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Homepage>BS Standards>11 HEALTH CARE TECHNOLOGY>11.040 Medical equipment>11.040.10 Anaesthetic, respiratory and reanimation equipment>BS EN ISO 18562-4:2024 Biocompatibility evaluation of breathing gas pathways in healthcare applications Tests for leachables in condensate
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BS EN ISO 18562-4:2024 Biocompatibility evaluation of breathing gas pathways in healthcare applications Tests for leachables in condensate

BS EN ISO 18562-4:2024

Biocompatibility evaluation of breathing gas pathways in healthcare applications Tests for leachables in condensate

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Standard number:BS EN ISO 18562-4:2024
Pages:32
Released:2024-11-01
ISBN:978 0 539 17697 1
Status:Standard
BS EN ISO 18562-4:2024 - Biocompatibility Evaluation of Breathing Gas Pathways

BS EN ISO 18562-4:2024 - Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications

Introducing the BS EN ISO 18562-4:2024, a pivotal standard that sets the benchmark for the biocompatibility evaluation of breathing gas pathways in healthcare applications. This comprehensive document is essential for ensuring the safety and efficacy of medical devices that involve the delivery of breathing gases to patients. Released on October 25, 2024, this standard is a must-have for manufacturers, healthcare professionals, and regulatory bodies involved in the design, production, and assessment of medical devices.

Key Features of BS EN ISO 18562-4:2024

This standard, identified by the Standard Number: BS EN ISO 18562-4:2024, provides detailed guidelines and methodologies for testing leachables in condensate, which are critical for maintaining the biocompatibility of breathing gas pathways. With a total of 32 pages, this document offers a thorough exploration of the necessary tests and evaluations required to ensure that medical devices meet the highest safety standards.

Why Biocompatibility Evaluation is Crucial

Biocompatibility evaluation is a fundamental aspect of medical device development, particularly for devices that come into contact with patients' respiratory systems. The presence of leachables in condensate can pose significant health risks, including allergic reactions, toxicity, and other adverse effects. Therefore, adhering to the guidelines set forth in BS EN ISO 18562-4:2024 is essential for minimizing these risks and ensuring patient safety.

Comprehensive Testing for Leachables

The standard outlines specific tests designed to identify and quantify leachables in condensate. These tests are crucial for determining the potential impact of these substances on patient health. By following the procedures detailed in this standard, manufacturers can ensure that their products are free from harmful leachables, thereby enhancing the overall safety and reliability of their medical devices.

Who Should Use This Standard?

The BS EN ISO 18562-4:2024 is an invaluable resource for a wide range of stakeholders in the healthcare industry, including:

  • Medical Device Manufacturers: To ensure their products comply with international safety standards and regulations.
  • Healthcare Professionals: To understand the safety measures and evaluations involved in the devices they use.
  • Regulatory Bodies: To assess and approve medical devices for market entry based on rigorous safety criteria.
  • Research and Development Teams: To guide the design and testing of new medical devices.

ISBN and Accessibility

The standard is easily accessible and can be identified using the ISBN: 978 0 539 17697 1. This unique identifier ensures that you are obtaining the correct and most up-to-date version of the document, which is crucial for maintaining compliance with current industry standards.

Stay Ahead with the Latest Standards

In the rapidly evolving field of healthcare technology, staying informed about the latest standards is essential for maintaining a competitive edge. The BS EN ISO 18562-4:2024 provides the latest insights and methodologies for ensuring the biocompatibility of breathing gas pathways, making it an indispensable tool for anyone involved in the development and regulation of medical devices.

Conclusion

In conclusion, the BS EN ISO 18562-4:2024 is a critical standard for ensuring the safety and effectiveness of medical devices that deliver breathing gases. By providing detailed guidelines for testing leachables in condensate, this document helps manufacturers and healthcare professionals protect patient health and comply with international safety standards. Whether you are a manufacturer, healthcare provider, or regulatory authority, this standard is an essential resource for ensuring the highest levels of safety and quality in medical device development.

DESCRIPTION

BS EN ISO 18562-4:2024


This standard BS EN ISO 18562-4:2024 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 substances leached by liquid water condensing in 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 chemical characterization methods described in this document apply to chemical substances that could leach from the medical device, its parts or accessories into the condensate. This document establishes verifiable acceptance criteria for these tests. The identity and quantity of each chemical released is intended for toxicological risk assessment as described in ISO 18562-1:2024. This document addresses potential contamination of the gas stream arising from the gas pathways, which deliver breathing gas 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 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. This document does not address contact with drugs or anaesthetic agents. If a medical device or accessory is intended to be used with anaesthetic agents or drugs, then additional testing can be required. This document is intended to quantify hazardous water-soluble substances that are leached from the medical device, its parts or accessories by condensate and then conveyed by that liquid to the patient.