
Sähköturvallisuus IEC 60601
About the IEC 60601-1 StandardIEC 60601-1 is the basic safety standard for medical electrical devices and systems. It is a risk-based standard. The IEC 60601-1 standard is essential for manufacturers or repair shops of electrically operated medical devices. By meeting the requirements of IEC 60601-1, a medical device meets the requirements for Basic Safety. By meeting the requirements of the standard, a medical device also meets the requirements for Essential Performance. The IEC 60601-1 standard includes 405 pages and covers, e.g.: ✔ General requirements: risk management, essential performance, expected service life, patient contact, single fault condition The standard is a harmonized standard for the Medical Device Directive. How can Labquality help?Labquality’s experts will provide you with all the information you need about the IEC 60601-1 standard. With their help, you will: ✔ Understand the content of the standard and how to use it. ✔ Be able to combine the standard with other device-specific standards. |
About the IEC 60601-1-2 StandardIEC 60601-1-2 is one of the collateral standards within IEC 60601-1 and it concerns electromagnetic disturbances. It is a risk-based standard. The IEC 60601-1-2 standard is essential for medical device manufacturers. The standard covers an essential part of compliance with the EU MDR and FDA requirements. According to the IEC 60601-1-2, medical equipment and systems are expected to function and perform safely without interfering Additionally, the application of electromagnetic immunity standards is essential to ensure the safety of equipment and systems. The IEC 60601-1-2 standard includes 102 pages and covers, e.g.: ✔ General requirements: risk management, non-medical equipment, test conditions ✔ Identification, marking and documents The IEC 60601-1-2 standard is a harmonized standard for the Medical Device Directive. It will be harmonized to the Medical Device Regulation ETA in 2024 as EN 60601-1-2. How can Labquality help?Labquality’s experts will provide you with all the information you need about the IEC 60601-1 standard. With their help, you will: ✔ Understand the requirements of the standard and how to use it. ✔ Be able to combine the standard with other device-specific standards. |