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What's included
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
✔ Testing the equipment
✔ Classification of the equipment (IEC 60601-1 classification)
✔ Identification, marking and documents
✔ Accuracy of controls and instruments, and protection against hazardous output
✔ Hazardous situations, fault conditions and protection against hazards
✔ Software and systems
✔ Construction of the equipment
✔ Electromagnetic compatibility
The 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. The standard includes particular and collateral standards.
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What's included
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
✔ Documentation of the tests
✔ Electromagnetic emission and immunity requirements
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.
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Labquality
How can we help?
Labquality’s experts will provide you with all the information you need about the IEC 60601-1 and 60601-1-2 standards. 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.
- Recognize the risks that the standard requires you to consider.
- Know how the standard requirements will soon change.
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