BS EN ISO 80601-2-69:2020: Ensuring Safety and Performance in Oxygen Concentrator Equipment

In the ever-evolving field of medical technology, ensuring the safety and performance of medical electrical equipment is paramount. The BS EN ISO 80601-2-69:2020 standard is a critical document that sets forth the particular requirements for the basic safety and essential performance of oxygen concentrator equipment. Released on November 23, 2020, this standard is an essential resource for manufacturers, healthcare providers, and regulatory bodies involved in the design, production, and use of oxygen concentrators.

Key Features of the Standard

• Standard Number: BS EN ISO 80601-2-69:2020
• Pages: 76
• Release Date: November 23, 2020
• ISBN: 978 0 539 01163 0
• Status: Standard

Comprehensive Coverage

This 76-page document provides a comprehensive framework for ensuring that oxygen concentrators meet the necessary safety and performance criteria. It is designed to address the unique challenges and risks associated with the use of oxygen concentrators, which are critical devices used in various healthcare settings to provide supplemental oxygen to patients.

Why This Standard Matters

Oxygen concentrators are vital in treating patients with respiratory conditions, and their reliability can be a matter of life and death. The BS EN ISO 80601-2-69:2020 standard ensures that these devices are safe to use and perform as expected under various conditions. By adhering to this standard, manufacturers can demonstrate their commitment to quality and safety, which is crucial for gaining the trust of healthcare providers and patients alike.

Who Should Use This Standard?

This standard is indispensable for:

• Manufacturers: To ensure their products meet international safety and performance requirements.
• Healthcare Providers: To understand the safety and performance standards of the equipment they use.
• Regulatory Bodies: To enforce compliance and ensure public safety.

Benefits of Compliance

Compliance with the BS EN ISO 80601-2-69:2020 standard offers numerous benefits, including:

• Enhanced Safety: Reduces the risk of device malfunction and potential harm to patients.
• Improved Performance: Ensures that oxygen concentrators operate efficiently and effectively.
• Market Access: Facilitates entry into global markets by meeting international standards.
• Reputation: Builds trust with healthcare providers and patients by demonstrating a commitment to quality.

Conclusion

The BS EN ISO 80601-2-69:2020 standard is a vital document for anyone involved in the production, regulation, or use of oxygen concentrator equipment. By setting clear guidelines for safety and performance, it helps ensure that these life-saving devices are reliable and effective. Whether you are a manufacturer looking to certify your products, a healthcare provider seeking to understand the equipment you use, or a regulatory body enforcing compliance, this standard is an invaluable resource.

Invest in the safety and performance of your medical electrical equipment by adhering to the BS EN ISO 80601-2-69:2020 standard. Your commitment to quality can make a significant difference in the lives of patients who rely on oxygen concentrators for their health and well-being.

BS EN ISO 80601-2-69:2020

This standard BS EN ISO 80601-2-69:2020 Medical electrical equipment is classified in these ICS categories:

• 11.040.10 Anaesthetic, respiratory and reanimation equipment

IEC 60601‑1:2005+AMD1:2012, 1.1 is replaced by:

This document specifies requirements for the basic safety and essential performance of an oxygen concentrator in combination with its accessories, hereafter referred to as ME equipment, intended to increase the oxygen concentration of gas intended to be delivered to a single patient. Such oxygen concentrators are typically intended for use in the home healthcare environment by a single patient in various environments including any private and public transportation as well as in commercial aircraft.

NOTE 1 Such oxygen concentrators can also be used in professional healthcare facilities.

This document is applicable to a transit-operable and non-transit-operable oxygen concentrator. This document is applicable to an oxygen concentrator integrated into or used with other medical devices, ME equipment or ME systems.

EXAMPLE 1 An oxygen concentrator with integrated oxygen conserving equipment function or humidifier function.

EXAMPLE 2 An oxygen concentrator used with a flowmeter stand.

EXAMPLE 3 An oxygen concentrator as part of an anaesthetic system for use in areas with limited logistical supplies of electricity and anaesthetic gases^[2].

EXAMPLE 4 An oxygen concentrator with an integrated liquid reservoir function or gas cylinder filling system function.

This document is also applicable to those accessories intended by their manufacturer to be connected to an oxygen concentrator, where the characteristics of those accessories can affect the basic safety or essential performance of the oxygen concentrator.

NOTE 2 Such accessories can include, but are not limited to, masks, cannulae, extension tubing, humidifiers, carts, carrying cases, external power sources and oxygen conserving equipment.

This document does not specify requirements for oxygen concentrators for use with a medical gas pipeline system.

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 7.2.13 and 8.4.1 of the general standard.

NOTE 3 See also 4.2 of the general standard.