BS EN 80601-2-30:2010+A1:2015

Comprehensive Healthcare Technology Standard

The BS EN 80601-2-30:2010+A1:2015 is a crucial standard for the healthcare industry, providing detailed requirements and test methods for non-invasive sphygmomanometers used for automated measurement of blood pressure.

Ensuring Patient Safety and Device Performance

This standard, which is identical to IEC 80601-2-30:2009/AMD1:2013, is designed to ensure the safety and performance of non-invasive sphygmomanometers, a critical piece of medical equipment used in a wide range of healthcare settings.The standard covers a comprehensive range of requirements, including:• General requirements for basic safety and essential performance• Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometersBy adhering to the specifications outlined in this standard, manufacturers can demonstrate that their non-invasive sphygmomanometers meet the highest standards of safety and performance, providing healthcare professionals and patients with the confidence they need.

Key Features and Benefits

• Ensures the safety and essential performance of non-invasive sphygmomanometers• Covers a wide range of requirements, including electrical safety, electromagnetic compatibility, and usability• Helps manufacturers demonstrate compliance with international standards for medical devices• Supports the delivery of high-quality, reliable blood pressure measurements in healthcare settings• Remains current, even as it is replaced by the newer BS EN IEC 80601-2-30:2019 standard

Compliance and Regulatory Requirements

The BS EN 80601-2-30:2010+A1:2015 standard is a critical component of the regulatory framework for medical devices in the healthcare industry. Compliance with this standard is often a requirement for the CE marking of non-invasive sphygmomanometers, ensuring that these devices meet the essential requirements of the relevant EU directives.By adhering to the specifications outlined in this standard, manufacturers can demonstrate that their products meet the necessary safety and performance criteria, making it easier to navigate the complex regulatory landscape and bring their devices to market.

Conclusion

The BS EN 80601-2-30:2010+A1:2015 standard is an essential resource for healthcare technology professionals, providing a comprehensive set of requirements and test methods for non-invasive sphygmomanometers. By ensuring the safety and performance of these critical medical devices, this standard helps to support the delivery of high-quality, reliable healthcare services and improve patient outcomes.