BS EN ISO 18562-1:2024 - Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications

The BS EN ISO 18562-1:2024 is a pivotal standard that provides comprehensive guidelines for the biocompatibility evaluation of breathing gas pathways in healthcare applications. Released on October 25, 2024, this standard is an essential resource for professionals involved in the design, testing, and risk management of medical devices that involve breathing gas pathways.

Overview of the Standard

This standard, identified by the number BS EN ISO 18562-1:2024, is a critical document that outlines the necessary procedures and considerations for evaluating the biocompatibility of materials and components that come into contact with breathing gases. It is designed to ensure that these materials do not pose any harm to patients or healthcare providers during their use.

Key Features

• Comprehensive Evaluation: The standard provides a detailed framework for assessing the biocompatibility of breathing gas pathways, ensuring that all potential risks are identified and mitigated.
• Risk Management Process: It integrates evaluation and testing within a robust risk management process, aligning with international best practices for medical device safety.
• 52 Pages of In-Depth Guidance: With 52 pages of detailed instructions and guidelines, this standard is a thorough resource for healthcare professionals and manufacturers.
• ISBN: 978 0 539 18655 0

Importance in Healthcare Applications

In healthcare settings, the safety and efficacy of medical devices are paramount. The BS EN ISO 18562-1:2024 standard plays a crucial role in ensuring that devices involving breathing gas pathways are safe for use. This is particularly important in environments where patients rely on these devices for life-sustaining functions.

The standard addresses various aspects of biocompatibility, including the potential for chemical leaching, particulate contamination, and other factors that could compromise patient safety. By adhering to the guidelines set forth in this standard, manufacturers can ensure that their products meet the highest safety standards.

Who Should Use This Standard?

This standard is indispensable for a wide range of professionals, including:

• Medical Device Manufacturers: To ensure that their products comply with international safety standards.
• Quality Assurance Teams: For implementing rigorous testing and evaluation processes.
• Regulatory Affairs Specialists: To understand and apply the necessary compliance requirements.
• Healthcare Providers: To ensure the safety and effectiveness of the devices they use.

Integration with Risk Management

The BS EN ISO 18562-1:2024 standard emphasizes the integration of biocompatibility evaluation within a risk management framework. This approach ensures that all potential risks are systematically identified, assessed, and controlled throughout the product lifecycle. By doing so, it aligns with the broader objectives of ISO 14971, the international standard for risk management of medical devices.

Risk management is a continuous process that involves:

• Risk Analysis: Identifying potential hazards associated with breathing gas pathways.
• Risk Evaluation: Assessing the likelihood and severity of these risks.
• Risk Control: Implementing measures to mitigate identified risks.
• Monitoring and Review: Continuously monitoring the effectiveness of risk control measures and making necessary adjustments.

Conclusion

The BS EN ISO 18562-1:2024 standard is an essential tool for ensuring the safety and biocompatibility of breathing gas pathways in healthcare applications. By providing a comprehensive framework for evaluation and testing within a risk management process, it helps manufacturers and healthcare providers deliver safe and effective medical devices.

With its detailed guidelines and integration with risk management practices, this standard is a valuable resource for anyone involved in the design, production, and use of medical devices that involve breathing gas pathways. By adhering to its principles, stakeholders can ensure that their products meet the highest standards of safety and quality, ultimately protecting patient health and well-being.

BS EN ISO 18562-1:2024

This standard BS EN ISO 18562-1:2024 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: —     the general principles governing the biological evaluation within a risk management process of 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 general categorization of gas pathways based on the nature and duration of their contact with the gas stream; —     the evaluation of existing relevant data from all sources; —     the identification of gaps in the available data set on the basis of a risk analysis; —     the identification of additional data sets necessary to analyse the biological safety of the gas pathway; —      the assessment of the biological safety of the gas pathway. This document covers general principles regarding biocompatibility assessment of medical device materials, which make up the gas pathway, in normal use and normal condition. This document does not cover biological hazards arising from mechanical damage. The other parts of ISO 18562 cover specific tests that address potentially hazardous substances that are added to the respirable gas stream and establish acceptance criteria for these substances. This document addresses potential contamination of the gas stream arising from the gas pathways within the medical device, which might then be conducted to the patient. This document applies over the expected lifetime of the medical device when operated according to the instructions for use. This includes degradation arising from exposure to environmental conditions as well as cleaning, disinfection and sterilisation (i.e. processing). It also includes user action or inaction (omission) that leads to an unintended or unexpected outcome (result) (i.e. use error). It does not include conscious/intentional action or inaction that violates the instructions for use and is beyond reasonable risk control by the manufacturer (i.e. abnormal use). This document does not address biological evaluation of the surfaces of medical devices that have direct contact with the patient or user. 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 equipment, 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 system filters and Y-pieces as well as any breathing accessories intended to be used with such medical 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).