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“Not for children under 36 months” Toys wearing this European standardization label should not be made available to children. Particularly parents should know this sym...



Medical devices – the topic of the new issue of “BDS Compass” magazine

Medical devices – the topic of the new issue of “BDS Compass” magazine

 

Medical devices – the topic of the new issue of “BDS Compass” magazine

  

Standards for medical devices are extremely important as they take care of our lives, health and safety. How to provide a quality management system specifically for medical devices based on the best known standard ISO 9001? Therefore, we present the requirements that any organization involved in one or several stages of the life cycle of the medical device should fulfil.

 

We also present a standard containing requirements for the information, which the manufacturer of the medical device should provide. The standard has to determine what the information might be and how detailed should be, taking into account factors such as the knowledge and skills of the potential user, especially in home-cared patients or undergoing self-treatment.

 

There are three categories of European standards for assistive products for persons with disability, so we show how their safety is assessed.

 

Ambulances rush to save someone’s life. Here some standards help and we tell about them in the magazine. We also present other standards for disposable gloves medical use as well as the good practice for clinical testing of medicinal products on humans.

 

The expert Emil Petrov says under the heading "Experience" that standards, even voluntary, are absolutely necessary for designers and manufacturers.

11 Jul 2018