Skip to main content
Contact Us
MEDICAL · STANDARDS

What Is IEC 60601-1?

IEC 60601-1 is the international safety standard for medical electrical equipment. It sets requirements for basic safety and essential performance, covering protection against electric shock, leakage current, insulation, temperature, fire and mechanical hazards. EN 60601-1 is the European adoption of the same standard, and related parts such as IEC 60601-1-2 cover electromagnetic compatibility.

01

The Short Answer

The standard matters most near the patient. Equipment within the patient environment, the space around a patient where contact is possible, has to meet IEC 60601-1 itself or be combined with other equipment into a compliant medical electrical system, for example by using isolation or a medical grade power supply.

  • //
    Leakage current Strict limits on current that could flow through a patient or operator.
  • //
    Insulation and isolation Defined levels of protection, measured as MOOP and MOPP.
  • //
    Power supplies Medical grade supplies help a system meet the limits.
  • //
    System approval A cart or workstation is assessed as a whole, not just its parts.
02

Why It Matters

Our MOOP vs MOPP FAQ and medical grade power supply FAQ go deeper. The medical cart computer case study used EN 60601-1 certified hardware; see our work in medical and pharmaceutical.