The final article in a six part series on CE marking
The Final Step
The final step in the CE marking process involves affixing the CE mark to the product. This signifies the manufacturer's declaration that the product meets all applicable EU health, safety, and environmental requirements.
However, there are a number of other product labeling requirements to consider before affixing the CE mark.
Safety Labeling
Many directives and standards used for CE compliance require the use of labeling to inform the user, maintenance, or service personnel of specific hazards or critical information such as safety earth circuits.
This labeling is usually identified during the conformity assessment phase of the CE marking process and may consist of a number of ISO graphical symbols used to communicate specific hazards. These labels and their locations need to be identified and documented before affixing the CE mark.
The Product Information Label
The product information label contains critical information about the product and the manufacturer (or representative). The exact information needed on the product label varies by directive, however the following information is recommended for most equipment:
Manufacturer's Information:
Contact information for the product's manufacturer and/or official European representative must be included on the label.
Name
Address
Contact information (website, telephone, etc.)
This information ensures the manufacturer can be easily identified and contacted if needed
Product Identification:
The product label must include enough information about the specific product that it can be uniquely identified in case of a safety incident or product recall. Suggested information includes:
Product name
Product model
Product serial number (if serialized)
Date of manufacture
Country of Origin:
Indicates the country where the product was manufactured.
Electrical Specifications:
Any electrical specifications needed for safe and reliable operation of the product should be included on the product information label, such as:
Voltage, including AC/DC indication
Current
Frequency
Product Weight:
Equipment and machinery product labels should include the weight of the product to inform the user, installer, or service person about lifting and appropriate surface for storage and operation.
Safety Warnings and Instructions:
Any necessary warnings or instructions to ensure safe use of the product should be included on the product label or the user should be referred back to a safety document, such as the Operator's Manual.
Notified Body Number:
If an EU Notified Body was used for product conformity assessment, the Notified Body registration number needs to be included on the product label.
The Operator's Manual:
An often overlooked component of the product information label is a reference to the operator's manual or other provided safety documentation.
If the manufacturer has identified product risk and reduced that risk by providing information in the operating instructions, they have an obligation to inform the user. This is usually done with a symbol such as ISO 7000-1641.
In some instances, the information symbol may also be accompanied by the attention symbol (exclamation point) to draw attention to important instructions. These symbols are typically placed on the product information label where they can by readily seen by the operator or service personnel.
Environmental Labeling:
There is no longer a requirement for RoHS labeling, the CE mark indicates compliance with all applicable directives. The manufacturer may voluntarily chose to include information on their product labels for marketing purposes.
Affixing the CE Mark
And finally we get to the CE mark.
The CE mark can be applied independent of other labels, however it is typically included as part of the product information label. Artwork for the CE mark can be found on the European Commission website.
The following marking requirements are required by most directives, these requirements should be followed for the entire product information label:
Visibility and Legibility:
The CE marking must be clearly visible, legible, and indelible. It should be permanently affixed to the product or its data plate in a location readily accessible for inspection by authorities or consumers.
Size and Proportion:
The marking's size and proportions must be appropriate to the product's size and surface. There's no minimum size requirement, but it should be large enough to be easily seen and read.
The manufacturer can appoint an authorized representative based in the EU to affix the marking on their behalf. This representative must have a mandate from the manufacturer to act on their behalf for CE marking purposes.
Striper Solutions LLC, Your Regulatory Partner
With over 30 years development experience and more than a decade providing consulting services, Striper Solutions has demonstrated a commitment to excellence and integrity in developing new products. Embracing a shift to regulatory compliance allows us to focus on a critical area of product development with the dedication and quality our customers need.
See more at www.striperllc.com
コメント