Compliance

Compliance with the BS EN ISO 18562-2:2024 standard offers numerous benefits, including:

• Enhanced Patient Safety: By minimizing the risk of exposure to harmful particulate matter, healthcare providers can significantly improve patient outcomes.
• Regulatory Compliance: Adhering to this standard ensures that medical devices meet international safety requirements, facilitating market access and acceptance.
• Reputation and Trust: Compliance demonstrates a commitment to quality and safety, enhancing the reputation of manufacturers and healthcare providers alike.
• Risk Management: Systematic testing and evaluation help identify potential risks early, allowing for timely interventions and corrective actions.

Conclusion

The BS EN ISO 18562-2:2024 standard is an essential tool for anyone involved in the design, manufacture, or use of medical devices that include breathing gas pathways. By providing a clear framework for testing particulate matter emissions, this standard helps ensure that medical devices are safe, effective, and compliant with international regulations. Embrace the highest standards of patient care and safety by integrating the guidelines of this crucial standard into your operations.

BS EN ISO 18562-2:2024

This standard BS EN ISO 18562-2:2024 Biocompatibility evaluation of breathing gas pathways in healthcare applications is classified in these ICS categories:

• 11.040.10 Anaesthetic, respiratory and reanimation equipment

This document specifies tests for the emissions of particulate matter from the gas pathways of a medical device, its parts or accessories, which are intended to provide respiratory care or supply substances via the respiratory tract to a patient in all environments. The tests of this document are intended to quantify particles from 0,25 µm diameter to 10 µm diameter that are emitted by the medical device, its parts or accessories into the respirable gas stream. This document establishes acceptance criteria for these tests. This document does not address nanoparticles. Insufficient data exist to establish exposure limits for particles less than 0,25 µm diameter. This document does not address particles larger than 10 µm diameter. These particles are deposited in the nasal cavity. Additional information can be needed for medical devices or accessories that bypass the nose. This is outside the scope of this document but can be required by some authorities having jurisdiction. This document therefore adopts the same approach as the US Environmental Protection Agency (EPA) in setting limits based solely on particle size and not their chemistry. This document addresses potential contamination of the gas stream arising from the gas pathways, which is then conducted to the patient. This document applies over the expected lifetime of the medical device in normal use and takes into account the effects of any intended processing. This document does not address biological evaluation of the particles that are deliberately released by a nebulizer (i.e. the therapeutic agent). This document does not address biological evaluation of the surfaces of gas pathways that have direct contact with the patient. The requirements for direct contact surfaces are found in the ISO 10993 series. Medical devices, parts or accessories, containing gas pathways that are addressed by this document, include, but are not limited to, ventilators, anaesthesia workstations (including gas mixers), breathing systems, oxygen conserving devices, oxygen concentrators, nebulizers, low-pressure hose assemblies, humidifiers, heat and moisture exchangers, respiratory gas monitors, respiration monitors, masks, medical respiratory personal protective equipment, mouth pieces, resuscitators, breathing tubes, breathing systems filters, Y-pieces, and any breathing accessories intended to be used with such devices. The enclosed chamber of an incubator, including the mattress, and the inner surface of an oxygen hood are considered to be gas pathways and are also addressed by this document. This document does not address contamination already present in the gas supplied from the gas sources while medical devices are in normal use. EXAMPLE            Contamination arriving at the medical device from gas sources such as medical gas pipeline systems (including the non-return valves in the pipeline outlets), outlets of pressure regulators connected or integral to a medical gas cylinder or room air taken into the medical device is not addressed by ISO 18562 (all parts).