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Homepage>BS Standards>11 HEALTH CARE TECHNOLOGY>11.040 Medical equipment>11.040.01 Medical equipment in general>BS EN IEC 80601-2-30:2019 Medical electrical equipment Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
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BS EN IEC 80601-2-30:2019 Medical electrical equipment Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers

BS EN IEC 80601-2-30:2019

Medical electrical equipment Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers

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Standard number:BS EN IEC 80601-2-30:2019
Pages:64
Released:2019-07-03
ISBN:978 0 539 05222 0
Status:Standard

BS EN IEC 80601-2-30:2019 - Elevate Your Medical Equipment Standards

In the ever-evolving world of medical technology, ensuring the safety and performance of medical devices is paramount. Introducing the BS EN IEC 80601-2-30:2019, a comprehensive standard that sets the benchmark for the basic safety and essential performance of automated non-invasive sphygmomanometers. This standard is an indispensable resource for manufacturers, healthcare providers, and regulatory bodies committed to maintaining the highest levels of patient care and safety.

Unveiling the Essentials of BS EN IEC 80601-2-30:2019

The BS EN IEC 80601-2-30:2019 standard is meticulously crafted to address the specific requirements for automated non-invasive sphygmomanometers, which are crucial devices used in measuring blood pressure. With a focus on both safety and performance, this standard ensures that these medical devices operate effectively and reliably, minimizing risks to patients and healthcare professionals alike.

Key Features and Benefits

  • Comprehensive Coverage: Spanning across 64 pages, this standard provides an in-depth exploration of the requirements necessary for the safe and effective operation of automated non-invasive sphygmomanometers.
  • Up-to-Date Guidelines: Released on July 3, 2019, the standard reflects the latest advancements and best practices in medical device safety and performance.
  • International Recognition: As part of the IEC (International Electrotechnical Commission) standards, it is recognized globally, facilitating international trade and compliance.
  • ISBN Reference: Easily identifiable with the ISBN 978 0 539 05222 0, ensuring you have the correct and authoritative source for your needs.

Why Choose BS EN IEC 80601-2-30:2019?

In the realm of medical electrical equipment, precision and reliability are non-negotiable. The BS EN IEC 80601-2-30:2019 standard is designed to provide a robust framework that supports the development and maintenance of high-quality sphygmomanometers. By adhering to this standard, manufacturers can demonstrate their commitment to safety and quality, while healthcare providers can trust in the devices they use to deliver accurate and reliable results.

Ensuring Patient Safety

Patient safety is at the heart of the BS EN IEC 80601-2-30:2019 standard. It outlines stringent requirements for the design, construction, and testing of sphygmomanometers, ensuring that they meet the highest safety standards. This includes guidelines for electrical safety, mechanical safety, and performance under various conditions, all aimed at protecting patients from potential harm.

Enhancing Device Performance

Performance is a critical aspect of any medical device, and the BS EN IEC 80601-2-30:2019 standard provides detailed criteria to ensure that sphygmomanometers deliver consistent and accurate measurements. This includes specifications for measurement accuracy, response time, and durability, ensuring that devices perform optimally in clinical settings.

Facilitating Compliance and Certification

Compliance with the BS EN IEC 80601-2-30:2019 standard is a significant step towards achieving certification and regulatory approval. By meeting the requirements outlined in this standard, manufacturers can streamline the certification process, reducing time to market and enhancing their competitive edge.

Who Should Use This Standard?

The BS EN IEC 80601-2-30:2019 standard is an essential tool for a wide range of stakeholders in the medical device industry, including:

  • Manufacturers: Ensure your products meet international safety and performance standards, enhancing marketability and consumer trust.
  • Healthcare Providers: Equip your facilities with devices that adhere to the highest safety and performance standards, ensuring optimal patient care.
  • Regulatory Bodies: Utilize this standard as a benchmark for evaluating the safety and performance of sphygmomanometers in your jurisdiction.

Conclusion

The BS EN IEC 80601-2-30:2019 standard is more than just a set of guidelines; it is a commitment to excellence in the field of medical electrical equipment. By adopting this standard, you are not only ensuring compliance but also contributing to the advancement of healthcare technology and patient safety. Invest in the future of medical device innovation with the BS EN IEC 80601-2-30:2019 standard, and be a part of the global movement towards safer, more reliable healthcare solutions.

DESCRIPTION

BS EN IEC 80601-2-30:2019


This standard BS EN IEC 80601-2-30:2019 Medical electrical equipment is classified in these ICS categories:
  • 11.040.01 Medical equipment in general
  • 11.040.55 Diagnostic equipment
IEC 80601-2-30:2018 is also available as IEC 80601-2-30:2018 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.

IEC 80601-2-30:2018 applies to the basic safety and essential performance of automated sphygmomanometers, hereafter referred to as ME equipment, which by means of an inflatable cuff, are used for non continuous indirect estimation of the blood pressure without arterial puncture. This document specifies requirements for the basic safety and essential performance for this ME equipment and its accessories, including the requirements for the accuracy of a determination. This document covers automatic electrically-powered ME equipment used for the intermittent, indirect estimation of the blood pressure without arterial puncture, including blood pressure monitors for the home healthcare environment. Requirements for indirect estimation of the blood pressure without arterial puncture ME equipment with an electrically-powered pressure transducer and/or displays used in conjunction with a stethoscope or other manual methods for determining blood pressure (non-automated sphygmomanometers) are specified in document ISO 81060-1. 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 201.11 and 201.105.3.3, as well as 7.2.13 and 8.4.1 of IEC 60601-1:2005. This second edition cancels and replaces the first edition published in 2009 and Amendment 1:2013. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition:
a) alignment with IEC 60601-1:2005/AMD1:2012 and IEC 60601-1-8:2006/AMD1:2012 , and with IEC 60601-1-2:2014 and IEC 60601-1-11:2015;
b) referencing IEC 60601-1-10:2007 and IEC 60601-1-12;
c) changing an operator-accessible cuff-sphygmomanometer connector from not compatible with the ISO 594 series to compatible with the ISO 80369 series;
d) added additional requirements for public self-use sphygmomanometers;
e) added a list of primary operating functions.