Understanding the CE Mark for Measurement, Control and Laboratory Equipment

Compliance with regulations and obtaining the CE Mark are essential for accessing the European market. The CE Mark demonstrates proof of conformity and is a mandatory label for products sold within the European Economic Area (EEA).

Three particular groups of equipment that require CE Marking include measurement, control, and laboratory equipment. The applicable standards are EN 61326-1 for EMC and EN 61010-1 for safety. These standards are used to declare compliance with the EMC Directive (2014/30/EU) and the Low-Voltage Directives (2014/35/EU)./p>

Green Mountain Electromagnetics is an ISO 17025 accredited laboratory evaluating products for compliance with the European Union Directives. We offer EMC and safety testing services to help ensure that your equipment achieves compliance with all necessary regulations. 

Why is CE Marking Important for Measurement, Control and Laboratory Equipment?

CE Marking is a legal requirement for products that fall into measurement, control and laboratory equipment categories. Without demonstrating compliance with the EN 61326-1 and EN 61010-1, your equipment cannot be sold or used within the EEA, which will severely limit the reach of your products.

In addition to being a legal requirement, CE Marking is also a sign of quality and compliance. It reassures customers that your equipment is safe to use and will not cause electromagnetic interference.

What is the EN 61326-1 Standard?

The EN 61326-1 standard specifies EMC requirements for the design, manufacture and testing of measurement, control and laboratory equipment. This standard is designed to ensure that the equipment is robust when subjected to EMI and does not create electromagnetic emissions that could affect other nearby or connected equipment.

What is the EN 61010-1 Standard?

The EN 61010-1 standard specifies general safety requirements for the design, manufacture and testing of measurement, control and laboratory equipment. This standard is designed to ensure that the equipment is safe for use and does not pose any risk to operators or the environment.

The EN 61326-1 and EN 61010-1 standards apply to a wide range of equipment, including but not limited to:

Test and Measurement Equipment

Including digital multimeters, oscilloscopes, signal analyzers, and spectrum analyzers.

Process Control Equipment

Including programmable logic controllers (PLCs) and distributed control systems (DCSs).

Electrical Laboratory Equipment

Including laboratory balances, centrifuges (up to 250 ml capacity), environmental chambers, fume hoods, and lab reactors.

It's important to note that this is not an exhaustive list and that the standard applies to any equipment used for measurement, control, and laboratory use.

What Protection Does the EN 61326-1 Standard Provide?

The EN 61326-1 standard includes emissions testing to ensure a product does not affect other equipment and immunity testing to ensure the product can function in a commercial or industrial electromagnetic environment.

The primary components of the EN 61326-1 Standard include:

• Radiated Emissions.
• Conducted Emissions.
• Electrostatic Discharge (ESD) Immunity.
• Radiated (RF) Immunity.
• Electrical Fast Transient (EFT) Immunity.
• Surge Immunity.
• Conducted (RF) Immunity.

What Protection Does the EN 61010-1 Standard Provide?

The EN 61010-1 standard is based on risk assessment, which involves identifying hazards associated with the equipment and implementing appropriate measures to reduce or eliminate the risks.

The primary protections of the EN 61010-1 Standard include:

• Protection against electric shock.
• Protection against mechanical hazards.
• Protection against heat hazards.
• Protection against radiation hazards.
• Protection against hazards from fluids and gases.
• Protection against explosions and implosions.

What is the EN 61010-2 Series of Standards?

While the EN 61010-1 deals with general safety requirements, the EN 61010-2 series of standards outlines specific safety requirements for particular equipment categories. This series is divided into several parts, each covering specific equipment and their accessories. The purpose of these standards is to ensure that electrical equipment used in a laboratory is safe for both users and property.

The EN 61010-2 series covers the following equipment:

• Centrifuges (with a capacity higher than 250 ml)
• Autoclaves
• Refrigeration equipment
• Microscopes
• Laboratory ovens
• Ionizing radiation sources
• Analytical equipment

What Protection Does the EN 61010-2 Series of Standard Provide?

The EN 61010-2 series of standards complement the basic safety requirements set out by the EN 61010-1 standard. They add specific safety requirements that are not covered by the general standard.

How to Use the CE Mark for Measurement, Control and Laboratory Equipment?

For a manufacturer to declare compliance with EMC and Low-Voltage Directives and apply the CE Mark to equipment, they must prove that it complies with all applicable standards.

When your product has been deemed as compliant with relevant standards, a Declaration of Conformity (DoC) is created by the manufacturer. Supporting documentation including test results and design documentation are also collected and kept in a Technical File with the DoC.

It's important to note that the process of using the CE Marking can be complicated, depending on the type of equipment involved. Working with a reputable testing and certification company that specializes in CE Mark testing can make the process much more efficient and cost-effective.

Reach out to us today with any questions.