BS EN ISO 18562-3:2024

Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications

Tests for Emissions of Volatile Organic Substances

The BS EN ISO 18562-3:2024 is a crucial standard for ensuring the safety and biocompatibility of breathing gas pathways in healthcare applications. Released on October 25, 2024, this standard provides comprehensive guidelines and testing methods to evaluate the emissions of volatile organic substances (VOCs) from medical devices that deliver breathing gases to patients.

With the increasing complexity and usage of medical devices in healthcare settings, ensuring the safety of these devices is paramount. The BS EN ISO 18562-3:2024 standard addresses this need by providing a structured approach to assess the potential risks associated with VOC emissions, which can have significant health implications if not properly managed.

Key Features of the Standard

• Standard Number: BS EN ISO 18562-3:2024
• Pages: 30
• Release Date: October 25, 2024
• ISBN: 978 0 539 18657 4
• Status: Standard

Importance of Biocompatibility Evaluation

Biocompatibility evaluation is a critical aspect of medical device development and usage. It ensures that the materials and components used in medical devices do not cause adverse effects when they come into contact with the human body. The BS EN ISO 18562-3:2024 standard specifically focuses on the pathways through which breathing gases are delivered, ensuring that these pathways do not emit harmful levels of VOCs.

Volatile organic substances can be emitted from various materials used in medical devices, including plastics, adhesives, and coatings. These emissions can lead to respiratory issues, allergic reactions, and other health problems if not adequately controlled. By adhering to the guidelines set forth in this standard, manufacturers can ensure that their products are safe for patient use.

Comprehensive Testing Methods

The BS EN ISO 18562-3:2024 standard outlines detailed testing methods to evaluate VOC emissions. These methods are designed to simulate real-world conditions, providing accurate and reliable data on the safety of breathing gas pathways. The standard covers various aspects of testing, including:

• Identification and quantification of VOCs emitted from medical devices.
• Assessment of the potential health risks associated with these emissions.
• Guidelines for acceptable levels of VOC emissions to ensure patient safety.

By following these testing methods, manufacturers can identify potential issues early in the development process, allowing for timely modifications and improvements to their products.

Benefits of Compliance

Compliance with the BS EN ISO 18562-3:2024 standard offers numerous benefits for manufacturers, healthcare providers, and patients alike. These benefits include:

• Enhanced Patient Safety: By ensuring that medical devices meet stringent safety standards, manufacturers can protect patients from potential health risks associated with VOC emissions.
• Regulatory Compliance: Adhering to this standard helps manufacturers meet regulatory requirements, facilitating market access and reducing the risk of product recalls.
• Improved Product Quality: The rigorous testing and evaluation processes outlined in the standard lead to higher quality products that perform reliably in healthcare settings.
• Increased Trust: Compliance with recognized standards enhances the reputation of manufacturers, fostering trust among healthcare providers and patients.

Conclusion

The BS EN ISO 18562-3:2024 standard is an essential tool for ensuring the safety and effectiveness of medical devices that deliver breathing gases. By providing comprehensive guidelines for evaluating VOC emissions, this standard helps manufacturers produce safe, reliable, and high-quality products that meet the needs of healthcare providers and patients.

Whether you are a manufacturer looking to ensure compliance with industry standards or a healthcare provider seeking to understand the safety of the devices you use, the BS EN ISO 18562-3:2024 standard is an invaluable resource. Its detailed testing methods and guidelines provide the assurance needed to deliver safe and effective healthcare solutions.

BS EN ISO 18562-3:2024

This standard BS EN ISO 18562-3:2024 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 volatile organic substances 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 emissions of volatile organic substances that are added to the respirable gas stream by the materials of the gas pathway. This document establishes acceptance criteria for these tests. NOTE            Gaseous emission of volatile organic substances includes emissions of volatile organic compounds, semi-volatile organic compounds and very volatile organic compounds. This document addresses potential contamination of the gas stream arising from the gas pathways of medical devices or accessories, 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 surfaces of gas pathways that are in 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 series. This document is intended to be read in conjunction with ISO 18562-1.