IEC 60601-1 : General requirements for basic safety and essential performance
IEC 60601-1 standard is a standard that contains the rules and requirements regarding the basic safety and required performance of electrical medical equipment and electrical medical systems. Addressing most of the risks associated with electronic medical devices, the TS EN 60601-1, IEC 60601-1 standard has become a de facto requirement for electromedical products by most institutions and organizations. As LVT Test Laboratory, we carry out tests of electrical medical equipment and systems in our accreditation scope in accordance with TS EN 60601-1, IEC 60601-1 standards.
Main Requirements Required by TS EN 60601-1, IEC 60601-1 Standards;
- Risk Management File: The IEC 60601-1 standard provides requirements on the risk management file prepared for the device in order to identify and control the risks that may arise from the use of the electrical medical device. There are references to the TS EN ISO 14971 standard on these issues.
- Mechanical Requirements: IEC 60601-1 standard electrical medical device against the wear, abrasion, there are criteria in which the standard has appeared for the specified lifetime of the device. It is available in the IEC 60601-1 standard within the criteria for the operator, patient and the environment within medical devices with moving parts.
- Labels and Markings: The IEC 60601-1 standard provides requirements for labels, signs and symbols on the electrical medical device. These signs and symbols are defined in test protocols for erasure, wear and deformation.
- Documentation Supplied with Electrical Medical Device: IEC 60601-1 standard is provided for the documents provided with the product, for example; user manual etc. specifies the requirements regarding the content of the documents.
- Safety Against Electric Shock: The IEC 60601-1 standard provides requirements and criteria according to the class of the electrical medical device (Class I, Class II, IP). The electrical medical device's grounding, insulation, leakage current levels and other requirements are within its standard scope.
- Electrical Medical Device Software Safety: The IEC 60601-1 standard provides requirements for medical devices with software in accordance with the design and use. There are references to the IEC 62304 standard on these issues.
- Exceeding Temperatures: The IEC 60601-1 standard states that the electrical medical device does not create a hazardous situation for the operator and patient when the manufacturer's specified and prescribed use is achieved. These issues include test protocols and criteria in the IEC 60601-1 standard.
As the LVT Test Laboratory, we carry out the tests of the TS EN 60601-1-6 standard, which contains the requirements regarding the ease of use of electrical medical devices, and the standard of the TS EN 60601-1-8 electrical medical devices' warning&alarm systems.