BS EN ISO 17510:2020 - Medical Devices for Sleep Apnoea Therapy

Discover the essential standard for ensuring the safety and effectiveness of medical devices used in sleep apnoea breathing therapy. The BS EN ISO 17510:2020 is a comprehensive guideline that provides detailed specifications for masks and application accessories used in the treatment of sleep apnoea, a condition that affects millions of people worldwide.

Overview

Released on February 19, 2020, this standard is a critical resource for manufacturers, healthcare providers, and regulatory bodies involved in the design, production, and use of sleep apnoea therapy devices. With a total of 42 pages, it offers in-depth information and requirements to ensure that these medical devices meet the highest standards of quality and safety.

Key Features

• Standard Number: BS EN ISO 17510:2020
• ISBN: 978 0 539 04504 8
• Status: Standard

Importance of the Standard

Sleep apnoea is a serious sleep disorder where breathing repeatedly stops and starts. It can lead to a range of health issues, including cardiovascular problems, daytime fatigue, and complications with surgery and medications. The BS EN ISO 17510:2020 standard plays a crucial role in mitigating these risks by ensuring that the devices used in therapy are reliable and effective.

This standard is particularly important for:

• Manufacturers: Ensures that products meet international safety and performance criteria, facilitating market access and consumer trust.
• Healthcare Providers: Provides assurance that the devices used in treatment are of high quality, enhancing patient care and outcomes.
• Regulatory Bodies: Offers a benchmark for evaluating the compliance of medical devices, ensuring public health and safety.

Detailed Specifications

The BS EN ISO 17510:2020 standard covers a wide range of specifications, including:

• Design and Construction: Guidelines on the materials and construction of masks and accessories to ensure durability and comfort.
• Performance Requirements: Criteria for the functionality of devices, including air flow, pressure stability, and noise levels.
• Safety Considerations: Measures to prevent risks such as skin irritation, air leakage, and mechanical failure.
• Testing and Validation: Procedures for testing devices to verify compliance with the standard's requirements.

Benefits of Compliance

Adhering to the BS EN ISO 17510:2020 standard offers numerous benefits, including:

• Enhanced Patient Safety: By ensuring that devices meet stringent safety standards, the risk of adverse events is minimized.
• Improved Treatment Efficacy: High-quality devices contribute to more effective therapy, improving patient outcomes and quality of life.
• Market Competitiveness: Compliance with international standards can enhance a manufacturer's reputation and competitiveness in the global market.
• Regulatory Approval: Meeting the standard's requirements can facilitate the approval process with regulatory authorities, expediting time to market.

Conclusion

The BS EN ISO 17510:2020 standard is an indispensable tool for anyone involved in the field of sleep apnoea therapy. By providing clear and comprehensive guidelines, it ensures that medical devices are safe, effective, and reliable. Whether you are a manufacturer, healthcare provider, or regulatory body, this standard is essential for ensuring the highest quality of care for patients suffering from sleep apnoea.

Invest in the BS EN ISO 17510:2020 standard to ensure that your products and services meet the highest international standards, providing peace of mind to both healthcare providers and patients alike.

BS EN ISO 17510:2020

This standard BS EN ISO 17510:2020 Medical devices. Sleep apnoea breathing therapy. Masks and application accessories is classified in these ICS categories:

• 11.040.10 Anaesthetic, respiratory and reanimation equipment

This International Standard applies to masks and their accessories used to connect sleep apnoea breathing therapy equipment to the patient. It specifies requirements for masks and accessories, including any connecting element, that are required to connect the patient-connection port of sleep apnoea breathing therapy equipment to a patient for the application of sleep apnoea breathing therapy (e.g. nasal masks, exhaust ports and headgear).

Sleep apnoea breathing therapy equipment is covered by ISO 80601‑2‑70. Figure A.1 shows the typical elements of this International Standard together with the sleep apnoea breathing therapy equipment of ISO 80601‑2‑70 that form a sleep apnoea breathing system.

This International Standard does not cover oral appliances.