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Homepage>BS Standards>11 HEALTH CARE TECHNOLOGY>11.040 Medical equipment>11.040.10 Anaesthetic, respiratory and reanimation equipment>BS EN ISO 10651-4:2023 Lung ventilators Particular requirements for user-powered resuscitators
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immediate downloadReleased: 2023-04-06
BS EN ISO 10651-4:2023 Lung ventilators Particular requirements for user-powered resuscitators

BS EN ISO 10651-4:2023

Lung ventilators Particular requirements for user-powered resuscitators

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Standard number:BS EN ISO 10651-4:2023
Pages:78
Released:2023-04-06
ISBN:978 0 539 03818 7
Status:Standard

BS EN ISO 10651-4:2023 Lung Ventilators - Particular Requirements for User-Powered Resuscitators

Introducing the BS EN ISO 10651-4:2023 Lung Ventilators - Particular Requirements for User-Powered Resuscitators, a comprehensive guide that sets the standard for the design, safety, and performance of user-powered resuscitators. This document is an essential resource for manufacturers, healthcare professionals, and anyone involved in the production or use of lung ventilators.

Released on April 6, 2023, this standard is the latest in the field, ensuring you have the most up-to-date information at your fingertips. With a total of 78 pages, it provides an in-depth look at the specific requirements for user-powered resuscitators, ensuring the highest level of safety and efficiency in their use.

Key Features

The BS EN ISO 10651-4:2023 standard provides a comprehensive set of guidelines for user-powered resuscitators. It covers everything from design considerations to safety requirements, ensuring that these devices are as effective and safe as possible. Here are some of the key features of this standard:

  • Comprehensive Guidelines: This standard provides a complete set of guidelines for the design, safety, and performance of user-powered resuscitators. It ensures that these devices meet the highest standards of safety and effectiveness.
  • Up-to-Date Information: Released in 2023, this standard provides the most recent information in the field. It ensures that you are up-to-date with the latest developments and best practices.
  • Detailed Information: With 78 pages of detailed information, this standard provides an in-depth look at the specific requirements for user-powered resuscitators. It ensures that you have all the information you need to produce or use these devices safely and effectively.

Why Choose BS EN ISO 10651-4:2023?

The BS EN ISO 10651-4:2023 standard is an essential resource for anyone involved in the production or use of lung ventilators. It provides a comprehensive set of guidelines that ensure these devices are as safe and effective as possible. By following this standard, you can ensure that your devices meet the highest standards of safety and effectiveness.

Furthermore, this standard is the most recent in the field, ensuring that you have the most up-to-date information. With 78 pages of detailed information, it provides an in-depth look at the specific requirements for user-powered resuscitators. Whether you are a manufacturer, a healthcare professional, or simply someone interested in the field, this standard is an invaluable resource.

The BS EN ISO 10651-4:2023 standard is available in print and digital formats, with an ISBN of 978 0 539 03818 7. Order your copy today and ensure that you are at the forefront of safety and effectiveness in the field of lung ventilators.

Conclusion

In conclusion, the BS EN ISO 10651-4:2023 standard is an essential resource for anyone involved in the production or use of lung ventilators. It provides a comprehensive set of guidelines that ensure these devices are as safe and effective as possible. Don't compromise on safety and effectiveness - order your copy of the BS EN ISO 10651-4:2023 standard today.

DESCRIPTION

BS EN ISO 10651-4:2023


This standard BS EN ISO 10651-4:2023 Lung ventilators is classified in these ICS categories:
  • 11.040.10 Anaesthetic, respiratory and reanimation equipment
This document specifies requirements for user-powered resuscitators intended for use with all age groups and which are intended to provide lung ventilation to patients whose breathing is inadequate. User-powered resuscitators are designated according to ideal body mass range. Example user-powered resuscitators include: —    self-inflating bag resuscitators intended to be squeezed by the user’s hand and refilled by elastic recoil; and NOTE 1    Self-inflating bag resuscitators are generally transit-operable and can be used in a wide range of environmental and emergency situations. —    flow-inflating bag resuscitators intended to be squeezed by the user’s hand and refilled by a flow from a medical gas source. This document is also applicable to those accessories that are intended for use with resuscitators where the characteristics of those accessories can affect the safety of the user-powered resuscitator. Examples of such accessories include face masks, PEEP valves, capnometric indicators, manometers, metronomes, flow restrictors, filters, gas refill valves, oxygen gas mixers, connectors, electronic feedback devices, electronic sensors and transmission of data to other equipment. This document is also applicable to point-of-use packaging. This document does not specify the requirements for: —    gas-powered emergency resuscitators, which are given in ISO 10651-5; —    electrically-powered resuscitators; —    gas powered resuscitators for professional healthcare facilities; and —    anaesthetic reservoir bags, which are given in ISO 5362. NOTE 2    This document has been prepared to address the relevant essential principles[24] and labelling[25] guidances of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex D. NOTE 3    This document has been prepared to address the relevant essential principles of safety and performance of ISO 16142-1:2016 as indicated in Annex E. NOTE 4    This document has been prepared to address the relevant general safety and performance requirements of European regulation (EU) 2017/745[23] as indicated in Annex F.