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>BSI Standards >11 HEALTH CARE TECHNOLOGY>11.040 Medical equipment>11.040.10 Anaesthetic, respiratory and reanimation equipment>BS EN ISO 80601-2-90:2026 Medical electrical equipment Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment
immediate downloadReleased: 2026-04-22
BS EN ISO 80601-2-90:2026 Medical electrical equipment Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment

BS EN ISO 80601-2-90:2026

Medical electrical equipment Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment

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Standard number:BS EN ISO 80601-2-90:2026
Pages:120
Released:2026-04-22
ISBN:978 0 539 27307 6
Status:Standard
DESCRIPTION

BS EN ISO 80601-2-90:2026


This standard BS EN ISO 80601-2-90:2026 Medical electrical equipment is classified in these ICS categories:
  • 11.040.10 Anaesthetic, respiratory and reanimation equipment
This document applies to the basic safety and essential performance of respiratory high-flow therapy equipment, as defined in ?2 01.3.262, hereafter also referred to as ME equipment or ME system, in combination with its accessories: intended for use with patients who can breathe spontaneously; and intended for patients who would benefit from improved alveolar gas exchange; and who would benefit from receiving high-flow humidified respiratory gases, which can include a patient whose upper airway is bypassed. EXAMPLE 1 Patients with Type 1 Respiratory Failure who exhibit a reduction in arterial blood oxygenation. EXAMPLE 2 Patients who would benefit from reduced work of breathing, as needed in Type 2 Respiratory Failure, where arterial carbon dioxide is high. EXAMPLE 3 Patients requiring humidification to improve mucociliary clearance. Respiratory high-flow therapy equipment is utilized in both professional healthcare facilities and the home healthcare environment. This standard specifically addresses respiratory high-flow therapy equipment for acute or infant care, predominantly found in hospitals. A separate document for long term high-flow therapy in the home healthcare environment is expected to be forthcoming. Respiratory high-flow therapy equipment can be: fully integrated ME equipment; or a combination of separate items forming a ME system. This document also applies to other types of respiratory equipment when that equipment includes a respiratory high-flow therapy mode. NOTE 2  This document and ISO 80601-2-12 are applicable to a critical care ventilator with a high-flow therapy mode. NOTE 3  This document and ISO 80601-2-72 are applicable to ventilator for ventilator-dependent patients in the home healthcare environment with a high-flow therapy mode. NOTE 4  This document and ISO 80601-2-13 are applicable to an anaesthetic workstation with a high-flow therapy mode. Respiratory high-flow therapy equipment can be transit-operable. This document is also applicable to those accessories intended by their manufacturer to be connected to the respiratory high-flow therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the respiratory high-flow therapy equipment. EXAMPLE 4         Breathing sets, connectors, humidifier, breathing system filter, external electrical power source, distributed alarm system, high-flow nasal cannula, tracheal tube, tracheostomy tube, face mask and supra-laryngeal airway. NOTE 5        Accessories are assessed with the relevant clauses of this document when configured as part of respiratory high-flow therapy equipment. If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in the general standard, 7.2.13 and 8.4.1. NOTE 6        Additional information can be found in the general standard, 4.2. This document does not specify the requirements for: ventilators or accessories for ventilator-dependent patients intended for critical care applications, which are given in ISO 80601?2?12; ventilators or accessories intended for anaesthet

BS EN ISO 80601-2-90:2026 - Elevate Your Respiratory High-Flow Therapy Equipment Standards

Introducing the BS EN ISO 80601-2-90:2026, a comprehensive standard that sets the benchmark for the basic safety and essential performance of respiratory high-flow therapy equipment. This standard is an indispensable resource for manufacturers, healthcare professionals, and regulatory bodies who are committed to ensuring the highest levels of safety and performance in medical electrical equipment.

Key Features of BS EN ISO 80601-2-90:2026

  • Standard Number: BS EN ISO 80601-2-90:2026
  • Pages: 120
  • Release Date: April 22, 2026
  • ISBN: 978 0 539 27307 6
  • Status: Standard

This standard is meticulously crafted to address the specific requirements for respiratory high-flow therapy equipment, ensuring that these devices meet the rigorous demands of modern healthcare environments. With its release in 2026, it reflects the latest advancements and best practices in the field, making it a crucial tool for anyone involved in the design, production, or regulation of these medical devices.

Why Choose BS EN ISO 80601-2-90:2026?

The BS EN ISO 80601-2-90:2026 standard is not just a document; it is a commitment to excellence in patient care and safety. Here’s why it stands out:

Comprehensive Coverage

Spanning 120 pages, this standard provides an exhaustive overview of the requirements for respiratory high-flow therapy equipment. It covers everything from design and construction to performance and safety, ensuring that no aspect is overlooked.

Up-to-Date Guidelines

Released on April 22, 2026, this standard incorporates the latest technological advancements and regulatory requirements. It is designed to keep pace with the rapidly evolving landscape of medical technology, ensuring that your equipment remains compliant and competitive.

Global Recognition

As part of the internationally recognized ISO standards, BS EN ISO 80601-2-90:2026 is accepted and respected worldwide. This global recognition facilitates international trade and ensures that your products meet the expectations of healthcare providers and patients across the globe.

Enhanced Safety and Performance

At its core, this standard is about enhancing the safety and performance of respiratory high-flow therapy equipment. By adhering to its guidelines, manufacturers can ensure that their products deliver reliable and effective therapy, minimizing risks and improving patient outcomes.

Who Should Use This Standard?

The BS EN ISO 80601-2-90:2026 standard is essential for a wide range of stakeholders in the healthcare and medical device industries, including:

  • Manufacturers: Ensure your products meet the highest safety and performance standards.
  • Healthcare Providers: Gain confidence in the equipment you use to deliver critical respiratory therapy.
  • Regulatory Bodies: Utilize a trusted benchmark for evaluating and approving medical devices.
  • Quality Assurance Professionals: Implement robust quality control measures based on internationally recognized standards.

Conclusion

The BS EN ISO 80601-2-90:2026 standard is more than just a set of guidelines; it is a vital tool for ensuring the safety, efficacy, and reliability of respiratory high-flow therapy equipment. By adopting this standard, you are not only complying with international regulations but also committing to the highest standards of patient care and safety.

Stay ahead in the competitive field of medical technology by integrating the BS EN ISO 80601-2-90:2026 standard into your operations. Elevate your products and services to new heights of excellence and ensure that you are delivering the best possible outcomes for patients worldwide.

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