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SGS CEBEC is the only Belgian organisation accredited for the certification of electro-medical equipment. SGS CEBEC wants to play a growing role in this field under the terms of the European “Medical Devices” directive.
The standards
The ISO 13485 standard is the equivalent of ISO 9000 applied to medical equipment. It provides the frame of reference for statutory controls, while ISO 60601-1 is a general standard for electrical medical safety. Only zero-risk is acceptable, especially where the device is to touch to human body: the smallest loss of power would present a real danger. ISO 6060-1 keeps evolving, because with ever faster technological innovation, new computer and robotic equipment is now being introduced into surgery rooms. And hospitals are increasingly coupling devices from various sources. These combinations must be 100% safe. A third edition of standard ISO 60601-1 is scheduled for 2006 to ensure proper control of such developments.
Risk Management
Over the past 10 years, medical science has made considerable progresses. The equipments are more and more sophisticated, and the electric risks must be under control. These risks can be originated from the different equipments but also from the installations to which they are connected. For the safety of employees, visitors and especially patients, it is vital to reduce them to the very minimum. There are 3 basic rules for that: safety of equipments, of installation, and of application.
Different controls are guaranteeing these rules:
- Medical equipment is tested by European organisations accredited for the certification of products. For example, in Belgium, the CEB (Belgian Electrotechnical Committee).
- Installation equipment is tested by accredited bodies such as SGS-CEBEC.
- Electro-medical installations are also tested by an accredited body.
Mandatory certification
Manufacturers are obliged to certify their products and their production systems, depending on the class to which they belong. Medical equipment is indeed divided into classes based on the risks for patients. Class I products do not have to be certified because they do not contain a measurement function or are not sterile. However, when a product must be sterile, CEBEC can certify the sterilisation process, and if it contains a measurement instrument, CEBEC can verify its accuracy and its algorithms.
Skills of the SGS Group
To respond to a diversity of demands, CEBEC has its own laboratories and can also count on the resources of the SGS Group, like the Simon laboratory in Bierges, Belgium, which carries out microbiological measurements and sterility controls. With its high level of qualification and its extensive testing capabilities, SGS CEBEC provides high quality services for the medical industry.
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