BS EN 60601-1-6:2010+A1:2015

What is this standard about? 

BS EN 60601-1-6 is part of a series of international standards on medical electrical equipment, covering basic safety and essential performance for both equipment and systems.It is a collateral standard – its objective is to specify requirements that are in addition to those of the general standard. BS EN 60601-1-6 looks specifically at the usability of medical electrical equipment. It complements BS EN 60601-1.

Who is this standard for?

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

Why should you use this standard?

This collateral standard specifies a process for a manufacturer to analyse, specify, design, verify and validate the usability of equipment, relating to safety and performance. As medical equipment develops, it is also increasingly being used by patients and non-specialist health care professionals, so improvements to usability are needed. It outlines a usability engineering process which assesses and mitigates risks caused by usability problems associated with normal use.

NOTE: The standard can be used to identify but does not assess or mitigate risks associated with abnormal use.

What’s changed since the last update?

The third edition of this standard has been systematically reviewed by experts to ensure its continued market relevance and to take into consideration technological developments. Changes include:

• Revisions to align with the usability engineering process in IEC 62366
• Table B-1 has been developed to map the clauses and sub-clauses relevant to IEC 62366
• The reference to the complete life cycle process (including post production monitoring and surveillance) has been removed