BS EN ISO 80601-2-79:2024
Medical electrical equipment Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment
Standard number: | BS EN ISO 80601-2-79:2024 |
Pages: | 118 |
Released: | 2024-10-25 |
ISBN: | 978 0 539 18674 1 |
Status: | Standard |
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