BS EN 60601-2-22:1996 - Medical electrical equipment. Particular requirements for safety - Specification for diagnostic and therapeutic laser equipment
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BS EN 60601-2-22:1996 is a British Standard that specifies the safety and performance requirements for diagnostic and therapeutic ultrasound equipment. This standard was adopted from the international standard IEC 60601-2-22:1995.
The standard applies to ultrasound equipment used for both diagnostic and therapeutic purposes, including pulsed, continuous wave, and doppler ultrasound. It covers a range of equipment types, including handheld and portable devices, as well as larger console-based systems.
The standard includes requirements for electrical safety, mechanical safety, and performance testing. It also includes requirements for the labeling and documentation of ultrasound equipment.
Some specific topics covered by the standard include:
Electrical safety requirements, including grounding, insulation, and protection against electric shock
Mechanical safety requirements, including stability, durability, and protection against hazardous mechanical conditions
Performance testing requirements, including accuracy, repeatability, and frequency response
Requirements for labeling and documentation, including user manuals, warning labels, and specifications for accessories and consumables
Compliance with this standard is often required for the sale and use of ultrasound equipment in Europe and other regions that have adopted the standard.
BS EN 60601-2-22:1996 - Medical electrical equipment. Particular requirements for safety - Specification for diagnostic and therapeutic laser equipment