What Is IEC 60601?

IEC 60601 is a series of technical standards for the safety and essential performance of medical electrical equipment, published by the International Electrotechnical Commission. The IEC is an international standard and widely excepted. However, it is not the only standard; there are regional standards such as EN for Europe, CSA for Canada, and ANSI/​AAMI for the US. They are based on the IEC and similar in scope and execution.

The intent of the standard is to provide safety requirements for medical electrical equipment, and it is widely used by medical device manufacturers. Safety features that are taken into account include sharp edges, pinch points, how it handles while leaning, tipping potential and broaching thresholds.

Since GCX designs and manufactures mechanical products, only the mechanical safety section of IEC 60601 can be applied to GCX products. The other sections of IEC 60601 mainly deal with electrical parts and, thus, are not applicable. Our customers will typically expect our products to comply with these requirements. We can perform testing in-house to verify compliance(1). Testing beyond these standards can be accommodated for an additional fee. 

*1. IEC 60601 testing standards are included as part of the NRE fee at the onset of project.

NOTE: GCX is not a certified lab. For GCX-branded products, we consider this standard a baseline reference and typically test well beyond it.