Medical Device Testing Services
What is IEC 60601-1?
Standards play a paramount role in product design and development. IEC 60601-1 is a series of technical standards for the safety and effectiveness of medical electrical equipment. The force of this standard is to require two level of protection to guard the patient and operator from any injury. It is recognized worldwide. This standard is of four parts:
- Base standard: General requirements for basic safety and essential performance. IEC 60601-1
- Collateral standards: Generally numbered as IEC 60601-1-) for example IEC 60601-1-11 General requirement for basic safety and essential performance collateral standard requirement for medical electrical equipment and medical electrical system used in the home health care environment.
- Particulate standards: They are numbered as IEC 60601-2-) for example IEC 60601-2-52 particular requirement for the basic safety and essential performance of medical beds.
- Performance standards: Generally numbered as IEC 60601-3-
Essential performance requirement for transcutaneous oxygen and carbon dioxide partial pressure monitoring equipment.