IEC 60601-1 - Medical Electrical Equipment Safety
Clauses 11 to 13: temperatures, fire, outputs, hazardous situations and fault conditions – IEC 60601-1 - Medical Electrical Equipment Safety

IEC 60601-1 - Medical Electrical Equipment Safety 11.7: 11.7 Biocompatibility of ME equipment and ME systems

Any equipment, system, part or accessory meant to touch body fluids, cells or biological tissues, directly or indirectly, is evaluated and documented following the principles and guidance of the ISO 10993 series, checked by inspecting the manufacturer's information.

Maintained by Gerard BlokdykControl text last updated

Other controls in Clauses 11 to 13: temperatures, fire, outputs, hazardous situations and fault conditions – IEC 60601-1 - Medical Electrical Equipment Safety

Query this from an agent

The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.