BS EN ISO 80601-2-79:2024 - Medical Electrical Equipment Standard

Standard Number: BS EN ISO 80601-2-79:2024

Pages: 118

Released: 2024-09-06

ISBN: 978 0 539 18674 1

Name: Medical electrical equipment Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment

Status: Standard

Overview

The BS EN ISO 80601-2-79:2024 standard is a comprehensive guideline that sets forth the particular requirements for the basic safety and essential performance of ventilatory support equipment designed for ventilatory impairment. This standard is crucial for manufacturers, healthcare providers, and regulatory bodies to ensure that ventilatory support equipment meets the highest safety and performance criteria.

Key Features

• Comprehensive Coverage: Spanning 118 pages, this standard provides an in-depth look at the requirements for ventilatory support equipment, ensuring no detail is overlooked.
• Latest Release: Released on September 6, 2024, this standard incorporates the most recent advancements and updates in the field of medical electrical equipment.
• Global Recognition: As an ISO standard, it is recognized and respected worldwide, making it a critical document for international compliance and interoperability.
• ISBN: 978 0 539 18674 1, ensuring easy reference and cataloging in libraries and databases.

Importance of Compliance

Compliance with the BS EN ISO 80601-2-79:2024 standard is essential for several reasons:

• Patient Safety: Ensures that ventilatory support equipment is safe for use, minimizing the risk of harm to patients.
• Regulatory Approval: Facilitates the approval process with regulatory bodies, as adherence to this standard is often a prerequisite for market entry.
• Quality Assurance: Provides a benchmark for quality, helping manufacturers maintain high standards in their production processes.
• Market Competitiveness: Enhances the credibility and marketability of products, as compliance with ISO standards is a mark of quality and reliability.

Who Should Use This Standard?

This standard is indispensable for a wide range of stakeholders in the medical field, including:

• Manufacturers: To design and produce ventilatory support equipment that meets international safety and performance standards.
• Healthcare Providers: To ensure the equipment they use meets the highest safety and performance criteria, thereby providing the best care for their patients.
• Regulatory Bodies: To evaluate and approve ventilatory support equipment for market entry and use.
• Quality Assurance Professionals: To implement and maintain quality control processes that align with international standards.

Detailed Content

The BS EN ISO 80601-2-79:2024 standard covers a wide range of topics, including but not limited to:

• General Requirements: Basic safety and essential performance criteria for ventilatory support equipment.
• Testing and Validation: Procedures for testing and validating the performance and safety of the equipment.
• Risk Management: Guidelines for identifying and mitigating risks associated with the use of ventilatory support equipment.
• Labeling and Documentation: Requirements for labeling, instructions for use, and other documentation to ensure proper usage and maintenance.
• Electrical Safety: Specific requirements for the electrical safety of ventilatory support equipment.
• Performance Criteria: Detailed performance criteria to ensure the equipment functions as intended under various conditions.

Why Choose BS EN ISO 80601-2-79:2024?

Choosing the BS EN ISO 80601-2-79:2024 standard offers numerous benefits:

• Up-to-Date Information: Stay current with the latest advancements and regulatory requirements in the field of ventilatory support equipment.
• Global Acceptance: As an ISO standard, it is accepted and respected worldwide, facilitating international trade and compliance.
• Comprehensive Guidance: Provides detailed guidance on all aspects of safety and performance, ensuring no critical area is overlooked.
• Enhanced Credibility: Compliance with this standard enhances the credibility and reliability of your products, making them more attractive to customers and regulatory bodies.

Conclusion

The BS EN ISO 80601-2-79:2024 standard is an essential document for anyone involved in the design, production, regulation, or use of ventilatory support equipment. By adhering to this standard, you can ensure that your equipment meets the highest safety and performance criteria, providing peace of mind to both healthcare providers and patients. With its comprehensive coverage, up-to-date information, and global recognition, this standard is a valuable resource for achieving excellence in the field of medical electrical equipment.

BS EN ISO 80601-2-79:2024

This standard BS EN ISO 80601-2-79:2024 Medical electrical equipment is classified in these ICS categories:

• 11.040.10 Anaesthetic, respiratory and reanimation equipment
• 11.040.10 Anaesthetic, respiratory and reanimation equipment

NOTE 1       There is guidance or rationale for this subclause contained in Clause AA.2. This document applies to the basic safety and essential performance of ventilatory support equipment, as defined in 201.3.302, for ventilatory impairment, as defined in 201.3.300, hereafter also referred to as ME equipment, in combination with its accessories: —    intended for use in the home healthcare environment; NOTE 2       In the home healthcare environment, the supply mains driving the ventilatory support equipment is often not reliable. NOTE 3       Such ventilatory support equipment can also be used in professional health care facilities. —    intended for use by a lay operator; —    intended for use with patients who have ventilatory impairment, the most fragile of these patients, would not likely experience injury with the loss of this artificial ventilation; and —    not intended for patients who are dependent on artificial ventilation for their immediate life support. EXAMPLE 1        Patients with mild to moderate chronic obstructive pulmonary disease (COPD). Ventilatory support equipment is not considered to use a physiologic closed-loop control system unless it uses a physiological patient variable to adjust the artificial ventilation therapy settings. This document is also applicable to those accessories intended by their manufacturer to be connected to the breathing system of ventilatory support equipment for ventilatory impairment, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilatory support equipment for ventilatory impairment. EXAMPLE 2        Breathing sets, connectors, water traps, expiratory valve, humidifier, breathing system filter, external electrical power source, distributed alarm system. 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 IEC 60601?1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1. NOTE 4       Additional information can be found in IEC 60601?1:2005+AMD1:2012+AMD2:2020, 4.2. NOTE 5       See ISO/TR 21954 for guidance on the selection of the appropriate ventilator for a given patient.  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 insufficiency, which are given in ISO 80601?2?80; —    sleep apnoea therapy ME equipment, which are given in ISO 80601?2?70; —    high-frequency jet ventilators (HFJVs), which are given in ISO 80601?2?87; —    high-frequency oscillatory ventilators (HFOVs); —    respiratory high flow equipment, which are given in