Quality and Safety

For more than a century, Andreas GmbH & Co.KG has manufactured products with a dedication to quality and safety that has been recognized the world over. We combine quality materials and experienced German engineering to deliver products with the performance and durability to match today’s busy workflows and to keep our customers safe. All units are tested for safety and comply with all international regulatory standards. In-house engineering and manufacturing allow us to keep quality standards at the highest level. It is the quality, safety, and reliability of Hettich products that has made us one of the leading centrifuge and incubator manufacturers worldwide.

International marks of conformity such as CE or IEC 61010 along with ISO 9001, ISO 13485 and ISO 14001 certificates show the extreme care and responsibility Hettich puts into the manufacturing of its centrifuges and accessories.

REGULATORY CERTIFICATIONS

Hettich centrifuges comply with the European IvD guide-line’s requirements (98/79/EC) and guarantee a standardized level of quality and safety.

Under Rule 3 in the Classification section of Annex IX to the EU Directive 93/42/EEC, centrifuges used for the manufacture of blood products for transfusion purposes require approval as Class IIa medical products. Hettich holds this approval for the ROTO SILENTA 630 RS, ROTIXA 500 RS and ROTANTA 460 line of centrifuges, as shown by a declaration of conformity in accordance with Annex V to Directive 93/42/EEC.

ISO Certified

• ISO 13485: a comprehensive set of standards for quality management systems that apply to medical device manufacturers. The standards ensure not only that compliant medical devices are designed in response to customers’ needs but also that regulations are met and that an effective traceability system is implemented.
• ISO 9001: a comprehensive set of standards for quality management systems. Holds strong focus on meeting the needs of customers and mandates a system for continual improvement.
• ISO 14001: a set of criteria for environmental management systems. It assists organizations to control and reduce their environmental impact.

TÜV Certified 

• TÜV (Technischer Überwachungsverein) is a German third-party assessor of quality and safety. They provide their seal as well as the European CE mark that signify safety-regulations conformity. TÜV is recognized by OSHA and the SCC as a Nationally Recognized Testing Laboratory (NRTL).

FDA registered and audited manufacturer

• Hettich is compliant with US law regarding the manufacture and sale of clinical medical equipment and that Hettich implements an effective quality control system including the documentation of and response to quality concerns.

IEC 61010 compliant

• The IEC (International Electrotechnical Commission) composed the IEC 61010 standard to regulate electrical laboratory equipment. Certified by TÜV.

Non-polluting waste disposal

• Since 1.1.2006, Hettich has been registered in Germany under WEEE Reg. No. DE 92954423 with the Elektro-Altgeraete Register – Foundation for the implementation of the 2002/96/EC directive (ElektroG), regarding the disposal of electrical and electronic equipment in the EU. With the symbol of the crossed-out bin, it is made clear that centrifuges may not be disposed of with household waste. The disposal regulations in the individual EU countries can vary. Please ask your supplier, if necessary.

Authorized Economic Operator

• As an authorized economic operator you can expect expeditious customs clearance.

REACH Compliance

• Andreas Hettich GmbH & Co. KG is not an importer or manufacturer of substances or preparations, but the company does import products in accordance with REACH. Consequently, the products which we supply you with do not need to be pre-registered or registered. Our supply chain partners are in compliance with the REACH EU Regulation for Chemicals and their safe use (Regulation (EC) No. 1907/2006). You can find our complete statement on REACH compliance by visiting the Hettich Global website.