BS EN ISO 80601-2-90:2021 - Medical Electrical Equipment Standard

Ensure the highest level of safety and performance for your respiratory high-flow therapy equipment with the BS EN ISO 80601-2-90:2021 standard. This comprehensive document provides detailed requirements and guidelines to guarantee that your medical electrical equipment meets the essential criteria for basic safety and optimal performance.

Key Features and Benefits

• Standard Number: BS EN ISO 80601-2-90:2021
• Pages: 100
• Released: 2021-10-06
• ISBN: 978 0 539 14630 1
• Name: Medical electrical equipment Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment
• Status: Standard

Comprehensive Coverage

This standard spans 100 pages, meticulously detailing the specific requirements for respiratory high-flow therapy equipment. Released on October 6, 2021, it reflects the latest advancements and regulatory expectations in the field of medical electrical equipment. The document is an indispensable resource for manufacturers, healthcare providers, and regulatory bodies, ensuring that all equipment adheres to the highest standards of safety and performance.

Why Choose BS EN ISO 80601-2-90:2021?

Adopting the BS EN ISO 80601-2-90:2021 standard offers numerous advantages:

• Enhanced Safety: The standard outlines critical safety requirements, minimizing risks associated with the use of respiratory high-flow therapy equipment.
• Optimal Performance: Detailed performance criteria ensure that the equipment operates efficiently and effectively, providing the best possible care for patients.
• Regulatory Compliance: Compliance with this standard helps manufacturers meet regulatory requirements, facilitating market access and acceptance.
• Quality Assurance: The standard serves as a benchmark for quality, guiding manufacturers in the design, production, and testing of their equipment.

Who Should Use This Standard?

The BS EN ISO 80601-2-90:2021 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: Select equipment that complies with the latest safety and performance guidelines.
• Regulatory Bodies: Reference the standard to evaluate and approve respiratory high-flow therapy equipment.
• Quality Assurance Professionals: Use the standard to develop and implement robust quality control processes.

Detailed Requirements

The BS EN ISO 80601-2-90:2021 standard provides in-depth requirements covering various aspects of respiratory high-flow therapy equipment, including:

• Electrical Safety: Guidelines to prevent electrical hazards and ensure safe operation.
• Mechanical Safety: Requirements to avoid mechanical failures and ensure structural integrity.
• Performance Testing: Criteria for evaluating the performance and reliability of the equipment.
• Usability: Standards to enhance user interface and ease of use for healthcare professionals.
• Maintenance and Servicing: Recommendations for regular maintenance and servicing to ensure long-term reliability.

Stay Ahead with the Latest Standards

In the rapidly evolving field of medical technology, staying updated with the latest standards is crucial. The BS EN ISO 80601-2-90:2021 standard represents the cutting edge of safety and performance requirements for respiratory high-flow therapy equipment. By adhering to this standard, you demonstrate a commitment to excellence and patient safety, positioning your products and services at the forefront of the industry.

Conclusion

The BS EN ISO 80601-2-90:2021 standard is an essential resource for anyone involved in the design, manufacture, regulation, or use of respiratory high-flow therapy equipment. With its comprehensive guidelines and detailed requirements, this standard ensures that your equipment meets the highest levels of safety and performance, providing peace of mind for both healthcare providers and patients.

Invest in the BS EN ISO 80601-2-90:2021 standard today and take a significant step towards ensuring the safety, performance, and reliability of your respiratory high-flow therapy equipment.

BS EN ISO 80601-2-90:2021

This standard BS EN ISO 80601-2-90:2021 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 ventilatory high-flow therapy equipment, as defined in 201.3.204, hereafter also referred to as ME equipment, in combination with its accessories: - intended for use in the home healthcare environment; - intended for use in professional healthcare facilities; - intended for use by a lay operator or a healthcare professional operator; - intended for use with patients who can breathe spontaneously; - intended for patients who would benefit from improved alveolar gas exchange; and who would benefit from receiving high-flow humidified respiratory gases, including a patient whose upper airway is bypassed; and EXAMPLE 1 Patients with Type 1 Respiratory Failure, which exhibits a reduction in arterial blood oxygenation or patients who would benefit from reduced work of breathing, as needed in Type 2 Respiratory Failure, where arterial carbon dioxide is high. - not intended for patients who are dependent on artificial ventilation for their life support. NOTE 1 In the home healthcare environment, the supply mains is often not reliable. Ventilatory high-flow therapy equipment is typically composed of four parts: 1) gas sources, - air, and - if needed, oxygen; NOTE 2 Gas sources include medical gas pipeline systems, gas cylinders, oxygen concentrators and ambient air. 2) humidifier; NOTE 3 When dry gas is utilized, a humidifier is typically needed. 3) breathing tube; 4) a patient interface, which is used to deliver gas to the patient; and 5) a flow controller, which is used to select and deliver the desired flow. NOTE 4 The flow controller can be at a fixed rate. NOTE 5 The flowrate range is dependent upon the intended patient population (e.g., neonatal, paediatric and adult patients can require different flowrates). These parts can be combined (e.g., the gas source and humidifier can be combined). Ventilatory highflow therapy equipment interfaces with the patient whose upper airway is intact via a nasal cannula or mask as well as a patient whose upper airway is bypassed via an endotracheal tube, oropharyngeal mask, or tracheostomy. Ventilatory 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 ventilatory high-flow therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilatory high-flow therapy equipment. EXAMPLE 2 Breathing sets, connectors, water traps, expiratory valve, humidifier, breathing system filter, external electrical power source, distributed alarm system. 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 anaesthetic applications, which are given in ISO 80601 2 13; - ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601 2 84; - ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601 2 72; - ventilatory support equipment or accessories intended for ventilatory impairment, which are given in ISO 80601 2 79; - ventilatory support equipment or accessories intended for ventilatory insufficiency, which are given in ISO 80601 2 80; - sleep apnoea therapy ME equipment, which are given in ISO 80601 2 70; - continuous positive airway pressure (CPAP) ME equipment; - high-frequency jet ventilators (HFJVs); - high-frequency oscillatory ventilators (HFOVs), which are given in ISO 80601 2 87; and - cuirass or "iron-lung" ventilation equipment. NOTE 4 Ventilatory high-flow therapy equipment can be incorporated into any of the above equipment, in which case those standards would be applicable for those ventilation-modes. This docum.....