BS EN 80601-2-35:2009+A1:2016

What is this standard about? 

BS EN 80601 is a series of technical standards covering medical electrical equipment. Part-2-35 is the latest revision to the standard that covers the safety and performance requirements for heating devices using blankets, pads or mattresses.

Who is this standard for?

• Manufacturers, suppliers and operators of heating devices
• All healthcare facilities/hospitals
• Health and safety professionals
• Healthcare regulatory bodies

Why should you use this standard? 

The guidelines specified in this part of BS EN 80601 aim to minimize the dangers to patients and medical operators that might arise from using these type of heating devices. The standard also specifies tests for demonstrating compliance with these requirements. 

Heating devices intended to pre-warm a bed are also included in the scope of this European standard. 

What’s changed since the last update?

This edition constitutes a technical revision. It provides consistency with the third edition of BS EN 60601-1, as well as with other standards related to paediatric equipment and includes the following changes:

• Amendment specifying heating devices shall have type BF applied parts or type CF applied parts
• Additional minimum requirements for marking
• Additional requirements for warning and safety notices and start-up procedures
• Additional requirements for means of patient protection (MOPP)