BS EN 60601-2-23:1996 - Medical electrical equipment. Particular requirements for safety - Specification for magnetic resonance equipment for medical diagnosis
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BS EN 60601-2-23:1996 is a British Standard that specifies the safety and performance requirements for transcutaneous electrical nerve stimulators (TENS). This standard was adopted from the international standard IEC 60601-2-23:1993.
TENS units are medical devices that use low voltage electrical impulses to treat pain and promote healing. They are typically used for conditions such as chronic pain, arthritis, and sports injuries.
The standard covers safety requirements for TENS units, including electrical safety, mechanical safety, and environmental safety. It also specifies performance requirements, including accuracy, reliability, and consistency.
Some specific topics covered by the standard include:
Electrical safety requirements, including insulation, grounding, and protection against electric shock
Mechanical safety requirements, including stability, durability, and protection against hazardous mechanical conditions
Environmental safety requirements, including protection against moisture and heat
Performance requirements, including accuracy and reliability of electrical output, and consistency of therapy over time
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 TENS units in Europe and other regions that have adopted the standard. It is intended to ensure the safety and effectiveness of these devices for patients who rely on them for pain relief and other therapeutic purposes.
BS EN 60601-2-23:1996 - Medical electrical equipment. Particular requirements for safety - Specification for magnetic resonance equipment for medical diagnosis
