B. Braun confirms with the CE-labelling and with the declaration of conformity of our medical devices that the respective products are in compliance with the “essential requirements” of the European Medical Device Directive (93/42/EWG) dated June 14th, 1993 and the German Act on Medical Devices.
This includes that the below mentioned medical devices are designed and manufactured in a way that when used under the conditions and for the purpose intended, they will not compromise the clinical condition or the safety of patients nor the safety and health of users or third parties if the products are used under the intended condition and purpose. Respective assessments are executed e.g. in combination with the implementation of the risk management system according to ISO 14971.
Since adoption of the European Directive ‚REACH’ (Registration, Evaluation and Authorisation of Chemicals) we have to inform which devices include a substance named in the so called list of candidates in a concentration of more than 0.1 mass percentage. This list has been announced to public on the ‘ECHA’ website (European chemical Agency) on October 28th, 2008 and has been updated continuously.
According to substances published in the list of candidates only DEHP (Bis (2-ethyl (hexyl) phthalate) is present in relevant concentrations in some of our products / medical devices.
The affected products from the Hospital Care Division, the DEHP to more than 0.1 mass percentage mentioned are labeled as follows:
The identification is based on the following rules: Directives 67/548/EEC, 1999/45/EC and EC Regulation No. 1272/2008 (CLP Regulation) and the REACH Regulation (1907/2006).
With this labeling we comply with the obligation to provide information in compliance with article 33 § 1 of the REACH Regulation.
This letter will be actualized if a substance relevant to our products has been added to the list of candidates. Until then this letter is valid.