BS EN 60601-1-6:2010+A2:2021 Medical Electrical Equipment - General Requirements for Basic Safety and Essential Performance

Collateral Standard: Usability

Ensure the highest standards of safety and performance in medical electrical equipment with the BS EN 60601-1-6:2010+A2:2021 standard. This comprehensive document outlines the general requirements for basic safety and essential performance, focusing on the critical aspect of usability. Released on August 13, 2021, this standard is an essential resource for manufacturers, designers, and healthcare professionals committed to delivering safe and effective medical devices.

Key Features and Benefits

• Standard Number: BS EN 60601-1-6:2010+A2:2021
• Pages: 26
• Released: August 13, 2021
• ISBN: 978 0 580 97718 3
• Status: Standard

Comprehensive Coverage

This standard provides a detailed framework for ensuring the usability of medical electrical equipment. It addresses the essential performance and safety requirements that must be met to protect patients and healthcare providers. By adhering to these guidelines, manufacturers can enhance the reliability and effectiveness of their medical devices, ultimately improving patient outcomes.

Usability Focus

Usability is a critical factor in the design and operation of medical electrical equipment. The BS EN 60601-1-6:2010+A2:2021 standard emphasizes the importance of user-centered design, ensuring that devices are intuitive and easy to use. This focus on usability helps to minimize the risk of user error, enhancing the overall safety and effectiveness of medical devices.

Global Relevance

As a widely recognized standard, BS EN 60601-1-6:2010+A2:2021 is relevant to medical device manufacturers and healthcare providers around the world. Compliance with this standard demonstrates a commitment to quality and safety, facilitating market access and acceptance in various regions. By following these guidelines, manufacturers can ensure that their products meet international safety and performance standards.

Up-to-Date Information

Released in 2021, this standard incorporates the latest advancements and best practices in the field of medical electrical equipment. It reflects current industry trends and regulatory requirements, providing manufacturers with the most up-to-date information to guide their design and production processes. Staying current with these standards is essential for maintaining compliance and ensuring the highest levels of safety and performance.

Essential for Compliance

Compliance with the BS EN 60601-1-6:2010+A2:2021 standard is crucial for manufacturers seeking to market their medical electrical equipment. This standard provides a clear and comprehensive set of requirements that must be met to achieve regulatory approval. By following these guidelines, manufacturers can streamline the approval process and ensure that their products meet the necessary safety and performance criteria.

Detailed and Accessible

With 26 pages of detailed information, the BS EN 60601-1-6:2010+A2:2021 standard is both comprehensive and accessible. It provides clear and concise guidelines that are easy to understand and implement. This makes it an invaluable resource for manufacturers, designers, and healthcare professionals who need to ensure the safety and effectiveness of their medical devices.

ISBN and Identification

The standard is identified by the ISBN 978 0 580 97718 3, ensuring that it can be easily referenced and sourced. This unique identifier helps to distinguish it from other standards and ensures that users can quickly and accurately locate the document they need.

Conclusion

The BS EN 60601-1-6:2010+A2:2021 standard is an essential resource for anyone involved in the design, manufacture, or use of medical electrical equipment. By providing clear and comprehensive guidelines for basic safety and essential performance, with a particular focus on usability, this standard helps to ensure that medical devices are safe, effective, and user-friendly. Stay ahead of the curve and ensure compliance with the latest industry standards by incorporating this critical document into your processes.

BS EN 60601-1-6:2010+A2:2021

This standard BS EN 60601-1-6:2010+A2:2021 Medical electrical equipment is classified in these ICS categories:

• 11.040.01 Medical equipment in general

1.1 * Scope

This International Standard specifies a process for a manufacturer to analyse, specify, develop and evaluate the usability, as it relates to basic safety and essential performance of medical electrical equipment, hereafter referred to as me equipment.

This usability engineering process assesses and mitigates risks caused by usability problems associated with correct use and use errors, i.e., normal use. It can be used to identify but does not assess or mitigate risks associated with abnormal use.

If the usability engineering process detailed in this collateral standard has been complied with, then the usability of me equipment as it relates to basic safety and essential performance is presumed to be acceptable, unless there is objective evidence to the contrary.

NOTE Such objective evidence can subsequently originate from post-production surveillance.

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, 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 alone, including any amendments;

• "this collateral standard" designates IEC 60601‑1‑6 alone, including any amendments;

• "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.