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Homepage>BS Standards>11 HEALTH CARE TECHNOLOGY>11.020 Medical sciences and health care facilities in general>11.020.10 Health care services in general>BS EN 60601-1-11:2015+A1:2021 Medical electrical equipment General requirements for basic safety and essential performance. Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
immediate downloadReleased: 2021-08-20
BS EN 60601-1-11:2015+A1:2021 Medical electrical equipment General requirements for basic safety and essential performance. Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

BS EN 60601-1-11:2015+A1:2021

Medical electrical equipment General requirements for basic safety and essential performance. Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

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Standard number:BS EN 60601-1-11:2015+A1:2021
Pages:72
Released:2021-08-20
ISBN:978 0 580 97594 3
Status:Standard
BS EN 60601-1-11:2015+A1:2021 Medical Electrical Equipment Standard

BS EN 60601-1-11:2015+A1:2021 Medical Electrical Equipment Standard

In the rapidly evolving world of healthcare, ensuring the safety and performance of medical electrical equipment is paramount. The BS EN 60601-1-11:2015+A1:2021 standard is a crucial document that provides comprehensive guidelines for the basic safety and essential performance of medical electrical equipment and systems, specifically tailored for use in the home healthcare environment.

Overview

This standard is an essential resource for manufacturers, healthcare providers, and regulatory bodies involved in the design, production, and implementation of medical electrical equipment. It addresses the unique challenges and requirements associated with using such equipment in non-clinical settings, ensuring that patients receive safe and effective care in the comfort of their homes.

Key Features

  • Standard Number: BS EN 60601-1-11:2015+A1:2021
  • Pages: 72
  • Released: 2021-08-20
  • ISBN: 978 0 580 97594 3
  • Status: Standard

Why This Standard is Important

The home healthcare environment presents unique challenges that differ significantly from traditional clinical settings. Factors such as varying levels of user expertise, environmental conditions, and the need for equipment to be portable and user-friendly are all considered in this standard. By adhering to the guidelines set forth in BS EN 60601-1-11:2015+A1:2021, manufacturers can ensure that their products are not only compliant with regulatory requirements but also optimized for real-world use in home settings.

Ensuring Safety and Performance

Safety is a critical concern when it comes to medical electrical equipment. This standard outlines the necessary precautions and design considerations to mitigate risks associated with electrical hazards, mechanical failures, and environmental factors. It also emphasizes the importance of maintaining essential performance, ensuring that equipment functions reliably under expected conditions.

Design and Usability

One of the standout features of this standard is its focus on usability. It recognizes that home healthcare equipment must be intuitive and easy to use for both patients and caregivers. The guidelines encourage manufacturers to consider user interfaces, instructions, and training materials that enhance the overall user experience, reducing the likelihood of misuse or error.

Adaptability to Home Environments

Unlike controlled clinical environments, home settings can vary widely in terms of space, lighting, and accessibility. This standard provides guidance on designing equipment that can adapt to these diverse conditions, ensuring that it remains functional and effective regardless of the environment in which it is used.

Who Should Use This Standard?

The BS EN 60601-1-11:2015+A1:2021 standard is invaluable for a wide range of stakeholders in the healthcare industry, including:

  • Manufacturers: To design and produce compliant and market-ready medical electrical equipment.
  • Healthcare Providers: To select and implement equipment that meets safety and performance standards.
  • Regulatory Bodies: To ensure that products entering the market adhere to established safety and performance criteria.
  • Home Healthcare Professionals: To understand the capabilities and limitations of equipment used in patient care.

Conclusion

The BS EN 60601-1-11:2015+A1:2021 standard is a vital tool for ensuring the safety and effectiveness of medical electrical equipment used in home healthcare settings. By providing clear guidelines and requirements, it helps manufacturers, healthcare providers, and regulatory bodies work together to deliver high-quality care to patients in their homes. With its focus on safety, performance, and usability, this standard is an essential resource for anyone involved in the development and implementation of home healthcare solutions.

Invest in the BS EN 60601-1-11:2015+A1:2021 standard today to ensure that your medical electrical equipment meets the highest standards of safety and performance, providing peace of mind to both patients and healthcare providers alike.

DESCRIPTION

BS EN 60601-1-11:2015+A1:2021


This standard BS EN 60601-1-11:2015+A1:2021 Medical electrical equipment is classified in these ICS categories:
  • 11.020.10 Health care services in general
  • 11.040.01 Medical equipment in general

This International Standard applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems for use in the home healthcare environment, as defined in 3.1, and specified by the manufacturer in the instructions for use. This International Standard applies regardless of whether the me equipment or me system is intended for use by a lay operator or by trained healthcare personnel.

The home healthcare environment includes:

  • the dwelling place in which a patient lives;

  • other places where patients are present both indoors and outdoors, excluding professional healthcare facility environments where operators with medical training are continually available when patients are present.

This International Standard does not apply to me equipment and me systems intended solely for use in the emergency medical services environment, covered by IEC 60601‑1‑12 or solely for use in professional healthcare facilities covered by IEC 60601‑1 without the additions of IEC 60601‑1‑12 or this collateral standard. Nonetheless, me equipment or me systems can be intended for multiple use environments, and as such, if also intended for use in the home healthcare environment, are within the scope of this standard.

EXAMPLE Me equipment or me systems intended for both the home healthcare environment and the professional healthcare facility environment.

NOTE Home healthcare environment me equipment and me systems can frequently be used in locations with unreliable electrical sources and poor electrical grounding.

1.2 Object

The object of this collateral standard is to specify general requirements that are in addition to those of the general standard and to serve as the basis for particular standards.

1.3 Related standards

1.3.1 IEC 60601‑1

For me equipment and me systems, this collateral standard complements IEC 60601‑1.

When referring to IEC 60601‑1 or to this collateral standard, either individually or in combination, the following conventions are used:

  • "the general standard" designates IEC 60601‑1 aloneA1_start, including any amendmentsA1_end;

  • "this collateral standard" designates IEC 60601‑1‑11 aloneA1_start, including any amendmentsA1_end;

  • "this standard" designates the combination of the general standard and this collateral standard.

1.3.2 Particular standards

A requirement in a particular standard takes priority over the corresponding requirement in this collateral standard.