News & Info
18.10.2010
New CE Certification for disinfactant fluids
Kleinmann's new disinfection product Destix MK75 for surfaces, otoplasty and hearing aids Until now Kleinmann had restricted its range to disinfectants for office equipment. The offering will be extended with the Destix Mk75 brand and now contains disinfectant cleaning wipes for medical inventory. The disinfection of medical inventory requires that the disinfectant be produced in accordance with the EC Directive 93/42/EWG. The fluid has been successfully tested against: Staphylococcus aureus, Escherichia coli, Proteus mirabilis, Pseudomonas aeruginosa, Candida albicans. Kleinmann was already certified according to ISO 13485, and has now achieved EC certification in accordance with 93/42/EWG. Previously ISO 13485 enabled us to fill CE-approved fluids for our customers. The EC certification now authorises us to market a product under our name ourselves. As a specialist for private label products, we also want to be able to offer this product under our customers' own brands. The questions below are designed to provide interested customers with an initial overview of the potential applications and also of the prerequisites for using the product under a private label format.
What benefits does this certification of Kleinmann have for the customers?
The disinfection of medical inventory is understandably subject to stricter regulations than the disinfection of office equipment. Such certification is a legal requirement for application on surfaces such as dentists' chairs, otoplasty and hearing aids. In addition, it facilitates the movement of goods within the EU region.
What private label products can in principle be certified?
Disinfectant cleaning wipes which contain our Destix (MK75) fluid can be certified. The products must be explicitly labelled as intended for use on medical inventory, such as disinfectants for doctors' surgeries, hospitals, etc. This does not apply for disinfectant products for office equipment! The product may only be used on surfaces such as couches, cupboards and shelves, but not on medical instruments.
What must be observed for the declaration?
The "specified authority" at which the product is certified must be listed. Kleinmann must also be mentioned on the label as the company which brought the product onto the market. Alternatively, the customer themselves can be named if they have EC certification and thus the authorisation to be specified as the manufacturer.
What obligations does the customer take on here, and what duties Kleinmann?
These obligations will be regulated in an OEM agreement between the customer and Kleinmann. The customer will always take over our product and its EC certification 100%. As a result the customer is obligated not to change the properties, application and declaration of this product and to register it with the public authorities. Kleinmann is responsible for the product's properties and for maintaining the quality.
How long is such a certificate valid?
The EC certificate is valid for 5 years.
Can customers have an existing, alternative CE-certified fluid filled by Kleinmann?
ISO 13485 authorises us to fill a fluid provided by the customer. What must be observed when the products are exported to EU countries? The movement of goods involving disinfectant products is subject to a number of guidelines of the EU and of the country in which the product is to be marketed. A product approved with CE considerably facilitates the movement of goods. Currently we are working on registering the products in Austria and Poland. France and Spain are due to follow in the near future.