BS EN 80601-2-58:2015+A1:2019

Comprehensive Health Care Technology Standard

BS EN 80601-2-58:2015+A1:2019 is a critical standard that establishes safety and performance requirements for medical devices used in health care settings. This standard, which is identical to IEC 80601-2-58:2014/AMD1:2016, ensures that medical equipment is designed and manufactured to the highest quality and safety standards.

Key Specifications

- Applies to medical electrical equipment and medical electrical systems used for the delivery of oxygen to the patient- Covers requirements for basic safety and essential performance, including electrical, mechanical, and environmental safety- Specifies test methods to verify compliance with the standard's requirements- Harmonized with the Medical Devices Directive (93/42/EEC) and the In Vitro Diagnostic Medical Devices Directive (98/79/EC)

Benefits of Compliance

- Ensures medical devices meet stringent safety and performance requirements, protecting patients and healthcare workers- Demonstrates compliance with relevant EU regulations and directives, enabling market access- Promotes the use of standardized, high-quality medical equipment across the healthcare industry- Helps manufacturers design and produce medical devices that are safe, reliable, and effective

Comprehensive Guidance for Medical Device Manufacturers

BS EN 80601-2-58:2015+A1:2019 provides detailed technical specifications and test methods to verify the safety and performance of medical devices used for oxygen delivery. This standard is an essential reference for manufacturers of oxygen therapy equipment, including:- Oxygen concentrators- Oxygen generators- Oxygen regulators- Oxygen flowmeters- Oxygen humidifiers- Oxygen tubing and accessoriesBy adhering to the requirements outlined in this standard, medical device manufacturers can ensure their products meet the highest safety and quality standards, giving healthcare providers and patients the confidence they need.

Comprehensive Compliance Support

In addition to the standard itself, BSI offers a range of resources and services to support manufacturers in achieving compliance with BS EN 80601-2-58:2015+A1:2019, including:- Technical guidance and interpretation- Conformity assessment and certification services- Training and education programs- Access to the latest standards updates and revisionsWith the help of BSI's expertise, medical device manufacturers can navigate the complex regulatory landscape and bring their products to market with confidence.