What is BS EN 60601-2-18 - Safety and performance of endoscopic equipment about?
BS EN 60601 is a European standard that discusses medical electrical equipment. BS EN 60601-2-18 is the eighteenth subpart of the second part of a multi-part series that provides the basic safety and performance of endoscopic equipment together with its interconnection conditions and interface conditions to ensure the practical degree of safety in the operation of endoscopic equipment.
The object of BS EN 60601-2-18 is to establish basic safety and essential performance requirements for endoscopic equipment.
Note: The object under BS EN 60601-2-18 includes endoscopic intense light source equipment which is part of the endoscopic equipment including its supply unit, therefore IEC 60601-2-57 does not apply.
Who is BS EN 60601-2-18 - Safety and performance of endoscopic equipment for?
BS EN 60601-2-18 on safety and performance of endoscopic equipment is useful for:
- Manufacturers of endoscopic equipment
- Operators and technical staff for endoscopic equipment
- Medical test laboratories
- Regulatory authorities
Why should you use BS EN 60601-2-18 - Safety and performance of endoscopic equipment?
An endoscope is a medical instrument having viewing means, with or without optics, introduced into a body cavity through a natural or surgically created body opening for examination, diagnosis, or therapy. Endoscopic equipment is an energized endoscope together with its supply unit(s), as required for its intended use.
BS EN 60601-2-18 guideline assists you with general requirements for testing of medical electrical equipment, protection against electrical hazards, protection against mechanical hazards, protection against unwanted, protection against excessive radiation hazards, protection against excessive temperatures, and other hazards for basic safety and essential performance of endoscopic equipment.
BS EN 60601-2-18 also provides guidance on the accuracy of controls, protection against hazardous outputs, hazardous situations, fault conditions, programmable electrical medical systems, and electromagnetic compatibility for endoscopic equipment.
With obedience and compliance to BS EN 60601-2-18, you can enhance the efficacy and standardise the performance of endoscopic equipment. In addition, ensures the health and safety of patients and operators.
What’s changed since the last update?
BS EN 60601-2-18:2015 supersedes IEC 60601-2-18:1996, which is withdrawn. BS EN 60601-2-18:2015 is the third edition that replaces the second edition published in 1996. As compared to the second edition, the main changes are:
- Alignment of requirements with IEC 60601-1:2005
- Inclusion of essential performance requirements
- The inclusion of energized endoscopes and energized endo-therapy devices used through second and subsequent punctures within the scope of the standard
- Reference to IEC 60601-2-2 for the dielectric strength testing of HF energized endo-therapy devices, rather than defining different tests