BS EN 60601-1-8:2007+A11:2017

What is this standard about? 

BS EN 60601-1-8 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 60601-1-8 covers alarm systems and signals related to medical electrical equipment. It complements BS EN 60601-1.

Who is this standard for?

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

Why should you use this standard?

Part 1-8 of this collateral standard specifies basic safety and essential performance requirements and tests for the application of alarm systems and signals. It also provides guidance for their application.

The standard defines alarm categories (priorities) by degree of urgency and also covers consistent alarm signals and consistent control states and their marking for alarm systems.

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. Changes include:

• Additional technical requirements for the marking of controls and instruments are specified in this collateral standard, listed in Annex B
• Additional requirements on accompanying documents are specified in Table B2
• Additional requirements on instructions for use are listed in Table B3
• There is greater definition of visual information signals and visual alarm signals