Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
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 the uncontrolled home environment? This standard gives guidance on how to address these issues.
BS EN 60601-1-11 gives requirements and recommendations for the safety and performance of medical electrical equipment and medical electrical systems for home healthcare. Developed with contributions from clinicians, engineers and regulators, and originally published in 2010, it has now been revised to align with the current version of the general standard in this series, BS EN 60601-1:2006+-A12:2014.
The standard applies to use by both lay operators and trained healthcare personnel. Among many other aspects of safety and performance, its scope includes:
- Transport and storage
- Requirements for testing
- Operating instructions
- Marking and labelling
- Usability of documents
BS EN 60601-1-11:2015 will benefit manufacturers of medical electrical equipment and systems. Compliance with this standard can provide a presumption of conformity with EC Directive 93/42/EEC.