BS EN IEC 80601-2-78:2020 - Medical Electrical Equipment Standard

In the rapidly evolving field of medical technology, ensuring the safety and performance of medical equipment is paramount. The BS EN IEC 80601-2-78:2020 standard is a crucial document that sets out the particular requirements for the basic safety and essential performance of medical robots used in rehabilitation, assessment, compensation, or alleviation. Released on April 6, 2020, this standard is an indispensable resource for manufacturers, healthcare providers, and regulatory bodies involved in the development and use of medical robots.

Comprehensive Coverage

Spanning 82 pages, this standard provides a comprehensive framework for ensuring that medical robots meet the necessary safety and performance criteria. It addresses a wide range of considerations, from electrical safety to mechanical performance, ensuring that these sophisticated devices can be used effectively and safely in clinical settings.

Key Features

• Standard Number: BS EN IEC 80601-2-78:2020
• ISBN: 978 0 580 96579 1
• Status: Standard
• Release Date: April 6, 2020

Why This Standard Matters

As medical robots become increasingly integral to patient care, particularly in rehabilitation and assessment, the need for stringent safety standards becomes ever more critical. This standard ensures that medical robots are designed and manufactured to the highest safety and performance standards, minimizing risks to patients and healthcare professionals alike.

Ensuring Patient Safety

Patient safety is at the heart of the BS EN IEC 80601-2-78:2020 standard. It outlines the essential performance requirements that medical robots must meet to ensure they do not pose any undue risk to patients. This includes guidelines on electrical safety, mechanical stability, and software reliability, all of which are crucial for preventing accidents and ensuring effective treatment outcomes.

Enhancing Performance

Beyond safety, this standard also focuses on the essential performance of medical robots. It provides detailed criteria for evaluating the functionality and effectiveness of these devices, ensuring they deliver the intended therapeutic benefits. This is particularly important in rehabilitation settings, where the precise performance of a robot can significantly impact patient recovery.

Who Should Use This Standard?

The BS EN IEC 80601-2-78:2020 standard is an invaluable resource for a wide range of stakeholders in the medical technology field, including:

• Manufacturers: To ensure their products meet international safety and performance standards.
• Healthcare Providers: To understand the safety and performance criteria of the medical robots they use.
• Regulatory Bodies: To assess compliance with international standards.
• Researchers and Developers: To guide the design and development of new medical robotic technologies.

Conclusion

The BS EN IEC 80601-2-78:2020 standard is a critical document for anyone involved in the development, regulation, or use of medical robots. By adhering to this standard, stakeholders can ensure that these advanced technologies are safe, effective, and reliable, ultimately enhancing patient care and outcomes. Whether you are a manufacturer looking to certify your products, a healthcare provider seeking to understand the equipment you use, or a regulatory body ensuring compliance, this standard is an essential tool in your arsenal.

Invest in the safety and performance of your medical robots with the BS EN IEC 80601-2-78:2020 standard, and be at the forefront of medical technology innovation.

BS EN IEC 80601-2-78:2020

This standard BS EN IEC 80601-2-78:2020 Medical electrical equipment is classified in these ICS categories:

• 11.040.01 Medical equipment in general

IEC 80601-2-78:2019 applies to the general requirements for BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ROBOTS that physically interact with a PATIENT with an IMPAIRMENT to support or perform REHABILITATION, ASSESSMENT, COMPENSATION or ALLEVIATION related to the PATIENT’S MOVEMENT FUNCTIONS, as intended by the MANUFACTURER.
IEC 80601-2-78:2019 does not apply to
• external limb prosthetic devices (use ISO 22523),
• electric wheelchairs (use ISO 7176 (all parts)),
• diagnostic imaging equipment (e.g. MRI, use IEC 60601-2-33), and
• personal care ROBOTS (use ISO 13482).