What is this standard about?
BS EN 60601-1-11:2015 is part of a series of international standards on medical electrical equipment, covering basic safety and essential performance for both equipment and systems.This part covers medical equipment used in the home. It is a collateral standard which means its objective is to specify requirements that are in addition to those of the general standard. It also complements BS EN 60601-1.
Who is this standard for?
- Those working in the home healthcare industry
- Users of medical equipment in the home
- Manufacturers of electrical medical equipment
- Suppliers of medical electronic equipment and components
- Health and safety professionals
- Regulatory bodies
Why should you use this standard?
People are increasingly using medical equipment in their own homes, for monitoring, treatment and diagnosis – which raises the question, will the equipment work properly and safely when used by untrained operators in an uncontrolled home environment? This standard gives guidance on how to address these issues and includes recommendations on testing, marking and labelling, maintenance, operating instructions and transport, and storage.
What’s changed since the last update?
This part of the collateral standard has been systematically reviewed by experts to ensure its continued market relevance. Significant changes include:
- Closer alignment with the current version of the general standard in this series, BS EN 60601-1:2006+A12:2014
- Redrafting of sub clauses
- Correction of test method for relative humidity control at temperatures above 35 °C