Class AP: For anaesthesia products
For anaesthesia products utilized in anaesthesia areas apply special requirements. For these extremely sensible range of use we offer control devices suitable as approved anaesthesia product for surgical applications (class AP). This is documented with the AP mark.
DIN EN ISO 13485:2003: Quality requirements
The requirements on the quality of medical equipment is fixed in the DIN EN ISO 13485:2003. The QM system at steute takes this standard into consideration; the steute production of medical devices was certified by an independent Assay Office correspondingly. Hence our devices are classified as »Approved Medical Product«.
IEC 60529: Protections
IEC 60529 defines protections informing about the applicability of the products in a rough environment and - this is decisive for the hygienic cleaning of medical equipment - about their resistance against humidity and moisture.
IEC 60601: Safety requirements
The safety concepts for electrical medical devices are characterized by the standards IEC 60601 defining at first general safety requirements and in the additional standards specific requirements on different device classes (e.g. laser devices and infusion pumps).
This standard is being revised at the moment. The third edition underlining the system combine medical equipment, will most prospectively be published shortly. Moreover the safety aspects of use and the idea of risk management known from the ISO 14971, will be emphasized in the revised edition.
ISO 14971: Risk management
The requirements of risk management are met by the harmonisation of the standard EN ISO 14971 »medical devices – application of the risk management to medical devices« on the 31st of July 2002 referring to the EC directives 90/385/EEC, 93/42/EEC and 98/79/EC for medical equipment. This standard replaces the EN 1441 of which the harmonisation expired on the 1st of April 2004.
Medical Devices Directive: Fundamental requirements and risk classes
The EC directive for medical devices (93/42/EEC; MDD) and the German Medizinproduktegesetz, annex 1, indicate fundamental requirements to medical equipment. It differs between four risk classes (I, IIa, IIb and III) to which a medical equipment has to be classified whereas class I has got the lowest and class III the highest risk potential. Because our control devices for medical equipment come within the purview of these directives, our products are classified accordingly.
Voluntary test
In order to meet the high demand on safety and quality for medical equipment we do not only observe the relevant directives, standards and regulations. As a manufacturer of medical equipment we also submit to the voluntary safety examination by a competent authority (notified body). This safety examination contains a type test of the product on the basis of European standards, a plausibility test of the prescribed conformity process for the CE mark, including the technical documentation according to the EC directive and a factory inspection with repeated production controls.
Further information?
With our new 76-page full-line catalogue of our range of medical devices we inform you in detail about the directives and standards in the field of medical equipment as well as about changes involving by the »new« EN 60601. Ask for this new catalogue.