BS EN 60601-1:2006+A2:2021

What is BS EN 60601-1 - Medical equipment safety about?

This is the first in an extensive series of European standards on medical electrical equipment safety. It is the first “Part 1” standard and covers basic safety and essential performance for all medical electrical equipment and systems. The other Part 1 standards – known as “collateral standards” – set out requirements that are in addition to those in BS EN 60601-1:2006+A2:2020. The “Part 2” standards in the series cover requirements for specific product groups.

Who is BS EN 60601-1 - Medical equipment safety for:

• Manufacturers and users of medical equipment
• Suppliers of medical electronic equipment and components
• All healthcare facilities/hospitals/intensive care units
• Health and safety professionals
• Regulatory bodies

Why should you use BS EN 60601-1 - Medical equipment safety?

This is the “parent” standard, covering the basic safety and essential performance of medical electrical equipment and medical electrical systems. BS EN 60601-1:2006+A2:2020 can also be applied to equipment used for compensation or alleviation of disease, injury or disability. Its purpose is to specify general requirements and to serve as the basis for further collateral standards.

NOTE: The IEC 60601 series does not apply to:

• In vitro diagnostic equipment that does not fall within the definition of ME Equipment, which is covered by the IEC 61010 series
• Implantable parts of active implantable medical devices, which is covered by the ISO 14708 series
• Medical gas pipeline systems covered by ISO 7396-1

What has changed since the last update?

Inconsistencies were identified in the previous version which caused confusion for users. These were in references, measurement units, testing requirements, and in the regional application of the standard. Amendments have been made to clarify points of reference throughout the standard.

BS EN 60601-1:2006+A2:2020 contributes to UN Sustainable Development Goal 3 on ensuring healthy lives and promoting well-being for all at all ages. Specifically the standard underpins the safety of medical electrical equipment and systems.