BS EN ISO 80601-2-13:2022 - Medical Electrical Equipment Standard

Ensure the highest level of safety and performance in your medical practice with the BS EN ISO 80601-2-13:2022 standard. This comprehensive document outlines the particular requirements for the basic safety and essential performance of an anaesthetic workstation, making it an indispensable resource for healthcare professionals and medical equipment manufacturers.

Key Features and Benefits

• Standard Number: BS EN ISO 80601-2-13:2022
• Pages: 118
• Released: 2022-06-17
• ISBN: 978 0 539 02351 0
• Name: Medical electrical equipment Particular requirements for basic safety and essential performance of an anaesthetic workstation
• Status: Standard

Comprehensive Coverage

This standard provides detailed guidelines and requirements to ensure that anaesthetic workstations meet the highest safety and performance criteria. With 118 pages of in-depth information, it covers all aspects of design, testing, and maintenance, ensuring that your equipment is reliable and safe for patient use.

Up-to-Date Information

Released on June 17, 2022, the BS EN ISO 80601-2-13:2022 standard reflects the latest advancements and best practices in the field of medical electrical equipment. By adhering to this standard, you can be confident that your anaesthetic workstations are compliant with the most current safety and performance requirements.

Essential for Compliance

Compliance with the BS EN ISO 80601-2-13:2022 standard is crucial for medical facilities and equipment manufacturers. It ensures that your anaesthetic workstations meet international safety and performance standards, reducing the risk of equipment failure and enhancing patient safety.

Detailed Guidelines

The standard provides specific requirements for various aspects of anaesthetic workstations, including:

• Electrical safety
• Mechanical safety
• Performance testing
• Maintenance protocols
• Environmental considerations

These guidelines help manufacturers design and produce equipment that is not only safe but also efficient and reliable.

International Recognition

The BS EN ISO 80601-2-13:2022 standard is recognized internationally, making it a valuable resource for global medical equipment manufacturers and healthcare providers. Adopting this standard can enhance your reputation and credibility in the medical industry, demonstrating your commitment to safety and quality.

Why Choose BS EN ISO 80601-2-13:2022?

By choosing the BS EN ISO 80601-2-13:2022 standard, you are investing in the safety and performance of your anaesthetic workstations. This standard provides a comprehensive framework for ensuring that your equipment meets the highest standards of safety and performance, protecting both patients and healthcare providers.

Conclusion

The BS EN ISO 80601-2-13:2022 standard is an essential resource for anyone involved in the design, manufacture, or use of anaesthetic workstations. With its detailed guidelines and up-to-date information, it ensures that your equipment is safe, reliable, and compliant with international standards. Invest in the safety and performance of your medical equipment with the BS EN ISO 80601-2-13:2022 standard.

BS EN ISO 80601-2-13:2022

This standard BS EN ISO 80601-2-13:2022 Medical electrical equipment is classified in these ICS categories:

• 11.040.10 Anaesthetic, respiratory and reanimation equipment

This document is applicable to the basic safety and essential performance of an anaesthetic workstation for administering inhalational anaesthesia whilst continuously attended by a professional operator. This document specifies particular requirements for a complete anaesthetic workstation and the following anaesthetic workstation components which, although considered as individual devices in their own right, may be utilized, in conjunction with other relevant anaesthetic workstation components, to form an anaesthetic workstation to a given specification: anaesthetic gas delivery system; anaesthetic breathing system; anaesthetic gas scavenging system (AGSS); anaesthetic vapour delivery system; anaesthetic ventilator; monitoring equipment; alarm system; protection device. NOTE 1        Monitoring equipment, alarm systems and protection devices are summarized in Table AA.1. An anaesthetic workstation supplied complete and its individual components are considered as ME equipment or ME systems with regard to the general standard. NOTE 2        The applicability of this document is indicated in Table AA.2. This document is also applicable to those accessories intended by their manufacturer to be connected to an anaesthetic workstation where the characteristics of those accessories can affect the basic safety and essential performance of the anaesthetic workstation. If a clause or subclause is specifically intended to be applicable to anaesthetic workstation components or its accessories 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 an anaesthetic workstation and its individual components including accessories, as relevant. Hazards inherent in the intended physiological function of an anaesthetic workstation and its individual components including accessories 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 3        See also IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2. This document is not applicable to any anaesthetic workstation intended for use with flammable anaesthetic agents, as determined by Annex BB.