PRICES include / exclude VAT

Homepage>BS Standards>11 HEALTH CARE TECHNOLOGY>11.040 Medical equipment>11.040.10 Anaesthetic, respiratory and reanimation equipment>BS EN ISO 80601-2-12:2023 Medical electrical equipment Particular requirements for basic safety and essential performance of critical care ventilators

BS EN ISO 80601-2-12:2023

Medical electrical equipment Particular requirements for basic safety and essential performance of critical care ventilators

English Secure PDF

Immediate download

399.30 EUR

You can read the standard for 1 hour. More information in the category: E-reading

Reading the standard

for 1 hour

39.93 EUR

You can read the standard for 24 hours. More information in the category: E-reading

Reading the standard

for 24 hours

119.79 EUR

English Hardcopy

In stock

399.30 EUR

Standard number:	BS EN ISO 80601-2-12:2023
Pages:	170
Released:	2023-11-16
ISBN:	978 0 539 17233 1
Status:	Standard

BS EN ISO 80601-2-12:2023 - Medical Electrical Equipment: Essential Safety and Performance Standards for Critical Care Ventilators

Introducing the BS EN ISO 80601-2-12:2023, the latest and most comprehensive standard for medical electrical equipment, specifically focusing on the basic safety and essential performance of critical care ventilators. This indispensable document is a must-have for healthcare professionals, medical device manufacturers, and regulatory bodies committed to ensuring the highest standards of patient care and safety.

Key Features and Benefits

The BS EN ISO 80601-2-12:2023 standard is meticulously designed to address the unique requirements and challenges associated with critical care ventilators. Here are some of the standout features and benefits:

Standard Number: BS EN ISO 80601-2-12:2023
Pages: 170
Release Date: 2023-11-16
ISBN: 978 0 539 17233 1
Status: Standard

Comprehensive Coverage

With a total of 170 pages, this standard provides an exhaustive overview of the essential safety and performance requirements for critical care ventilators. It covers everything from design and manufacturing to testing and maintenance, ensuring that every aspect of ventilator performance is thoroughly addressed.

Up-to-Date Information

Released on 2023-11-16, the BS EN ISO 80601-2-12:2023 standard incorporates the latest advancements and best practices in the field of medical electrical equipment. This ensures that you are working with the most current and relevant information available.

Global Recognition

As an internationally recognized standard, the BS EN ISO 80601-2-12:2023 is widely accepted and respected by healthcare professionals and regulatory bodies around the world. This makes it an invaluable resource for ensuring compliance with global safety and performance standards.

Enhanced Patient Safety

One of the primary goals of the BS EN ISO 80601-2-12:2023 standard is to enhance patient safety. By adhering to the guidelines and requirements outlined in this document, healthcare providers can significantly reduce the risk of adverse events and improve patient outcomes.

Improved Device Performance

The standard also focuses on the essential performance of critical care ventilators, ensuring that these life-saving devices operate at their highest potential. This includes guidelines for performance testing, maintenance, and quality control, all of which contribute to the overall reliability and effectiveness of the equipment.

Why Choose BS EN ISO 80601-2-12:2023?

There are several reasons why the BS EN ISO 80601-2-12:2023 standard is the preferred choice for healthcare professionals and medical device manufacturers:

Expertly Crafted

This standard has been expertly crafted by a team of industry professionals and subject matter experts. Their collective knowledge and experience ensure that the document is both comprehensive and practical, providing valuable insights and guidance for all stakeholders.

Easy to Understand

Despite its technical nature, the BS EN ISO 80601-2-12:2023 standard is written in a clear and concise manner, making it easy to understand and implement. This ensures that even those with limited technical expertise can effectively utilize the information provided.

Versatile Application

The guidelines and requirements outlined in this standard are applicable to a wide range of critical care ventilators, making it a versatile resource for various healthcare settings. Whether you are working in a hospital, clinic, or research facility, this standard provides the necessary tools to ensure optimal device performance and patient safety.

Future-Proof

By incorporating the latest advancements and best practices, the BS EN ISO 80601-2-12:2023 standard is designed to be future-proof. This means that it will remain relevant and useful for years to come, providing long-term value for healthcare professionals and medical device manufacturers.

Conclusion

In conclusion, the BS EN ISO 80601-2-12:2023 standard is an essential resource for anyone involved in the design, manufacture, testing, or use of critical care ventilators. Its comprehensive coverage, up-to-date information, and focus on patient safety and device performance make it an invaluable tool for ensuring the highest standards of care.

Don't miss out on this opportunity to enhance your knowledge and expertise in the field of medical electrical equipment. Invest in the BS EN ISO 80601-2-12:2023 standard today and take the first step towards ensuring the safety and well-being of your patients.

DESCRIPTION

BS EN ISO 80601-2-12:2023

This standard BS EN ISO 80601-2-12:2023 Medical electrical equipment is classified in these ICS categories:

11.040.10 Anaesthetic, respiratory and reanimation equipment

This document applies to the basic safety and essential performance of a critical care ventilator in combination with its accessories, hereafter referred to as ME equipment: ¾ intended for use in an environment that provides specialized care for patients whose conditions can be life-threatening and who can require comprehensive care and constant monitoring in a professional healthcare facility; NOTE 2 For the purposes of this document, such an environment is referred to as a critical care environment. Ventilators for this environment are considered life-sustaining. NOTE 3 For the purposes of this document, such a critical care ventilator can provide ventilation during transport within a professional healthcare facility (i.e. be a transit-operable ventilator). NOTE 4 A critical care ventilator intended for use in transport within a professional healthcare facility is not considered as an emergency medical services environment ventilator. ¾ intended to be operated by a healthcare professional operator; and ¾ intended for those patients who need differing levels of support from artificial ventilation including for ventilator-dependent patients. A critical care ventilator 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 a ventilator breathing system, or to a ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator. NOTE 5 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 6 Additional information can be found in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2. This document is not applicable to ME equipment or an ME system operating in a ventilator-operational mode solely intended for patients who are not dependent on artificial ventilation. NOTE 7 A critical care ventilator, when operating in such a ventilator-operational mode, is not considered life-sustaining. This document is not applicable to ME equipment that is intended solely to augment the ventilation of spontaneously breathing patients within a professional healthcare facility. This document does not specify the requirements for: NOTE 8 See ISO/TR 21954 for guidance on the selection of the appropriate ventilator for a given patient. ¾ ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601?2?13; ¾ ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601-2-84; ¾ ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601?2-72; ¾ ventilators or accessories intended for home-care ventilatory support devices, which are given in ISO 80601-2-79 and ISO 80601-2-80; ¾ obstructive sleep a

Print RECOMMEND