For the marketing of laboratory equipment and facilities and IVD devices in the EU, CE marking is mandatory. In addition, the essential requirements for each product must be evaluated and documented in accordance with the Low Voltage Directive 2014/35/EU and the EMC Directive 2014/30/EU.
The IEC 61010-1 series of standards is to be applied in the area of product safety for "Electrical test and measurement equipment," "Electrical industrial process-control equipment," and "Electrical laboratory equipment". The basic standard IEC 61010-1 specifies the general safety requirements for measuring, control, and laboratory equipment. This involves checking through the basic safety requirements.
These include the following topics:
- Marking and documentation
- Protection against electric shock
- Protection against mechanical hazards
- Resistance to mechanical stresses
- Protection against the spread of fire
- Device temperatures and heat resistance
- Protection against fluid hazards
- Protection against radiation, including laser radiation, and against sound and ultrasonic pressure
- Protection against released gases and substances, explosion, and implosion
- Components and assemblies
- Protection by locking
- Hazards arising from the application and risk assessment
In addition to the basic standard, the safety criteria for specific types of measuring, control, and laboratory equipment are covered by "61010-2 Standards / Special Requirements." Both the basic standard and the 61010-2 standards must be met to confer presumption of conformity on your device.
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