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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 17510:2025 Medical devices — Sleep apnoea breathing therapy — Masks and application accessories
immediate downloadReleased: 2025-12-11

BS EN ISO 17510:2025

Medical devices — Sleep apnoea breathing therapy — Masks and application accessories

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Standard number:BS EN ISO 17510:2025
Pages:46
Released:2025-12-11
ISBN:978 0 539 30559 3
Status:Standard
BS EN ISO 17510:2025 - Medical Devices for Sleep Apnoea Therapy

BS EN ISO 17510:2025 - Medical Devices for Sleep Apnoea Breathing Therapy

Introducing the BS EN ISO 17510:2025, a comprehensive standard that sets the benchmark for medical devices used in sleep apnoea breathing therapy. This essential document is designed to ensure the highest quality and safety of masks and application accessories used in the treatment of sleep apnoea, a condition that affects millions of individuals worldwide.

Overview

With the release date set for December 11, 2025, this standard is the latest in a series of updates aimed at improving the efficacy and safety of sleep apnoea treatment devices. The document spans 46 pages and is identified by the ISBN 978 0 539 30559 3. As a recognized standard, it provides a detailed framework for manufacturers, healthcare providers, and regulatory bodies to follow, ensuring that all products meet the necessary requirements for patient safety and therapeutic effectiveness.

Key Features

  • Comprehensive Guidelines: The standard offers detailed instructions on the design, testing, and performance of masks and application accessories used in sleep apnoea therapy.
  • Safety and Efficacy: Emphasizes the importance of safety and efficacy, ensuring that all devices meet stringent quality control measures.
  • Global Relevance: As an international standard, it harmonizes requirements across different regions, facilitating global trade and compliance.
  • Patient-Centric Design: Focuses on the comfort and usability of masks and accessories, enhancing patient compliance and treatment outcomes.

Why Choose BS EN ISO 17510:2025?

Sleep apnoea is a serious condition that can lead to significant health issues if left untreated. The BS EN ISO 17510:2025 standard is crucial for ensuring that the devices used in its treatment are both safe and effective. By adhering to this standard, manufacturers can guarantee that their products are of the highest quality, providing peace of mind to both healthcare providers and patients.

Moreover, the standard's focus on patient-centric design means that the masks and accessories are not only effective but also comfortable to wear, which is essential for patient adherence to therapy. This can lead to better health outcomes and an improved quality of life for those suffering from sleep apnoea.

Who Should Use This Standard?

The BS EN ISO 17510:2025 is an invaluable resource for a wide range of stakeholders, including:

  • Manufacturers: To ensure that their products meet international safety and performance standards.
  • Healthcare Providers: To select the best devices for their patients, ensuring effective treatment.
  • Regulatory Bodies: To establish guidelines and regulations that protect patient safety.
  • Researchers and Academics: To stay informed about the latest standards in medical device technology.

Conclusion

The BS EN ISO 17510:2025 standard is a critical tool in the fight against sleep apnoea. By setting clear guidelines for the design and use of masks and application accessories, it ensures that patients receive the highest standard of care. Whether you are a manufacturer, healthcare provider, or regulatory body, this standard is an essential addition to your resources, helping to improve patient outcomes and advance the field of sleep apnoea therapy.

Stay ahead in the field of medical devices with the BS EN ISO 17510:2025, and ensure that your products and practices are aligned with the latest international standards.

DESCRIPTION

BS EN ISO 17510:2025


This standard BS EN ISO 17510:2025 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 document 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). This document applies to masks and their accessories used to connect sleep apnoea breathing therapy equipment to the patient. The requirements in this document take priority over the requirements in ISO 18190. This document does not cover oral appliances. NOTE            This document has been prepared to address the relevant essential principles[14] and labelling principles[15] of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex I.